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Sample records for influenza vaccine safety

  1. The safety of influenza vaccines in children: An Institute for Vaccine Safety white paper.

    PubMed

    Halsey, Neal A; Talaat, Kawsar R; Greenbaum, Adena; Mensah, Eric; Dudley, Matthew Z; Proveaux, Tina; Salmon, Daniel A

    2015-12-30

    Most influenza vaccines are generally safe, but influenza vaccines can cause rare serious adverse events. Some adverse events, such as fever and febrile seizures, are more common in children than adults. There can be differences in the safety of vaccines in different populations due to underlying differences in genetic predisposition to the adverse event. Live attenuated vaccines have not been studied adequately in children under 2 years of age to determine the risks of adverse events; more studies are needed to address this and several other priority safety issues with all influenza vaccines in children. All vaccines intended for use in children require safety testing in the target age group, especially in young children. Safety of one influenza vaccine in children should not be extrapolated to assumed safety of all influenza vaccines in children. The low rates of adverse events from influenza vaccines should not be a deterrent to the use of influenza vaccines because of the overwhelming evidence of the burden of disease due to influenza in children. PMID:26822822

  2. The safety of influenza vaccines in children: An Institute for Vaccine Safety white paper.

    PubMed

    Halsey, Neal A; Talaat, Kawsar R; Greenbaum, Adena; Mensah, Eric; Dudley, Matthew Z; Proveaux, Tina; Salmon, Daniel A

    2015-12-30

    Most influenza vaccines are generally safe, but influenza vaccines can cause rare serious adverse events. Some adverse events, such as fever and febrile seizures, are more common in children than adults. There can be differences in the safety of vaccines in different populations due to underlying differences in genetic predisposition to the adverse event. Live attenuated vaccines have not been studied adequately in children under 2 years of age to determine the risks of adverse events; more studies are needed to address this and several other priority safety issues with all influenza vaccines in children. All vaccines intended for use in children require safety testing in the target age group, especially in young children. Safety of one influenza vaccine in children should not be extrapolated to assumed safety of all influenza vaccines in children. The low rates of adverse events from influenza vaccines should not be a deterrent to the use of influenza vaccines because of the overwhelming evidence of the burden of disease due to influenza in children.

  3. Efficacy and safety of influenza vaccination in children with asthma.

    PubMed

    Patria, Maria Francesca; Tenconi, Rossana; Esposito, Susanna

    2012-04-01

    The mean global prevalence of asthma among children is approximately 12%, making it the most common chronic disease in children. Influenza infection has been associated with complications such as exacerbations of wheezing and asthma, increased airway hyper-reactivity and hospitalization. Although influenza vaccination is recommended for asthmatic patients by all health authorities, vaccination coverage remains significantly lower than expected and is lowest of all in children. Compliance is affected by the uncertainty of parents and physicians concerning the clinical risk of influenza in asthmatic subjects, the benefits of influenza vaccination in preventing asthma exacerbations and the safety of immunization. The aim of this review is to analyze the rationale for using influenza vaccine, discuss the relationship between influenza and the severity of asthmatic episodes and document the efficacy and safety of influenza vaccination in the pediatric asthmatic population.

  4. Safety of trivalent inactivated influenza vaccines in adults: background for pandemic influenza vaccine safety monitoring.

    PubMed

    Vellozzi, Claudia; Burwen, Dale R; Dobardzic, Azra; Ball, Robert; Walton, Kimp; Haber, Penina

    2009-03-26

    In preparation for pandemic vaccine safety monitoring, we assessed adverse events reported to the Vaccine Adverse Event Reporting System following receipt of trivalent inactivated influenza vaccines among adults from 1990 through 2005. We calculated reporting rates for nonserious, serious, and neurological adverse events. We reviewed reports of recurrent events and deaths, as well as reports identified through advanced signal detection. The most frequently reported events were local reactions and systemic symptoms. Guillain-Barré syndrome was the most frequently reported serious event (0.70 reports per million vaccinations). Adverse event reporting rates have been reasonably constant over time. No new safety concerns emerged after our review of 15 years of post-licensure surveillance data. These findings provide useful information if pandemic vaccine is rapidly distributed and pre-licensure data are limited.

  5. 21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Inactivated influenza vaccine, general safety test... Inactivated influenza vaccine, general safety test. For inactivated influenza vaccine, the general safety test... subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each...

  6. 21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Inactivated influenza vaccine, general safety test... Inactivated influenza vaccine, general safety test. For inactivated influenza vaccine, the general safety test... subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each...

  7. 21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Inactivated influenza vaccine, general safety test... Inactivated influenza vaccine, general safety test. For inactivated influenza vaccine, the general safety test... subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each...

  8. 21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Inactivated influenza vaccine, general safety test... Inactivated influenza vaccine, general safety test. For inactivated influenza vaccine, the general safety test... subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each...

  9. 21 CFR 610.11a - Inactivated influenza vaccine, general safety test.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Inactivated influenza vaccine, general safety test... Inactivated influenza vaccine, general safety test. For inactivated influenza vaccine, the general safety test... subcutaneous or intraperitoneal injection of 5.0 milliliters of inactivated influenza vaccine into each...

  10. Assessing the safety of influenza vaccination in specific populations: children and the elderly.

    PubMed

    Rowhani-Rahbar, Ali; Klein, Nicola P; Baxter, Roger

    2012-08-01

    Comprehensive monitoring of the safety of influenza vaccines remains a public health priority, particularly as immunization coverage increases across different age groups at the global level. In this review, the authors provide state-of-the-art knowledge on the safety of influenza immunization among children and the elderly. The authors review the safety information in each group separately for inactivated and live attenuated influenza vaccines. Adverse events of special concern including febrile seizure, narcolepsy, asthma and Guillain-Barré syndrome are covered under specific considerations. The authors discuss the current status of the field, particularly the use of new technologies for influenza vaccines and their potential safety profile.

  11. Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015.

    PubMed

    Pillsbury, Alexis; Cashman, Patrick; Leeb, Alan; Regan, Annette; Westphal, Darren; Snelling, Tom; Blyth, Christopher; Crawford, Nigel; Wood, Nicholas; Macartney, Kristine

    2015-01-01

    Increased febrile reactions in Australian children from one influenza vaccine brand in 2010 diminished confidence in influenza immunisation, highlighting the need for improved vaccine safety surveillance. AusVaxSafety, a national vaccine safety surveillance system collected adverse events in young children for 2015 influenza vaccine brands in real time through parent/carer reports via SMS/email. Weekly cumulative data on 3,340 children demonstrated low rates of fever (4.4%) and medical attendance (1.1%). Fever was more frequent with concomitant vaccination. PMID:26536867

  12. Parental views on vaccine safety and future vaccinations of children who experienced an adverse event following routine or seasonal influenza vaccination in 2010.

    PubMed

    Parrella, Adriana; Gold, Michael; Marshall, Helen; Braunack-Mayer, Annette; Watson, Maureen; Baghurst, Peter

    2012-05-01

    To assess parental vaccine safety views and future vaccination decisions after an adverse event following immunization (AEFI) experienced by their child. A cross-sectional telephone survey was conducted of parents of children aged 0-7 y, identified in AEFI reports submitted to the South Australian Immunization Section, Department Health. The reports included childhood National Immunization Program (NIP), seasonal or pandemic influenza vaccines. Interviews were conducted following a national suspension of the 2010 seasonal trivalent influenza (STIV) vaccine. Parental attitudes toward vaccine safety, reasons for reporting the AEFI and impact on future vaccination intent were assessed. Of 179 parents interviewed, 88% were confident in the safety of vaccines in general. Parents reporting an AEFI to the STIV were more likely to state the event had influenced future vaccination decisions than the NIP vaccine reporters (65% vs 14%, p < 0.001), with 63% stating refusal or hesitance to re-vaccinate their children against influenza. Media reports of the 2010 STIV program suspension was the most common reason for reporting an AEFI for parents of children who received an influenza vaccination. The AEFI experience did not impact on parental decision to continue with routine childhood NIP schedules, regardless of whether children received influenza or NIP vaccines. In contrast, most parents whose child experienced an AEFI to the 2010 STIV stated decreased confidence in the safety of influenza vaccines, which is likely to have impacted on the uptake of seasonal influenza vaccination in 2011. Addressing influenza vaccine safety concerns to promote influenza vaccination in the community is required.

  13. Safety and immunogenicity of influenza vaccine among HIV-infected adults: Conventional vaccine vs. intradermal vaccine

    PubMed Central

    Seo, Yu Bin; Lee, Jacob; Song, Joon Young; Choi, Hee Jung; Cheong, Hee Jin; Kim, Woo Joo

    2016-01-01

    Several studies have reported poor immune responses to conventional influenza vaccines in HIV-infected individuals. This study sought to elicit more potent immunogenicity in HIV-infected adults using an intradermal vaccine compared with a conventional intramuscular vaccine. This multicenter, randomized, controlled, open-label study was conducted at 3 university hospitals during the 2011/2012 pre-influenza season. Three vaccines were used in HIV-infected adults aged 18 – 60 years: an inactivated intramuscular vaccine (Agrippal), a reduced-content intradermal vaccine (IDflu9μg) and a standard-content intradermal vaccine (IDflu15μg). Serum hemagglutination-inhibiting (HI) antibodies and INF-γ ELISpot assay were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded for 7 d. A total of 28 Agrippal, 30 IDflu9μg, and 28 IDflu15μg volunteers were included in this analysis. One month after vaccination, the GMTs and differences in INF-γ ELISpot assay results were similar among the 3 groups. Seroprotection rates, seroconversion rates and mean fold increases (MFI) among the 3 groups were also similar, at approximately 80%, 50–60% and 2.5 – 10.0, respectively. All three vaccines satisfied the CHMP criteria for the A/H1N1 and A/H3N2 strains, but not those for the B strain. In univariate analysis, no demographic or clinical factors, including age, CD4+ T-cell counts, HIV viral load, ART status and vaccine type, were related to failure to achieve seroprotection. The three vaccines were all well-tolerated and all reported reactions were mild to moderate. However, there was a tendency toward a higher incidence of local and systemic reactions in the intradermal vaccine groups. The intradermal vaccine did not result in higher immunogenicity compared to the conventional intramuscular vaccine, even with increased antigen dose. PMID:26431466

  14. Safety and effectiveness of MF-59 adjuvanted influenza vaccines in children and adults.

    PubMed

    Black, Steven

    2015-06-01

    The squalene oil-in-water emulsion MF-59 adjuvant was developed initially to enhance the immunogenicity of influenza vaccines in populations such as children and adults with known suboptimal response. Developed in the 1990s, it was initially licensed in Europe for use in seasonal influenza vaccine in the elderly. Since that time, both Avian and p2009H1N1 vaccines have also been developed. Overall, more than 30,000 individuals have participated in clinical trials of MF-59 adjuvanted vaccine and more than 160 million doses of licensed vaccine have been administered. Safety and effectiveness data from clinical trials and observation studies attest to the safety of MF-59 and to its ability to enhance the effectiveness of influenza vaccines in children and the elderly.

  15. Responding to Vaccine Safety Signals during Pandemic Influenza: A Modeling Study

    PubMed Central

    Maro, Judith C.; Fryback, Dennis G.; Lieu, Tracy A.; Lee, Grace M.; Martin, David B.

    2014-01-01

    Background Managing emerging vaccine safety signals during an influenza pandemic is challenging. Federal regulators must balance vaccine risks against benefits while maintaining public confidence in the public health system. Methods We developed a multi-criteria decision analysis model to explore regulatory decision-making in the context of emerging vaccine safety signals during a pandemic. We simulated vaccine safety surveillance system capabilities and used an age-structured compartmental model to develop potential pandemic scenarios. We used an expert-derived multi-attribute utility function to evaluate potential regulatory responses by combining four outcome measures into a single measure of interest: 1) expected vaccination benefit from averted influenza; 2) expected vaccination risk from vaccine-associated febrile seizures; 3) expected vaccination risk from vaccine-associated Guillain-Barre Syndrome; and 4) expected change in vaccine-seeking behavior in future influenza seasons. Results Over multiple scenarios, risk communication, with or without suspension of vaccination of high-risk persons, were the consistently preferred regulatory responses over no action or general suspension when safety signals were detected during a pandemic influenza. On average, the expert panel valued near-term vaccine-related outcomes relative to long-term projected outcomes by 3∶1. However, when decision-makers had minimal ability to influence near-term outcomes, the response was selected primarily by projected impacts on future vaccine-seeking behavior. Conclusions The selected regulatory response depends on how quickly a vaccine safety signal is identified relative to the peak of the pandemic and the initiation of vaccination. Our analysis suggested two areas for future investment: efforts to improve the size and timeliness of the surveillance system and behavioral research to understand changes in vaccine-seeking behavior. PMID:25536228

  16. Establishment of a New Quality Control and Vaccine Safety Test for Influenza Vaccines and Adjuvants Using Gene Expression Profiling

    PubMed Central

    Momose, Haruka; Mizukami, Takuo; Kuramitsu, Madoka; Takizawa, Kazuya; Masumi, Atsuko; Araki, Kumiko; Furuhata, Keiko; Yamaguchi, Kazunari; Hamaguchi, Isao

    2015-01-01

    We have previously identified 17 biomarker genes which were upregulated by whole virion influenza vaccines, and reported that gene expression profiles of these biomarker genes had a good correlation with conventional animal safety tests checking body weight and leukocyte counts. In this study, we have shown that conventional animal tests showed varied and no dose-dependent results in serially diluted bulk materials of influenza HA vaccines. In contrast, dose dependency was clearly shown in the expression profiles of biomarker genes, demonstrating higher sensitivity of gene expression analysis than the current animal safety tests of influenza vaccines. The introduction of branched DNA based-concurrent expression analysis could simplify the complexity of multiple gene expression approach, and could shorten the test period from 7 days to 3 days. Furthermore, upregulation of 10 genes, Zbp1, Mx2, Irf7, Lgals9, Ifi47, Tapbp, Timp1, Trafd1, Psmb9, and Tap2, was seen upon virosomal-adjuvanted vaccine treatment, indicating that these biomarkers could be useful for the safety control of virosomal-adjuvanted vaccines. In summary, profiling biomarker gene expression could be a useful, rapid, and highly sensitive method of animal safety testing compared with conventional methods, and could be used to evaluate the safety of various types of influenza vaccines, including adjuvanted vaccine. PMID:25909814

  17. Establishment of a new quality control and vaccine safety test for influenza vaccines and adjuvants using gene expression profiling.

    PubMed

    Momose, Haruka; Mizukami, Takuo; Kuramitsu, Madoka; Takizawa, Kazuya; Masumi, Atsuko; Araki, Kumiko; Furuhata, Keiko; Yamaguchi, Kazunari; Hamaguchi, Isao

    2015-01-01

    We have previously identified 17 biomarker genes which were upregulated by whole virion influenza vaccines, and reported that gene expression profiles of these biomarker genes had a good correlation with conventional animal safety tests checking body weight and leukocyte counts. In this study, we have shown that conventional animal tests showed varied and no dose-dependent results in serially diluted bulk materials of influenza HA vaccines. In contrast, dose dependency was clearly shown in the expression profiles of biomarker genes, demonstrating higher sensitivity of gene expression analysis than the current animal safety tests of influenza vaccines. The introduction of branched DNA based-concurrent expression analysis could simplify the complexity of multiple gene expression approach, and could shorten the test period from 7 days to 3 days. Furthermore, upregulation of 10 genes, Zbp1, Mx2, Irf7, Lgals9, Ifi47, Tapbp, Timp1, Trafd1, Psmb9, and Tap2, was seen upon virosomal-adjuvanted vaccine treatment, indicating that these biomarkers could be useful for the safety control of virosomal-adjuvanted vaccines. In summary, profiling biomarker gene expression could be a useful, rapid, and highly sensitive method of animal safety testing compared with conventional methods, and could be used to evaluate the safety of various types of influenza vaccines, including adjuvanted vaccine.

  18. Influenza Vaccines: Unmet Needs and Recent Developments

    PubMed Central

    Noh, Ji Yun

    2013-01-01

    Influenza is a worldwide public health concern. Since the introduction of trivalent influenza vaccine in 1978, vaccination has been the primary means of prevention and control of influenza. Current influenza vaccines have moderate efficacy, good safety, and acceptable tolerability; however, they have unsatisfactory efficacy in older adults, are dependent on egg supply for production, and are time-consuming to manufacture. This review outlines the unmet medical needs of current influenza vaccines. Recent developments in influenza vaccines are also described. PMID:24475351

  19. Comparison of the Immunogenicity and Safety of the Conventional Subunit, MF59-Adjuvanted, and Intradermal Influenza Vaccines in the Elderly

    PubMed Central

    Seo, Yu Bin; Choi, Won Suk; Lee, Jacob; Song, Joon Young; Kim, Woo Joo

    2014-01-01

    The influenza vaccination is known as the most effective method for preventing influenza infection and its complications in the elderly. Conventional subunit (Agrippal S1; Novartis), MF59-adjuvanted (Fluad; Novartis), and intradermal (IDflu15; Sanofi Pasteur) influenza vaccines are widely used throughout South Korea. However, few comparative studies evaluating the safety and immunogenicity of these vaccines are available. Prior to the beginning of the 2011-2012 influenza season, 335 healthy elderly volunteers randomly received one of three seasonal trivalent influenza vaccines, the conventional subunit, MF59-adjuvanted, or intradermal influenza vaccine. Serum hemagglutination-inhibiting antibody levels were measured at the time of vaccination and at 1 and 6 months after vaccination. Adverse events were recorded prospectively. A total of 113 conventional subunit, 111 MF59-adjuvanted, and 111 intradermal influenza vaccine volunteers were followed up during a 6-month postvaccination period. One month after vaccination, all three vaccines satisfied Committee for Medical Products for Human Use (CHMP) immunogenicity criteria for the A/H1N1 and A/H3N2 strains but not for the B strain. Compared with the subunit vaccine, the intradermal vaccine exhibited noninferiority, while the MF59-adjuvanted vaccine exhibited superiority. Furthermore, the MF59-adjuvanted vaccine was more immunogenic against the A/H3N2 strain than was the subunit vaccine up to 6 months postvaccination. The most common local and systemic reactions to the conventional subunit, MF59-adjuvanted, and intradermal influenza vaccines were pain at the injection site (7.1%, 10.8%, and 6.3%, respectively) and generalized myalgia (0.9%, 8.1%, and 5.4%, respectively). Local and systemic reactions were similar among the three vaccine groups. MF59-adjuvanted vaccine exhibited superior immunogenicity compared with a conventional subunit vaccine and had a comparable safety profile. For older adults, the MF59-adjuvanted

  20. Influenza Vaccine, Live Intranasal

    MedlinePlus

    ... the recombinant influenza vaccine (RIV). The nasal spray flu vaccine (live attenuated influenza vaccine or LAIV) should NOT ... to your doctor or pharmacist about the best flu vaccine option for you or your family.

  1. Fluarix quadrivalent vaccine for influenza.

    PubMed

    Graaf, Hans de; Faust, Saul N

    2015-01-01

    Influenza A and B infections cause significant morbidity and mortality. Over the past 30 years, two main influenza B strains have been circulating globally. The trivalent influenza vaccine used in the last 25 years contains one B strain, with approximately 31% of B strain disease coverage over the last 10 years. Fluarix quadrivalent vaccine, containing two A and two B strains, combines the components of two existing trivalent vaccines to prevent this mismatch. This review gives an overview of the published data about Fluarix quadrivalent vaccines, showing an immunogenicity and safety profile of the vaccine comparable with the two licensed trivalent vaccines containing the same strains, but with no evidence for efficacy in the literature. Future vaccines aim for a universal influenza vaccine that will give a long-lasting protection against all influenza strains.

  2. Immunogenicity and safety of a trivalent inactivated 2010-2011 influenza vaccine in Taiwan infants aged 6-12 months.

    PubMed

    Hwang, Kao-Pin; Hsu, Yu-Lung; Hsieh, Tsung-Hsueh; Lin, Hsiao-Chuan; Yen, Ting-Yu; Wei, Hsiu-Mei; Lin, Hung-Chih; Chen, An-Chyi; Chow, Julie Chi; Huang, Li-Min

    2014-05-01

    This prospective study aimed to investigate the immune responses and safety of an influenza vaccine in vaccine-naïve infants aged 6-12 months, and was conducted from November 2010 to May 2011. Fifty-nine infants aged 6-12 months received two doses of trivalent inactivated influenza vaccine 4 weeks apart. Hemagglutination inhibition titers were measured 4 weeks after the two doses of study vaccine. Based on the assumption that a hemagglutination inhibition titer of 1:40 or greater against the antigen would be protective in adults, two doses of the study vaccine generated a protective immune response of 63.2% against influenza A(H1N1), 82.5% against influenza A(H3N2) and 38.6% against influenza B viruses in infants aged 6-12 months. The geometric mean fold rises against influenza type A and B viruses also met the European Medicines Agency criteria for flu vaccines. The solicited events within 7 days after vaccination were mild in intensity. No deaths or adverse events such as optic neuritis, cranial neuropathy, and brachial neuropathy or Guillain-Barre syndrome were reported. Two doses of inactivated influenza vaccine were well tolerated and induced a protective immune response against influenza in infants aged 6-12 months.

  3. Safety and immunogenicity of 3 seasonal trivalent influenza vaccines in the Chinese military

    PubMed Central

    Gao, Dongqi; Yang, Huisuo; Deng, Bing; Yin, Gang; Song, Wenjing; Zhang, Haiyang; Li, Yapin

    2016-01-01

    ABSTRACT Influenza, caused by the influenza virus, is a contagious acute viral respiratory disease with a high incidence rate and wide and rapid spread. Influenza-related morbidity, mortality, and hospitalization rates remain high and are increasing continuously in high-risk groups, with a significant impact on human health and the economy. In order to evaluate the immunogenicity of 3 seasonal trivalent influenza vaccines in Chinese military, we conducted this field trial. We assessed the safety and immunogenicity of 3 seasonal trivalent influenza vaccines(TIVs)manufactured by GlaxoSmithKline(GSK), Beijing Sinovac Biotech (Sinovac), and Shenzhen Sanofi Pasteur (Pasteur) in healthy Chinese servicemen. We used theimported GSKTIV as the control, comparing it with the 2 domestic TIVs in a 1:1:1randomized, double-blind, controlled trial in a military command in Beijing. Healthy individuals, aged between 18 and 34 years, who had not received any influenza vaccine in the preceding3 years were enrolled and administered one dose of a TIV. Safety data were collected throughout the whole study (day 0 to day 30). Blood samples were collected to assess the subjects' immunogenicity before vaccination and 21 d after vaccination. In total, 292 subjects enrolled in the study. Twelve participants (4.1%) reported 12 adverse events. The incidence of adverse events was 1%, 5%, and7% for the GSK, Sinovac, and Pasteur TIVs, respectively. The reported injection-site reaction frequencies were similar for all 3 TIVs (p = 0.217). However, the proportion of systemic reactions was higher after the GSKTIV than after the Pasteur or Sinovac TIV (7.1% vs 3.1% or1%, respectively; p = 0.020). Three TIVs satisfied both the European and US Food and Drug Administration criteria for H1N1–179, H1N1–74, H3N2, and B strains based on the post vaccination sero-protection, the sero-conversion rate, and the geometric mean titer ratio. The Sinovac TIV, Pasteur TIV, and GSK TIV were well tolerated and

  4. [Selected problems of manufacturing influenza vaccines].

    PubMed

    Augustynowicz, Ewa

    2010-01-01

    In the study chosen issues of manufacturing influenza vaccines running to increase effectiveness were performed. New concepts into development of process of safety and efficacy influenza vaccines are connected with use a new adjuvants, use of alternative routes of administration of vaccine, new structural virus subunits including DNA, new way of virus culture and use of live, attenuated vaccines.

  5. Advances in influenza vaccination

    PubMed Central

    Reperant, Leslie A.; Rimmelzwaan, Guus F.

    2014-01-01

    Influenza virus infections yearly cause high morbidity and mortality burdens in humans, and the development of a new influenza pandemic continues to threaten mankind as a Damoclean sword. Influenza vaccines have been produced by using egg-based virus growth and passaging techniques that were developed more than 60 years ago, following the identification of influenza A virus as an etiological agent of seasonal influenza. These vaccines aimed mainly at eliciting neutralizing antibodies targeting antigenically variable regions of the hemagglutinin (HA) protein, which requires regular updates to match circulating seasonal influenza A and B virus strains. Given the relatively limited protection induced by current seasonal influenza vaccines, a more universal influenza vaccine that would protect against more—if not all—influenza viruses is among the largest unmet medical needs of the 21st century. New insights into correlates of protection from influenza and into broad B- and T-cell protective anti-influenza immune responses offer promising avenues for innovative vaccine development as well as manufacturing strategies or platforms, leading to the development of a new generation of vaccines. These aim at the rapid and massive production of influenza vaccines that provide broad protective and long-lasting immunity. Recent advances in influenza vaccine research demonstrate the feasibility of a wide range of approaches and call for the initiation of preclinical proof-of-principle studies followed by clinical trials in humans. PMID:24991424

  6. Immunogenicity and safety of an inactivated trivalent split influenza virus vaccine in young children with recurrent wheezing.

    PubMed

    Bae, E Young; Choi, Ui Yoon; Kwon, Hyo Jin; Jeong, Dae Chul; Rhim, Jung Woo; Ma, Sang Hyuk; Lee, Kyung Il; Kang, Jin Han

    2013-06-01

    Influenza virus vaccination is recommended for children, but so far, active vaccination has not been achieved because most parents lack knowledge of vaccine safety and many doctors are reluctant to administer vaccine due to concerns that steroids might alter immunogenicity. The aim of this study was to compare the immunogenicity and safety of inactivated trivalent split influenza virus vaccine between children with recurrent wheezing and healthy children of the same age group. Sixty-eight healthy children and 62 children with recurrent wheezing took part in this study. Seroconversion rates, seroprotection rates, geometric mean titers (GMTs), and geometric mean titer ratios (GMTRs) were measured by a hemagglutination inhibition assay for the assessment of immunogenicity. Solicited and unsolicited local and systemic adverse events were measured for the assessment of safety. Regarding immunogenicity, the seroconversion and seroprotection rates showed no difference overall between healthy children and children with recurrent wheezing. Also, no difference was observed between steroid-treated and nontreated groups with recurrent wheezing. Generally, the GMTs after vaccination were higher in the one-dose vaccination groups for healthy children and children with recurrent wheezing, but the GMTRs revealed different results according to strain in the two groups. Regarding safety, solicited local and systemic adverse events showed no differences between healthy children and children with recurrent wheezing. This study demonstrates that inactivated split influenza virus vaccine is able to induce protective immune responses in healthy children, as observed in previous studies, as well as in children with recurrent wheezing who require frequent steroid treatment.

  7. Validation of the safety of MDCK cells as a substrate for the production of a cell-derived influenza vaccine.

    PubMed

    Onions, David; Egan, William; Jarrett, Ruth; Novicki, Deborah; Gregersen, Jens-Peter

    2010-09-01

    Cell culture-based production methods may assist in meeting increasing demand for seasonal influenza vaccines and developing production flexibility required for addressing influenza pandemics. MDCK-33016PF cells are used in propagation of a cell-based seasonal influenza vaccine (Optaflu); but, like most continuous cell lines, can grow in immunocompromised mice to produce tumors. It is, therefore, essential that no residual cells remain within the vaccine, that cell lysates or DNA are not oncogenic, and that the cell substrate does not contain oncogenic viruses or oncogenic DNA. Multiple, redundant processes ensure the safety of influenza vaccines produced in MDCK-33016PF cells. The probability of a residual cell being present in a dose of vaccine is approximately 1 in 10(34). Residual MDCK-DNA is < or =10 ng per dose and the ss-propiolactone used to inactivate influenza virus results in reduction of detectable DNA to less than 200 base pairs (bp). Degenerate PCR and specific PCR confirm exclusion of oncogenic viruses. The manufacturing process has been validated for its capacity to remove and inactivate viruses. We conclude that the theoretical risks arising from manufacturing seasonal influenza vaccine using MDCK-33016PF cells are reduced to levels that are effectively zero by the multiple, orthogonal processes used during production. PMID:20537553

  8. Vaccine Safety

    MedlinePlus

    ... During Pregnancy Frequently Asked Questions about Vaccine Recalls Historical Vaccine Safety Concerns FAQs about GBS and Menactra ... CISA Resources for Healthcare Professionals Evaluation Current Studies Historical Background 2001-12 Publications Technical Reports Vaccine Safety ...

  9. Immunogenicity and Safety of Influenza Vaccination in Systemic Lupus Erythematosus Patients Compared with Healthy Controls: A Meta-Analysis

    PubMed Central

    Liao, Zhengfa; Tang, Hao; Xu, Xiaojia; Liang, Yaping; Xiong, Yongzhen; Ni, Jindong

    2016-01-01

    Objective To assess the immunogenicity and safety of influenza vaccine in patients with systemic lupus erythematosus (SLE). Methods Relevant articles were retrieved from electronic databases. Seroprotection rate, seroconversion rate and factors that increase antibody geometric mean titer (GMT) were used as indices to measure the immunogenicity. The safety of vaccine was assessed through monitoring adverse events, which included side effects and SLE exacerbations. We performed a meta-analysis of influenza vaccine seroprotection, seroconversion and adverse effects. SLE exacerbation after vaccination was comprehensively described. We used the Committee for Proprietary Medicinal Products (CPMP) guidelines to determine whether influenza can induce adequate immunogenicity in patients with SLE. Results Eighteen studies with 1966 subjects met the inclusion criteria. At least 565 of the subjects were patients with low-to-moderate SLE Disease Activity Index (SLEDAI) score or stable SLE disease. Compared with the general population, seroprotection rate in SLE patients was significantly decreased in patients with H1N1 [odds ratio (OR) = 0.36, 95% confidence interval (CI): 0.27–0.50] and H3N2 vaccination (OR = 0.48, 95% CI: 0.24–0.93), but not influenza B vaccination (OR = 0.55, 95% CI: 0.24–1.25). Seroconversion rate also significantly decreased in patients with H1N1 (OR = 0.39, 95% CI: 0.27–0.57) and influenza B (OR = 0.47, 95% CI: 0.29–0.76) vaccination, but not H3N2 vaccination (OR = 0.62, 95% CI: 0.21–1.79). However, the immunogenicity of influenza vaccine in SLE patients almost reached that of the CPMP guidelines. The OR for side effects (patients versus healthy controls) was 3.24 (95% CI: 0.62–16.76). Among 1966 patients with SLE, 32 experienced mild exacerbation of SLE and five had serious side effects for other reasons. Conclusion Influenza vaccine has moderate effect on protecting patients with SLE. The side effects of influenza vaccine are not serious

  10. Prospective safety monitoring of Haemophilus influenzae type b and heptavalent pneumococcal conjugate vaccines in Kagoshima, Japan.

    PubMed

    Nishi, Junichiro; Tokuda, Koichi; Imuta, Naoko; Minami, Taketsugu; Kawano, Yoshifumi

    2013-01-01

    Haemophilus influenzae type b (Hib) conjugate vaccine (PRP-T) and heptavalent pneumococcal conjugate vaccine (PCV7) were introduced in Japan in December 2008 and February 2010, respectively. The concurrent administration of these vaccines is routinely performed worldwide. However, the safety of the simultaneous administration of these vaccines has not been fully evaluated in Japan, because it has rarely been performed thus far. We conducted a 2-year prospective, observational, multicenter study on PRP-T and PCV7 safety from February 2009 through January 2011 in 29 facilities located in Kagoshima Prefecture, Japan. Objective severe adverse events included anaphylactoid reaction, encephalitis/encephalopathy, neurological events, severe focal reactions, systemic eruption/urticaria, fever above 39℃ within 2 days after inoculation, and other complications requiring hospitalization. The incidences of these events for PRP-T and PCV7 administration were 0.68% (76/11,197) and 0.92% (28/3,049), respectively. No deaths or subsequent complications were reported during the course of the study. There was no significant difference in the incidence of severe adverse events between the single and co-administration groups for both vaccines: PRP-T, 0.55% (31/5,662) versus 0.81% (45/5,535; P = 0.11); PCV7, 0.88% (11/1,247) versus 0.94% (17/1,802; P = 0.86). These results suggest that the simultaneous administration of vaccines including PRP-T and/or PCV7 does not increase the incidence of severe adverse events in Japanese children.

  11. Developing vaccines against pandemic influenza.

    PubMed Central

    Wood, J M

    2001-01-01

    Pandemic influenza presents special problems for vaccine development. There must be a balance between rapid availability of vaccine and the safeguards to ensure safety, quality and efficacy of vaccine. Vaccine was developed for the pandemics of 1957, 1968, 1977 and for the pandemic alert of 1976. This experience is compared with that gained in developing vaccines for a possible H5N1 pandemic in 1997-1998. Our ability to mass produce influenza vaccines against a pandemic threat was well illustrated by the production of over 150 million doses of 'swine flu' vaccine in the USA within a 3 month period in 1976. However, there is cause for concern that the lead time to begin vaccine production is likely to be about 7-8 months. Attempts to reduce this time should receive urgent attention. Immunogenicity of vaccines in pandemic situations is compared over the period 1968-1998. A consistent feature of the vaccine trials is the demonstration that one conventional 15 microg haemagglutinin dose of vaccine is not sufficiently immunogenic in naive individuals. Much larger doses or two lower doses are needed to induce satisfactory immunity. There is some evidence that whole-virus vaccines are more immunogenic than split or subunit vaccines, but this needs substantiating by further studies. H5 vaccines appeared to be particularly poor immunogens and there is evidence that an adjuvant may be needed. Prospects for improving the development of pandemic vaccines are discussed. PMID:11779397

  12. Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine Candidate: A Phase III Randomized Controlled Trial in Children

    PubMed Central

    Langley, Joanne M.; Carmona Martinez, Alfonso; Chatterjee, Archana; Halperin, Scott A.; McNeil, Shelly; Reisinger, Keith S.; Aggarwal, Naresh; Huang, Li-Min; Peng, Ching-Tien; Garcia-Sicilia, José; Salamanca de la Cueva, Ignacio; Cabañas, Fernando; Treviño-Garza, Consuelo; Rodríguez-Weber, Miguel Angel; de la O, Manuel; Chandrasekaran, Vijayalakshmi; Dewé, Walthère; Liu, Aixue; Innis, Bruce L.; Jain, Varsha K.

    2013-01-01

    Background. Mismatch between circulating influenza B viruses (Yamagata and Victoria lineages) and vaccine strains occurs frequently. Methods. In a randomized controlled trial, immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate (QIV) versus trivalent inactivated influenza vaccine (TIV)-Victoria(Vic) and TIV-Yamagata(Yam) in children 3–17 years of age was evaluated. In an open-label study arm, QIV only was assessed in children 6–35 months of age. Results. A total of 3094 children (932 QIV, 929 TIV-Vic, 932 TIV-Yam, and 301 QIV only) were vaccinated. QIV was noninferior to the TIVs for shared strains (A/H3N2 and A/H1N1) based on hemagglutination-inhibition (HI) antibodies 28 days after last vaccination, and superior for the unique B strains Victoria and Yamagata (geometric mean titer ratios 2.61, 3.78; seroconversion rate differences 33.96%, 44.63%). Among children in the randomized trial, adverse event rates were similar except for injection site pain (dose 1: 65.4% QIV, 54.6% TIV-Vic, 55.7% TIV-Yam). Conclusion. QIV elicited superior HI responses to the added B strains compared to TIV controls, potentially improving its effectiveness against influenza B. HI responses were similar between QIV and TIV controls for the shared strains. QIV had an acceptable safety profile relative to TIVs. Clinical Trials Registration. NCT01198756. PMID:23847058

  13. Influenza vaccination and Guillain Barre syndrome.

    PubMed

    Geier, Mark R; Geier, David A; Zahalsky, Arthur C

    2003-05-01

    Acute and severe Guillain Barre Syndrome (GBS) cases reported following influenza vaccine to the Vaccine Adverse Events Reporting System (VAERS) database from 1991 through 1999 were examined. Endotoxin concentrations were measured using the Limulus amebocyte lysate assay in influenza vaccines. There were a total of 382 cases of GBS reported to the VAERS database following influenza vaccination (male/female ratio, 1.2). The median onset of GBS following influenza vaccine was 12 days (interquartile range, 7 days to 21 days). There was an increased risk of acute GBS (relative risk, 4.3; 95% confidence interval, 3.0 to 6.4) and severe GBS (relative risk, 8.5; 95% confidence interval, 3.7 to 18.9) in comparison to an adult tetanus-diphtheria (Td) vaccine control group. There were maximums in the incidence of GBS following influenza vaccine that occurred approximately every third year (1993, 1996, and 1998) and statistically significant variation in the incidence of GBS among different influenza manufacturers. Influenza vaccines contained from a 125- to a 1250-fold increase in endotoxin concentrations in comparison to an adult Td vaccine control and endotoxin concentrations varied up to 10-fold among different lots and manufacturers of influenza vaccine. The biologic mechanism for GBS following influenza vaccine may involve the synergistic effects of endotoxin and vaccine-induced autoimmunity. There were minimal potential reporting biases in the data reported to the VAERS database in this study. Patients should make an informed consent decision on whether to take this optional vaccine based upon its safety and efficacy and physicians should vigilantly report GBS following influenza vaccination to the VAERS in the United States so that continued evaluation of the safety of influenza vaccine may be undertaken.

  14. The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety.

    PubMed

    McNeil, Michael M; Gee, Julianne; Weintraub, Eric S; Belongia, Edward A; Lee, Grace M; Glanz, Jason M; Nordin, James D; Klein, Nicola P; Baxter, Roger; Naleway, Allison L; Jackson, Lisa A; Omer, Saad B; Jacobsen, Steven J; DeStefano, Frank

    2014-09-22

    The Vaccine Safety Datalink (VSD) is a collaborative project between the Centers for Disease Control and Prevention (CDC) and 9 health care organizations. Established in 1990, VSD is a vital resource informing policy makers and the public about the safety of vaccines used in the United States. Large linked databases are used to identify and evaluate adverse events in over 9 million individuals annually. VSD generates rapid, important safety assessments for both routine vaccinations and emergency vaccination campaigns. VSD monitors safety of seasonal influenza vaccines in near-real time, and provided essential information on the safety of influenza A (H1N1) 2009 monovalent vaccine during the recent pandemic. VSD investigators have published important studies demonstrating that childhood vaccines are not associated with autism or other developmental disabilities. VSD prioritizes evaluation of new vaccines; searches for possible unusual health events after vaccination; monitors vaccine safety in pregnant women; and has pioneered development of biostatistical research methods. PMID:25108215

  15. The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety.

    PubMed

    McNeil, Michael M; Gee, Julianne; Weintraub, Eric S; Belongia, Edward A; Lee, Grace M; Glanz, Jason M; Nordin, James D; Klein, Nicola P; Baxter, Roger; Naleway, Allison L; Jackson, Lisa A; Omer, Saad B; Jacobsen, Steven J; DeStefano, Frank

    2014-09-22

    The Vaccine Safety Datalink (VSD) is a collaborative project between the Centers for Disease Control and Prevention (CDC) and 9 health care organizations. Established in 1990, VSD is a vital resource informing policy makers and the public about the safety of vaccines used in the United States. Large linked databases are used to identify and evaluate adverse events in over 9 million individuals annually. VSD generates rapid, important safety assessments for both routine vaccinations and emergency vaccination campaigns. VSD monitors safety of seasonal influenza vaccines in near-real time, and provided essential information on the safety of influenza A (H1N1) 2009 monovalent vaccine during the recent pandemic. VSD investigators have published important studies demonstrating that childhood vaccines are not associated with autism or other developmental disabilities. VSD prioritizes evaluation of new vaccines; searches for possible unusual health events after vaccination; monitors vaccine safety in pregnant women; and has pioneered development of biostatistical research methods.

  16. Influenza and Pneumococcal Vaccination in Hematological Malignancies: a Systematic Review of Efficacy, Effectiveness, and Safety

    PubMed Central

    La Torre, Giuseppe; Mannocci, Alice; Colamesta, Vittoria; D’Egidio, Valeria; Sestili, Cristina; Spadea, Antonietta

    2016-01-01

    Background The risk of getting influenza and pneumococcal disease is higher in cancer patients, and serum antibody levels tend to be lower in patients with hematological malignancy. Objective To assess flu and pneumococcal vaccinations efficacy, effectiveness, and safety in onco-hematological patients. Methods Two systematic reviews and possible meta-analysis were conducted to summarize the results of all primary study in the scientific literature about the flu and pneumococcal vaccine in onco-hematological patients. Literature searches were performed using Pub-Med and Scopus databases. StatsDirect 2.8.0 was used for the analysis. Results 22 and 26 studies were collected respectively for flu and pneumococcal vaccinations. Protection rate of booster dose was 30% (95% CI=6–62%) for H1N1. Pooled prevalence protection rate of H3N2 and B was available for meta-analysis only for first dose, 42.6% (95% CI=23.2 – 63.3 %) and 39.6 % (95% CI=26%–54.1%) for H3N2 and B, respectively. Response rate of booster dose resulted 35% (95% CI=19.7–51.2%) for H1N1, 23% (95% CI=16.6–31.5%) for H3N2, 29% (95% CI=21.3–37%) for B. Conclusion Despite the low rate of response, flu, and pneumococcal vaccines are worthwhile for patients with hematological malignancies. Patients undergoing chemotherapy in particular rituximab, splenectomy, transplant recipient had lower and impaired response. No serious adverse events were reported for both vaccines.

  17. Influenza and Pneumococcal Vaccination in Hematological Malignancies: a Systematic Review of Efficacy, Effectiveness, and Safety

    PubMed Central

    La Torre, Giuseppe; Mannocci, Alice; Colamesta, Vittoria; D’Egidio, Valeria; Sestili, Cristina; Spadea, Antonietta

    2016-01-01

    Background The risk of getting influenza and pneumococcal disease is higher in cancer patients, and serum antibody levels tend to be lower in patients with hematological malignancy. Objective To assess flu and pneumococcal vaccinations efficacy, effectiveness, and safety in onco-hematological patients. Methods Two systematic reviews and possible meta-analysis were conducted to summarize the results of all primary study in the scientific literature about the flu and pneumococcal vaccine in onco-hematological patients. Literature searches were performed using Pub-Med and Scopus databases. StatsDirect 2.8.0 was used for the analysis. Results 22 and 26 studies were collected respectively for flu and pneumococcal vaccinations. Protection rate of booster dose was 30% (95% CI=6–62%) for H1N1. Pooled prevalence protection rate of H3N2 and B was available for meta-analysis only for first dose, 42.6% (95% CI=23.2 – 63.3 %) and 39.6 % (95% CI=26%–54.1%) for H3N2 and B, respectively. Response rate of booster dose resulted 35% (95% CI=19.7–51.2%) for H1N1, 23% (95% CI=16.6–31.5%) for H3N2, 29% (95% CI=21.3–37%) for B. Conclusion Despite the low rate of response, flu, and pneumococcal vaccines are worthwhile for patients with hematological malignancies. Patients undergoing chemotherapy in particular rituximab, splenectomy, transplant recipient had lower and impaired response. No serious adverse events were reported for both vaccines. PMID:27648207

  18. A randomized, controlled, blinded study of the safety, immunogenicity and batch consistency of Aleph inactivated split influenza vaccine made in China in Chinese people.

    PubMed

    Li, Shuming; Li, Li; Ai, Xing; Yang, Liqing; Bai, Yunhua; Wang, Zhaoyun; Han, Huixia; Lu, Qiang; Luo, Fengji; Zhang, Zheng; Liu, Chunyu; Xiao, Jun; Shi, Nianmin

    2014-01-01

    To evaluate the safety, immunogenicity and batch consistency of Aleph inactivated split influenza vaccine, 3308 healthy Chinese people more than 3 years old were enrolled in a randomized, controlled, blinded study and divided into four age groups: 3-10 years, 11-17 years, 18-54 years, and more than 55 years. Each age group was then randomized (2:1) to receive either influenza vaccine or control vaccine (recombinant hepatitis B) for one dose. Also each influenza vaccine group was randomized (1:1:1) to receive three different batches of influenza vaccine. Systematic and local adverse reactions for 28 days after vaccination were recorded, and influenza antibody titer was determined by hemagglutination inhibition (HI) assay at 28 days after vaccination. There were significant differences in seroconversion and seroprotection rates achieved post-immunization of three strains of influenza antibody (H1N1, H3N2, B) between experimental group and control group in all age groups (P<0.05). In addition, there were no statistically significant differences in local and systematic reaction rates after vaccination between the experimental and control group in all age groups (P>0.05), except for the systematic reaction rates in the 18-54 years and ≥ 55 years age groups (P<0.05). Thus, Aleph inactivated split influenza vaccine has good safety and immunogenicity.

  19. Immunogenicity and safety of pandemic influenza A (H1N1) 2009 vaccine: systematic review and meta-analysis.

    PubMed

    Yin, J Kevin; Khandaker, Gulam; Rashid, Harunor; Heron, Leon; Ridda, Iman; Booy, Robert

    2011-09-01

    The emergence of the 2009 H1N1 pandemic has highlighted the need to have immunogenicity and safety data on the new pandemic vaccines. There is already considerable heterogeneity in the types of vaccine available and of study performed around the world. A systematic review and meta-analysis is needed to assess the immunogenicity and safety of pandemic influenza A (H1N1) 2009 vaccines. We searched Medline, EMBASE, the Cochrane Library and other online databases up to 1st October 2010 for studies in any language comparing different pandemic H1N1 vaccines, with or without placebo, in healthy populations aged at least 6 months. The primary outcome was seroprotection according to haemagglutination inhibition (HI). Safety outcomes were adverse events. Meta-analysis was performed for the primary outcome. We identified 18 articles, 1 only on safety and 17 on immunogenicity, although 1 was a duplicate. We included 16 articles in the meta-analysis, covering 17,921 subjects. Adequate seroprotection (≥70%) was almost invariably achieved in all age groups, and even after one dose and at low antigen content (except in children under 3 years receiving one dose of non-adjuvanted vaccine). Non-adjuvanted vaccine from international companies and adjuvanted vaccines containing oil in water emulsion (e.g. AS03, MF59), rather than aluminium, performed better. Two serious vaccination-associated adverse events were reported, both of which resolved fully. No death or case of Guillain-Barré syndrome was reported. The pandemic influenza (H1N1) 2009 vaccine, with or without adjuvant, appears generally to be seroprotective after just one dose and safe among healthy populations aged ≥36 months; very young children (6-35 months) may need to receive two doses of non-adjuvanted vaccine or one dose of AS03(A/B)-adjuvanted product to achieve seroprotection.

  20. Comparison between a conventional subunit vaccine and the MF59-adjuvanted subunit influenza vaccine in the elderly: an evaluation of the safety, tolerability and immunogenicity.

    PubMed

    Sindoni, D; La Fauci, V; Squeri, R; Cannavò, G; Bacilieri, S; Panatto, D; Gasparini, R; Amicizia, D

    2009-06-01

    The objective of this study was to evaluate and compare the safety, tolerability and immunogenicity for two seasonal influenza subunit vaccines, one with MF59 adjuvant (Fluad) and one without an adjuvant (Agrippal). A total of 195 subjects aged > or = 65 years were enrolled to receive one dose of vaccine intramuscularly, 96 were vaccinated with Fluad, 99 received Agrippal. Blood samples were taken from all subjects in order to assess their antibody titre by the haemagglutination inhibition assay (HI), before (Time 0) and after (Time 1: 28 +/- 7 days) vaccination, against the A/H3N2 (A/Moscow/10/99), A/H1N1 (A/New Caledonia/20/99) and B/Shandong/7/97 antigens contained in the influenza vaccine in the 2002/2003 influenza season for the northern hemisphere. A good humoral antibody response was detected for both vaccines, meeting all the criteria of EMEA. The number of subjects in whom > or = 4-fold increase in antibody titre was recorded, in comparison with the pre-vaccination value, proved to be lower in the group vaccinated with AgrippaPl than in those vaccinated with the adjuvated preparation. Fluad" exhibited better immunogenicity than Agrippal. This difference was probably linked to the potentiated immune stimulation exerted by the adjuvant molecules. These results take on a particular importance if we consider that the immune system is weaker in the elderly; the administration of an adjuvated vaccine in such subjects is clearly preferable in that it provides greater and more prolonged protection. Both vaccines were generally well tolerated; no severe adverse events occurred in any of the subjects vaccinated, confirming the excellent safety profile of Fluad and Agrippal.

  1. Prospective cohort study of the safety of an influenza A(H1N1) vaccine in pregnant Chinese women.

    PubMed

    Ma, Fubao; Zhang, Longhua; Jiang, Renjie; Zhang, Jinlin; Wang, Huaqing; Gao, Xiaozhi; Li, Xiuhong; Liu, Yuanbao

    2014-09-01

    To monitor and evaluate the safety of the influenza A(H1N1) vaccine in pregnant women and its influence on the fetus and neonate, we performed a prospective study in which 122 pregnant Chinese women who received the influenza A(H1N1) vaccine and 104 pregnant women who did not receive any vaccine (serving as controls) were observed. The results indicated that the seroconversion rate in the vaccinated group was 90.4% (95% confidence interval [CI], 82.6% to 95.5%). The rate of adverse events following immunization in the pregnant women who received the influenza A(H1N1) vaccine was 3.3%. The spontaneous abortion rates in the vaccinated group and the unvaccinated group were 0.8% and 1.9%, respectively (exact probability test, P = 0.470), the prolonged-pregnancy rates were 8.2% and 4.8%, respectively (χ(2) = 1.041, P = 0.308), the low-birth-weight rates were 1.6% and 0.95%, respectively (exact probability test, P = 1.000), and the spontaneous-labor rates were 70.5% and 75%, respectively (χ(2) = 0.573, P = 0.449). All newborns who have an Apgar score of ≥7 are considered healthy; Apgar scores of ≥9 were observed in 38.5% and 57.7% of newborns in the vaccinated group and the unvaccinated group, respectively (χ(2) = 8.274, P = 0.004). From these results, we conclude that the influenza A(H1N1) vaccine is safe for pregnant women and has no observed adverse effects on fetal growth. (This study has been registered at ClinicalTrials.gov under registration no. NCT01842997.).

  2. Immunogenicity and safety of Intanza(®)/IDflu(®) intradermal influenza vaccine in South Korean adults: a multicenter, randomized trial.

    PubMed

    Hoon Han, Sang; Hee Woo, Jun; Weber, Francoise; Joo Kim, Woo; Ran Peck, Kyong; Il Kim, Sang; Hwa Choi, Young; Myung Kim, June

    2013-09-01

    Intanza(®)/IDflu(®) (Sanofi Pasteur, Lyon, France) is an intradermal inactivated trivalent influenza vaccine developed as an alternative to intramuscular influenza vaccine. The objective of this study was to confirm the immunogenicity and safety of Intanza/IDflu in South Korean adults. In a phase IV multicenter trial, South Korean adults 18-59 y old (n = 120) and ≥ 60 y old (n = 120) were randomized 1:1 to receive a single dose of Intanza/IDflu (9 µg for 18-59 y, 15 µg for ≥ 60 y) or trivalent intramuscular vaccine (Vaxigrip(®) 15 µg, Sanofi Pasteur, Lyon, France). Blood was collected on pre-vaccination (day 0) and on day 21. Hemagglutination inhibition titers, seroprotection rates and seroconversion rates were determined on day 21. Geometric mean titers, seroprotection and seroconversion rates were similar between the intradermal and intramuscular vaccines in both age groups for all three vaccine strains (A/H1N1, A/H3N2 and B). Both vaccines met Committee for Medicinal Products for Human Use criteria for all three strains. Solicited systemic reactions of the intradermal groups were generally mild, transient, and similar to those of the intramuscular groups. Solicited injection site reactions were more frequent in the intradermal groups but were mostly mild, transient, and consisted mainly of pain, erythema, and pruritus. No treatment-related serious adverse events or other safety concerns were reported. These results confirm that Intanza/IDflu is an effective and well-tolerated alternative to IM influenza vaccination. (Clinicaltrials.gov NCT ID: NCT01215669).

  3. Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines.

    PubMed

    Black, Steven; Eskola, Juhani; Siegrist, Claire-Anne; Halsey, Neal; Macdonald, Noni; Law, Barbara; Miller, Elizabeth; Andrews, Nick; Stowe, Julia; Salmon, Daniel; Vannice, Kirsten; Izurieta, Hector S; Akhtar, Aysha; Gold, Mike; Oselka, Gabriel; Zuber, Patrick; Pfeifer, Dina; Vellozzi, Claudia

    2009-12-19

    Because of the advent of a new influenza A H1N1 strain, many countries have begun mass immunisation programmes. Awareness of the background rates of possible adverse events will be a crucial part of assessment of possible vaccine safety concerns and will help to separate legitimate safety concerns from events that are temporally associated with but not caused by vaccination. We identified background rates of selected medical events for several countries. Rates of disease events varied by age, sex, method of ascertainment, and geography. Highly visible health conditions, such as Guillain-Barré syndrome, spontaneous abortion, or even death, will occur in coincident temporal association with novel influenza vaccination. On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21.5 cases of Guillain-Barré syndrome and 5.75 cases of sudden death would be expected to occur within 6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86.3 cases of optic neuritis per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant women would be predicted to have a spontaneous abortion within 1 day of vaccination.

  4. Safety and immunogenicity of CPG 7909 injection as an adjuvant to Fluarix influenza vaccine.

    PubMed

    Cooper, C L; Davis, H L; Morris, M L; Efler, S M; Krieg, A M; Li, Y; Laframboise, C; Al Adhami, M J; Khaliq, Y; Seguin, I; Cameron, D W

    2004-08-13

    CPG 7909, a 24-mer B-Class CpG oligodeoxynucleotide (ODN), was tested for safety, tolerability and its ability to augment the immunogenicity of a commercial trivalent killed split influenza vaccine (Fluarix containing A/Beijing/262/95, A/Sydney/5/97 and B/Harbin/7/94; SmithKline Beecham) in a phase Ib blinded, randomized, controlled clinical trial. Sixty healthy volunteers were recruited in two consecutive cohorts of 30 subjects, who were randomly assigned to receive Fluarix plus 1mg CPG 7909 or Fluarix plus saline control (15 subjects each). Vaccines were administered by intramuscular injection on a single occasion with subjects in the first cohort receiving a 1/10th dose of Fluarix and those in the second cohort receiving the full-dose. All safety measures including physical evaluation, laboratory blood assays, and assays for DNA autoimmunity were within normal values except for transient and clinically inconsequential decreases in total white blood cell counts in groups receiving CPG 7909. All vaccines were found to be generally well tolerated with similar frequency and intensity for most adverse reactions for groups receiving CPG 7909 as controls. Exceptions were injection site pain and headache, which were reduced in frequency in subjects receiving the 1/10th Fluarix dose without CpG, compared to the frequency in all other groups. There was a lack of pre-existing immunity, defined as hemagglutinin inhibition (HI) activity < or =20, for all subjects to the influenza strains A/Beijing/262/95 and B/Harbin/7/94 and for some subjects to A/Sydney/5/97. Post-vaccination humoral immune responses, as determined 2 and 4 weeks later by assay of HI activity and ELISA to detect antibodies against hemagglutinin (anti-HA) were similar for both full and reduced Fluarix doses but the cellular immune responses (measured as PBMC antigen-specific IFN-gamma secretion) were reduced in the 1/10th Fluarix dose group. Humoral responses were not significantly enhanced by the addition

  5. Enhancement of the safety of live influenza vaccine by attenuating mutations from cold-adapted hemagglutinin.

    PubMed

    Lee, Yoon Jae; Jang, Yo Han; Kim, Paul; Lee, Yun Ha; Lee, Young Jae; Byun, Young Ho; Lee, Kwang-Hee; Kim, Kyusik; Seong, Baik Lin

    2016-04-01

    In our previous study, X-31ca-based H5N1 LAIVs, in particular, became more virulent in mice than the X-31ca MDV, possibly by the introduction of the surface antigens of highly pathogenic H5N1 influenza virus, implying that additional attenuation is needed in this cases to increase the safety level of the vaccine. In this report we suggest an approach to further increase the safety of LAIV through additional cold-adapted mutations in the hemagglutinin. The cold-adaptation of X-31 virus resulted in four amino acid mutations in the HA. We generated a panel of 7:1 reassortant viruses each carrying the hemagglutinins with individual single amino acid mutations. We examined their phenotypes and found a major attenuating mutation, N81K. This attenuation marker conferred additional temperature-sensitive and attenuation phenotype to the LAIV. Our data indicate that the cold-adapted mutation in the HA confers additional attenuation to the LAIV strain, without compromising its productivity and immune response.

  6. Randomized trial to compare the safety and immunogenicity of CSL Limited's 2009 trivalent inactivated influenza vaccine to an established vaccine in United States children.

    PubMed

    Brady, Rebecca C; Hu, Wilson; Houchin, Vonda G; Eder, Frank S; Jackson, Kenneth C; Hartel, Gunter F; Sawlwin, Daphne C; Albano, Frank R; Greenberg, Michael

    2014-12-12

    A trivalent inactivated influenza vaccine (CSL's TIV, CSL Limited) was licensed under USA accelerated approval regulations for use in persons≥18 years. We performed a randomized, observer-blind study to assess the safety and immunogenicity of CSL's TIV versus an established US-licensed vaccine in a population≥6 months to <18 years of age. Subjects were stratified as follows: Cohort A (≥6 months to <3 years); Cohort B (≥3 years to <9 years); and Cohort C (≥9 years to <18 years). The subject's age and influenza vaccination history determined the dosing regimen (one or two vaccinations). Subjects received CSL's TIV (n=739) or the established vaccine (n=735) in the autumn of 2009. Serum hemagglutination-inhibition titers were determined pre-vaccination and 30 days after the last vaccination. No febrile seizures or other vaccine-related SAEs were reported. After the first vaccination for Cohorts A and B, respectively, the relative risks of fever were 2.73 and 2.32 times higher for CSL's TIV compared to the established vaccine. Irritability and loss of appetite (for Cohort A) and malaise (for Cohort B) were also significantly higher for CSL's TIV compared to the established vaccine. Post-vaccination geometric mean titers (GMTs) for CSL's TIV versus the established vaccine were 385.49 vs. 382.45 for H1N1; 669.13 vs. 705.61 for H3N2; and 100.65 vs. 93.72 for B. CSL's TIV demonstrated immunological non-inferiority to the established vaccine in all cohorts.

  7. DNA-based influenza vaccines as immunoprophylactic agents toward universality.

    PubMed

    Zhang, Han; El Zowalaty, Mohamed E

    2016-01-01

    Influenza is an illness of global public health concern. Influenza viruses have been responsible for several pandemics affecting humans. Current influenza vaccines have proved satisfactory safety; however, they have limitations and do not provide protection against unexpected emerging influenza virus strains. Therefore, there is an urgent need for alternative approaches to conventional influenza vaccines. The development of universal influenza vaccines will help alleviate the severity of influenza pandemics. Influenza DNA vaccines have been the subject of many studies over the past decades due to their ability to induce broad-based protective immune responses in various animal models. The present review highlights the recent advances in influenza DNA vaccine research and its potential as an affordable universal influenza vaccine.

  8. Protective immunity and safety of a genetically modified influenza virus vaccine.

    PubMed

    Barbosa, Rafael Polidoro Alves; Salgado, Ana Paula Carneiro; Garcia, Cristiana Couto; Filho, Bruno Galvão; Gonçalves, Ana Paula de Faria; Lima, Braulio Henrique Freire; Lopes, Gabriel Augusto Oliveira; Rachid, Milene Alvarenga; Peixoto, Andiara Cristina Cardoso; de Oliveira, Danilo Bretas; Ataíde, Marco Antônio; Zirke, Carla Aparecida; Cotrim, Tatiane Marques; Costa, Érica Azevedo; Almeida, Gabriel Magno de Freitas; Russo, Remo Castro; Gazzinelli, Ricardo Tostes; Machado, Alexandre de Magalhães Vieira

    2014-01-01

    Recombinant influenza viruses are promising viral platforms to be used as antigen delivery vectors. To this aim, one of the most promising approaches consists of generating recombinant viruses harboring partially truncated neuraminidase (NA) segments. To date, all studies have pointed to safety and usefulness of this viral platform. However, some aspects of the inflammatory and immune responses triggered by those recombinant viruses and their safety to immunocompromised hosts remained to be elucidated. In the present study, we generated a recombinant influenza virus harboring a truncated NA segment (vNA-Δ) and evaluated the innate and inflammatory responses and the safety of this recombinant virus in wild type or knock-out (KO) mice with impaired innate (Myd88 -/-) or acquired (RAG -/-) immune responses. Infection using truncated neuraminidase influenza virus was harmless regarding lung and systemic inflammatory response in wild type mice and was highly attenuated in KO mice. We also demonstrated that vNA-Δ infection does not induce unbalanced cytokine production that strongly contributes to lung damage in infected mice. In addition, the recombinant influenza virus was able to trigger both local and systemic virus-specific humoral and CD8+ T cellular immune responses which protected immunized mice against the challenge with a lethal dose of homologous A/PR8/34 influenza virus. Taken together, our findings suggest and reinforce the safety of using NA deleted influenza viruses as antigen delivery vectors against human or veterinary pathogens. PMID:24927156

  9. Live attenuated intranasal influenza vaccine.

    PubMed

    Esposito, Susanna; Montinaro, Valentina; Groppali, Elena; Tenconi, Rossana; Semino, Margherita; Principi, Nicola

    2012-01-01

    Annual vaccination is the most effective means of preventing and controlling influenza epidemics, and the traditional trivalent inactivated vaccine (TIV) is by far the most widely used. Unfortunately, it has a number of limitations, the most important of which is its poor immunogenicity in younger children and the elderly, the populations at greatest risk of severe influenza. Live attenuated influenza vaccine (LAIV) has characteristics that can overcome some of these limitations. It does not have to be injected because it is administered intranasally. It is very effective in children and adolescents, among whom it prevents significantly more cases of influenza than the traditional TIV. However, its efficacy in adults has not been adequately documented, which is why it has not been licensed for use by adults by the European health authorities. LAIV is safe and well tolerated by children aged > 2 y and adults, but some concerns arisen regarding its safety in younger children and subjects with previous asthma or with recurrent wheezing. Further studies are needed to solve these problems and to evaluate the possible role of LAIV in the annual vaccination of the general population.

  10. [Influenza vaccine and adjuvant].

    PubMed

    Nakayama, Tetsuo

    2011-01-01

    Adjuvant is originated from the Latin word "adjuvare" which means "help" in English to enhance the immunological responses when given together with antigens. The beginning of adjuvant was mineral oil which enhanced the immune response when it was given with inactivated Salmonella typhimurium. Aluminium salt was used to precipitate diphtheria toxoid and increased level of antibody response was demonstrated when administered with alum-precipitated antigens. Since 1930, aluminium salt has been used as DTaP (diphtheria-tetanus-acellular pertussis vaccine) adjuvant. Many candidates were tested for adjuvant activity but only aluminum salt is allowed to use for human vaccines. New adjuvant MF59, oil-in-water emulsion type, was developed for influenza vaccine for elderly (Fluad) and series of AS adjuvant are used for hepatitis B, pandemic flue, and human papiloma virus vaccines. Oil-adjuvanted influenza pandemic vaccines induced higher antibody response than alum-adjuvanted vaccine with higher incidence of adverse events, especially for local reactions. Alum-adjuvanted whole virion inactivated H5N1 vaccine was developed in Japan, and it induced relatively well immune responses in adults. When it applied for children, febrile reaction was noted in approximately 60% of the subjects, with higher antibodies. Recent investigation on innate immunity demonstrates that adjuvant activity is initiated from the stimulation on innate immunity and/or inflammasome, resulting in cytokine induction and antigen uptake by monocytes and macrophages. The probable reason for high incidence of febrile reaction should be investigated to develop a safe and effective influenza vaccine.

  11. Safety and Immunogenicity of Influenza A H5 Subunit Vaccines: Effect of Vaccine Schedule and Antigenic Variant

    PubMed Central

    Frey, Sharon E.; Graham, Irene; Mulligan, Mark J.; Edupuganti, Srilatha; Jackson, Lisa A.; Wald, Anna; Poland, Gregory; Jacobson, Robert; Keyserling, Harry L.; Spearman, Paul; Hill, Heather; Wolff, Mark

    2011-01-01

    Background. The current US national stockpile of influenza H5 vaccine was produced using the antigen from the strain A/Vietnam/1203/2004 (a clade 1 H5 virus). Recent H5 disease has been caused by antigenically divergent H5 viruses, including A/Indonesia/05/2005 (a clade 2 H5 virus). Methods. The influence of schedule on the antibody response to 2 doses of H5 vaccines (one a clade 1 hemagglutinin protein [HA] vaccine and one a clade 2 HA vaccine) containing 90 μg of antigen was evaluated in healthy adults 18–49 years of age. Results. Two doses of vaccine were required to induce antibody titers ≥1:10 in most subjects. Accelerated schedules were immunogenic, and antibody developed after vaccinations on days 0 and 7, 0 and 14, and 0 and 28, with the day 0 and 7 schedule inducing lower titers than those induced with the other schedules. With mixed vaccine schedules of clade 1 followed by clade 2 vaccine administration, the first vaccination primed for a heterologous boost. The heterologous response was improved when the second vaccination was given 6 months after the first, compared with the response when the second vaccination was given after an interval of 1 month. Conclusions. An accelerated vaccine schedule of injections administered at days 0 and 14 was as immunogenic as a vaccine schedule of injections at days 0 and 28, but both schedules were inferior to a vaccine schedule of injections administered at 0 and 6 months for priming for heterologous vaccine boosting. Clinical Trial Registry Number: NCT00703053 PMID:21282194

  12. Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged ≥18 years

    PubMed Central

    2013-01-01

    Background Two antigenically distinct influenza B lineages have co-circulated since the 1980s, yet inactivated trivalent influenza vaccines (TIVs) include strains of influenza A/H1N1, A/H3N2, and only one influenza B from either the Victoria or Yamagata lineage. This means that exposure to B-lineage viruses mismatched to the TIV is frequent, reducing vaccine protection. Formulations including both influenza B lineages could improve protection against circulating influenza B viruses. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in adults in stable health. Methods A total of 4659 adults were randomized 5:5:5:5:3 to receive one dose of QIV (one of three lots) or a TIV containing either a B/Victoria or B/Yamagata strain. Hemagglutination-inhibition assays were performed pre-vaccination and 21-days after vaccination. Lot-to-lot consistency of QIV was assessed based on geometric mean titers (GMT). For QIV versus TIV, non-inferiority against the three shared strains was demonstrated if the 95% confidence interval (CI) upper limit for the GMT ratio was ≤1.5 and for the seroconversion difference was ≤10.0%; superiority of QIV versus TIV for the alternate B lineage was demonstrated if the 95% CI lower limit for the GMT ratio was > 1.0 and for the seroconversion difference was > 0%. Reactogenicity and safety profile of each vaccine were assessed. Clinicaltrials.gov: NCT01204671. Results Consistent immunogenicity was demonstrated for the three QIV lots. QIV was non-inferior to TIV for the shared vaccine strains, and was superior for the added alternate-lineage B strains. QIV elicited robust immune responses against all four vaccine strains; the seroconversion rates were 77.5% (A/H1N1), 71.5% (A/H3N2), 58.1% (B/Victoria), and 61.7% (B/Yamagata). The reactogenicity and safety profile of QIV was consistent with TIV. Conclusions QIV provided superior immunogenicity for the additional B strain compared with

  13. Safety and immunogenicity of prepandemic H5N1 influenza vaccines: a systematic review of the literature.

    PubMed

    Prieto-Lara, Elisa; Llanos-Méndez, Aurora

    2010-06-11

    A systematic review was performed to assess the safety and immunogenicity of the prepandemic H5N1 influenza vaccines licensed so far. A bibliographic search according to the COSI protocol was carried out and 8 of 235 potentially relevant publications were selected. Quality assessment was defined with both CASP and Jadad checklists. Taken together, the results from the present systematic review suggest that the inactivated split-virion formulation that includes a low antigen dose (3.8 microg) and an oil-in-water emulsion-based adjuvant, represents the best option in the case of a pandemic, due to its antigen-sparing capacity and its favorable safety profile.

  14. Influenza Vaccine, Inactivated or Recombinant

    MedlinePlus

    ... die from flu, and many more are hospitalized.Flu vaccine can:keep you from getting flu, make flu ... inactivated or recombinant influenza vaccine?A dose of flu vaccine is recommended every flu season. Children 6 months ...

  15. Novel vaccines against influenza viruses

    PubMed Central

    Kang, Sang-Moo; Song, Jae-Min; Compans, Richard W.

    2011-01-01

    Killed and live attenuated influenza virus vaccines are effective in preventing and curbing the spread of influenza epidemics when the strains present in the vaccines are closely matched with the predicted epidemic strains. These vaccines are primarily targeted to induce immunity to the variable major target antigen, hemagglutinin (HA) of influenza virus. However, current vaccines are not effective in preventing the emergence of new pandemic or highly virulent viruses. New approaches are being investigated to develop universal influenza virus vaccines as well as to apply more effective vaccine delivery methods. Conserved vaccine targets including the influenza M2 ion channel protein and HA stalk domains are being developed using recombinant technologies to improve the level of cross protection. In addition, recent studies provide evidence that vaccine supplements can provide avenues to further improve current vaccination. PMID:21968298

  16. Safety of AS03-adjuvanted split-virion H1N1 (2009) pandemic influenza vaccine: a prospective cohort study

    PubMed Central

    Nazareth, Irwin; Tavares, Fernanda; Rosillon, Dominique; Haguinet, François; Bauchau, Vincent

    2013-01-01

    Objectives To assess the safety of an AS03-adjuvanted split virion H1N1 (2009) vaccine (Pandemrix) in persons vaccinated during the national pandemic influenza vaccination campaign in the UK. Design Prospective, cohort, observational, postauthorisation safety study. Setting 87 general practices forming part of the Medical Research Council General Practice Research Framework and widely distributed throughout England. Participants A cohort of 9143 individuals aged 7 months to 97 years who received at least one dose of the AS03-adjuvanted H1N1 pandemic vaccine during the national pandemic influenza vaccination campaign in the UK was enrolled. 94% completed the 6-month follow-up. Exclusion criteria were previous vaccination with other H1N1 pandemic vaccine and any child in care. Primary and secondary outcome measures Medically attended adverse events (MAEs) occurring within 31 days after any dose, serious adverse events (SAEs) and adverse events of special interest (AESIs) following vaccination were collected for all participants. Solicited adverse events (AEs) were assessed in a subset of participants. Results MAEs were reported in 1219 participants and SAEs in 113 participants during the 31-day postvaccination period. The most frequently reported MAEs and SAEs were consistent with events expected to be reported during the winter season in this population: lower respiratory tract infections, asthma and pneumonia. The most commonly reported solicited AEs were irritability in young children aged <5 years (61.8%), muscle aches in children aged 5–17 years (61.9%) and adults (46.9%). 18 AESIs, experienced by 14 patients, met the criteria to be considered for the observed-to-expected analyses. AESIs above the expected number were neuritis (1 case within 31 days) and convulsions (8 cases within 181 days). There were 41 deaths during the 181-day period after vaccination, fewer than expected. Conclusions Results indicate that the AS03-adjuvanted H1N1 pandemic

  17. Increasing Childhood Influenza Vaccination

    PubMed Central

    Nowalk, Mary Patricia; Lin, Chyongchiou J.; Hannibal, Kristin; Reis, Evelyn C.; Gallik, Gregory; Moehling, Krissy K.; Huang, Hsin-Hui; Allred, Norma J.; Wolfson, David H.; Zimmerman, Richard K.

    2014-01-01

    Background Since the 2008 inception of universal childhood influenza vaccination, national rates have risen more dramatically among younger children than older children and reported rates across racial/ethnic groups are inconsistent. Interventions may be needed to address age and racial disparities to achieve the recommended childhood influenza vaccination target of 70%. Purpose To evaluate an intervention to increase childhood influenza vaccination across age and racial groups. Methods In 2011–2012, 20 primary care practices treating children were randomly assigned to Intervention and Control arms of a cluster randomized controlled trial to increase childhood influenza vaccination uptake using a toolkit and other strategies including early delivery of donated vaccine, in-service staff meetings, and publicity. Results The average vaccination differences from pre-intervention to the intervention year were significantly larger in the Intervention arm (n=10 practices) than the Control arm (n=10 practices), for children aged 2–8 years (10.2 percentage points (pct pts) Intervention vs 3.6 pct pts Control) and 9–18 years (11.1 pct pts Intervention vs 4.3 pct pts Control, p<0.05), for non-white children (16.7 pct pts Intervention vs 4.6 pct pts Control, p<0.001), and overall (9.9 pct pts Intervention vs 4.2 pct pts Control, p<0.01). In multi-level modeling that accounted for person- and practice-level variables and the interactions among age, race and intervention, the likelihood of vaccination increased with younger age group (6–23 months), white race, commercial insurance, the practice’s pre-intervention vaccination rate, and being in the Intervention arm. Estimates of the interaction terms indicated that the intervention increased the likelihood of vaccination for non-white children in all age groups and white children aged 9–18 years. Conclusions A multi-strategy intervention that includes a practice improvement toolkit can significantly improve influenza

  18. Safety, immunogenicity, and tolerability of three influenza vaccines in older adults: results of a randomized, controlled comparison.

    PubMed

    Scheifele, David W; McNeil, Shelly A; Ward, Brian J; Dionne, Marc; Cooper, Curtis; Coleman, Brenda; Loeb, Mark; Rubinstein, Ethan; McElhaney, Janet; Hatchette, Todd; Li, Yan; Montomoli, Emanuele; Schneeberg, Amy; Bettinger, Julie A; Halperin, Scott A

    2013-11-01

    To determine if newer influenza vaccines can safely improve seroprotection rates of older adults, we compared three licensed trivalent inactivated vaccines (TIVs) in a randomized, controlled trial with evaluator blinding. Participants were non-frail adults ≥ 65 y old, annually TIV-immunized. Study vaccines included intradermal (IDV), MF59-adjuvanted (ADV) and subunit (TIV) formulations of equal potency and strain composition. Blood was obtained before vaccination (V1) and 21 (V2) and 180 d (V3) afterward and tested by hemagglutination inhibition (HAI) assay. Safety diaries were completed daily by participants and specific tolerability questions were posed regarding injections and symptoms. In total, 911 participants were immunized and 887 (97.4%) completed V3. Groups had similar demographics. General symptom rates post-vaccination were similar among groups. Rates of injection site redness after IDV/ADV/TIV were 75%/13%/13% and rates of pain were 29%/38%/20%, respectively, but each vaccine was well tolerated, with symptoms causing little bother. Baseline antibody titers did not differ significantly among groups but B/Brisbane titers were too high for meaningful response assessments. At V2, seroprotection rates (HAI titer ≥ 40) were highest after ADV, the rate advantage over IDV and TIV being significant at 11.8% and 11.4% for H3N2 and 10.2% and 12.5% for H1N1, respectively. At day 180, seroprotection rates had declined ~25% and no longer differed significantly among groups. While IDV and TIV were also well tolerated, ADV induced modestly higher antibody titers in seniors to influenza A strains at 3 weeks but not 6 mo post-vaccination. Immune responses to IDV and TIV were similar in this population.

  19. DNA vaccines against influenza.

    PubMed

    Stachyra, Anna; Góra-Sochacka, Anna; Sirko, Agnieszka

    2014-01-01

    Genetic vaccine technology has been considerably developed within the last two decades. This cost effective and promising strategy can be applied for therapy of cancers and for curing allergy, chronic and infectious diseases, such as a seasonal and pandemic influenza. Despite numerous advantages, several limitations of this technology reduce its performance and can retard its commercial exploitation in humans and its veterinary applications. Inefficient delivery of the DNA vaccine into cells of immunized individuals results in low intracellular supply of suitable expression cassettes encoding an antigen, in its low expression level and, in turn, in reduced immune responses against the antigen. Improvement of DNA delivery into the host cells might significantly increase effectiveness of the DNA vaccine. A vast array of innovative methods and various experimental strategies have been applied in order to enhance the effectiveness of DNA vaccines. They include various strategies improving DNA delivery as well as expression and immunogenic potential of the proteins encoded by the DNA vaccines. Researchers focusing on DNA vaccines against influenza have applied many of these strategies. Recent examples of the most successful modern approaches are discussed in this review.

  20. Preliminary data on immunogenicity, safety and tolerability of trivalent inactivated influenza vaccine in children with inborn errors of metabolism at risk of decompensation.

    PubMed

    Esposito, Susanna; Salvini, Filippo; Menni, Francesca; Scala, Alessia; Salvatici, Elisabetta; Manzoni, Francesca; Riva, Enrica; Giovannini, Marcello; Principi, Nicola

    2013-10-25

    In order to evaluate the immunogenicity, safety and tolerability of influenza vaccination in children with inborn errors of metabolism (IEMs), we enrolled 20 patients with IEMs at risk of decompensation (14 males; mean age±SD, 8.5±3.9years) and 20 healthy age- and gender-matched controls. Four weeks after vaccination, seroconversion rates were 75-85% and seroprotection rates 85-95%, with high geometric mean titers (GMTs) of all three influenza antigen strains in both groups. Three months after vaccination, most of the subjects remained seroconverted with high seroprotection rates and high GMTs for all the three influenza strains. Safety and tolerability were also very good, with no differences between the groups.

  1. Immunogenicity and safety assessment of a trivalent, inactivated split influenza vaccine in Korean children: Double-blind, randomized, active-controlled multicenter phase III clinical trial

    PubMed Central

    Han, Seung Beom; Rhim, Jung-Woo; Shin, Hye Jo; Lee, Soo Young; Kim, Hyun-Hee; Kim, Jong-Hyun; Lee, Kyung-Yil; Ma, Sang Hyuk; Park, Joon Soo; Kim, Hwang Min; Kim, Chun Soo; Kim, Dong Ho; Choi, Young Youn; Cha, Sung-Ho; Hong, Young Jin; Kang, Jin Han

    2015-01-01

    A multicenter, double-blind, randomized, active-control phase III clinical trial was performed to assess the immunogenicity and safety of a trivalent, inactivated split influenza vaccine. Korean children between the ages of 6 months and 18 y were enrolled and randomized into a study (study vaccine) or a control vaccine group (commercially available trivalent, inactivated split influenza vaccine) in a 5:1 ratio. Antibody responses were determined using hemagglutination inhibition assay, and post-vaccination immunogenicity was assessed based on seroconversion and seroprotection rates. For safety assessment, solicited local and systemic adverse events up to 28 d after vaccination and unsolicited adverse events up to 6 months after vaccination were evaluated. Immunogenicity was assessed in 337 and 68 children of the study and control groups. In the study vaccine group, seroconversion rates against influenza A/H1N1, A/H3N2, and B strains were 62.0% (95% CI: 56.8–67.2), 53.4% (95% CI: 48.1–58.7), and 54.9% (95% CI: 48.1–60.2), respectively. The corresponding seroprotection rates were 95.0% (95% CI: 92.6–97.3), 93.8% (95% CI: 91.2–96.4), and 95.3% (95% CI: 93.0–97.5). The lower 95% CI limits of the seroconversion and seroprotection rates were over 40% and 70%, respectively, against all strains. Seroconversion and seroprotection rates were not significantly different between the study and control vaccine groups. Furthermore, the frequencies of adverse events were not significantly different between the 2 vaccine groups, and no serious vaccination-related adverse events were noted. In conclusion, the study vaccine exhibited substantial immunogenicity and safety in Korean children and is expected to be clinically effective. PMID:25875868

  2. Immunogenicity and safety assessment of a trivalent, inactivated split influenza vaccine in Korean children: Double-blind, randomized, active-controlled multicenter phase III clinical trial.

    PubMed

    Han, Seung Beom; Rhim, Jung-Woo; Shin, Hye Jo; Lee, Soo Young; Kim, Hyun-Hee; Kim, Jong-Hyun; Lee, Kyung-Yil; Ma, Sang Hyuk; Park, Joon Soo; Kim, Hwang Min; Kim, Chun Soo; Kim, Dong Ho; Choi, Young Youn; Cha, Sung-Ho; Hong, Young Jin; Kang, Jin Han

    2015-01-01

    A multicenter, double-blind, randomized, active-control phase III clinical trial was performed to assess the immunogenicity and safety of a trivalent, inactivated split influenza vaccine. Korean children between the ages of 6 months and 18 y were enrolled and randomized into a study (study vaccine) or a control vaccine group (commercially available trivalent, inactivated split influenza vaccine) in a 5:1 ratio. Antibody responses were determined using hemagglutination inhibition assay, and post-vaccination immunogenicity was assessed based on seroconversion and seroprotection rates. For safety assessment, solicited local and systemic adverse events up to 28 d after vaccination and unsolicited adverse events up to 6 months after vaccination were evaluated. Immunogenicity was assessed in 337 and 68 children of the study and control groups. In the study vaccine group, seroconversion rates against influenza A/H1N1, A/H3N2, and B strains were 62.0% (95% CI: 56.8-67.2), 53.4% (95% CI: 48.1-58.7), and 54.9% (95% CI: 48.1-60.2), respectively. The corresponding seroprotection rates were 95.0% (95% CI: 92.6-97.3), 93.8% (95% CI: 91.2-96.4), and 95.3% (95% CI: 93.0-97.5). The lower 95% CI limits of the seroconversion and seroprotection rates were over 40% and 70%, respectively, against all strains. Seroconversion and seroprotection rates were not significantly different between the study and control vaccine groups. Furthermore, the frequencies of adverse events were not significantly different between the 2 vaccine groups, and no serious vaccination-related adverse events were noted. In conclusion, the study vaccine exhibited substantial immunogenicity and safety in Korean children and is expected to be clinically effective.

  3. [Influenza vaccination present and future].

    PubMed

    Eich, G

    2007-11-01

    In healthy adults younger than 65 years the effectiveness of influenza vaccination is up to 90% for laboratory confirmed influenza, but is far less in elderly individuals over 65 years and those with comorbidities. However the vaccination in elderly people is effective in preventing complications of influenza infection: pneumonia, hospital admission and death from influenza or pneumonia. This effect is larger for elderly individuals living in nursing homes than in those living in the community. Recommendations at present include vaccination of all people over the age of 65, of high-risk groups, and of those who can transmit influenza to high-risk individuals (healthcare workers). Since 2005 it is recommended that people with occupational contact with wild or domestic birds should be vaccinated to reduce the risk of simultaneous infection with a human and an avian influenza virus. Influenza vaccination is considered to be safe: side effects are reversible within 1-2 days, severe complications are exceedingly rare. Most frequently inactivated vaccines are used, but in the USA there is also an attenuated live vaccine available. They all contain surface antigens of two influenza A strains and one influenza B strain. The world health organization (WHO) selects every year the strains to be included in the vaccine and the viruses are then grown on embryonated chicken eggs. This process requires detailed planning up to 6 months. Because a pandemic event cannot be predicted, this period is too long and there is an urgent need to develop techniques to reduce the vaccine production time and enhance its efficacy. Additionally, several researchers are exploring the possibility of generating a universal vaccine against influenza A virus that does not require reformulation on an annual basis.

  4. Safety of live attenuated influenza vaccine in young people with egg allergy: multicentre prospective cohort study

    PubMed Central

    Southern, Jo; Andrews, Nick J; Miller, Elizabeth; Erlewyn-Lajeunesse, Michel

    2015-01-01

    Study question How safe is live attenuated influenza vaccine (LAIV), which contains egg protein, in young people with egg allergy? Methods In this open label, phase IV intervention study, 779 young people (2-18 years) with egg allergy were recruited from 30 UK allergy centres and immunised with LAIV. The cohort included 270 (34.7%) young people with previous anaphylaxis to egg, of whom 157 (20.1%) had experienced respiratory and/or cardiovascular symptoms. 445 (57.1%) had doctor diagnosed asthma or recurrent wheeze. Participants were observed for at least 30 minutes after vaccination and followed-up by telephone 72 hours later. Participants with a history of recurrent wheeze or asthma underwent further follow-up four weeks later. The main outcome measure was incidence of an adverse event within two hours of vaccination in young people with egg allergy. Study answer and limitations No systemic allergic reactions occurred (upper 95% confidence interval for population 0.47% and in participants with anaphylaxis to egg 1.36%). Nine participants (1.2%, 95% CI 0.5% to 2.2%) experienced mild symptoms, potentially consistent with a local, IgE mediated allergic reaction. Delayed events potentially related to the vaccine were reported in 221 participants. 62 participants (8.1%, 95% CI for population 6.3% to 10.3%) experienced lower respiratory tract symptoms within 72 hours, including 29 with parent reported wheeze. No participants were admitted to hospital. No increase in lower respiratory tract symptoms occurred in the four weeks after vaccination (assessed with asthma control test). The study cohort may represent young people with more severe allergy requiring specialist input, since they were recruited from secondary and tertiary allergy centres. What this study adds LAIV is associated with a low risk of systemic allergic reactions in young people with egg allergy. The vaccine seems to be well tolerated in those with well controlled asthma or recurrent wheeze. Funding

  5. Immunogenicity and Clinical Efficacy of Influenza Vaccination in Pregnancy

    PubMed Central

    Kay, Alexander W.; Blish, Catherine A.

    2015-01-01

    Pregnant women are at high risk from influenza due to disproportionate morbidity, mortality, and adverse pregnancy outcomes following infection. As such, they are classified as a high-priority group for vaccination. However, changes in the maternal immune system required to accommodate the allogeneic fetus may alter the immunogenicity of influenza vaccines. A large number of studies have evaluated the safety of the influenza vaccine. Here, we will review available studies on the immunogenicity and efficacy of the influenza vaccine during pregnancy, focusing on both humoral and cellular immunity. PMID:26089824

  6. Universal influenza vaccines: Shifting to better vaccines.

    PubMed

    Berlanda Scorza, Francesco; Tsvetnitsky, Vadim; Donnelly, John J

    2016-06-01

    Influenza virus causes acute upper and lower respiratory infections and is the most likely, among known pathogens, to cause a large epidemic in humans. Influenza virus mutates rapidly, enabling it to evade natural and vaccine-induced immunity. Furthermore, influenza viruses can cross from animals to humans, generating novel, potentially pandemic strains. Currently available influenza vaccines induce a strain specific response and may be ineffective against new influenza viruses. The difficulty in predicting circulating strains has frequently resulted in mismatch between the annual vaccine and circulating viruses. Low-resource countries remain mostly unprotected against seasonal influenza and are particularly vulnerable to future pandemics, in part, because investments in vaccine manufacturing and stockpiling are concentrated in high-resource countries. Antibodies that target conserved sites in the hemagglutinin stalk have been isolated from humans and shown to confer protection in animal models, suggesting that broadly protective immunity may be possible. Several innovative influenza vaccine candidates are currently in preclinical or early clinical development. New technologies include adjuvants, synthetic peptides, virus-like particles (VLPs), DNA vectors, messenger RNA, viral vectors, and attenuated or inactivated influenza viruses. Other approaches target the conserved exposed epitope of the surface exposed membrane matrix protein M2e. Well-conserved influenza proteins, such as nucleoprotein and matrix protein, are mainly targeted for developing strong cross-protective T cell responses. With multiple vaccine candidates moving along the testing and development pipeline, the field is steadily moving toward a product that is more potent, durable, and broadly protective than previously licensed vaccines.

  7. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine in healthy adults: a phase II, open-label, uncontrolled trial in Japan.

    PubMed

    Tsurudome, Yukari; Kimachi, Kazuhiko; Okada, Yusuke; Matsuura, Kenta; Ooyama, Yusuke; Ibaragi, Kayo; Kino, Yoichiro; Ueda, Kohji

    2015-10-01

    Two antigenically distinct B strain lineages of influenza virus have co-circulated since the mid-1980s; however, inactivated trivalent influenza vaccines contain only one B lineage. The mismatch between the circulating and vaccine lineages has been a worldwide issue. In this study, an inactivated quadrivalent influenza vaccine (QIV) candidate containing two B lineages was manufactured and its immunogenicity and safety evaluated in an open-label, uncontrolled trial. In this phase II trial, 50 subjects aged 20-64 years received two doses of QIV s.c. 1 to 4 weeks apart. Sera were collected pre- and post-vaccination and safety assessed from the first vaccination to 21 ± 7 days after the second vaccination. After the first vaccination, hemagglutination inhibition titers against each strain increased markedly; the seroconversion rate, geometric mean titer ratio and seroprotection rate being 94.0%, 24.93, and 100.0%, respectively, for the A/H1N1pdm09 strain; 94.0%, 12.47, and 98.0%, respectively, for the A/H3N2 strain; 54.0%, 4.99, and 66.0%, respectively, for B/Yamagata strain, and 72.0%, 6.23 and 80.0%, respectively, for the B/Victoria strain, thus fulfilling the criteria of the European Medical Agency's Committee for Medicinal Products for Human Use. Also, the QIV induced sufficient single radial hemolysis and neutralizing antibodies against all four vaccine strains. No noteworthy adverse events were noted. The results of this trial demonstrate that QIV is well tolerated and immunogenic for each strain, suggesting that QIV potentially improves protection against influenza B by resolving the issue of B lineage mismatch.

  8. Barriers Associated with Seasonal Influenza Vaccination among College Students

    PubMed Central

    Benjamin, Stephanie M.; Bahr, Kaitlin O.

    2016-01-01

    Influenza can spread rapidly on college campuses because of high-density living conditions and frequent social interactions. However, seasonal influenza vaccination rates on college campuses are low. The purpose of this study is to identify barriers associated with receipt of the seasonal influenza vaccination. Questionnaires were completed by a convenience sample of 383 undergraduate students in January 2014. Data were analyzed to identify barriers associated with receiving the seasonal influenza vaccine. Only 20.6% of students reported receiving the vaccine within the last 6 months. Among students who did not receive the vaccine, 47.8% believed they would get influenza from the vaccine, 41.6% believed the vaccination may have dangerous side effects, and 39.6% believed they were not at risk for contracting influenza. The majority of nonvaccinated students did not believe cost of the vaccine or access to the vaccine were barriers. Many college students are not receiving the seasonal influenza vaccine, representing an important area for improvement. Understanding potential barriers associated with receipt of this vaccine is important for identifying and creating effective public health education programs and campaigns. There is a need for enhanced vaccination education efforts among college students, particularly with respect to the safety and importance of this vaccine. PMID:27110397

  9. Barriers Associated with Seasonal Influenza Vaccination among College Students.

    PubMed

    Benjamin, Stephanie M; Bahr, Kaitlin O

    2016-01-01

    Influenza can spread rapidly on college campuses because of high-density living conditions and frequent social interactions. However, seasonal influenza vaccination rates on college campuses are low. The purpose of this study is to identify barriers associated with receipt of the seasonal influenza vaccination. Questionnaires were completed by a convenience sample of 383 undergraduate students in January 2014. Data were analyzed to identify barriers associated with receiving the seasonal influenza vaccine. Only 20.6% of students reported receiving the vaccine within the last 6 months. Among students who did not receive the vaccine, 47.8% believed they would get influenza from the vaccine, 41.6% believed the vaccination may have dangerous side effects, and 39.6% believed they were not at risk for contracting influenza. The majority of nonvaccinated students did not believe cost of the vaccine or access to the vaccine were barriers. Many college students are not receiving the seasonal influenza vaccine, representing an important area for improvement. Understanding potential barriers associated with receipt of this vaccine is important for identifying and creating effective public health education programs and campaigns. There is a need for enhanced vaccination education efforts among college students, particularly with respect to the safety and importance of this vaccine. PMID:27110397

  10. Influenza vaccine and the elderly.

    PubMed

    Kattan, Nadia; Wooding, Fae G

    2009-09-01

    Although some controversy exists about the necessity of the annual influenza vaccine in the elderly population, it has been established that the benefits outweigh the risks. Vaccinating elderly patients helps prevent influenza-related mortality, avoids debilitating complications, and even averts exacerbation of certain comorbidities including chronic obstructive pulmonary disease, asthma, and metabolic disorders such as diabetes. Even with all of its established benefits, barriers to access can prevent elderly individuals from receiving the vaccine. These barriers include a lack of education regarding the vaccine and a lack of vaccination enforcement by health care providers. As health care providers, it is our responsibility not only to treat disease, but also to prevent disease from occurring. The influenza vaccine is an easy and cost-effective way to prevent infection from the virus and the serious complications that may accompany it which, in turn, helps improve patients' quality of life.

  11. Mandatory influenza vaccination for health care workers as the new standard of care: a matter of patient safety and nonmaleficent practice.

    PubMed

    Cortes-Penfield, Nicolas

    2014-11-01

    A growing body of literature defends the efficacy of seasonal influenza vaccination for health care workers in reducing the mortality of hospitalized patients. I review the evidence concerning influenza vaccination, concluding that universal vaccination of health care workers against influenza should be considered standard patient care and that nonvaccination represents maleficent care. I further argue that the ethical responsibility to ensure universal vaccination of staff against seasonal influenza lies not only with individual health care providers but with each individual health care institution.

  12. New vaccines against influenza virus

    PubMed Central

    Lee, Young-Tae; Kim, Ki-Hye; Ko, Eun-Ju; Lee, Yu-Na; Kim, Min-Chul; Kwon, Young-Man; Tang, Yinghua; Cho, Min-Kyoung; Lee, Youn-Jeong

    2014-01-01

    Vaccination is one of the most effective and cost-benefit interventions that prevent the mortality and reduce morbidity from infectious pathogens. However, the licensed influenza vaccine induces strain-specific immunity and must be updated annually based on predicted strains that will circulate in the upcoming season. Influenza virus still causes significant health problems worldwide due to the low vaccine efficacy from unexpected outbreaks of next epidemic strains or the emergence of pandemic viruses. Current influenza vaccines are based on immunity to the hemagglutinin antigen that is highly variable among different influenza viruses circulating in humans and animals. Several scientific advances have been endeavored to develop universal vaccines that will induce broad protection. Universal vaccines have been focused on regions of viral proteins that are highly conserved across different virus subtypes. The strategies of universal vaccines include the matrix 2 protein, the hemagglutinin HA2 stalk domain, and T cell-based multivalent antigens. Supplemented and/or adjuvanted vaccination in combination with universal target antigenic vaccines would have much promise. This review summarizes encouraging scientific advances in the field with a focus on novel vaccine designs. PMID:24427759

  13. New vaccines against influenza virus.

    PubMed

    Lee, Young-Tae; Kim, Ki-Hye; Ko, Eun-Ju; Lee, Yu-Na; Kim, Min-Chul; Kwon, Young-Man; Tang, Yinghua; Cho, Min-Kyoung; Lee, Youn-Jeong; Kang, Sang-Moo

    2014-01-01

    Vaccination is one of the most effective and cost-benefit interventions that prevent the mortality and reduce morbidity from infectious pathogens. However, the licensed influenza vaccine induces strain-specific immunity and must be updated annually based on predicted strains that will circulate in the upcoming season. Influenza virus still causes significant health problems worldwide due to the low vaccine efficacy from unexpected outbreaks of next epidemic strains or the emergence of pandemic viruses. Current influenza vaccines are based on immunity to the hemagglutinin antigen that is highly variable among different influenza viruses circulating in humans and animals. Several scientific advances have been endeavored to develop universal vaccines that will induce broad protection. Universal vaccines have been focused on regions of viral proteins that are highly conserved across different virus subtypes. The strategies of universal vaccines include the matrix 2 protein, the hemagglutinin HA2 stalk domain, and T cell-based multivalent antigens. Supplemented and/or adjuvanted vaccination in combination with universal target antigenic vaccines would have much promise. This review summarizes encouraging scientific advances in the field with a focus on novel vaccine designs.

  14. Influenza vaccination in children at high risk of respiratory disease.

    PubMed

    Patria, Maria Francesca; Tagliabue, Claudia; Longhi, Benedetta; Esposito, Susanna

    2013-05-01

    Chronic respiratory diseases (CRDs) are a heterogeneous group of diseases that can affect the pediatric population and health authorities throughout the world recommend influenza vaccination because of the significant risk of influenza-related complications. However, despite this recommendation, vaccine coverage is generally unsatisfactory. The aim of this review is to analyze the impact of influenza on children at high risk of respiratory disease, and the immunogenicity, safety and efficacy of influenza vaccination in such children. The results show that there is a significant risk of influenza-related complications in preterm neonates and infants, in whom influenza vaccines are immunogenic and safe (although their efficacy has not been specifically studied). There are conflicting data concerning the effect of influenza infection on asthma morbidity in children, and whether or not influenza vaccination helps to prevent asthma exacerbations. Recent data provide no evidence that influenza is more frequent in patients with cystic fibrosis than in healthy subjects, or that it is responsible for increased lower respiratory tract morbidity. The lack of any clear correlate of protection suggests that future studies should also consider the efficacy of the different influenza vaccines and not only evaluate them in terms of immunogenicity. Furthermore, there is a need for clinical studies to assess the effectiveness of the available vaccines in patients with other rare CRDs and other chronic underlying diseases with possibly severe respiratory involvement. It is also important to determine whether children with recurrent respiratory tract infections should be included in the list of those for whom influenza vaccination is recommended. In the meantime, given the increasing evidence of the burden of influenza on the population as a whole and the benefits associated with vaccination, annual influenza vaccinations should be recommended for all children at high risk of

  15. Traditional and New Influenza Vaccines

    PubMed Central

    Wong, Sook-San

    2013-01-01

    SUMMARY The challenges in successful vaccination against influenza using conventional approaches lie in their variable efficacy in different age populations, the antigenic variability of the circulating virus, and the production and manufacturing limitations to ensure safe, timely, and adequate supply of vaccine. The conventional influenza vaccine platform is based on stimulating immunity against the major neutralizing antibody target, hemagglutinin (HA), by virus attenuation or inactivation. Improvements to this conventional system have focused primarily on improving production and immunogenicity. Cell culture, reverse genetics, and baculovirus expression technology allow for safe and scalable production, while adjuvants, dose variation, and alternate routes of delivery aim to improve vaccine immunogenicity. Fundamentally different approaches that are currently under development hope to signal new generations of influenza vaccines. Such approaches target nonvariable regions of antigenic proteins, with the idea of stimulating cross-protective antibodies and thus creating a “universal” influenza vaccine. While such approaches have obvious benefits, there are many hurdles yet to clear. Here, we discuss the process and challenges of the current influenza vaccine platform as well as new approaches that are being investigated based on the same antigenic target and newer technologies based on different antigenic targets. PMID:23824369

  16. A 2013/2014 northern hemisphere season surface antigen inactivated trivalent influenza vaccine--Assessing the immunogenicity and safety in an open label, uncontrolled study.

    PubMed

    Roggelin, Louise; Vinnemeier, Christof D; Meyer, Seetha; Witte, Kai; Marx, Lydia; Theeß, Wiebke; Burchard, Gerd D; Rolling, Thierry; Cramer, Jakob P

    2015-01-01

    The present study evaluated the safety and immunogenicity of the 2013/2014 trivalent surface antigen inactivated subunit seasonal influenza virus vaccine Fluvirin® in healthy adults (18 - ≤ 60 years) and elderly (>60 years). The vaccine contained 15 µg haemagglutinin protein from each of influenza A/California/7/2009 (H1N1)pdm09-like strain, A/Victoria/361/2011 (H3N2)-like strain and B/Massachusetts/2/2012-like strain (B/Yamagata) as recommended by the WHO in the 2013/2014 Northern Hemisphere season. Antibody response to each influenza antigen after vaccination was measured prior to vaccination and 21 d after by single radial hemolysis (SRH) assay or hemagglutination inhibition (HI) assay in accordance with Guidance CPMP/BWP/214/96. 125 subjects (61 adults and 64 elderly) were enrolled in the study. Pre-vaccination protective antibody levels (SRH area ≥ 25 mm(2)) against A(H1N1), A(H3N2) and the B strain were detected in 17%, 20% and 57% of adults and in 36%, 20% and 55% of elderly, respectively, Post-vaccination, SRH area ≥ 25 mm(2) was detectable in 95%, 82% and 92% in adult and in 80%, 84% and 92% of the elderly subjects for A(H1N1), A(H3N2) and the B strain, respectively. Geometric mean ratio (GMR) was higher in adult subjects (2.62-7.62) than in elderly subjects (2.33-3.42). All three CHMP licensure criteria were met for all strains contained in the vaccine for both age groups. The most frequently reported solicited local and systemic reactions were pain at the injection side, headache and fatigue. In conclusion, the vaccine demonstrated a good immunogenicity and an acceptable safety profile in both adults and elderly.

  17. Safety and immunogenicity of co-administered MF59-adjuvanted 2009 pandemic and plain 2009-10 seasonal influenza vaccines in rheumatoid arthritis patients on biologicals.

    PubMed

    Milanetti, F; Germano, V; Nisini, R; Donatelli, I; Di Martino, A; Facchini, M; Ferlito, C; Cappella, A; Crialesi, D; Caporuscio, S; Biselli, R; Rossi, F; Salemi, S; D'Amelio, R

    2014-07-01

    Rheumatoid arthritis (RA) patients under immunosuppressive therapy are particularly susceptible to infections, mainly of the respiratory tract, thus vaccination may represent a strategy to reduce their incidence in this vulnerable population. In the 2009-10 influenza season, the safety and immunogenicity of co-administered non-adjuvanted seasonal and MF59-adjuvanted pandemic influenza vaccines were evaluated in this study in 30 RA patients under therapy with anti-tumour necrosis factor (TNF)-α agents or Abatacept and in 13 healthy controls (HC). Patients and HC underwent clinical and laboratory evaluation before (T0), 1 (T1) and 6 months (T2) after vaccinations. No severe adverse reactions, but a significant increase in total mild side effects in patients versus HC were observed. Both influenza vaccines fulfilled the three criteria of the Committee for Proprietary Medicinal Products (CPMP). Seroconversion rate for any viral strain in patients and HC was, respectively, 68 versus 45 for H1-A/Brisbane/59/07, 72 versus 81 for H3-A/Brisbane/10/07, 68 versus 54 for B/Brisbane/60/08 and 81 versus 54 for A/California/7/2009. A slight increase in activated interferon (IFN)-γ-, TNF-α- or interleukin (IL)-17A-secreting T cells at T1 compared to T0, followed by a reduction at T2 in both patients and HC, was registered. In conclusion, simultaneous administration of adjuvanted pandemic and non-adjuvanted seasonal influenza vaccines is safe and highly immunogenic. The largely overlapping results between patients and HC, in terms of antibody response and cytokine-producing T cells, may represent further evidence for vaccine safety and immunogenicity in RA patients on biologicals.

  18. Safety and immunogenicity of co-administered MF59-adjuvanted 2009 pandemic and plain 2009-10 seasonal influenza vaccines in rheumatoid arthritis patients on biologicals.

    PubMed

    Milanetti, F; Germano, V; Nisini, R; Donatelli, I; Di Martino, A; Facchini, M; Ferlito, C; Cappella, A; Crialesi, D; Caporuscio, S; Biselli, R; Rossi, F; Salemi, S; D'Amelio, R

    2014-07-01

    Rheumatoid arthritis (RA) patients under immunosuppressive therapy are particularly susceptible to infections, mainly of the respiratory tract, thus vaccination may represent a strategy to reduce their incidence in this vulnerable population. In the 2009-10 influenza season, the safety and immunogenicity of co-administered non-adjuvanted seasonal and MF59-adjuvanted pandemic influenza vaccines were evaluated in this study in 30 RA patients under therapy with anti-tumour necrosis factor (TNF)-α agents or Abatacept and in 13 healthy controls (HC). Patients and HC underwent clinical and laboratory evaluation before (T0), 1 (T1) and 6 months (T2) after vaccinations. No severe adverse reactions, but a significant increase in total mild side effects in patients versus HC were observed. Both influenza vaccines fulfilled the three criteria of the Committee for Proprietary Medicinal Products (CPMP). Seroconversion rate for any viral strain in patients and HC was, respectively, 68 versus 45 for H1-A/Brisbane/59/07, 72 versus 81 for H3-A/Brisbane/10/07, 68 versus 54 for B/Brisbane/60/08 and 81 versus 54 for A/California/7/2009. A slight increase in activated interferon (IFN)-γ-, TNF-α- or interleukin (IL)-17A-secreting T cells at T1 compared to T0, followed by a reduction at T2 in both patients and HC, was registered. In conclusion, simultaneous administration of adjuvanted pandemic and non-adjuvanted seasonal influenza vaccines is safe and highly immunogenic. The largely overlapping results between patients and HC, in terms of antibody response and cytokine-producing T cells, may represent further evidence for vaccine safety and immunogenicity in RA patients on biologicals. PMID:24666311

  19. Selecting Viruses for the Seasonal Influenza Vaccine

    MedlinePlus

    ... which viruses are selected for use in vaccine production? The influenza viruses in the seasonal flu vaccine ... to get a good vaccine virus for vaccine production? There are a number of factors that can ...

  20. [Influenza vaccination rates in Hessian hospitals].

    PubMed

    Wicker, S; Gottschalk, R; Wolff, U; Krause, G; Rabenau, H F

    2012-08-01

    Influenza infections have been shown to spread in hospitals rapidly; nosocomial transmissions occur frequently. Influenza vaccination of health care personnel (HCP) is an effective strategy for preventing influenza infections among personnel and patients. In summer 2011 we conducted an anonymous questionnaire among Hessian hospitals assessing influenza vaccination rates, kind and concept of vaccination programmes. Overall, 95.8% (68/71) of hospitals surveyed offered influenza vaccinations for HCP free of charge. Influenza vaccination rates have been recorded only by 70.4% (50/71). Over 80% (season 2009/2010: 41/50- season 2010/2011: 44/50) of hospitals questioned, mentioned influenza vaccination rates under 20%. Our findings confirm that the influenza vaccination rates might be less than the generally assumed and communicated influenza vaccination rates of 20-25%. Thirty years since the German Standing Committee on Vaccination (STIKO) recommended that all HCP get vaccinated against influenza, vaccination rates still remain below 30%. Measures to improve influenza vaccination rates among HCP are required. Monitoring of vaccination rates is a precondition to assess the acceptance of a vaccination programme.

  1. The Global Influenza Initiative recommendations for the vaccination of pregnant women against seasonal influenza.

    PubMed

    Macias, Alejandro E; Precioso, Alexander R; Falsey, Ann R

    2015-08-01

    There is a heavy disease burden due to seasonal influenza in pregnant women, their fetuses, and their newborns. The main aim of this study was to review and analyze current evidence on safety, immunogenicity, and clinical benefits of the inactivated influenza vaccine (IIV) in pregnant women. Current evidence shows that in pregnant women, the seasonal and pandemic IIVs are safe and well tolerated. After vaccination, pregnant women have protective concentrations of anti-influenza antibodies, conferring immunogenicity in newborns. The best evidence, to date, suggests that influenza vaccination confers clinical benefits in both pregnant women and their newborns. Vaccination with either the seasonal or pandemic vaccine has been shown to be cost-effective in pregnancy. There are scarce data from randomized clinical trials; fortunately, new phase 3 clinical trials are under way. In the Northern and Southern Hemispheres, data suggest that the greatest clinical benefit for infants occurs if the IIV is administered within the first weeks of availability of the vaccine, at the beginning of the influenza season, regardless of the pregnancy trimester. The optimal timing to vaccinate pregnant women who live in tropical regions is unclear. Based on evaluation of the evidence, the Global Influenza Initiative (GII) recommends that to prevent seasonal influenza morbidity and mortality in infants and their mothers, all pregnant women, regardless of trimester, should be vaccinated with the IIV. For countries where vaccination against influenza is starting or expanding, the GII recommends that pregnant women have the highest priority. PMID:26256293

  2. The Global Influenza Initiative recommendations for the vaccination of pregnant women against seasonal influenza

    PubMed Central

    Macias, Alejandro E; Precioso, Alexander R; Falsey, Ann R

    2015-01-01

    There is a heavy disease burden due to seasonal influenza in pregnant women, their fetuses, and their newborns. The main aim of this study was to review and analyze current evidence on safety, immunogenicity, and clinical benefits of the inactivated influenza vaccine (IIV) in pregnant women. Current evidence shows that in pregnant women, the seasonal and pandemic IIVs are safe and well tolerated. After vaccination, pregnant women have protective concentrations of anti-influenza antibodies, conferring immunogenicity in newborns. The best evidence, to date, suggests that influenza vaccination confers clinical benefits in both pregnant women and their newborns. Vaccination with either the seasonal or pandemic vaccine has been shown to be cost-effective in pregnancy. There are scarce data from randomized clinical trials; fortunately, new phase 3 clinical trials are under way. In the Northern and Southern Hemispheres, data suggest that the greatest clinical benefit for infants occurs if the IIV is administered within the first weeks of availability of the vaccine, at the beginning of the influenza season, regardless of the pregnancy trimester. The optimal timing to vaccinate pregnant women who live in tropical regions is unclear. Based on evaluation of the evidence, the Global Influenza Initiative (GII) recommends that to prevent seasonal influenza morbidity and mortality in infants and their mothers, all pregnant women, regardless of trimester, should be vaccinated with the IIV. For countries where vaccination against influenza is starting or expanding, the GII recommends that pregnant women have the highest priority. PMID:26256293

  3. Skin immunization with influenza vaccines.

    PubMed

    Skountzou, Ioanna; Compans, Richard W

    2015-01-01

    Problems with existing influenza vaccines include the strain specificity of the immune response, resulting in the need for frequent reformulation in response to viral antigenic drift. Even in years when the same influenza strains are prevalent, the duration of immunity is limited, and results in the need for annual revaccination. The immunogenicity of the present split or subunit vaccines is also lower than that observed with whole inactivated virus, and the vaccines are not very effective in high risk groups such as the young or the elderly. Vaccine coverage is incomplete, due in part to concerns about the use of hypodermic needles for delivery. Alternative approaches for vaccination are being developed which address many of these concerns. Here we review new approaches which focus on skin immunization, including the development of needle-free delivery systems which use stable dry formulations and induce stronger and longer-lasting immune responses.

  4. Influenza vaccination in the elderly.

    PubMed Central

    Morgan, R.; King, D.

    1996-01-01

    There is overwhelming evidence for the clinical efficacy of the influenza vaccine, especially in the elderly with chronic disease, reducing mortality and hospital admissions. There is also evidence to suggest that the influenza vaccine may be beneficial in the healthy elderly. There is some evidence to suggest that the antibody response in the elderly to the vaccine may decrease with increasing age, although there are several confounding factors that have not been taken into account in many of these studies. That aside, even if antibody response is not as good as that in younger people, the evidence that vaccination saves lives and reduces morbidity in the elderly means that the vaccination should be offered to elderly patients at high risk and perhaps even to the elderly healthy population. Although vaccination of an elderly at-risk patient does not necessarily mean that that particular patient will mount an appropriate antibody response, a significant number of elderly patients will respond appropriately. Serious side-effects from vaccination are extremely rare and the more common side-effects are mild and self-limiting. Increasing the number of elderly people receiving the influenza vaccination will not only result in cost savings for the National Health Service in terms of reduced hospitalisation but, more significantly, the elderly will benefit in terms of reduced morbidity and mortality. PMID:8758010

  5. Immunogenicity and safety of a cell culture-based quadrivalent influenza vaccine in adults: A Phase III, double-blind, multicenter, randomized, non-inferiority study

    PubMed Central

    Bart, Stephan; Cannon, Kevin; Herrington, Darrell; Mills, Richard; Forleo-Neto, Eduardo; Lindert, Kelly; Abdul Mateen, Ahmed

    2016-01-01

    ABSTRACT Quadrivalent influenza vaccines (QIVs), which include both B lineage strains, are expected to provide broader protection than trivalent influenza vaccines (TIVs). The non-inferiority, immunogenicity, and safety of a cell culture-based investigational QIVc and 2 TIVs (TIV1c, TIV2c), in adults (≥18 y), were evaluated in this Phase III, double-blind, multicenter study. A total of 2680 age-stratified subjects were randomized (2:1:1) to receive 1 dose of QIVc (n = 1335), TIV1c (n = 676), or TIV2c (n = 669). TIV1c (B/Yamagata) and TIV2c (B/Victoria) differed only in B strain lineage. The primary objective was to demonstrate non-inferiority of the hemagglutinin-inhibition antibody responses of QIVc against TIVc, 22 d post-vaccination. Secondary objectives included the evaluation of immunogenicity of QIVc and TIVc in younger (≥18 – <65 y) and older (≥65 y) adults. Hemagglutinin inhibition assays were performed at days 1 and 22. Solicited local and systemic adverse events (AEs) were monitored for 7 d post-vaccination, and unsolicited AEs and serious AEs until day 181. QIVc met the non-inferiority criteria for all 4 vaccine strains and demonstrated superiority for both influenza B strains over the unmatched B strain included in the TIV1c and TIV2c, when geometric mean titers and seroconversion rates with TIVc were compared at day 22. Between 48%–52% of subjects experienced ≥1 solicited AE, the most common being injection-site pain and headache. Serious AEs were reported by ≤1% of subjects, none were vaccine-related. The results indicate that QIVc is immunogenic and well tolerated in both younger and older adults. The immunogenicity and safety profiles of QIVc and TIVc were comparable at all ages evaluated. PMID:27322354

  6. Virus-Vectored Influenza Virus Vaccines

    PubMed Central

    Tripp, Ralph A.; Tompkins, S. Mark

    2014-01-01

    Despite the availability of an inactivated vaccine that has been licensed for >50 years, the influenza virus continues to cause morbidity and mortality worldwide. Constant evolution of circulating influenza virus strains and the emergence of new strains diminishes the effectiveness of annual vaccines that rely on a match with circulating influenza strains. Thus, there is a continued need for new, efficacious vaccines conferring cross-clade protection to avoid the need for biannual reformulation of seasonal influenza vaccines. Recombinant virus-vectored vaccines are an appealing alternative to classical inactivated vaccines because virus vectors enable native expression of influenza antigens, even from virulent influenza viruses, while expressed in the context of the vector that can improve immunogenicity. In addition, a vectored vaccine often enables delivery of the vaccine to sites of inductive immunity such as the respiratory tract enabling protection from influenza virus infection. Moreover, the ability to readily manipulate virus vectors to produce novel influenza vaccines may provide the quickest path toward a universal vaccine protecting against all influenza viruses. This review will discuss experimental virus-vectored vaccines for use in humans, comparing them to licensed vaccines and the hurdles faced for licensure of these next-generation influenza virus vaccines. PMID:25105278

  7. Influenza vaccination of healthcare personnel.

    PubMed

    Wicker, Sabine; Marckmann, Georg

    2014-01-01

    The thought is terrifying--you are admitted to the hospital and you die of a nosocomial infection. What sounds like a horror scenario, happens every day in hospitals all over the world. Nosocomial influenza is associated with considerable morbidity and mortality among patients with underlying diseases (especially immunocompromised patients), the elderly, and neonates. Although vaccination of healthcare personnel (HCP) is the main measure for preventing nosocomial influenza and is consistently recommended by public-health authorities, vaccine uptake among HCP remains low. (1.) PMID:25483507

  8. Requiring Influenza Vaccination for Health Care Workers

    PubMed Central

    Anikeeva, Olga; Rogers, Wendy

    2009-01-01

    Annual influenza vaccination for health care workers has the potential to benefit health care professionals, their patients, and their families by reducing the transmission of influenza in the health care setting. Furthermore, staff vaccination programs are cost-effective for health care institutions because of reduced staff illness and absenteeism. Despite international recommendations and strong ethical arguments for annual influenza immunization for health care professionals, staff utilization of vaccination remains low. We have analyzed the ethical implications of a variety of efforts to increase vaccination rates, including mandatory influenza vaccination. A program of incentives and sanctions may increase health care worker compliance with fewer ethical impediments than mandatory vaccination. PMID:19008501

  9. Randomized Clinical Trial Of Immunogenicity And Safety Of A Recombinant H1N1/2009 Pandemic Influenza Vaccine Containing Advax™ Polysaccharide Adjuvant

    PubMed Central

    Gordon, David L.; Sajkov, Dimitar; Woodman, Richard J.; Honda-Okubo, Yoshikazu; Cox, Manon M.J.; Heinzel, Susanne; Petrovsky, Nikolai

    2012-01-01

    Background Timely vaccine supply is critical during influenza pandemics. A recombinant hemagglutinin (rHA)-based vaccine could overcome production hurdles of egg-based vaccines but has never previously been tested in a real-life pandemic setting. The primary aim was to determine the efficacy of a recombinant pandemic vaccine and whether its immunogenicity could be enhanced by a novel polysaccharide adjuvant (Advax™). Methods 281 adults aged 18–70 years were recruited in a randomized, subject and observer blinded, parallel-group study of rHA H1N1/2009 vaccine with or without adjuvant. Immunizations were at 0 and 3 weeks with rHA 3, 11 or 45 ug. Serology and safety was followed for 6 months. Results At baseline, only 9.1% of subjects (95% CI = 6.0 – 13.2) had seroprotective H1N1/2009 titers. Seroconversion rates varied by rHA dose, presence of adjuvant, subject age and number of immunizations. Eighty percent (95% CI = 52 – 96) of 18 – 49 year olds who received rHA 45ug with adjuvant were seroprotected at week 3, representing a 11.1-fold increase in antibody titers from baseline. Advax™ adjuvant increased seroprotection rates by 1.9 times after the first, and 2.5 times after the second, immunization when compared to rHA alone. Seroprotection was sustained at 26 weeks and the vaccine was well tolerated with no safety issues. Conclusions The study confirmed the ability to design, manufacture, and release a recombinant vaccine within a short time from the start of an actual influenza pandemic. Advax™ adjuvant significantly enhanced rHA immunogenicity. PMID:22717330

  10. Mandatory Influenza Vaccination for Health Care Workers as the New Standard of Care: A Matter of Patient Safety and Nonmaleficent Practice

    PubMed Central

    2014-01-01

    A growing body of literature defends the efficacy of seasonal influenza vaccination for health care workers in reducing the mortality of hospitalized patients. I review the evidence concerning influenza vaccination, concluding that universal vaccination of health care workers against influenza should be considered standard patient care and that nonvaccination represents maleficent care. I further argue that the ethical responsibility to ensure universal vaccination of staff against seasonal influenza lies not only with individual health care providers but with each individual health care institution. PMID:24328628

  11. Influenza virus vaccine live intranasal--MedImmune vaccines: CAIV-T, influenza vaccine live intranasal.

    PubMed

    2003-01-01

    submitting a licence application in Europe, a $US27.5 million payment for approval of a refrigerator-stable liquid formulation of FluMist and as much as $US50 million for licensing of FluMist internationally. In July 2003 MedImmune announced that it had received approximately $US28 million in milestone payments during Q2 of 2003 for the approval of FluMist. CSL Ltd of Australia will collaborate on the development, sale and distribution of MedImmune Vaccine's vaccine in Australia, New Zealand and certain countries in the South Pacific. MedImmune is to acquire vaccine research programmes in respiratory syncytial virus and cytomegalovirus from MedImmune Vaccines. The company's primary interest is in FluMist. In May 2002, MedImmune licensed exclusive rights to Crucell's proprietary human cell line PER.C6 for use in its influenza vaccine programmes. On 11 March 2002, American Home Products changed its name and the names of its subsidiaries Wyeth-Ayerst and Wyeth-Lederle to Wyeth. Wyeth's vaccines division is called Wyeth Vaccines. On 29 September 2000, Aviron announced that it had been awarded a $US2.7 million Challenge Grant from NIAID for development of vaccines against pandemic strains of influenza based on FluMist intranasal technology. The cold-adapted live influenza vaccine has been widely evaluated in the US and Japan since 1975 in clinical trials involving several thousand people. Aviron completed phase II clinical trials in adults in the US and phase III trials in US children aged 15-71 months. Additional phase III trials in adults and the elderly are ongoing. Aviron also commenced phase III trials to test the safety of its intranasal live vaccine in children with moderate to severe asthma. The vaccine is delivered using the AccuSpray nasal delivery system by Becton Dickinson, which will supply the system for FluMist through the 2001-2002 influenza season under an agreement with Aviron made in August 1998. On 7 March 2000, Aviron announced that Wyeth-Lederle Vaccines

  12. Influenza virus vaccine live intranasal--MedImmune vaccines: CAIV-T, influenza vaccine live intranasal.

    PubMed

    2003-01-01

    submitting a licence application in Europe, a $US27.5 million payment for approval of a refrigerator-stable liquid formulation of FluMist and as much as $US50 million for licensing of FluMist internationally. In July 2003 MedImmune announced that it had received approximately $US28 million in milestone payments during Q2 of 2003 for the approval of FluMist. CSL Ltd of Australia will collaborate on the development, sale and distribution of MedImmune Vaccine's vaccine in Australia, New Zealand and certain countries in the South Pacific. MedImmune is to acquire vaccine research programmes in respiratory syncytial virus and cytomegalovirus from MedImmune Vaccines. The company's primary interest is in FluMist. In May 2002, MedImmune licensed exclusive rights to Crucell's proprietary human cell line PER.C6 for use in its influenza vaccine programmes. On 11 March 2002, American Home Products changed its name and the names of its subsidiaries Wyeth-Ayerst and Wyeth-Lederle to Wyeth. Wyeth's vaccines division is called Wyeth Vaccines. On 29 September 2000, Aviron announced that it had been awarded a $US2.7 million Challenge Grant from NIAID for development of vaccines against pandemic strains of influenza based on FluMist intranasal technology. The cold-adapted live influenza vaccine has been widely evaluated in the US and Japan since 1975 in clinical trials involving several thousand people. Aviron completed phase II clinical trials in adults in the US and phase III trials in US children aged 15-71 months. Additional phase III trials in adults and the elderly are ongoing. Aviron also commenced phase III trials to test the safety of its intranasal live vaccine in children with moderate to severe asthma. The vaccine is delivered using the AccuSpray nasal delivery system by Becton Dickinson, which will supply the system for FluMist through the 2001-2002 influenza season under an agreement with Aviron made in August 1998. On 7 March 2000, Aviron announced that Wyeth-Lederle Vaccines

  13. Vaccination against influenza: role and limitations in pandemic intervention plans.

    PubMed

    Rebmann, Terri; Zelicoff, Alan

    2012-08-01

    Influenza pandemics occur periodically and the subtype of the next pandemic strain cannot be predicted. Vaccination remains a critical intervention during pandemics, but current production technology requires several months to develop sufficient vaccine to meet anticipated worldwide need. Candidate prepandemic vaccines for use in population priming or rapid deployment during an epidemic are in development but are subtype specific and logistical obstacles to timely distribution exist. Intensive research is underway to identify a universal vaccine, providing protection against all known influenza strains based on shared epitopes. Vaccine access is expected to be limited during early response to a pandemic, necessitating ethical vaccine distribution plans for within-country and global allocation. Mass vaccination plans must be in place prior to an event to ensure appropriate infrastructures are in place. Carefully crafted education campaigns regarding pandemic vaccine safety and efficacy should aid in maximizing pandemic vaccine uptake during a future event.

  14. Progress on adenovirus-vectored universal influenza vaccines

    PubMed Central

    Xiang, Kui; Ying, Guan; Yan, Zhou; Shanshan, Yan; Lei, Zhang; Hongjun, Li; Maosheng, Sun

    2015-01-01

    Influenza virus (IFV) infection causes serious health problems and heavy financial burdens each year worldwide. The classical inactivated influenza virus vaccine (IIVV) and live attenuated influenza vaccine (LAIV) must be updated regularly to match the new strains that evolve due to antigenic drift and antigenic shift. However, with the discovery of broadly neutralizing antibodies that recognize conserved antigens, and the CD8+ T cell responses targeting viral internal proteins nucleoprotein (NP), matrix protein 1 (M1) and polymerase basic 1 (PB1), it is possible to develop a universal influenza vaccine based on the conserved hemagglutinin (HA) stem, NP, and matrix proteins. Recombinant adenovirus (rAd) is an ideal influenza vaccine vector because it has an ideal stability and safety profile, induces balanced humoral and cell-mediated immune responses due to activation of innate immunity, provides ‘self-adjuvanting’ activity, can mimic natural IFV infection, and confers seamless protection against mucosal pathogens. Moreover, this vector can be developed as a low-cost, rapid-response vaccine that can be quickly manufactured. Therefore, an adenovirus vector encoding conserved influenza antigens holds promise in the development of a universal influenza vaccine. This review will summarize the progress in adenovirus-vectored universal flu vaccines and discuss future novel approaches. PMID:25876176

  15. Progress on adenovirus-vectored universal influenza vaccines.

    PubMed

    Xiang, Kui; Ying, Guan; Yan, Zhou; Shanshan, Yan; Lei, Zhang; Hongjun, Li; Maosheng, Sun

    2015-01-01

    Influenza virus (IFV) infection causes serious health problems and heavy financial burdens each year worldwide. The classical inactivated influenza virus vaccine (IIVV) and live attenuated influenza vaccine (LAIV) must be updated regularly to match the new strains that evolve due to antigenic drift and antigenic shift. However, with the discovery of broadly neutralizing antibodies that recognize conserved antigens, and the CD8(+) T cell responses targeting viral internal proteins nucleoprotein (NP), matrix protein 1 (M1) and polymerase basic 1 (PB1), it is possible to develop a universal influenza vaccine based on the conserved hemagglutinin (HA) stem, NP, and matrix proteins. Recombinant adenovirus (rAd) is an ideal influenza vaccine vector because it has an ideal stability and safety profile, induces balanced humoral and cell-mediated immune responses due to activation of innate immunity, provides 'self-adjuvanting' activity, can mimic natural IFV infection, and confers seamless protection against mucosal pathogens. Moreover, this vector can be developed as a low-cost, rapid-response vaccine that can be quickly manufactured. Therefore, an adenovirus vector encoding conserved influenza antigens holds promise in the development of a universal influenza vaccine. This review will summarize the progress in adenovirus-vectored universal flu vaccines and discuss future novel approaches.

  16. Rapid production of synthetic influenza vaccines.

    PubMed

    Dormitzer, Philip R

    2015-01-01

    The strain composition of influenza vaccines must be changed regularly to track influenza virus antigenic evolution. During outbreaks with pandemic potential, strain changes are urgent. The systems for accomplishing vaccine strain changes have required the shipment of viruses and other biological materials around the globe, with delays in vaccine availability, and have used legacy techniques of egg-based virus cultivation, resulting in vaccine mismatches. In collaboration with Synthetic Genomics Vaccines Inc. and the US Biomedical Advanced Research and Development Authority, Novartis has developed a synthetic approach to influenza vaccine virus generation. Synthetic influenza vaccine viruses and mammalian cell culture technology promise influenza vaccines that match circulating influenza strains more closely and are delivered in greater quantities, more rapidly than vaccines produced by conventional technologies. These new technologies could yield an improved influenza vaccine response system in which viral sequence data from many sources are posted on the Internet, are downloaded by vaccine manufacturers, and are used to rescue multiple, attenuated vaccine viruses directly on high yielding backbones. Elements of this system were deployed in the response to the 2013 H7N9 influenza outbreak in China. The result was the production, clinical testing, and stockpiling of an H7N9 vaccine before the second wave of the outbreak struck at the end of 2013. Future directions in synthetic influenza vaccine technology include the automation of influenza virus rescue from sequence data and the merger of synthetic and self-amplifying mRNA vaccine technologies. The result could be a more robust and effective influenza vaccine system.

  17. Influenza (Flu) vaccine (Live, Intranasal): What you need to know

    MedlinePlus

    ... is taken in its entirety from the CDC Influenza Live, Intranasal Flu Vaccine Information Statement (VIS): www.cdc.gov/vaccines/ ... flulive.html . CDC review information for Live, Intranasal Influenza VIS: Vaccine Information Statement Influenza Page last reviewed: ...

  18. Influenza B vaccine lineage selection—An optimized trivalent vaccine

    PubMed Central

    Mosterín Höpping, Ana; Fonville, Judith M.; Russell, Colin A.; James, Sarah; Smith, Derek J.

    2016-01-01

    Epidemics of seasonal influenza viruses cause considerable morbidity and mortality each year. Various types and subtypes of influenza circulate in humans and evolve continuously such that individuals at risk of serious complications need to be vaccinated annually to keep protection up to date with circulating viruses. The influenza vaccine in most parts of the world is a trivalent vaccine, including an antigenically representative virus of recently circulating influenza A/H3N2, A/H1N1, and influenza B viruses. However, since the 1970s influenza B has split into two antigenically distinct lineages, only one of which is represented in the annual trivalent vaccine at any time. We describe a lineage selection strategy that optimizes protection against influenza B using the standard trivalent vaccine as a potentially cost effective alternative to quadrivalent vaccines. PMID:26896685

  19. Influenza B vaccine lineage selection--an optimized trivalent vaccine.

    PubMed

    Mosterín Höpping, Ana; Fonville, Judith M; Russell, Colin A; James, Sarah; Smith, Derek J

    2016-03-18

    Epidemics of seasonal influenza viruses cause considerable morbidity and mortality each year. Various types and subtypes of influenza circulate in humans and evolve continuously such that individuals at risk of serious complications need to be vaccinated annually to keep protection up to date with circulating viruses. The influenza vaccine in most parts of the world is a trivalent vaccine, including an antigenically representative virus of recently circulating influenza A/H3N2, A/H1N1, and influenza B viruses. However, since the 1970s influenza B has split into two antigenically distinct lineages, only one of which is represented in the annual trivalent vaccine at any time. We describe a lineage selection strategy that optimizes protection against influenza B using the standard trivalent vaccine as a potentially cost effective alternative to quadrivalent vaccines.

  20. Prioritization of delayed vaccination for pandemic influenza.

    PubMed

    Shim, Eunha

    2011-01-01

    Limited production capacity and delays in vaccine development are major obstacles to vaccination programs that are designed to mitigate a pandemic influenza. In order to evaluate and compare the impact of various vaccination strategies during a pandemic influenza, we developed an age/risk-structured model of influenza transmission, and parameterized it with epidemiological data from the 2009 H1N1 influenza A pandemic. Our model predicts that the impact of vaccination would be considerably diminished by delays in vaccination and staggered vaccine supply. Nonetheless, prioritizing limited H1N1 vaccine to individuals with a high risk of complications, followed by school-age children, and then preschool-age children, would minimize an overall attack rate as well as hospitalizations and deaths. This vaccination scheme would maximize the benefits of vaccination by protecting the high-risk people directly, and generating indirect protection by vaccinating children who are most likely to transmit the disease. PMID:21361402

  1. Deaths following influenza vaccination--background mortality or causal connection?

    PubMed

    Kokia, Ehud S; Silverman, Barbara G; Green, Manfred; Kedem, Hagai; Guindy, Michal; Shemer, Joshua

    2007-12-12

    In October 2006, four deaths occurred in Israel shortly after influenza immunization, resulting in a temporary halt to the vaccination campaign. After an epidemiologic investigation, the Ministry of Health concluded that these deaths were not related to the vaccine itself and the campaign resumed; however, vaccine uptake was markedly reduced. Estimates of true background mortality in this high-risk population would aid in public education and quell unnecessary concerns regarding vaccine safety. We used data from a large HMO to estimate mortality in influenza vaccine recipients aged 55 and over during four consecutive winters (2003, 2004, 2005 and 2006). Date of immunization was ascertained from patient treatment files, vital status through Israeli National Insurance Institute data. We calculated crude death rates within 7, 14 and 30 days of influenza immunization, and used a Cox Proportional Hazards Model to estimate the risk of death within 14 days of vaccination, adjusting for age and comorbid conditions (age over 75, history of diabetes or cardiovascular disease, status as homebound patient) in 2006. The death rate among influenza vaccine recipients ranged from 0.01 to 0.02% within 7 days and 0.09-0.10% at 30 days. Influenza immunization was associated with a decreased risk of death within 14 days after adjustment for comorbidities (Hazard ratio, 0.33, 95% CI, 0.18-0.61). Our findings support the assumption that influenza vaccination is not associated with increased risk of death in the short term.

  2. Prospects for broadly protective influenza vaccines.

    PubMed

    Treanor, John Jay

    2015-11-27

    The development of vaccines that could provide broad protection against antigenically variant influenza viruses has long been the ultimate prize in influenza research. Recent developments have pushed us closer to this goal, and such vaccines may now be within reach. This brief review outlines the current approaches to broadly protective vaccines, and the probable hurdles and roadblocks to achieving this goal.

  3. Adolescent Attitudes toward Influenza Vaccination and Vaccine Uptake in a School-Based Influenza Vaccination Intervention: A Mediation Analysis

    ERIC Educational Resources Information Center

    Painter, Julia E.; Sales, Jessica M.; Pazol, Karen; Wingood, Gina M.; Windle, Michael; Orenstein, Walter A.; DiClemente, Ralph J.

    2011-01-01

    Background: School-based vaccination programs may provide an effective strategy to immunize adolescents against influenza. This study examined whether adolescent attitudes toward influenza vaccination mediated the relationship between receipt of a school-based influenza vaccination intervention and vaccine uptake. Methods: Participants were…

  4. Influenza and pneumococcal vaccination: patient perceptions

    PubMed Central

    Findlay, P.; Gibbons, Y; Primrose, W; Ellis, G; Downie, G

    2000-01-01

    The efficacy of the influenza vaccine in reducing mortality and hospital admissions is established, particularly in the elderly. However, up to 50% of those at risk do not receive the vaccine. These patients are also at risk from pneumococcal infection and there is considerable overlap between the target group for each vaccine.
This study sought to identify at risk individuals from consecutive admissions to an acute geriatric unit and to gain an insight into their perceptions with regard to vaccination. The awareness of each vaccine was recorded, together with the vaccination history.
Seventy four per cent of the final cohort had heard of the influenza vaccine, while only 13% had heard of the pneumococcal vaccine. Fifty per cent perceived themselves to be at risk from influenza and its complications and 87% of the cohort believed it to be a serious infection.
Influenza vaccine was judged to confer good protection by 72% of the sample and yet up to 50% believed that the vaccine can make the recipient ill.
Influenza is perceived as a serious infection by patients and yet many do not believe themselves to be at particular risk. Although influenza vaccination is believed to confer protection, the decision whether, or not, to accept the vaccine is coloured by many factors, including popular myths and anecdotal information from friends and relatives. The uptake of influenza vaccine is suboptimal and the awareness of the pneumococcal vaccine certainly in the elderly is poor. The need for a comprehensive nationwide education campaign promoting both influenza and pneumococcal vaccine is highlighted.


Keywords: influenza vaccine; pneumococcal vaccine PMID:10727564

  5. Efficacy and safety of the standardised Ginseng extract G115 for potentiating vaccination against the influenza syndrome and protection against the common cold [corrected].

    PubMed

    Scaglione, F; Cattaneo, G; Alessandria, M; Cogo, R

    1996-01-01

    The aim of the study was to determine the properties of a standardized extract of ginseng root in inducing a higher immune response in vaccination against influenza. Attention was also paid to the common cold in this multicentre, two-arm, randomized, placebo-controlled, double-blind investigation. A total of 227 volunteers who visited 3 private practices in Milan received daily oral capsule doses of either placebo (113) or 100 mg of standardized ginseng extract Ginsana G 115 (114) for a period of 12 weeks within which they received an anti-influenza polyvalent vaccination at week 4. As a result, while the frequency of influenza or common cold between weeks 4 and 12 was 42 cases in the placebo group, it was only 15 cases in the G115 group, the difference being statistically highly significant (p < 0.001). Whereas antibody titres by week 8 rose to an average of 171 units in the placebo group, they rose to an average of 272 units in the G115 group (p < 0.0001). Natural killer (NK) activity levels at weeks 8 and 12 were nearly twice as high in the G115 group as compared to the placebo group (p < 0.0001). In all the volunteers, laboratory values of 24 safety parameters showed no significant differences between the end and the beginning of the 12-week study in either of the groups. There were only 9 adverse events in the study, the principal one being insomnia.

  6. Point-of-Use Mixing of Influenza H5N1 Vaccine and MF59 Adjuvant for Pandemic Vaccination Preparedness: Antibody Responses and Safety. A Phase 1 Clinical Trial

    PubMed Central

    Mulligan, Mark J.; Bernstein, David I.; Frey, Sharon; Winokur, Patricia; Rouphael, Nadine; Dickey, Michelle; Edupuganti, Srilatha; Spearman, Paul; Anderson, Edwin; Graham, Irene; Noah, Diana L.; Mangal, Brian; Kim, Sonnie; Hill, Heather; Whitaker, Jenifer; Emery, William; Beck, Allison; Stephens, Kathy; Hartwell, Brooke; Ogilvie, Melinda; Rimann, Nayoka; Osinski, Eileen; Destefano, Ellen; Gajadhar, Theda; Strudwick, Amanda; Pierce, Karen; Lai, Lilin; Yue, Ling; Wang, Dongli; Ying, Carl; Cline, Amy; Foltz, Tara; Wagner, Nancy; Dull, Geraldine; Pacatte, Thomas; Taggart, Barbara; Johnson, Valerie; Haller, Logan; Looney, Candi; Li, Shixiong; May, Megan; Myers, Bridgette; May, Rachel; Parker, Lawanda; Cochran, Nertaissa; Bowen, Donna; Bell, Michelle; Scoggins, Jeffery; Burns, Angela; Stablein, Claire; Wolff, Mark; Jolles, Bernadette; Leung, Brenda; Lambert, Linda; Shorer, Shy; Buchanan, Wendy; Murray, Suzanne; Chang, Soju; Gorman, Richard

    2014-01-01

    Background  Avian influenza A/H5N1 has threatened human health for nearly 2 decades. Avian influenza A vaccine without adjuvant is poorly immunogenic. A flexible rapid tactic for mass vaccination will be needed if a pandemic occurs. Methods  A multicenter, randomized, blinded phase 1 clinical trial evaluated safety and antibody responses after point-of-use mixing of influenza A/Indonesia/05/2005 (H5N1) vaccine with MF59 adjuvant. Field-site pharmacies mixed 3.75, 7.5, or 15 mcg of antigen with or without MF59 adjuvant just prior to intramuscular administration on days 0 and 21 of healthy adults aged 18–49 years. Results  Two hundred and seventy subjects were enrolled. After vaccination, titers of hemagglutination inhibition antibody ≥1:40 were achieved in 80% of subjects receiving 3.75 mcg + MF59 vs only 14% receiving 15 mcg without adjuvant (P < .0001). Peak hemagglutination inhibition antibody geometric mean titers for vaccine + MF59 were ∼65 regardless of antigen dose, and neutralizing titers were 2- to 3-fold higher. Vaccine + MF59 produced cross-reactive antibody responses against 4 heterologous H5N1 viruses. Excellent safety and tolerability were demonstrated. Conclusions  Point-of-use mixing of H5N1 antigen and MF59 adjuvant achieved target antibody titers in a high percentage of subjects and was safe. The feasibility of the point-of-use mixing should be studied further. PMID:25734170

  7. Universal influenza vaccines, science fiction or soon reality?

    PubMed

    de Vries, Rory D; Altenburg, Arwen F; Rimmelzwaan, Guus F

    2015-01-01

    Currently used influenza vaccines are only effective when the vaccine strains match the epidemic strains antigenically. To this end, seasonal influenza vaccines must be updated almost annually. Furthermore, seasonal influenza vaccines fail to afford protection against antigenically distinct pandemic influenza viruses. Because of an ever-present threat of the next influenza pandemic and the continuous emergence of drift variants of seasonal influenza A viruses, there is a need for an universal influenza vaccine that induces protective immunity against all influenza A viruses. Here, we summarize some of the efforts that are ongoing to develop universal influenza vaccines.

  8. [ADJUVANTED INFLUENZA VACCINES: DATA FROM DIRECT COMPARATIVE STUDIES].

    PubMed

    Chernikova, M I; Vasiliev, Yu M

    2015-01-01

    Vaccines are the cornerstone of influenza control, however available vaccines are subject to certain limitations. Adjuvanted vaccines are a promising approach, however available adjuvants have a suboptimal effectiveness and safety profile. Data from direct comparative trials are necessary for selection of optimal adjuvants among currently available and search for novel safe and effective adjuvants for next generation influenza vaccines. Data from published direct comparative studies of adjuvants for influenza vaccines are summarized, a lack of such studies is noted, especially those using adequate methods and designs and comparing adjuvants of major groups (nature/source and mechanism of action). Several promising approaches of adjuvant research and development could be identified: chitosan-based adjuvants, oil-in-water emulsions and multi-component formulations (depot + immune modulating components).

  9. Vaccine Safety Datalink

    Cancer.gov

    The Vaccine Safety Datalink is part of the National Immunization Program within the Centers for Disease Control and Prevention and was started in recognition of gaps in the scientific knowledge of rare vaccine side effects.

  10. DIVA vaccination strategies for avian influenza virus

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Vaccination for both low pathogenic and highly pathogenic avian influenza is commonly used for countries that have been endemic for avian influenza influenza virus, but stamping out policies are common for countries that are normally free of the disease. Stamping out policies of euthanizing infecte...

  11. Simulation study of the effect of influenza and influenza vaccination on risk of acquiring Guillain-Barré syndrome.

    PubMed

    Hawken, Steven; Kwong, Jeffrey C; Deeks, Shelley L; Crowcroft, Natasha S; McGeer, Allison J; Ducharme, Robin; Campitelli, Michael A; Coyle, Doug; Wilson, Kumanan

    2015-02-01

    It is unclear whether seasonal influenza vaccination results in a net increase or decrease in the risk for Guillain-Barré syndrome (GBS). To assess the effect of seasonal influenza vaccination on the absolute risk of acquiring GBS, we used simulation models and published estimates of age- and sex-specific risks for GBS, influenza incidence, and vaccine effectiveness. For a hypothetical 45-year-old woman and 75-year-old man, excess GBS risk for influenza vaccination versus no vaccination was -0.36/1 million vaccinations (95% credible interval -1.22% to 0.28) and -0.42/1 million vaccinations (95% credible interval, -3.68 to 2.44), respectively. These numbers represent a small absolute reduction in GBS risk with vaccination. Under typical conditions (e.g. influenza incidence rates >5% and vaccine effectiveness >60%), vaccination reduced GBS risk. These findings should strengthen confidence in the safety of influenza vaccine and allow health professionals to better put GBS risk in context when discussing influenza vaccination with patients.

  12. Simulation study of the effect of influenza and influenza vaccination on risk of acquiring Guillain-Barré syndrome.

    PubMed

    Hawken, Steven; Kwong, Jeffrey C; Deeks, Shelley L; Crowcroft, Natasha S; McGeer, Allison J; Ducharme, Robin; Campitelli, Michael A; Coyle, Doug; Wilson, Kumanan

    2015-02-01

    It is unclear whether seasonal influenza vaccination results in a net increase or decrease in the risk for Guillain-Barré syndrome (GBS). To assess the effect of seasonal influenza vaccination on the absolute risk of acquiring GBS, we used simulation models and published estimates of age- and sex-specific risks for GBS, influenza incidence, and vaccine effectiveness. For a hypothetical 45-year-old woman and 75-year-old man, excess GBS risk for influenza vaccination versus no vaccination was -0.36/1 million vaccinations (95% credible interval -1.22% to 0.28) and -0.42/1 million vaccinations (95% credible interval, -3.68 to 2.44), respectively. These numbers represent a small absolute reduction in GBS risk with vaccination. Under typical conditions (e.g. influenza incidence rates >5% and vaccine effectiveness >60%), vaccination reduced GBS risk. These findings should strengthen confidence in the safety of influenza vaccine and allow health professionals to better put GBS risk in context when discussing influenza vaccination with patients. PMID:25625590

  13. Coping with the influenza vaccine shortage.

    PubMed

    Mossad, Sherif B

    2004-12-01

    Faced with a shortage of the inactivated intramuscular influenza vaccine this year, the Centers for Disease Control and Prevention (CDC) has revised its guidelines for immunization and use of antiviral agents. The most rational solution at this time is to direct the supply of scarce vaccine to patients at highest risk of influenza-related complications. PMID:15641521

  14. Live attenuated influenza vaccine--a review.

    PubMed

    Gasparini, R; Amicizia, D; Lai, P L; Panatto, D

    2011-09-01

    Owing to the variability of influenza viruses, vaccine composition needs to be up-dated annually. As many variables can influence their efficacy, vaccines are still considered "sub-optimal". Many studies have been carried out in recent years to improve vaccines. In particular, researchers and vaccine-producing corporations have focused on developing a live vaccine. Among the candidate vaccines, the strain developed by Maassab has recently been licensed in the USA and Europe, after extensive investigation. This vaccine is safe and well tolerated, and has shown very good genetic stability. Although vaccine recipients are able to spread the virus, transmission to close contacts is practically non-existent. Studies on cold-adapted attenuated influenza vaccines have demonstrated that such vaccines are effective, and sometimes more effective than inactivated influenza vaccines. Cold-adapted attenuated influenza vaccines therefore appear to be an important weapon against influenza. However, a more widespread use of these vaccines is to be recommended, especially in children, as the more acceptable way of administration can favour parental compliance.

  15. Influenza vaccination status of healthcare workers and the extent of their domestic contact with individuals at high risk for influenza-related complications.

    PubMed

    Ong, A K; Srimanunthiphol, J; Frankel, R I

    2000-11-01

    Many healthcare workers have frequent household contact with persons at high risk for influenza-related complications. Educating healthcare workers about the risk of domestic transmission of influenza may improve their acceptance of influenza vaccination. Concerns regarding vaccine efficacy and safety also need to be addressed.

  16. Influenza Vaccines: A Moving Interdisciplinary Field

    PubMed Central

    Schotsaert, Michael; García-Sastre, Adolfo

    2014-01-01

    Vaccination is by far the most effective way of preventing morbidity and mortality due to infection of the upper respiratory tract by influenza virus. Current vaccines require yearly vaccine updates as the influenza virus can escape vaccine-induced humoral immunity due to the antigenic variability of its surface antigens. In case of a pandemic, new vaccines become available too late with current vaccine practices. New technologies that allow faster production of vaccine seed strains in combination with alternative production platforms and vaccine formulations may shorten the time gap between emergence of a new influenza virus and a vaccine becoming available. Adjuvants may allow antigen-sparing, allowing more people to be vaccinated with current vaccine production capacity. Adjuvants and universal vaccines can target immune responses to more conserved influenza epitopes, which eventually will result in broader protection for a longer time. In addition, further immunological studies are needed to gain insights in the immune features that contribute to protection from influenza-related disease and mortality, allowing redefinition of correlates of protection beyond virus neutralization in vitro. PMID:25302957

  17. Immunogenicity and safety of three 2010-2011 seasonal trivalent influenza vaccines in Chinese toddlers, children and older adults: a double-blind and randomized trial.

    PubMed

    Luo, Feng-Ji; Yang, Li-Qing; Ai, Xing; Bai, Yun-Hua; Wu, Jiang; Li, Shu-Ming; Zhang, Zheng; Lu, Min; Li, Li; Wang, Zhao-Yun; Shi, Nian-Min

    2013-08-01

    The 2009 influenza A(H1N1) pandemic strain was for the first time included in the 2010-2011 seasonal trivalent influenza vaccine (TIV). We conducted a double-blind, randomized trial in Chinese population to assess the immunogenicity and safety of the 2010-2011 TIV manufactured by GlaxoSmithKline and compared it with the counterpart vaccines manufactured by Sanofi Pasteur and Sinovac Biotech. Healthy toddlers (6-36 mo), children (6-12 y) and older adults (≥60 y) with 300 participants in each age group were enrolled to randomly receive two doses (toddlers, 28 d apart) or one dose (children and older adults). The immunogenicity was assessed by hemagglutination-inhibition (HI) assay. The solicited injection-site and systemic adverse events (AEs) were collected within 7 d after vaccination. All the three TIVs were well-tolerated with 15.1% of participants reporting AEs, most of which were mild. No serious AEs and unusual AEs were reported. Fever and pain were the most common systemic and injection-site AEs, respectively. The three TIVs showed good immunogenicity. The seroprotection rates against both H1N1 and H3N2 strains were more than 87% in toddlers after two doses and more than 95% in children and more than 86% in older adults after one dose. The seroprotection rates against B strain were 68-71% in toddlers after two doses, 70-74% in children and 69-72% in older adults after one dose. In conclusion, the three 2010-2011 TIVs had good immunogenicity and safety in Chinese toddlers, children and older adults and were generally comparable in immunogenicity and reactogenicity.

  18. Influenza vaccines and vaccinations in Poland - past, present and future.

    PubMed

    Brydak, Lidia B; Woźniak Kosek, Agnieszka; Nitsch-Osuch, Aneta

    2012-11-01

    Influenza causes seasonal infections worldwide that can lead to complications and deaths in every age group. The most effective and cheapest way to combat influenza is through vaccination. In many countries, including Poland, for each age group, the rate of vaccination against influenza is still at a very low level, which generates high social costs, not infrequently family tragedies in the case of irreversible complications of influenza, or death of a loved one. Regular vaccination should be part of good medical practice, as well as an individual's engagement in their own health and in that of their family. Based on numerous studies, it is estimated that the effectiveness of current inactivated influenza vaccine in reducing morbidity and mortality in high-risk groups ranges from 50-70%. According to data from the National Institute of Public Health-National Institute of Hygiene, the rate of vaccination in children in 2008 in Poland was very low. In the group of children aged from 6 months to 14 years, only 1.1-1.6% were vaccinated. Although influenza vaccination for people aged over 65 years was free of charge in many provinces in this group, only 13.4% of this population was immunized, while in the case of people with chronic diseases, only 11.1% were immunized. The vaccination rate among health care employees is an embarrassing 6.4%. More educational activities addressed to both medical professionals and patients are required in order to increase influenza vaccine coverage in Poland.

  19. Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given With and Without AS03 Adjuvant System in Healthy Adults and Older Persons

    PubMed Central

    Jackson, Lisa A.; Chen, Wilbur H.; Stapleton, Jack T.; Dekker, Cornelia L.; Wald, Anna; Brady, Rebecca C.; Edupuganti, Srilatha; Winokur, Patricia; Mulligan, Mark J.; Keyserling, Harry L.; Kotloff, Karen L.; Rouphael, Nadine; Noah, Diana L.; Hill, Heather; Wolff, Mark C.

    2012-01-01

    Background. Adjuvanted vaccines have the potential to improve influenza pandemic response. AS03 adjuvant has been shown to enhance the immune response to inactivated influenza vaccines. Methods. This trial was designed to evaluate the immunogenicity and safety of an inactivated 2009 H1N1 influenza vaccine at varying dosages of hemagglutinin with and without extemporaneously mixed AS03 adjuvant system in adults ≥18 years of age. Adults were randomized to receive 2 doses of 1 of 5 vaccine formulations (3.75 µg, 7.5 µg, or 15 µg with AS03 or 7.5 µg or 15 µg without adjuvant). Results. The study population included 544 persons <65 years of age and 245 persons ≥65 years of age. Local adverse events tended to be more frequent in the adjuvanted vaccine groups, but severe reactions were uncommon. In both age groups, hemagglutination inhibition antibody geometric mean titers after dose one were higher in the adjuvanted groups, compared with the 15 µg unadjuvanted group, and this difference was statistically significant for the comparison of the 15 µg adjuvanted group with the 15 µg unadjuvanted group. Conclusions. AS03 adjuvant system improves the immune response to inactivated 2009 H1N1 influenza vaccine in both younger and older adults and is generally well tolerated. ClinicalTrials.gov NCT00963157 PMID:22782949

  20. Advances in the vaccination of the elderly against influenza: role of a high-dose vaccine.

    PubMed

    Sullivan, Seth J; Jacobson, Robert; Poland, Gregory A

    2010-10-01

    On 23 December 2009, the US FDA approved Fluzone® High Dose, a high-dose formulation of the trivalent inactivated influenza vaccine, for prevention of influenza in people 65 years of age and older. As it was approved via an accelerated process designed to allow expeditious availability of safe and effective products with promise to treat or prevent serious or life-threatening diseases, the manufacturer is required to conduct further studies to demonstrate effectiveness. Although these studies are underway, a recently completed randomized, controlled trial demonstrated that this vaccine, containing four-times more hemagglutinin than standard-dose inactivated influenza vaccines, can produce an enhanced immunologic response in subjects of 65 years of age and older, while maintaining a favorable safety profile. This article introduces the vaccine, presents currently available safety and immunogenicity data, discusses current recommendations for use, and proposes what we can expect in the coming years.

  1. Safety and reactogenicity of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTPa-IPV/Hib) vaccine in healthy Vietnamese toddlers: An open-label, phase III study.

    PubMed

    Anh, Dang Duc; Van Der Meeren, Olivier; Karkada, Naveen; Assudani, Deepak; Yu, Ta-Wen; Han, Htay Htay

    2016-03-01

    The introduction of combination vaccines plays a significant role in increasing vaccine acceptance and widening vaccine coverage. Primary vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenza type b (Hib) diseases has been implemented in Vietnam. In this study we evaluated the safety and reactogenicity of combined diphtheria-tetanus-pertussis-inactivated polio (DTPa-IPV)/Hib vaccine when administered as a booster dose in 300 healthy Vietnamese children <2 years of age (mean age: 15.8 months). During the 4-day follow-up period, pain (31.7%) and redness (27.3%) were the most frequent solicited local symptoms. Pain (2%) was also the most frequent grade 3 local symptom. One subject reported 2 serious adverse events that were not causally related to the study vaccine. DTPa-IPV/Hib conjugate vaccine was well tolerated as a booster dose in healthy Vietnamese children aged <2 years.

  2. Safety and reactogenicity of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTPa-IPV/Hib) vaccine in healthy Vietnamese toddlers: An open-label, phase III study

    PubMed Central

    Anh, Dang Duc; Van Der Meeren, Olivier; Karkada, Naveen; Assudani, Deepak; Yu, Ta-Wen; Han, Htay Htay

    2016-01-01

    abstract The introduction of combination vaccines plays a significant role in increasing vaccine acceptance and widening vaccine coverage. Primary vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenza type b (Hib) diseases has been implemented in Vietnam. In this study we evaluated the safety and reactogenicity of combined diphtheria-tetanus-pertussis-inactivated polio (DTPa-IPV)/Hib vaccine when administered as a booster dose in 300 healthy Vietnamese children <2 years of age (mean age: 15.8 months). During the 4-day follow-up period, pain (31.7%) and redness (27.3%) were the most frequent solicited local symptoms. Pain (2%) was also the most frequent grade 3 local symptom. One subject reported 2 serious adverse events that were not causally related to the study vaccine. DTPa-IPV/Hib conjugate vaccine was well tolerated as a booster dose in healthy Vietnamese children aged <2 years. PMID:26337197

  3. Variable efficacy of repeated annual influenza vaccination.

    PubMed

    Smith, D J; Forrest, S; Ackley, D H; Perelson, A S

    1999-11-23

    Conclusions have differed in studies that have compared vaccine efficacy in groups receiving influenza vaccine for the first time to efficacy in groups vaccinated more than once. For example, the Hoskins study [Hoskins, T. W., Davis, J. R., Smith, A. J., Miller, C. L. & Allchin, A. (1979) Lancet i, 33-35] concluded that repeat vaccination was not protective in the long term, whereas the Keitel study [Keitel, W. A., Cate, T. R., Couch, R. B., Huggins, L. L. & Hess, K. R. (1997) Vaccine 15, 1114-1122] concluded that repeat vaccination provided continual protection. We propose an explanation, the antigenic distance hypothesis, and test it by analyzing seven influenza outbreaks that occurred during the Hoskins and Keitel studies. The hypothesis is that variation in repeat vaccine efficacy is due to differences in antigenic distances among vaccine strains and between the vaccine strains and the epidemic strain in each outbreak. To test the hypothesis, antigenic distances were calculated from historical hemagglutination inhibition assay tables, and a computer model of the immune response was used to predict the vaccine efficacy of individuals given different vaccinations. The model accurately predicted the observed vaccine efficacies in repeat vaccinees relative to the efficacy in first-time vaccinees (correlation 0.87). Thus, the antigenic distance hypothesis offers a parsimonious explanation of the differences between and within the Hoskins and Keitel studies. These results have implications for the selection of influenza vaccine strains, and also for vaccination strategies for other antigenically variable pathogens that might require repeated vaccination. PMID:10570188

  4. Variable efficacy of repeated annual influenza vaccination.

    PubMed

    Smith, D J; Forrest, S; Ackley, D H; Perelson, A S

    1999-11-23

    Conclusions have differed in studies that have compared vaccine efficacy in groups receiving influenza vaccine for the first time to efficacy in groups vaccinated more than once. For example, the Hoskins study [Hoskins, T. W., Davis, J. R., Smith, A. J., Miller, C. L. & Allchin, A. (1979) Lancet i, 33-35] concluded that repeat vaccination was not protective in the long term, whereas the Keitel study [Keitel, W. A., Cate, T. R., Couch, R. B., Huggins, L. L. & Hess, K. R. (1997) Vaccine 15, 1114-1122] concluded that repeat vaccination provided continual protection. We propose an explanation, the antigenic distance hypothesis, and test it by analyzing seven influenza outbreaks that occurred during the Hoskins and Keitel studies. The hypothesis is that variation in repeat vaccine efficacy is due to differences in antigenic distances among vaccine strains and between the vaccine strains and the epidemic strain in each outbreak. To test the hypothesis, antigenic distances were calculated from historical hemagglutination inhibition assay tables, and a computer model of the immune response was used to predict the vaccine efficacy of individuals given different vaccinations. The model accurately predicted the observed vaccine efficacies in repeat vaccinees relative to the efficacy in first-time vaccinees (correlation 0.87). Thus, the antigenic distance hypothesis offers a parsimonious explanation of the differences between and within the Hoskins and Keitel studies. These results have implications for the selection of influenza vaccine strains, and also for vaccination strategies for other antigenically variable pathogens that might require repeated vaccination.

  5. A public-professional web-bridge for vaccines and vaccination: user concerns about vaccine safety.

    PubMed

    García-Basteiro, Alberto L; Alvarez-Pasquín, María-José; Mena, Guillermo; Llupià, Anna; Aldea, Marta; Sequera, Victor-Guillermo; Sanz, Sergi; Tuells, Jose; Navarro-Alonso, José-Antonio; de Arísteguí, Javier; Bayas, José-María

    2012-05-28

    Vacunas.org (http://www.vacunas.org), a website founded by the Spanish Association of Vaccinology offers a personalized service called Ask the Expert, which answers any questions posed by the public or health professionals about vaccines and vaccination. The aim of this study was to analyze the factors associated with questions on vaccination safety and determine the characteristics of questioners and the type of question asked during the period 2008-2010. A total of 1341 questions were finally included in the analysis. Of those, 30% were related to vaccine safety. Questions about pregnant women had 5.01 higher odds of asking about safety (95% CI 2.82-8.93) than people not belonging to any risk group. Older questioners (>50 years) were less likely to ask about vaccine safety compared to younger questioners (OR: 0.44, 95% CI 0.25-0.76). Questions made after vaccination or related to influenza (including H1N1) or travel vaccines were also associated with a higher likelihood of asking about vaccine safety. These results identify risk groups (pregnant women), population groups (older people) and some vaccines (travel and influenza vaccines, including H1N1) where greater efforts to provide improved, more-tailored vaccine information in general and on the Internet are required.

  6. Safety review: squalene and thimerosal in vaccines.

    PubMed

    Montana, Marc; Verhaeghe, Pierre; Ducros, Caroline; Terme, Thierry; Vanelle, Patrice; Rathelot, Pascal

    2010-01-01

    Few studies show the reluctance of the people to get vaccinated against A (H1N1) influenza for fear of side effects of squalene (MF59, AS03, AF03) and thimerosal. The aim of this paper is to assess the safety in using these adjuvants and preservative reviewing data of clinical trials relative to which formulation includes these compounds. In the current state of knowledge, these vaccines have proved to be effective even though they more frequently give local adverse events than non-adjuvanted influenza vaccines. Systemic side effects are generally not serious. In the studies, adjuvanted vaccines do not increase neither the risk of Guillain Barre syndrome nor auto-immune diseases. There is no convincing evidence that exposure to thimerosal in vaccines had any deletorious effect on physiological outcome.

  7. Safety review: squalene and thimerosal in vaccines.

    PubMed

    Montana, Marc; Verhaeghe, Pierre; Ducros, Caroline; Terme, Thierry; Vanelle, Patrice; Rathelot, Pascal

    2010-01-01

    Few studies show the reluctance of the people to get vaccinated against A (H1N1) influenza for fear of side effects of squalene (MF59, AS03, AF03) and thimerosal. The aim of this paper is to assess the safety in using these adjuvants and preservative reviewing data of clinical trials relative to which formulation includes these compounds. In the current state of knowledge, these vaccines have proved to be effective even though they more frequently give local adverse events than non-adjuvanted influenza vaccines. Systemic side effects are generally not serious. In the studies, adjuvanted vaccines do not increase neither the risk of Guillain Barre syndrome nor auto-immune diseases. There is no convincing evidence that exposure to thimerosal in vaccines had any deletorious effect on physiological outcome. PMID:21176760

  8. How Experience Shapes Health Beliefs: The Case of Influenza Vaccination

    ERIC Educational Resources Information Center

    Shahrabani, Shosh; Benzion, Uri

    2012-01-01

    This study examines the impact of past experience with influenza and the influenza vaccine on four categories of the Health Belief Model: beliefs about susceptibility to contracting influenza, severity of illness, perceived benefits of the vaccine in preventing influenza, and perceived barriers to getting vaccinated. The study population comprised…

  9. The immunogenicity and safety of a single 0.5 mL dose of virosomal subunit influenza vaccine administered to unprimed children aged ≥6 to <36 months: data from a randomized, Phase III study.

    PubMed

    Esposito, Susanna; Marchisio, Paola; Montinaro, Valentina; Bianchini, Sonia; Weverling, Gerrit Jan; Pariani, Elena; Amendola, Antonella; Fabiano, Valentina; Pivetti, Valentina; Zanetti, Alessandro; Zuccotti, Gian Vincenzo

    2012-11-19

    This study evaluated the immunogenicity, safety and tolerability of a single 0.5 mL dose of the seasonal virosomal subunit influenza vaccine (Inflexal V, Crucell, Switzerland) in 205 healthy, unprimed children aged at least 6 to <36 months, evaluated at four weeks post-vaccination and seven months from baseline. Of the enrolled children, 102 received one single 0.5 mL dose and 103 received the standard two 0.25 mL doses given four weeks apart. Both treatments evoked an immune response that satisfied the EMA/CHMP criteria for yearly vaccine licensing for all three vaccine strains. Exploratory analyses revealed no differences between the groups at four weeks post-vaccination. Furthermore, immunogenicity was maintained seven months after the first vaccination after both the 0.5 mL and standard two 0.25 mL doses. Adverse events were comparable between groups and were as expected according to the safety profile of the vaccine; overall, the vaccine was well tolerated. Our results show that a single 0.5 mL dose effectively and safely provided long-term immunogenicity to all three influenza strains in unprimed children aged at least 6 to <36 months.

  10. [Influenza vaccination. Effectiveness of current vaccines and future challenges].

    PubMed

    Ortiz de Lejarazu, Raúl; Tamames, Sonia

    2015-01-01

    Seasonal influenza is an annual challenge for health-care systems, due to factors such as co-circulation of 2 influenza A subtypes jointly with 2 influenza B lineages; the antigenic drift of these virus, which eludes natural immunity, as well as immunity conferred by vaccination; together with influenza impact in terms of morbidity and mortality. Influenza vaccines have been available for more than 70 years and they have progressed in formulation, production and delivery route. Recommendations on vaccination are focused on those with a higher probability of severe disease, and have a progressively wider coverage, and classically based on inactivated vaccines, but with an increasing importance of attenuated live vaccines. More inactivated vaccines are becoming available, from adyuvanted and virosomal vaccines to intradermal delivery, cell-culture or quadrivalent. Overall vaccine effectiveness is about 65%, but varies depending on characteristics of vaccines, virus, population and the outcomes to be prevented, and ranges from less than 10% to almost 90%. Future challenges are formulations that confer more extensive and lasting protection, as well as increased vaccination coverage, especially in groups such as pregnant women and health-care professionals, as well as being extended to paediatrics.

  11. Development of Stable Influenza Vaccine Powder Formulations: Challenges and Possibilities

    PubMed Central

    Amorij, J-P.; Huckriede, A.; Wilschut, J.; Frijlink, H. W.

    2008-01-01

    Influenza vaccination represents the cornerstone of influenza prevention. However, today all influenza vaccines are formulated as liquids that are unstable at ambient temperatures and have to be stored and distributed under refrigeration. In order to stabilize influenza vaccines, they can be brought into the dry state using suitable excipients, stabilizers and drying processes. The resulting stable influenza vaccine powder is independent of cold-chain facilities. This can be attractive for the integration of the vaccine logistics with general drug distribution in Western as well as developing countries. In addition, a stockpile of stable vaccine formulations of potential vaccines against pandemic viruses can provide an immediate availability and simple distribution of vaccine in a pandemic outbreak. Finally, in the development of new needle-free dosage forms, dry and stable influenza vaccine powder formulations can facilitate new or improved targeting strategies for the vaccine compound. This review represents the current status of dry stable inactivated influenza vaccine development. Attention is given to the different influenza vaccine types (i.e. whole inactivated virus, split, subunit or virosomal vaccine), the rationale and need for stabilized influenza vaccines, drying methods by which influenza vaccines can be stabilized (i.e. lyophilization, spray drying, spray-freeze drying, vacuum drying or supercritical fluid drying), the current status of dry influenza vaccine development and the challenges for ultimate market introduction of a stable and effective dry-powder influenza vaccine. PMID:18338241

  12. 75 FR 48712 - Proposed Vaccine Information Materials for Influenza Vaccine

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-11

    ... beginning of the upcoming influenza vaccination season, the proposed materials included in this notice are... every year, and an annual vaccination is recommended. Each year scientists try to match the viruses in... doctor or nurse about whether to reschedule the vaccination. People with a mild illness can usually...

  13. Head-to-head comparison of an intradermal and a virosome influenza vaccine in patients over the age of 60: evaluation of immunogenicity, cross-protection, safety and tolerability.

    PubMed

    Ansaldi, Filippo; Orsi, Andrea; de Florentiis, Daniela; Parodi, Valentina; Rappazzo, Emanuela; Coppelli, Martina; Durando, Paolo; Icardi, Giancarlo

    2013-03-01

    In the present study we first compare immunogenicity against vaccine and heterologous circulating A(H1N1)pdm09 strains, tolerability and safety of intradermal Intanza 15 μg and of virosomal adjuvanted, intramuscularly delivered influenza vaccine, Inflexal V, in healthy elderly volunteers. Five-hundred participants were enrolled in the study and randomly assigned to the two vaccine groups to receive either one dose of Intanza 15 μg or Inflexal V vaccine. All subjects reported solicited local and systemic reactions occurred within 7 d after vaccination and unsolicited adverse events up to 21 d post-immunization and any serious adverse event appeared during the study. A subset of 55 participants was randomly selected for immunogenicity and cross-protection evaluations. Serum samples were collected before and 1 and 3 mo after immunization. Antibody responses were measured using hemagglutination inhibition (HI) against all viruses used in the study and neutralization (NT) assays against A(H1N1)pdm09 strains. At least one of the CHMP criteria for influenza vaccine approval in the elderly was met by virosomal vaccine against all the tested viruses; intradermal vaccine met all criteria against all strains. Several parameters of immune response against strains with a different antigenic pattern from that of vaccine A/California/04/09(H1N1)pdm09 were significantly higher in the intradermal vaccine group compared with the virosomal group. Safety and systemic tolerability of both vaccines were excellent, but injection site reactions occurred significantly more frequently in the intradermal vaccination group. Immunogenicity of Intanza 15 μg intradermal vaccine tended to be higher than that of Inflexal V against heterologous strains in healthy elderly.

  14. Principles underlying rational design of live attenuated influenza vaccines

    PubMed Central

    Jang, Yo Han

    2012-01-01

    Despite recent innovative advances in molecular virology and the developments of vaccines, influenza virus remains a serious burden for human health. Vaccination has been considered a primary countermeasure for prevention of influenza infection. Live attenuated influenza vaccines (LAIVs) are particularly attracting attention as an effective strategy due to several advantages over inactivated vaccines. Cold-adaptation, as a classical means for attenuating viral virulence, has been successfully used for generating safe and effective donor strains of LAIVs against seasonal epidemics and occasional pandemics. Recently, the advent of reverse genetics technique expedited a variety of rational strategies to broaden the pool of LAIVs. Considering the breadth of antigenic diversity of influenza virus, the pool of LAIVs is likely to equip us with better options for controlling influenza pandemics. With a brief reflection on classical attenuating strategies used at the initial stage of development of LAIVs, especially on the principles underlying the development of cold-adapted LAIVs, we further discuss and outline other attenuation strategies especially with respect to the rationales for attenuation, and their practicality for mass production. Finally, we propose important considerations for a rational vaccine design, which will provide us with practical guidelines for improving the safety and effectiveness of LAIVs. PMID:23596576

  15. Immunogenicity, safety and tolerability of monovalent 2009 pandemic influenza A/H1N1 MF59-adjuvanted vaccine in children and adolescents with Williams or Cornelia De Lange syndrome.

    PubMed

    Esposito, Susanna; Selicorni, Angelo; Daleno, Cristina; Valzano, Antonia; Cerutti, Marta; Galeone, Carlotta; Consolo, Silvia; Menni, Francesca; Principi, Nicola

    2011-06-01

    In some subjects with severe neurological diseases, a reduced immune response to seasonal influenza vaccine has been demonstrated. Patients with Williams or Cornelia de Lange syndrome frequently have abnormalities in neurodevelopment. This study has evaluated the immunogenicity, safety and tolerability of a monovalent 2009 pandemic influenza A/H1N1 MF59-adjuvanted vaccine in these subjects. Eighteen patients with Williams syndrome (ten males; mean age ± standard deviation [SD] 12.74 ± 4.49 years), 11 with Cornelia de Lange syndrome (six males; mean age 12.90 ± 4.85 years) and 30 age- and gender-matched healthy controls (16 males; mean age 12.49 ± 4.55 years), never vaccinated against influenza, received a dose of the vaccine between 1 and 30 November 2009. Four weeks later, the seroconversion rates in the three groups were between 72% and 80% and the seroprotection rates were 100%, with a similar increase in antibody levels. Two months later, most of the subjects remained seroconverted with no statistically significant difference between the groups, and about 94% of the patients with Williams syndrome, all of those with Cornelia de Lange syndrome and all of the healthy controls were still seroprotected. Safety and tolerability were very good, with no difference between the groups. None of the patients developed documented influenza during the study period. These results show that the immunogenicity, safety, and tolerability of a single dose of the monovalent 2009 pandemic influenza A/H1N1 MF59-adjuvanted vaccine in children and adolescents with Williams or Cornelia de Lange syndrome and moderate to severe mental disabilities is very good, and similar to that of healthy subjects.

  16. Influenza vaccination in Austria, 1982-2003.

    PubMed

    Kunze, Ursula; Groman, Ernest; Böhm, Gabriela; Kunze, Michael

    2007-01-01

    Since the past decade influenza vaccination is becoming an increasingly important aspect of public health programs. In the early 1990s independent investigators began to gather information on the comparative use of influenza vaccine in developed countries. The annual level of influenza vaccine distributed in each country was calculated as the number of doses distributed per 1000 total resident population. During the first period of research in 18 developed countries influenza vaccine was widely underused. From 1980 to 1992 the annual vaccination rates increased in most of the 18 countries. But Austria (Switzerland and Finland) showed little change (20 doses/1000 in 1982 and 23 doses in 1992). When in 1992-1995 four new countries were included, doses increased slightly in Austria, too, to about 52 doses/1000 in 1995, but the country still belonged to the low-use countries compared to Spain 160 doses/1000, although vaccination was recommended for all elderly people <65 years and persons with high-risk medical conditions. Self-payment was usual, and there was no reimbursement within the national or social health insurance schemes. From 1996 (77 doses/1000), to 2000 (118 doses/1000) and 2003 (127 doses/1000), vaccination increased slightly, but Austria remained one of the lowest three Western European countries reported, together with Sweden (127) and Norway (102). Possible reasons for the low usage in Austria may be the following: people mistake influenza for an influenza-like illness, a lack of effective social marketing, costs are not taken over by social or private insurance and discordance in the Austrian medical fraternity about the importance of vaccination. Especially in view of a possible new influenza pandemic, public awareness of the importance of vaccination must increase. PMID:17427004

  17. Influenza vaccines: from whole virus preparations to recombinant protein technology.

    PubMed

    Huber, Victor C

    2014-01-01

    Vaccination against influenza represents our most effective form of prevention. Historical approaches toward vaccine creation and production have yielded highly effective vaccines that are safe and immunogenic. Despite their effectiveness, these historical approaches do not allow for the incorporation of changes into the vaccine in a timely manner. In 2013, a recombinant protein-based vaccine that induces immunity toward the influenza virus hemagglutinin was approved for use in the USA. This vaccine represents the first approved vaccine formulation that does not require an influenza virus intermediate for production. This review presents a brief history of influenza vaccines, with insight into the potential future application of vaccines generated using recombinant technology.

  18. Is Systemic Lupus Erythematosus Associated With a Declined Immunogenicity and Poor Safety of Influenza Vaccination?: A Systematic Review and Meta-Analysis.

    PubMed

    Huang, Yafang; Wang, Huili; Wan, Ling; Lu, Xiaoqin; Tam, Wilson W S

    2016-05-01

    There are conflicts on whether influenza vaccinated systemic lupus erythematosus (SLE) patients are associated with a decreased immunogenicity and safety, compared with healthy controls. We conducted meta-analyses to compare SLE patients with healthy controls for flu-vaccine immunogenicity, as well as for adverse events.PubMed, MEDLINE, and Cochrane Library were searched by October 15, 2015. Studies were included when they met the inclusion criteria. Two reviewers independently extracted data on study characteristics, methodological quality, and outcomes. The primary outcome was seroprotection (SP) rate after immunization.A total of 15 studies were included. There were significant differences in SP rates between the SLE patients and healthy controls, respectively, for H1N1 (RR 0.79, 95% CI 0.73-0.87) and B strain (RR 0.75, 95% CI 0.65-0.87), but not for H3N2 (RR 0.84, 95% CI 0.68-1.03). Subgroup analyses demonstrated SLE patients with immunosuppressants, corticosteroids, azathioprine and prednisone had significantly lower SP rates, compared with healthy controls. SLE patients with nonadjuvanted H1N1 vaccine had significantly lower SP rate, compared with healthy controls. SLE patients were not associated with increased adverse events (RR 1.88, 95% CI 0.94-3.77).SLE generates immunogenicity differently, compared with healthy controls in pandemic H1N1 and B strains, but same in seasonal H3N2 strain. Nonadjuvant and special kind of immunosuppressive biologics can play an important role in SLE immunogenicity to flu vaccine. There is no significant difference in adverse event rates between SLE patients and healthy controls. PMID:27175678

  19. Economic benefits of inactivated influenza vaccines in the prevention of seasonal influenza in children

    PubMed Central

    Salleras, Luis; Navas, Encarna; Torner, Nuria; Prat, Andreu A.; Garrido, Patricio; Soldevila, Núria; Domínguez, Angela

    2013-01-01

    The aim of this study was to systematically review published studies that evaluated the efficiency of inactivated influenza vaccination in preventing seasonal influenza in children. The vaccine evaluated was the influenza-inactivated vaccine in 10 studies and the virosomal inactivated vaccine in 3 studies. The results show that yearly vaccination of children with the inactivated influenza vaccine saves money from the societal and family perspectives but not from the public or private provider perspective. When vaccination does not save money, the cost-effectiveness ratios were very acceptable. It can be concluded, that inactivated influenza vaccination of children is a very efficient intervention. PMID:23295894

  20. A review of the changes to the licensing of influenza vaccines in Europe.

    PubMed

    Wijnans, Leonoor; Voordouw, Bettie

    2016-01-01

    In 2014, the European Committee for Medicinal Products for Human Use (CHMP) published a draft regulatory guideline for the evaluation of influenza vaccines. Following a public consultation round, the final guidance will be published in the near future. Here, we highlight the main changes in the clinical section in this guideline and discuss the background to these changes and whether the new consolidated guidance document can be expected to achieve a better understanding of the performance of seasonal, zoonotic and pandemic influenza vaccines during the regulatory licensing process. The new influenza guideline reflects a changed approach to the regulatory assessment of influenza vaccines, resulting in the abolition of serological criteria, known as the CHMP criteria, which have been the mainstay for evaluating the influenza vaccine immunogenicity for several decades. The new guideline adopts a more diversified approach to the measurement and reporting of the immune response to influenza vaccines and sets a requirement to conduct clinical outcome trials in young children. Importantly, more emphasis is placed on the post-licensure monitoring of the benefit risk of influenza vaccines, including a request for continuous monitoring of efficacy and enhanced safety surveillance. Despite the improvements these new requirements will expectedly bring to the regulatory assessment of influenza vaccines, major challenges remain which cannot be overcome by new guidance alone. Ongoing initiatives in which academia, manufacturers, public health institutes and regulators work together to address these challenges are central to the development of robust tools to evaluate and monitor performance of influenza vaccines in the future.

  1. [Influenza vaccine: globalization of public health stakes].

    PubMed

    Collin, N; Briand, S

    2009-08-01

    On June 11, 2009, Dr. Margaret Chan, Director-General of the World Health Organization (WHO), declared the first influenza pandemic of the 21st century. It was the first time in history that an influenza outbreak had been tracked in real-time from the emergence of a new strain of influenza A (H1N1) up to its spread to all continents over a period of 9 weeks. In recent years the international community has been working closely to prepare for such situations. A notable example of this cooperation occurred in response to the threat posed by the highly pathogenic avian influenza A virus (H5N1). Vaccine availability is a major challenge that will require increasing worldwide production and ensuring a widespread access. In this regard it is important to underline the fact that 70% of influenza vaccine is produced in Europe and the United States. In 2006 WHO implemented a global pandemic influenza action plan (GAP) aiming at increasing the world's production capacity for pandemic vaccine. The GAP contains three elements: (1) increased use of seasonal influenza vaccination in industrialized and developing countries (resolution WHA 56.19). (2) technology transfer. (3) development of new production technologies. Nevertheless numerous barriers still prevent people living in developing countries from rapid and fair access to pandemic influenza vaccine. Capacity for production of pandemic vaccine is limited and advanced purchase agreements between industrialized countries and vaccine manufacturers reduce potential access of developing countries to pandemic vaccine. Economic and logistic factors also limit global access to pandemic vaccine. Therefore, WHO is working with industrialized countries, pharmaceutical companies and the international community as a whole to promote global solidarity and cooperation and thus ensure distribution of pandemic vaccine in poor countries with no local production. The current pandemic situation highlights the increasing globalization of public

  2. Geographic Prioritization of Distributing Pandemic Influenza Vaccines

    PubMed Central

    Galvani, Alison; Meyers, Lauren A

    2014-01-01

    Pandemic influenza is an international public health concern. In light of the persistent threat of H5N1 avian influenza and the recent pandemic of A/H1N1swine influenza outbreak, public health agencies around the globe are continuously revising their preparedness plans. The A/H1N1 pandemic of 2009 demonstrated that influenza activity and severity might vary considerably among age groups and locations, and the distribution of an effective influenza vaccine may be significantly delayed and staggered. Thus, pandemic influenza vaccine distribution policies should be tailored to the demographic and spatial structures of communities. Here, we introduce a bi-criteria decision-making framework for vaccine distribution policies that is based on a geospatial and demographically-structured model of pandemic influenza transmission within and between counties of Arizona in the Unites States. Based on data from the 2009–2010 H1N1 pandemic, the policy predicted to reduce overall attack rate most effectively is prioritizing counties expected to experience the latest epidemic waves (a policy that may be politically untenable). However, when we consider reductions in both the attack rate and the waiting period for those seeking vaccines, the widely adopted pro rata policy (distributing according to population size) is also predicted to be an effective strategy. PMID:22618029

  3. Advancements in the development of subunit influenza vaccines

    PubMed Central

    Zhang, Naru; Zheng, Bo-Jian; Lu, Lu; Zhou, Yusen; Jiang, Shibo; Du, Lanying

    2014-01-01

    The ongoing threat of influenza epidemics and pandemics has emphasized the importance of developing safe and effective vaccines against infections from divergent influenza viruses. In this review, we first introduce the structure and life cycle of influenza A viruses, describing major influenza A virus-caused pandemics. We then compare different types of influenza vaccines and discuss current advancements in the development of subunit influenza vaccines, particularly those based on nucleoprotein (NP), extracellular domain of matrix protein 2 (M2e) and hemagglutinin (HA) proteins. We also illustrate potential strategies for improving the efficacy of subunit influenza vaccines. PMID:25529753

  4. Advancements in the development of subunit influenza vaccines.

    PubMed

    Zhang, Naru; Zheng, Bo-Jian; Lu, Lu; Zhou, Yusen; Jiang, Shibo; Du, Lanying

    2015-02-01

    The ongoing threat of influenza epidemics and pandemics has emphasized the importance of developing safe and effective vaccines against infections from divergent influenza viruses. In this review, we first introduce the structure and life cycle of influenza A viruses, describing major influenza A virus-caused pandemics. We then compare different types of influenza vaccines and discuss current advancements in the development of subunit influenza vaccines, particularly those based on nucleoprotein (NP), extracellular domain of matrix protein 2 (M2e) and hemagglutinin (HA) proteins. We also illustrate potential strategies for improving the efficacy of subunit influenza vaccines.

  5. Vaccination coverage among adults, excluding influenza vaccination - United States, 2013.

    PubMed

    Williams, Walter W; Lu, Peng-Jun; O'Halloran, Alissa; Bridges, Carolyn B; Kim, David K; Pilishvili, Tamara; Hales, Craig M; Markowitz, Lauri E

    2015-02-01

    Vaccinations are recommended throughout life to prevent vaccine-preventable diseases and their sequelae. Adult vaccination coverage, however, remains low for most routinely recommended vaccines and below Healthy People 2020 targets. In October 2014, the Advisory Committee on Immunization Practices (ACIP) approved the adult immunization schedule for 2015. With the exception of influenza vaccination, which is recommended for all adults each year, other adult vaccinations are recommended for specific populations based on a person's age, health conditions, behavioral risk factors (e.g., injection drug use), occupation, travel, and other indications. To assess vaccination coverage among adults aged ≥19 years for selected vaccines, CDC analyzed data from the 2013 National Health Interview Survey (NHIS). This report highlights results of that analysis for pneumococcal, tetanus toxoid-containing (tetanus and diphtheria vaccine [Td] or tetanus and diphtheria with acellular pertussis vaccine [Tdap]), hepatitis A, hepatitis B, herpes zoster (shingles), and human papillomavirus (HPV) vaccines by selected characteristics (age, race/ethnicity,† and vaccination indication). Influenza vaccination coverage estimates for the 2013-14 influenza season have been published separately. Compared with 2012, only modest increases occurred in Tdap vaccination among adults aged ≥19 years (a 2.9 percentage point increase to 17.2%), herpes zoster vaccination among adults aged ≥60 years (a 4.1 percentage point increase to 24.2%), and HPV vaccination among males aged 19-26 years (a 3.6 percentage point increase to 5.9%); coverage among adults in the United States for the other vaccines did not improve. Racial/ethnic disparities in coverage persisted for all six vaccines and widened for Tdap and herpes zoster vaccination. Increases in vaccination coverage are needed to reduce the occurrence of vaccine-preventable diseases among adults. Awareness of the need for vaccines for adults is low

  6. Influenza vaccination in children with cystic fibrosis.

    PubMed

    Patria, Maria Francesca; Longhi, Benedetta; Esposito, Susanna

    2013-04-01

    Cystic fibrosis (CF) is an inherited autosomal recessive disease characterized by progressive pulmonary damage and respiratory failure. It is known that bacterial infections play a critical role in the development of significant lung damage, whereas the role of respiratory viruses in CF pulmonary exacerbations and the relationship between viral infections and the progression of lung damage are uncertain. Health authorities throughout the world recommend influenza vaccination for CF patients. The aim of this review is to analyze the impact of seasonal and pandemic influenza on CF patients and data concerning influenza vaccination in order to assess the current situation and identify areas for future study. As data are limited, further well-constructed clinical studies of the effectiveness of influenza vaccination on the main clinical outcome measures of pulmonary function and nutritional status in patients with CF are required.

  7. [Research progress and prospect of universal influenza vaccine].

    PubMed

    Luo, Dong-Yu; Xue, Chun-Yi; Cao, Yong-Chang

    2013-11-01

    The constant outbreaks of influenza in a global scale have aroused great concern all over the world. Vaccine has been the most effective and economic means against influenza. However, the broad tropism and high mutation of influenza viruses have limited the effectiveness of influenza vaccines. Current influenza virus vaccines provide effective protection against virus strains that are identical or highly similar to the vaccine strain. Once a highly mutated or new strain of influenza virus appears, the current vaccine would lose its effectiveness. Therefore, the development of a universal vaccine against highly mutated or new influenza virus subtypes has become a hot spot in the field of influenza vaccine research. The major methods of developing the universal influenza vaccine are to select a conserved protein of influenza virus as an antigen. At least three universal influenza vaccines have been tested in clinical trials. Moreover, changing the routes of vaccine immunization and immunization schemes could also improve the effect of heterosubtypic immunity. This review summarized the research progresses of universal influenza vaccines and provided our prospective on universal influenza vaccine research.

  8. Influenza update 2007-2008: vaccine advances, pandemic preparation.

    PubMed

    Mossad, Sherif B

    2007-12-01

    Influenza vaccination remains our best measure to prevent epidemic and pandemic influenza. We must continue to improve vaccination rates for targeted populations. Antiviral options are currently limited to the neuraminidase inhibitors. PMID:18183839

  9. DIVA vaccination strategies for avian influenza virus.

    PubMed

    Suarez, David L

    2012-12-01

    Vaccination for both low pathogenicity avian influenza and highly pathogenic avian influenza is commonly used by countries that have become endemic for avian influenza virus, but stamping-out policies are still common for countries with recently introduced disease. Stamping-out policies of euthanatizing infected and at-risk flocks has been an effective control tool, but it comes at a high social and economic cost. Efforts to identify alternative ways to respond to outbreaks without widespread stamping out has become a goal for organizations like the World Organisation for Animal Health. A major issue with vaccination for avian influenza is trade considerations because countries that vaccinate are often considered to be endemic for the disease and they typically lose their export markets. Primarily as a tool to promote trade, the concept of DIVA (differentiate infected from vaccinated animals) has been considered for avian influenza, but the goal for trade is to differentiate vaccinated and not-infected from vaccinated and infected animals because trading partners are unwilling to accept infected birds. Several different strategies have been investigated for a DIVA strategy, but each has advantages and disadvantages. A review of current knowledge on the research and implementation of the DIVA strategy will be discussed with possible ways to implement this strategy in the field. The increased desire for a workable DIVA strategy may lead to one of these ideas moving from the experimental to the practical.

  10. The search for the ideal influenza vaccine.

    PubMed Central

    Davenport, F. M.

    1979-01-01

    The history of the development of influenza virus vaccine is traced from its origin with experimental studies of influenza virus in ferrets and mice and the first trials in man. Knowledge of the basis of immunity to the viruses in experimental animals and in man has grown steadily over the years and has been essential to successful immunization. Virus variation affecting the surface antigens of the virus is seen as the principal obstacle to the application of vaccines in man. So significant are the changes occurring during antigenic drift that former concepts of a polyvalent vaccine cannot provide a solution of the problem of the composition of vaccines. Disrupted virus vaccines appear to provide the answer to the prevention of vaccine reactions. PMID:461277

  11. [Implementation of seasonal influenza and human papillomavirus vaccination recommendations in gynecological practices in Germany].

    PubMed

    Bödeker, Birte; Seefeld, Linda; Buck, Stephanie; Ommen, Oliver; Wichmann, Ole

    2016-03-01

    In Germany, seasonal influenza vaccination has been recommended for pregnant women since 2010 and human papillomavirus (HPV) vaccination for girls since 2007. Gynecologists play an important role in the communication and vaccination of these two target groups. Moreover, seasonal influenza vaccination is also recommended for healthcare workers, as well as adults aged ≥ 60 years and individuals with underlying chronic diseases. The aim of this study was to gain first insights into the acceptance and implementation of the seasonal influenza und HPV vaccination recommendations in gynecological practices. In the context of the national influenza immunization campaign-which is jointly carried out by the Robert Koch Institute (RKI) and the Federal Centre for Health Education (BZgA)-a questionnaire was sent together with influenza information kits to 7477 gynecologists in September 2014. Data from 1469 (20 %) gynecologists were included in the analysis. 72 % of respondents reported that they themselves received a seasonal influenza shot each year. The majority of gynecologists recommended seasonal influenza vaccination for pregnant women (93 %) and HPV vaccination for girls (97 %). The most commonly stated reasons against influenza vaccination were safety concerns. Those against HPV vaccination were effectiveness concerns. Additionally, for both vaccinations the provision of vaccine-related information to the patient was considered too time consuming.The high acceptance of seasonal influenza and HPV vaccination among gynecologists is discordant with the available vaccination coverage figures in Germany. Gynecologists must be reminded of their important role in the prevention of vaccine-preventable diseases in adolescents and adult women. Immunization and communication skills should be considered more strongly as an integral part of medical education and further training for gynecologists.

  12. Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children: A randomized, controlled study

    PubMed Central

    Iwata, Satoshi; Kawamura, Naohisa; Kuroki, Haruo; Tokoeda, Yasunobu; Miyazu, Mitsunobu; Iwai, Asayuki; Oishi, Tomohiro; Sato, Tomohide; Suyama, Akari; François, Nancy; Shafi, Fakrudeen; Ruiz-Guiñazú, Javier; Borys, Dorota

    2015-01-01

    This phase III, randomized, open-label, multicenter study (NCT01027845) conducted in Japan assessed the immunogenicity, safety, and reactogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, given intramuscularly) co-administered with diphtheria-tetanus-acellular pertussis vaccine (DTPa, given subcutaneously). Infants (N=360 ) were randomized (2:1) to receive either PHiD-CV and DTPa (PHiD-CV group) or DTPa alone (control group) as 3-dose primary vaccination (3–4–5 months of age) and booster vaccination (17–19 months of age). Immune responses were measured before and one month after primary/booster vaccination and adverse events (AEs) were recorded. Post-primary immune responses were non-inferior to those in pivotal/efficacy European or Latin American pneumococcal protein D-conjugate vaccine studies. For each PHiD-CV serotype, at least 92.6% of infants post-primary vaccination and at least 97.7% of children post-booster had pneumococcal antibody concentrations ≥0.2 μg/ml, and at least 95.4% post-primary and at least 98.1% post-booster had opsonophagocytic activity (OPA) titers ≥8 . Geometric mean antibody concentrations and OPA titers (except OPA titer for 6B) were higher post-booster than post-priming for each serotype. All PHiD-CV-vaccinated children had anti-protein D antibody concentrations ≥100 EL.U/ml one month post-primary/booster vaccination and all were seroprotected/seropositive against each DTPa antigen. Redness and irritability were the most common solicited AEs in both groups. Incidences of unsolicited AEs were comparable between groups. Serious AEs were reported for 47 children (28 in PHiD-CV group); none were assessed as vaccine-related. In conclusion, PHiD-CV induced robust immune responses and was well tolerated when co-administered with DTPa in a 3-dose priming plus booster regimen to Japanese children. PMID:25830489

  13. Influenza Vaccinations, Fall 2009: Model School-Located Vaccination Clinics

    ERIC Educational Resources Information Center

    Herl Jenlink, Carolyn; Kuehnert, Paul; Mazyck, Donna

    2010-01-01

    The 2009 H1N1 influenza virus presented a major challenge to health departments, schools, and other community partners to effectively vaccinate large numbers of Americans, primarily children. The use of school-located vaccination (SLV) programs to address this challenge led health departments and schools to become creative in developing models for…

  14. Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial

    PubMed Central

    Kang, Kyuri; Han, Seunghoon; Hong, Taegon; Jeon, Sangil; Paek, Jeongki; Kang, Jin Han

    2016-01-01

    Purpose A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalent inactivated split influenza vaccine (TIV) in Korea. Materials and Methods The TIV was administered to 43 healthy male adults. Subjects with high pre-existing titers were excluded in a screening step. Immune response was measured by a hemagglutination inhibition (HI) assay. Results The seroprotection rates against A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2009 were 74.42% [95% confidence interval (CI): 61.38–87.46], 72.09% (95% CI: 58.69–85.50), and 86.05% (95% CI: 75.69–96.40), respectively. Calculated seroconversion rates were 74.42% (95% CI: 61.38–87.46), 74.42% (95% CI: 61.38–87.46), and 79.07% (95% CI: 66.91–91.23), respectively. There were 25 episodes of solicited local adverse events in 21 subjects (47.73%), 21 episodes of solicited general adverse events in 16 subjects (36.36%) and 5 episodes of unsolicited adverse events in 5 subjects (11.36%). All adverse events were grade 1 or 2 and disappeared within three days. Conclusion The immunogenicity and safety of TIV established in this phase I trial are sufficient to plan a larger scale clinical trial. PMID:27593862

  15. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010.

    PubMed

    Fiore, Anthony E; Uyeki, Timothy M; Broder, Karen; Finelli, Lyn; Euler, Gary L; Singleton, James A; Iskander, John K; Wortley, Pascale M; Shay, David K; Bresee, Joseph S; Cox, Nancy J

    2010-08-01

    This report updates the 2009 recommendations by CDC's Advisory Committee on Immunization Practices (ACIP) regarding the use of influenza vaccine for the prevention and control of influenza (CDC. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2009;58[No. RR-8] and CDC. Use of influenza A (H1N1) 2009 monovalent vaccine---recommendations of the Advisory Committee on Immunization Practices [ACIP], 2009. MMWR 2009;58:[No. RR-10]). The 2010 influenza recommendations include new and updated information. Highlights of the 2010 recommendations include 1) a recommendation that annual vaccination be administered to all persons aged >or=6 months for the 2010-11 influenza season; 2) a recommendation that children aged 6 months--8 years whose vaccination status is unknown or who have never received seasonal influenza vaccine before (or who received seasonal vaccine for the first time in 2009-10 but received only 1 dose in their first year of vaccination) as well as children who did not receive at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine regardless of previous influenza vaccine history should receive 2 doses of a 2010-11 seasonal influenza vaccine (minimum interval: 4 weeks) during the 2010--11 season; 3) a recommendation that vaccines containing the 2010-11 trivalent vaccine virus strains A/California/7/2009 (H1N1)-like (the same strain as was used for 2009 H1N1 monovalent vaccines), A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens be used; 4) information about Fluzone High-Dose, a newly approved vaccine for persons aged >or=65 years; and 5) information about other standard-dose newly approved influenza vaccines and previously approved vaccines with expanded age indications. Vaccination efforts should begin as soon as the 2010-11 seasonal influenza vaccine is available and continue through the influenza season. These recommendations also include a summary of safety data

  16. An international technology platform for influenza vaccines.

    PubMed

    Hendriks, Jan; Holleman, Marit; de Boer, Otto; de Jong, Patrick; Luytjes, Willem

    2011-07-01

    Since 2008, the World Health Organization has provided seed grants to 11 manufacturers in low- and middle-income countries to establish or improve their pandemic influenza vaccine production capacity. To facilitate this ambitious project, an influenza vaccine technology platform (or "hub") was established at the Netherlands Vaccine Institute for training and technology transfer to developing countries. During its first two years of operation, a robust and transferable monovalent pilot process for egg-based inactivated whole virus influenza A vaccine production was established under international Good Manufacturing Practice standards, as well as in-process and release assays. A course curriculum was designed, including a two-volume practical handbook on production and quality control. Four generic hands-on training courses were successfully realized for over 40 employees from 15 developing country manufacturers. Planned extensions to the curriculum include cell-culture based technology for viral vaccine production, split virion influenza production, and generic adjuvant formulation. We conclude that technology transfer through the hub model works well, significantly builds vaccine manufacturing capacity in developing countries, and thereby increases global and equitable access to vaccines of high public health relevance.

  17. Human vaccination experiments with Asian influenza vaccine in Japan

    PubMed Central

    Fukumi, Hideo

    1959-01-01

    Details are given of a number of experiments, carried out in 1957 in Japan among high school students, factory workers and student nurses and in military camps, to test the efficacy of Asian influenza vaccine at various strengths and doses and prepared from different virus strains. The Asian influenza virus strains used were A/Adachi/2/57, A/Kumamoto/Y5/57 and A/Kumamoto/K9/57. Results were tested by the haemagglutination-inhibition reaction. Antibody response to Adachi-strain vaccine was very satisfactory, particularly when inoculated at a strength of 300 CCA units per ml in two doses of 0.5 ml each. Monovalent Adachi-strain vaccine gave better results than a trivalent vaccine containing Adachi strain, an earlier A strain and a B strain in equal amounts. Vaccine prepared from the Y5 strain, considered representative of extreme Q-phase virus, was less effective than Adachi vaccine. PMID:13651919

  18. Public health and economic impact of seasonal influenza vaccination with quadrivalent influenza vaccines compared to trivalent influenza vaccines in Europe

    PubMed Central

    Uhart, Mathieu; Bricout, Hélène; Clay, Emilie; Largeron, Nathalie

    2016-01-01

    ABSTRACT Influenza B strains represent on average 23% of all circulating strains in Europe and when there is a vaccine mismatch on B strains, additional influenza-related hospitalizations and deaths as well as substantial additional costs are observed. The objective was to estimate the public health and economic impact of seasonal influenza vaccination with quadrivalent influenza vaccines (QIV) compared to trivalent influenza vaccines (TIV) in Europe (EU). Based on data from 5 EU countries (France, Germany, Italy, Spain and UK) during 10 influenza seasons from 2002 to 2013, epidemiological and associated economic outcomes were estimated for each season for the actual scenario where the TIV was used, and for a hypothetical scenario where QIV could have been used instead. By using QIV, this study estimated that for the 5 EU countries, an additional 1.03 million (327.9/100,000 inhabitants) influenza cases, 453,000 (143.9/100,000) general practitioners consultations, 672,000 (213.1/100,000) workdays lost, 24,000 (7.7/100,000) hospitalizations and 10,000 (3.1/100,000) deaths could have been avoided compared to the use of TIV over the 10-seasons-period. This study estimates that QIV can be of economic value since from a societal perspective 15 million Euros would have been saved on general practitioners consultations (14 million Euros from third-party payer perspective), 77 million on hospitalizations (74 million Euros from third-party payer perspective) and 150 million Euros on workdays lost, across the 5 EU countries. In conclusion, the present study estimates that, compared to TIV, QIV may result in a substantial decrease in epidemiological burden and in influenza-related costs. PMID:27166916

  19. Influenza Plasmid DNA Vaccines: Progress and Prospects.

    PubMed

    Bicho, Diana; Queiroz, João António; Tomaz, Cândida Teixeira

    2015-01-01

    Current influenza vaccines have long been used to fight flu infectious; however, recent advances highlight the importance of produce new alternatives. Even though traditional influenza vaccines are safe and usually effective, they need to be uploaded every year to anticipate circulating flu viruses. This limitation together with the use of embryonated chicken eggs as the substrate for vaccine production, is time-consuming and could involve potential biohazards in growth of new virus strains. Plasmid DNA produced by prokaryote microorganisms and encoding foreign proteins had emerged as a promising therapeutic tool. This technology allows the expression of a gene of interest by eukaryotic cells in order to induce protective immune responses against the pathogen of interest. In this review, we discuss the strategies to choose the best DNA vaccine to be applied in the treatment and prevention of influenza. Specifically, we give an update of influenza DNA vaccines developments, all involved techniques, their main characteristics, applicability and technical features to obtain the best option against influenza infections.

  20. 76 FR 78658 - Webinar Overview of the National Vaccine Advisory Committee Healthcare Personnel Influenza...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ... Influenza Vaccination Subgroup's Draft Report and Draft Recommendations for Achieving the Healthy People 2020 Annual Coverage Goals for Influenza Vaccination in Healthcare Personnel AGENCY: National Vaccine... of the National Vaccine Advisory Committee (NVAC), Healthcare Personnel Influenza...

  1. Modeling the effects of annual influenza vaccination

    SciTech Connect

    Smith, D.J.; Ackley, D.H.; Forrest, S.; Perelson, A.S.

    1998-12-31

    Although influenza vaccine efficacy is 70--90% in young healthy first-time vaccinees, the efficacy in repeat vaccinees has varied considerably. In some studies, vaccine efficacy in repeat vaccinees was higher than in first-time vaccinees, whereas in other studies vaccine efficacy in repeat vaccinees was significantly lower than in first-time vaccinees and sometimes no higher than in unvaccinated controls. It is known that the closeness of the antigenic match between the vaccine strain and the epidemic virus is important for vaccine effectiveness. In this study the authors show that the antigenic differences between a first vaccine strain and a second vaccine strain, and between the first vaccine strain and the epidemic strain, might account for the observed variation in attack rate among two-time vaccinees.

  2. Epidemiological and clinical reasons for vaccination against pertussis and influenza in pregnant women.

    PubMed

    Nitsch-Osuch, Aneta; Korzeniewski, Krzysztof; Gawlak, Maciej; Życińska, Katarzyna; Wardyn, Kazimierz; Kuchar, Ernest

    2015-01-01

    Vaccinations in pregnancy are an important aspect of prenatal care for improving both maternal health and neonatal outcomes. Despite the fact that protection against some infectious diseases for pregnant women can be easily provided through immunizations, current coverage rates are low. Two vaccines are notably recommended during pregnancy: influenza and the combined tetanus, diphtheria and acellular pertussis (Tdap) vaccine. In this review the authors discuss current recommendations for vaccination against pertussis and influenza in pregnant women in terms of epidemiological, clinical, and immunological reasons, taking into account safety and effectiveness. Promoting patients' awareness about pertussis and influenza and encouraging general practitioners, nurses and obstetricians to recommend the pertussis booster and influenza vaccine will hopefully increase the number of pregnant women who choose to become vaccinated. PMID:25398316

  3. Quality control of seasonal influenza vaccines.

    PubMed

    Mandušić Nazor, Tamara; Pipić Kosanović, Marta; Tomić, Siniša

    2010-12-01

    The purpose of seasonal influenza vaccination is to prevent its spread. The vaccines contain strains of the influenza virus recommended and approved for a particular season. Just like any other medicinal product, all vaccines require marketing approval. Batches of approved vaccines are extensively tested by the manufacturers and additionally controlled by the approving authorities, which issue the quality control certificates. This article not only to describes the legal background of quality control, but also how control test results obtained by a Croatian official control laboratory are compared to manufacturer's results. We have found that testing results can slightly differ depending on methods/analytical procedures used in different laboratories. This investigation has also shown how important it is to test finished medicinal products, independently of testing at intermediate stages, and how retesting by control authorities ensures that marketed vaccines meet quality standards.

  4. The Social Ecological Model as a Framework for Determinants of 2009 H1N1 Influenza Vaccine Uptake in the United States

    ERIC Educational Resources Information Center

    Kumar, Supriya; Quinn, Sandra Crouse; Kim, Kevin H.; Musa, Donald; Hilyard, Karen M.; Freimuth, Vicki S.

    2012-01-01

    Research on influenza vaccine uptake has focused largely on intrapersonal determinants (perceived risk, past vaccine acceptance, perceived vaccine safety) and on physician recommendation. The authors used a social ecological framework to examine influenza vaccine uptake during the 2009 H1N1 pandemic. Surveying an adult population (n = 2,079) in…

  5. School-Based Influenza Vaccination: Parents’ Perspectives

    PubMed Central

    Lind, Candace; Russell, Margaret L.; MacDonald, Judy; Collins, Ramona; Frank, Christine J.; Davis, Amy E.

    2014-01-01

    Background School-age children are important drivers of annual influenza epidemics yet influenza vaccination coverage of this population is low despite universal publicly funded influenza vaccination in Alberta, Canada. Immunizing children at school may potentially increase vaccine uptake. As parents are a key stakeholder group for such a program, it is important to consider their concerns. Purpose We explored parents’ perspectives on the acceptability of adding an annual influenza immunization to the immunization program that is currently delivered in Alberta schools, and obtained suggestions for structuring such a program. Participants Forty-eight parents of children aged 5-18 years participated in 9 focus groups. Participants lived in urban areas of the Alberta Health Services Calgary Zone. Findings Three major themes emerged: Advantages of school-based influenza vaccination (SBIV), Disadvantages of SBIV, and Implications for program design & delivery. Advantages were perceived to occur for different populations: children (e.g. emotional support), families (e.g. convenience), the community (e.g. benefits for school and multicultural communities), the health sector (e.g. reductions in costs due to burden of illness) and to society at large (e.g. indirect conduit of information about health services, building structure for pandemic preparedness, building healthy lifestyles). Disadvantages, however, might also occur for children (e.g. older children less likely to be immunized), families (e.g. communication challenges, perceived loss of parental control over information, choices and decisions) and the education sector (loss of instructional time). Nine second-level themes emerged within the major theme of Implications for program design & delivery: program goals/objectives, consent process, stakeholder consultation, age-appropriate program, education, communication, logistics, immunizing agent, and clinic process. Conclusions Parents perceived advantages and

  6. Influenza vaccines and guillain-barre syndrome: the continuing question.

    PubMed

    Sejvar, James J

    2013-10-29

    Influenza is a global public health problem, with complications of seasonal influenza resulting in thousands of deaths and substantial morbidity worldwide. Periodically, particularly virulent viral strains emerge, resulting in more infections and fatalities (e.g., influenza A [H1N1] virus and influenza A/H5N1, "bird flu"). Influenza infection may be prevented or mitigated by vaccination; seasonal vaccine is highly effective in reducing clinical illness and limiting viral spread through respiratory droplets.

  7. Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination

    PubMed Central

    Díez-Domingo, Javier; Baldó, José-María; Planelles-Catarino, Maria Victoria; Garcés-Sánchez, María; Ubeda, Isabel; Jubert–Rosich, Angels; Marès, Josep; Garcia-Corbeira, Pilar; Moris, Philippe; Teko, Maurice; Vanden Abeele, Carline; Gillard, Paul

    2015-01-01

    Background An AS03-adjuvanted H5N1 influenza vaccine elicited broad and persistent immune responses with an acceptable safety profile up to 6 months following the first vaccination in children aged 3–9 years. Methods In this follow-up of the Phase II study, we report immunogenicity persistence and safety at 24 months post-vaccination in children aged 3–9 years. The randomized, open-label study assessed two doses of H5N1 A/Vietnam/1194/2004 influenza vaccine (1·9 μg or 3·75 μg hemagglutinin antigen) formulated with AS03A or AS03B (11·89 mg or 5·93 mg tocopherol, respectively). Control groups received seasonal trivalent influenza vaccine. Safety was assessed prospectively and included potential immune-mediated diseases (pIMDs). Immunogenicity was assessed by hemagglutination-inhibition assay 12 and 24 months after vaccination; cross-reactivity and cell-mediated responses were also assessed. (NCT00502593). Results The safety population included 405 children. Over 24 months, five events fulfilled the criteria for pIMDs, of which four occurred in H5N1 vaccine recipients, including uveitis (n = 1) and autoimmune hepatitis (n = 1), which were considered to be vaccine-related. Overall, safety profiles of the vaccines were clinically acceptable. Humoral immune responses at 12 and 24 months were reduced versus those observed after the second dose of vaccine, although still within the range of those observed after the first dose. Persistence of cell-mediated immunity was strong, and CD4+ T cells with a TH1 profile were observed. Conclusions Two doses of an AS03-adjuvanted H5N1 influenza vaccine in children showed low but persistent humoral immune responses and a strong persistence of cell-mediated immunity, with clinically acceptable safety profiles up to 24 months following first vaccination. PMID:25652873

  8. Stimulating Influenza Vaccination via Prosocial Motives

    PubMed Central

    Taylor, Eric G.; Atkins, Katherine E.; Chapman, Gretchen B.; Galvani, Alison P.

    2016-01-01

    Objective Americans do not vaccinate nearly enough against Influenza (flu) infection, despite severe health and economic burden of influenza. Younger people are disproportionately responsible for transmission, but do not suffer severely from the flu. Thus, to achieve herd immunity, prosocial motivation needs to be a partial driver of vaccination decisions. Past research has not established the causal role of prosociality in flu vaccination, and the current research evaluates such causal relationship by experimentally eliciting prosociality through messages about flu victims. Methods In an experimental study, we described potential flu victims who would suffer from the decision of others to not vaccinate to 3952 Internet participants across eight countries. We measured sympathy, general prosociality, and vaccination intentions. The study included two identifiable victim conditions (one with an elderly victim and another with a young victim), an unidentified victim condition, and a no message condition. Results We found that any of the three messages increased flu vaccination intentions. Moreover, this effect was mediated by enhanced prosocial motives, and was stronger among people who were historical non-vaccinators. In addition, younger victim elicited greater sympathy, and describing identifiable victims increased general sympathy and prosocial motives. Conclusions These findings provide direct experimental evidence on the causal role of prosocial motives in flu vaccination, by showing that people can be prompted to vaccinate for the sake of benefiting others. PMID:27459237

  9. Effectiveness of pandemic and seasonal influenza vaccines in preventing pandemic influenza-associated hospitalization.

    PubMed

    Domínguez, Angela; Castilla, Jesús; Godoy, Pere; Delgado-Rodríguez, Miguel; Martín, Vicente; Saez, Marc; Soldevila, Núria; Quintana, José María; Mayoral, José María; Astray, Jenaro; González-Candelas, Fernando; Cantón, Rafael; Tamames, Sonia; Castro, Ady; Baricot, Maretva; Alonso, Jordi; Pumarola, Tomás

    2012-08-17

    Vaccines are leading pharmacological measures for limiting the impact of pandemic influenza in the community. The objective of this study was to investigate the effectiveness of influenza (pandemic and seasonal) vaccines in preventing pandemic influenza-associated hospitalization. We conducted a multicenter matched case-control study in 36 Spanish hospitals. Patients hospitalized with confirmed pandemic influenza between November 2009 and February 2010 and two hospitalized controls per case, matched according to age, date of hospitalization and province of residence, were selected. Multivariate analysis was performed using conditional logistic regression. Subjects were considered vaccinated if they had received the vaccine >14 days (seasonal influenza vaccine) or >7 days (pandemic influenza vaccine) before the onset of symptoms (cases) or the onset of symptoms of the matched case (controls). For the pandemic influenza vaccine, vaccination effectiveness (VE) was estimated taking into account only patients recruited from November 23, 2009, seven days after the beginning of the pandemic influenza vaccination campaign. 638 cases and 1250 controls were included. The adjusted VE of the pandemic vaccine in the ≥18 years age group was 74.2% (95% CI, 29-90) and that of the influenza seasonal vaccine 15.0% (-34 to 43). The recommendation of influenza vaccination should be reinforced as a regular measure to reduce influenza-associated hospitalization during pandemics and seasonal epidemics.

  10. Bivalent influenza vaccination with inactivated vaccines administered by nasal or oral route.

    PubMed

    Petrescu, A; Mihail, A; Popescu, A; Cojiţă, M; Sternberg, I; Steiner, N; Hondor, C

    1976-01-01

    Influenza vaccinations were performed either by administration of a bivalent A2 + B vaccine, or by successive application of monovalent B and A2 vaccines. During an influenza epidemic caused by an A2 strain, the following observations could be made: a) the best efficiency (no influenza cases) was recorded in adults and aged persons (over 65 years) irrespective of the vaccination scheme; b) in schoolchildren the best results (no influenza cases) were obtained in the lot having received monovalent A2 vaccine, and in the lot vaccinated nasally with monovalent B vaccine and 14 days later with monovalent A vaccine. PMID:941402

  11. Protective avian influenza in ovo vaccination with non-replicating human adenovirus vector

    PubMed Central

    Toro, Haroldo; Tang, De-chu C.; Suarez, David L.; Sylte, Matt J.; Pfeiffer, Jennifer; Van Kampen, Kent R.

    2009-01-01

    Protective immunity against avian influenza virus was elicited in chickens by single-dose in ovo vaccination with a non-replicating human adenovirus vector encoding an H5N9 avian influenza virus hemagglutinin. Vaccinated chickens were protected against both H5N1 (89% hemagglutinin homology; 68% protection) and H5N2 (94% hemagglutinin homology; 100% protection) highly pathogenic avian influenza virus challenges. Mass-administration of this bird flu vaccine can be streamlined with available robotic in ovo injectors. In addition, adenovirus-vectored vaccines can be produced rapidly and the safety margin of a non-replicating vector is superior to that of a replicating counterpart. Furthermore, this mode of vaccination is compatible with epidemiological surveys of natural avian influenza virus infections. PMID:17055126

  12. Parents' preferences for seasonal influenza vaccine for their children in Japan.

    PubMed

    Shono, Aiko; Kondo, Masahide

    2014-09-01

    In Japan, trivalent inactivated influenza vaccine is the only approved influenza vaccine. It is typically administrated by hypodermic injection, and children under 13 years of age are recommended to be vaccinated two times during each winter season. Live-attenuated influenza vaccine (LAIV) is administered by a thimerosal-free nasal spray. If LAIV is approved in the future in Japan, parents will have an alternative type of influenza vaccine for their children. This study investigated parents' preference for the type of seasonal influenza vaccine for their children if alternatives are available. The marginal willingness to pay for vaccine benefits was also evaluated. We conducted a discrete choice experiment, a quantitative approach that is often used in healthcare studies, in January 2013. Respondents were recruited from a registered online survey panel, and parents with at least one child under 13 years of age were offered questionnaires. This study showed that for seasonal influenza vaccines for their children, parents are more likely to value safety, including thimerosal-free vaccines and those with a lower risk of adverse events, instead of avoiding the momentary pain from an injection. If LAIV is released in Japan, the fact that it is thimerosal-free could be an advantage. However, for parents to choose LAIV, they would need to accept the slightly higher risk of minor adverse events from LAIV.

  13. Targeting B cell responses in universal influenza vaccine design

    PubMed Central

    Kaur, Kaval; Sullivan, Meghan; Wilson, Patrick C

    2011-01-01

    Since its first administration in the 1940s, the influenza vaccine has provided tremendous relief against influenza infections. However, time has revealed the vaccine’s ultimate limit and the call for its reinvention has now come, just as we are beginning to appreciate the antibody immune responses vital in preventing infections. New strategies to design the influenza vaccine rely on selectively inducing broadly neutralizing antibodies that are specific for highly conserved viral epitopes. Such approaches take us away from the limited range of protection provided by current seasonal influenza vaccines and towards a future with a pan-influenza vaccine capable of providing universal strain coverage. PMID:21940217

  14. Influenza vaccines: the good, the bad, and the eggs.

    PubMed

    Schultz-Cherry, Stacey; Jones, Jeremy C

    2010-01-01

    Outbreaks of influenza A viruses continue to cause morbidity and mortality worldwide. The global disease burden of influenza is substantial. While antiviral therapies are available, influenza vaccines are the mainstay of efforts to reduce the substantial health burden from seasonal influenza. Inactivated influenza vaccines have been available since the 1940s, with live attenuated, cold-adapted vaccines becoming available in the United States in 2003. In spite of the successes, more research is needed to develop more effective seasonal influenza vaccines that provide long-lasting immunity and broad protection against strains that differ antigenically from vaccine viruses. This review introduces the virus and its disease, the current state of seasonal and pandemic influenza vaccines, and the challenges we face in the future.

  15. Vaccinating Health Care Workers Against Influenza: The Ethical and Legal Rationale for a Mandate

    PubMed Central

    Wu, Joel T.; Poland, Gregory A.; Jacobson, Robert M.; Koenig, Barbara A.; Tilburt, Jon C.

    2011-01-01

    Despite improvements in clinician education, symptom awareness, and respiratory precautions, influenza vaccination rates for health care workers have remained unacceptably low for more than three decades, adversely affecting patient safety. When public health is jeopardized, and a safe, low-cost, and effective method to achieve patient safety exists, health care organizations and public health authorities have a responsibility to take action and change the status quo. Mandatory influenza vaccination for health care workers is supported not only by scientific data but also by ethical principles and legal precedent. The recent influenza pandemic provides an opportunity for policymakers to reconsider the benefits of mandating influenza vaccination for health care workers, including building public trust, enhancing patient safety, and strengthening the health care workforce. PMID:21228284

  16. Seasonal split influenza vaccine induced IgE sensitization against influenza vaccine.

    PubMed

    Nakayama, Tetsuo; Kumagai, Takuji; Nishimura, Naoko; Ozaki, Takao; Okafuji, Teruo; Suzuki, Eitaro; Miyata, Akiko; Okada, Kenji; Ihara, Toshiaki

    2015-11-01

    Although anaphylaxis is an extremely rare vaccine-associated adverse event, it occurred in young children following administration of the 2011/12 seasonal split influenza vaccine, which contained 2-phenoxyethanol as the preservative. These children had high levels of IgE antibodies against influenza vaccine components. We herein investigated why these children were sensitized. One hundred and seventeen series of serum samples were obtained immediately before, and one month after the first and second immunizations with the HA split vaccine of 2011/12. Forty-two sequential serum samples were collected in the acute and convalescent phases (2 and 4 weeks) after natural infection with H1N1 Pdm in 2009. IgE antibodies developed following the vaccination of young children with seasonal split vaccines, whereas no significant IgE response was observed following natural infection with H1N1 Pdm 2009. The prevalence of IgE antibodies was not influenced by outbreaks of H1N1 Pdm. Repeated immunization with the HA split vaccine induced IgE sensitization against the influenza vaccine irrespective of the H1N1, H3N2, or B influenza subtypes. The reasons why anaphylaxis only occurred in recipients of the influenza vaccine containing 2-phenoxyethanol are still being investigated, and the size distribution of antigen particles may have shifted to a slightly larger size. Since the fundamental reason was IgE sensitization, current split formulation for the seasonal influenza vaccine needs to be reconsidered to prevent the induction of IgE sensitization.

  17. Assaying the Potency of Influenza Vaccines

    PubMed Central

    Minor, Philip D.

    2015-01-01

    The potency of vaccines must be determined to ensure that the appropriate dose is given. The manufacture and assessment of influenza vaccines are complicated by the continuously changing nature of the pathogen, which makes efficacy estimates difficult but also confounds attempts to produce a well-validated, consistent potency assay. Single radial diffusion has been used for decades and provides a relatively simple way to measure the amount of biologically active materials present in the vaccine. It requires reagents, which are updated on a regular, frequently yearly, basis and alternative methods continue to be sought. PMID:26344948

  18. Progress and hurdles in the development of influenza virus-like particle vaccines for veterinary use

    PubMed Central

    2014-01-01

    Virus-like particles (VLPs), which resemble infectious virus particles in structure and morphology, have been proposed to provide a new generation of vaccine candidates against various viral infections. As effective immunogens, characterized by high immunogenicity and safety, VLPs have been employed in the development of human influenza vaccines. Recently, several influenza VLP vaccines have been developed for veterinary use and successfully evaluated in swine, canine, duck, and chicken models. These VLP vaccine candidates induced protective immune responses and enabled serological differentiation between vaccinated and infected animals in conjunction with a diagnostic test. Here, we review the current progress of influenza VLP development as a next-generation vaccine technology in the veterinary field and discuss the challenges and future direction of this technology. PMID:25003086

  19. Emerging influenza viruses and the prospect of a universal influenza virus vaccine.

    PubMed

    Krammer, Florian

    2015-05-01

    Influenza viruses cause annual seasonal epidemics and pandemics at irregular intervals. Several cases of human infections with avian and swine influenza viruses have been detected recently, warranting enhanced surveillance and the development of more effective countermeasures to address the pandemic potential of these viruses. The most effective countermeasure against influenza virus infection is the use of prophylactic vaccines. However, vaccines that are currently in use for seasonal influenza viruses have to be re-formulated and re-administered in a cumbersome process every year due to the antigenic drift of the virus. Furthermore, current seasonal vaccines are ineffective against novel pandemic strains. This paper reviews zoonotic influenza viruses with pandemic potential and technological advances towards better vaccines that induce broad and long lasting protection from influenza virus infection. Recent efforts have focused on the development of broadly protective/universal influenza virus vaccines that can provide immunity against drifted seasonal influenza virus strains but also against potential pandemic viruses.

  20. The predilection of chickenpox exanthema to influenza vaccine injection site.

    PubMed

    Ben-Shoshan, Moshe; Lejtenyi, Christine; Primeau, Marie-Noël

    2009-01-01

    Annual influenza immunization of children is highly recommended and is usually well tolerated. We report the first case of chickenpox exanthema localized to the influenza vaccination site in a boy with known egg allergy.

  1. Practical aspects of vaccination of poultry against avian influenza virus

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Although little has changed in vaccine technology for avian influenza virus (AIV) in the past 20 years, the approach to vaccination of poultry (chickens, turkeys and ducks) for avian influenza has evolved as highly pathogenic (HP) AIV has become endemic in several regions of the world. Vaccination f...

  2. Laboratory methods for assessing and licensing influenza vaccines for poultry

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Avian influenza vaccines for poultry are based on hemagglutinin proteins and protection is specific to the vaccine subtype. Over 113 billion doses have been used between 2002 and 2010 for high pathogenicity avian influenza control. No universal vaccines are currently available. The majority of avian...

  3. Safety and immunogenocity of a novel combined Haemophilus influenzae type b–Neisseria meningitidis serogroups A and C-tetanus-toxoid conjugate vaccine in healthy Chinese children aged 6 months to 5 years old

    PubMed Central

    Hu, Jian-li; Tao, Hong; Li, Jing-xin; Dai, Wei-ming; Song, Bin; Sun, Jin-fang; Liu, Pei; Tang, Jie; Liu, Wen-yu; Wang, Shi-yuan; Zhu, Feng-cai

    2015-01-01

    A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C-tetanus-toxoid conjugate vaccine (Hib-MenAC vaccine) has been developed to protect children against diseases caused by Hib, MenA, and MenC. This study investigated the safety and immunogenicity of the Hib-MenAC vaccine administered in 2-dose series to children aged 6–23 months and in a single dose to children aged 2–5 y. A randomized, positive-controlled, non-inferiority clinical trial was conducted for 1200 healthy participants in each age group. Within each age group, participants were randomly allocated to the Hib-MenAC group or the control group at a ratio of 1:1. Adverse reactions were recorded within 28 d after each dose. Blood samples were obtained to assess immunogenicity on day 0 and at 28 d after a complete vaccination course. For the investigational vaccine, the incidence of total adverse reactions in vaccinees aged 6–23 months was 46.8% and that in vaccinees aged 2–5 y was 29.8%. Most adverse reactions were mild or moderate. One non-fatal serious adverse event occurred in the Hib-MenAC group, but was unrelated to vaccination. The seroconversion rate to the 3 components reached 94.0%, and the proportion of vaccinees with rSBA titers ≥ 1:8 and PRP ≥ 0.15 g/mL reached 97.0% in both age groups. The safety and immunogenicity of the Hib-MenAC vaccine were non-inferior when compared to the licensed vaccines. It was concluded that the novel vaccine would be expected to protect children against all of the targeted diseases. PMID:25833163

  4. Safety and immunogenocity of a novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C-tetanus-toxoid conjugate vaccine in healthy Chinese children aged 6 months to 5 years old.

    PubMed

    Hu, Jian-li; Tao, Hong; Li, Jing-xin; Dai, Wei-ming; Song, Bin; Sun, Jin-fang; Liu, Pei; Tang, Jie; Liu, Wen-yu; Wang, Shi-yuan; Zhu, Feng-cai

    2015-01-01

    A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C-tetanus-toxoid conjugate vaccine (Hib-MenAC vaccine) has been developed to protect children against diseases caused by Hib, MenA, and MenC. This study investigated the safety and immunogenicity of the Hib-MenAC vaccine administered in 2-dose series to children aged 6-23 months and in a single dose to children aged 2-5 y. A randomized, positive-controlled, non-inferiority clinical trial was conducted for 1200 healthy participants in each age group. Within each age group, participants were randomly allocated to the Hib-MenAC group or the control group at a ratio of 1:1. Adverse reactions were recorded within 28 d after each dose. Blood samples were obtained to assess immunogenicity on day 0 and at 28 d after a complete vaccination course. For the investigational vaccine, the incidence of total adverse reactions in vaccinees aged 6-23 months was 46.8% and that in vaccinees aged 2-5 y was 29.8%. Most adverse reactions were mild or moderate. One non-fatal serious adverse event occurred in the Hib-MenAC group, but was unrelated to vaccination. The seroconversion rate to the 3 components reached 94.0%, and the proportion of vaccinees with rSBA titers ≥ 1:8 and PRP ≥ 0.15 g/mL reached 97.0% in both age groups. The safety and immunogenicity of the Hib-MenAC vaccine were non-inferior when compared to the licensed vaccines. It was concluded that the novel vaccine would be expected to protect children against all of the targeted diseases.

  5. Quadrivalent Ann Arbor strain live-attenuated influenza vaccine.

    PubMed

    Toback, Seth L; Levin, Myron J; Block, Stan L; Belshe, Robert B; Ambrose, Christopher S; Falloon, Judith

    2012-11-01

    Influenza B is responsible for significant morbidity in children and adults worldwide. For more than 25 years, two antigenically distinct lineages of influenza B viruses, B/Yamagata and B/Victoria, have cocirculated globally. Current influenza vaccine formulations are trivalent and contain two influenza subtype A strains (A/H1N1 and A/H3N2) but only one B strain. In a half of recent influenza seasons, the predominant circulating influenza B lineage was different from that contained in trivalent influenza vaccines. A quadrivalent live-attenuated influenza vaccine (Q/LAIV) that contains two B strains, one from each lineage, has been developed to help provide broad protection against influenza B. Q/LAIV was recently approved for use in the USA in eligible individuals 2-49 years of age. This review summarizes clinical trial data in support of Q/LAIV.

  6. Influenza vaccination during the first 6 months after solid organ transplantation is efficacious and safe.

    PubMed

    Pérez-Romero, P; Bulnes-Ramos, A; Torre-Cisneros, J; Gavaldá, J; Aydillo, T A; Moreno, A; Montejo, M; Fariñas, M C; Carratalá, J; Muñoz, P; Blanes, M; Fortún, J; Suárez-Benjumea, A; López-Medrano, F; Barranco, J L; Peghin, M; Roca, C; Lara, R; Cordero, E

    2015-11-01

    Preventing influenza infection early after transplantation is essential, given the disease's high mortality. A multicentre prospective cohort study in adult solid organ transplant recipients (SOTR) receiving the influenza vaccine during four consecutive influenza seasons (2009-2013) was performed to assess the immunogenicity and safety of influenza vaccination in SOTR before and 6 months after transplantation. A total of 798 SOTR, 130 of them vaccinated within 6 months of transplantation and 668 of them vaccinated more than 6 months since transplantation. Seroprotection was similar in both groups: 73.1% vs. 76.5% for A/(H1N1)pdm (p 0.49), 67.5% vs. 74.1% for A/H3N2 (p 0.17) and 84.2% vs. 85.2% for influenza B (p 0.80), respectively. Geometric mean titres after vaccination did not differ among groups: 117.32 (95% confidence interval (CI) 81.52, 168.83) vs. 87.43 (95% CI 72.87, 104.91) for A/(H1N1)pdm, 120.45 (95% CI 82.17, 176.57) vs. 97.86 (95% CI 81.34, 117.44) for A/H3N2 and 143.32 (95% CI 103.46, 198.53) vs. 145.54 (95% CI 122.35, 174.24) for influenza B, respectively. After adjusting for confounding factors, time since transplantation was not associated with response to vaccination. No cases of rejection or severe adverse events were detected in patients vaccinated within the first 6 months after transplantation. In conclusion, influenza vaccination within the first 6 months after transplantation is as safe and immunogenic as vaccination thereafter. Thus, administration of the influenza vaccine can be recommended as soon as 1 month after transplantation.

  7. 75 FR 10268 - Pandemic Influenza Vaccines-Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-05

    ..., H2, H6, H7, H9 and 2009 H1N1 Vaccines'' and replace with ``for Vaccines Against Pandemic Influenza A..., first paragraph, delete ``the pandemic countermeasures influenza A H5N1, H2, H6, H7, H9, and 2009 H1N1... HUMAN SERVICES Office of the Secretary Pandemic Influenza Vaccines--Amendment Authority: 42 U.S.C....

  8. [Comparison of seasonal influenza vaccines: composition and properties].

    PubMed

    Allwinn, R; Doerr, H W

    2011-11-01

    The influenza virus isolation in embryonated chicken eggs was possible early in 1930er years and allowed the influenza vaccine production. Most influenza vaccines were derived from this, but actually new virus cell culture methods are established. For better tolerability, influenza vaccines include only antigen proportions (split- and subunit vaccines) but with the disadvantage of minor vaccine efficacy. This was compared with the addition of adjuvants. Aluminium salts are used for many decades and still in use to enhance the effect of vaccines. New formulations are MF59, AS03, AS04 or toll- like receptor-agonists. Also virosomal formulations and "ISCOMs"(Immune Stimulating Complexes) are newly designed and compromises enhanced immune reactions. Actually a broad range of various influenza vaccines exist and are available for a very different group of patients (which depends on physical conditions, age, immune status or allergies). PMID:22048938

  9. Influenza epidemiology, vaccine coverage and vaccine effectiveness in sentinel Australian hospitals in 2013: the Influenza Complications Alert Network.

    PubMed

    Cheng, Allen C; Dwyer, Dominic E; Holmes, Mark; Irving, Lois B; Brown, Simon Ga; Waterer, Grant W; Korman, Tony M; Hunter, Cameron; Hewagama, Saliya; Friedman, Nadia D; Wark, Peter A; Simpson, Graham; Upham, John W; Bowler, Simon D; Senenayake, Sanjaya N; Kotsimbos, Tom C; Kelly, Paul M

    2014-06-01

    The National Influenza Program aims to reduce serious morbidity and mortality from influenza by providing public funding for vaccination to at-risk groups. The Influenza Complications Alert Network (FluCAN) is a sentinel hospital-based surveillance program that operates at 14 sites in all states and territories in Australia. This report summarises the epidemiology of hospitalisations with confirmed influenza, estimates vaccine coverage and influenza vaccine protection against hospitalisation with influenza during the 2013 influenza season. In this observational study, cases were defined as patients admitted to one of the sentinel hospitals, with influenza confirmed by nucleic acid testing. Controls were patients who had acute respiratory illnesses who were test-negative for influenza. Vaccine effectiveness was estimated as 1 minus the odds ratio of vaccination in case patients compared with control patients, after adjusting for known confounders. During the period 5 April to 31 October 2012, 631 patients were admitted with confirmed influenza at the 14 FluCAN sentinel hospitals. Of these, 31% were more than 65 years of age, 9.5% were Indigenous Australians, 4.3% were pregnant and 77% had chronic co-morbidities. Influenza B was detected in 30% of patients. Vaccination coverage was estimated at 81% in patients more than 65 years of age but only 49% in patients aged less than 65 years with chronic comorbidities. Vaccination effectiveness against hospitalisation with influenza was estimated at 50% (95% confidence interval: 33%, 63%, P<0.001). We detected a significant number of hospital admissions with confirmed influenza in a national observational study. Vaccine coverage was incomplete in at-risk groups, particularly non-elderly patients with medical comorbidities. Our results suggest that the seasonal influenza vaccine was moderately protective against hospitalisation with influenza in the 2013 season. PMID:25222208

  10. Prediction of influenza B vaccine effectiveness from sequence data.

    PubMed

    Pan, Yidan; Deem, Michael W

    2016-08-31

    Influenza is a contagious respiratory illness that causes significant human morbidity and mortality, affecting 5-15% of the population in a typical epidemic season. Human influenza epidemics are caused by types A and B, with roughly 25% of human cases due to influenza B. Influenza B is a single-stranded RNA virus with a high mutation rate, and both prior immune history and vaccination put significant pressure on the virus to evolve. Due to the high rate of viral evolution, the influenza B vaccine component of the annual influenza vaccine is updated, roughly every other year in recent years. To predict when an update to the vaccine is needed, an estimate of expected vaccine effectiveness against a range of viral strains is required. We here introduce a method to measure antigenic distance between the influenza B vaccine and circulating viral strains. The measure correlates well with effectiveness of the influenza B component of the annual vaccine in humans between 1979 and 2014. We discuss how this measure of antigenic distance may be used in the context of annual influenza vaccine design and prediction of vaccine effectiveness. PMID:27473305

  11. Pneumococcal and seasonal influenza vaccination among elderly patients with diabetes.

    PubMed

    Gorska-Ciebiada, Małgorzata; Saryusz-Wolska, Małgorzata; Ciebiada, Maciej; Loba, Jerzy

    2015-10-28

    Both seasonal influenza vaccination and pneumococcal vaccination are recommended for elderly diabetics. The aim of the study was to determine the rate of seasonal influenza vaccination over the previous twelve months, pneumococcal vaccination over a lifetime, and to identify predictors which affect likelihood of vaccination. 219 diabetics elders were detailed questioned 3 months after the end of 2012/2013 influenza season. 26.48% of patients have been vaccinated against influenza in the last year and only 9.13% of patients reported pneumococcal vaccination in the past. The logistic regression analysis revealed that variables which increased the likelihood of having been vaccinated against influenza were: higher number of anti-hyperglycemic medications, increased number of co-morbidities, higher patients' income, recommendation of vaccination from General Practitioners (GPs) and specialist. Significant predictors of pneumococcal vaccine uptake included increased number of co-morbidities and recommendation of vaccination received from GPs and specialist. The commonest reasons given by those unvaccinated were lack of information about immunization and low perceived benefits of vaccination. Of patients who were not treated with influenza vaccine 86.7% had never received recommendation from specialist and 71.4% had never been advised by GPs. Influenza vaccination was too expensive to 24.85% of patients. The vaccination rate among elderly diabetics in Poland is low. Lack of knowledge and patients' income are the main barriers. Increased awareness of healthcare professionals to educate and encourage vaccination and propagation of free vaccinations to all people at risk may increase the rate of vaccination against influenza and pneumococcal disease.

  12. Pneumococcal and seasonal influenza vaccination among elderly patients with diabetes.

    PubMed

    Gorska-Ciebiada, Małgorzata; Saryusz-Wolska, Małgorzata; Ciebiada, Maciej; Loba, Jerzy

    2015-01-01

    Both seasonal influenza vaccination and pneumococcal vaccination are recommended for elderly diabetics. The aim of the study was to determine the rate of seasonal influenza vaccination over the previous twelve months, pneumococcal vaccination over a lifetime, and to identify predictors which affect likelihood of vaccination. 219 diabetics elders were detailed questioned 3 months after the end of 2012/2013 influenza season. 26.48% of patients have been vaccinated against influenza in the last year and only 9.13% of patients reported pneumococcal vaccination in the past. The logistic regression analysis revealed that variables which increased the likelihood of having been vaccinated against influenza were: higher number of anti-hyperglycemic medications, increased number of co-morbidities, higher patients' income, recommendation of vaccination from General Practitioners (GPs) and specialist. Significant predictors of pneumococcal vaccine uptake included increased number of co-morbidities and recommendation of vaccination received from GPs and specialist. The commonest reasons given by those unvaccinated were lack of information about immunization and low perceived benefits of vaccination. Of patients who were not treated with influenza vaccine 86.7% had never received recommendation from specialist and 71.4% had never been advised by GPs. Influenza vaccination was too expensive to 24.85% of patients. The vaccination rate among elderly diabetics in Poland is low. Lack of knowledge and patients' income are the main barriers. Increased awareness of healthcare professionals to educate and encourage vaccination and propagation of free vaccinations to all people at risk may increase the rate of vaccination against influenza and pneumococcal disease. PMID:26561844

  13. IMMUNOGENICITY AND SAFETY OF QUINVAXEM® (DIPHTHERIA, TETANUS, WHOLE-CELL PERTUSSIS, HEPATITIS B AND HAEMOPHILUS INFLUENZAE TYPE B VACCINE) GIVEN TO VIETNAMESE INFANTS AT 2 TO 4 MONTHS OF AGE.

    PubMed

    Huu, Tran Ngoc; Phuong, Nguyen Thi Minh; Toan, Nguyen Trong; Thang, Ho Vinh

    2015-07-01

    Vietnam plans to replace the routine childhood diphtheria, pertussis and tetanus combination (DPT) vaccine with a pentavalent vaccine. The present study was performed to assess the immunogenicity and safety of the combined diphtheria, tetanus, whole-cell pertussis, hepatitis B (HepB), and Haemophilus influenzae type b (Hib) (DTwP-HepB-Hib) Quinvaxem® vaccine in children. A total of 131 infants received the Quinvaxem® vaccine at 2, 3 and 4 months. Antibody levels were measured at baseline, at one month after the third injection and one year after the first injection. Seroprotection rates were high for each vaccine antigen at one month after the third dose: 93.1% for diphtheria, 98.5% for tetanus, 99.2% for pertussis (seroconversion rate), 93.1% for HepB, and 100% for Hib (anti-PRP ≥ 0.15 µg/ml). The rate of children with protective antibodies persisting at one year after the first dose was 88.4% for diphtheria, 49.6% for pertussis, 82.2% for tetanus, 76.7% for HepB and 97.7% for Hib (anti-PRP ≥ 0.15 µg/ml). The Quinvaxem® vaccine was well tolerated and has a low rate of adverse events. Quinvaxem® given at 2, 3 and 4 months of age was immunogenic and safe for primary immunization among infants in Vietnam. PMID:26867396

  14. IMMUNOGENICITY AND SAFETY OF QUINVAXEM® (DIPHTHERIA, TETANUS, WHOLE-CELL PERTUSSIS, HEPATITIS B AND HAEMOPHILUS INFLUENZAE TYPE B VACCINE) GIVEN TO VIETNAMESE INFANTS AT 2 TO 4 MONTHS OF AGE.

    PubMed

    Huu, Tran Ngoc; Phuong, Nguyen Thi Minh; Toan, Nguyen Trong; Thang, Ho Vinh

    2015-07-01

    Vietnam plans to replace the routine childhood diphtheria, pertussis and tetanus combination (DPT) vaccine with a pentavalent vaccine. The present study was performed to assess the immunogenicity and safety of the combined diphtheria, tetanus, whole-cell pertussis, hepatitis B (HepB), and Haemophilus influenzae type b (Hib) (DTwP-HepB-Hib) Quinvaxem® vaccine in children. A total of 131 infants received the Quinvaxem® vaccine at 2, 3 and 4 months. Antibody levels were measured at baseline, at one month after the third injection and one year after the first injection. Seroprotection rates were high for each vaccine antigen at one month after the third dose: 93.1% for diphtheria, 98.5% for tetanus, 99.2% for pertussis (seroconversion rate), 93.1% for HepB, and 100% for Hib (anti-PRP ≥ 0.15 µg/ml). The rate of children with protective antibodies persisting at one year after the first dose was 88.4% for diphtheria, 49.6% for pertussis, 82.2% for tetanus, 76.7% for HepB and 97.7% for Hib (anti-PRP ≥ 0.15 µg/ml). The Quinvaxem® vaccine was well tolerated and has a low rate of adverse events. Quinvaxem® given at 2, 3 and 4 months of age was immunogenic and safe for primary immunization among infants in Vietnam.

  15. Recommendations pertaining to the use of influenza vaccines and influenza antiviral drugs, 2016.

    PubMed

    Walaza, Sibongile; Cohen, Cheryl

    2016-03-01

    Vaccination is the most effective strategy to prevent influenza. It is recommended that influenza vaccine be administered each year before the influenza season, i.e. from March to June, although for individuals at increased risk of severe influenza in whom vaccination was missed, vaccine may be administered later. For a review of the 2015 influenza season and ongoing real-time updates of the 2016 influenza season when it starts, refer to the website of the National Institute for Communicable Diseases of the National Health Laboratory Service (www.nicd.ac.za). In this article we provide recommendations for the use of influenza vaccines in anticipation of the 2016 Southern Hemisphere influenza season. Guidance is based on available evidence to assist clinicians in making decisions regarding influenza vaccination. It should be noted that this article includes general recommendations for vaccination with influenza vaccines available in South Africa and may differ from groups targeted in specific vaccination programmes, e.g. the National Department of Health Programme.

  16. Guillain-Barre syndrome, influenza, and influenza vaccination: the epidemiologic evidence.

    PubMed

    Vellozzi, Claudia; Iqbal, Shahed; Broder, Karen

    2014-04-01

    Guillain-Barré syndrome (GBS) is the most common cause of acute flaccid paralysis worldwide, and is thought to be immune-mediated. It is preceded by upper respiratory or gastrointestinal infection in about two-thirds of cases and is associated with some viral infections, including influenza. GBS has also been associated with the 1976 swine-influenza vaccine. Thereafter, some studies have shown a small increased risk of GBS following receipt of seasonal and 2009 H1N1 monovalent influenza vaccines. Studies over the years have also shown an increased risk of GBS following influenza infection, and the magnitude of risk is several times greater than that following influenza vaccination. Because GBS is rare, and even rarer following vaccination, it is difficult to estimate precise risk. We try to shed light on the complex relationship of GBS and its association with influenza and influenza vaccines over the past 35 years.

  17. Evaluation of Influenza Vaccination Efficacy: A Universal Epidemic Model

    PubMed Central

    Bazhan, Sergei I.

    2016-01-01

    By means of a designed epidemic model, we evaluated the influence of seasonal vaccination coverage as well as a potential universal vaccine with differing efficacy on the aftermath of seasonal and pandemic influenza. The results of the modeling enabled us to conclude that, to control a seasonal influenza epidemic with a reproduction coefficient R0 ≤ 1.5, a 35% vaccination coverage with the current seasonal influenza vaccine formulation is sufficient, provided that other epidemiology measures are regularly implemented. Increasing R0 level of pandemic strains will obviously require stronger intervention. In addition, seasonal influenza vaccines fail to confer protection against antigenically distinct pandemic influenza strains. Therefore, the necessity of a universal influenza vaccine is clear. The model predicts that a potential universal vaccine will be able to provide sufficient reliable (90%) protection against pandemic influenza only if its efficacy is comparable with the effectiveness of modern vaccines against seasonal influenza strains (70%–80%); given that at least 40% of the population has been vaccinated in advance, ill individuals have been isolated (observed), and a quarantine has been introduced. If other antiepidemic measures are absent, a vaccination coverage of at least 80% is required. PMID:27668256

  18. Evaluation of Influenza Vaccination Efficacy: A Universal Epidemic Model

    PubMed Central

    Bazhan, Sergei I.

    2016-01-01

    By means of a designed epidemic model, we evaluated the influence of seasonal vaccination coverage as well as a potential universal vaccine with differing efficacy on the aftermath of seasonal and pandemic influenza. The results of the modeling enabled us to conclude that, to control a seasonal influenza epidemic with a reproduction coefficient R0 ≤ 1.5, a 35% vaccination coverage with the current seasonal influenza vaccine formulation is sufficient, provided that other epidemiology measures are regularly implemented. Increasing R0 level of pandemic strains will obviously require stronger intervention. In addition, seasonal influenza vaccines fail to confer protection against antigenically distinct pandemic influenza strains. Therefore, the necessity of a universal influenza vaccine is clear. The model predicts that a potential universal vaccine will be able to provide sufficient reliable (90%) protection against pandemic influenza only if its efficacy is comparable with the effectiveness of modern vaccines against seasonal influenza strains (70%–80%); given that at least 40% of the population has been vaccinated in advance, ill individuals have been isolated (observed), and a quarantine has been introduced. If other antiepidemic measures are absent, a vaccination coverage of at least 80% is required.

  19. Comparison of the safety, vaccine virus shedding, and immunogenicity of influenza virus vaccine, trivalent, types A and B, live cold-adapted, administered to human immunodeficiency virus (HIV)-infected and non-HIV-infected adults.

    PubMed

    King, J C; Treanor, J; Fast, P E; Wolff, M; Yan, L; Iacuzio, D; Readmond, B; O'Brien, D; Mallon, K; Highsmith, W E; Lambert, J S; Belshe, R B

    2000-02-01

    Fifty-seven human immunodeficiency virus (HIV)-infected (CDC class A1-2) and 54 non-HIV-infected adults, not prescreened for influenza susceptibility, were randomized to receive trivalent live attenuated influenza vaccine (LAIV) or placebo intranasally. LAIV was safe and well tolerated with no serious adverse events attributable to vaccine. Reactogenicity rates were similar in LAIV and placebo recipients except that runny nose/nasal congestion was significantly more common in LAIV recipients regardless of HIV status. No prolonged shedding of LAIV was observed in HIV-infected participants. HIV RNA levels were not increased and CD4 counts were not decreased in HIV-infected LAIV recipients compared with placebo recipients after immunization. Shedding of LAIV and increases in antibody titers were infrequent, consistent with prior experience in unscreened adults. The data suggest that inadvertent vaccination with LAIV in relatively asymptomatic HIV-infected adults would not be associated with frequent significant adverse events.

  20. Safety and Immunogenicity of a Subvirion Monovalent Unadjuvanted Inactivated Influenza A(H3N2) Variant Vaccine in Healthy Persons ≥18 Years Old

    PubMed Central

    Keitel, Wendy A.; Jackson, Lisa A.; Edupuganti, Srilatha; Winokur, Patricia L.; Mulligan, Mark J.; Thornburg, Natalie J.; Patel, Shital M.; Rouphael, Nadine G.; Lai, Lilin; Bangaru, Sandhya; McNeal, Monica M.; Bellamy, Abbie R.; Hill, Heather R.; Bond, Nanette; Bosworth, Kathy; Brown, Janet; Banay, Jess; Cheesman, Coni; Lanford, Tracey; Munoz, Flor; Wells, Janet; Carste, Barb; Dunstan, Maya; Mathis, Angel; Parikh, Mihir; Phillips, C. Hallie; Spingola, Alyssa; Starkovich, Pat; Suyehira, Janice; Beck, Allison; Mask, Karen; Bower, Mary; Osinski, Eileen; Rimann, Nayoka; Turner, Pamela; Wang, DongLi; Stapleton, Jack; Won, Regina; Wagner, Nancy; Dull, Geraldine; Gerot, Necole; Reidy, Mary; Zhao, Dan; Segar, Ellen; Slaughter, James C.; McDonough, Megan; He, Fenhua; Salata, Robert; Meissner, Cody; Sheffield, Jeanne; Spigarelli, Michael; Greenberg, Stephen; Agrawal, Anoop; Dublin, Sascha; Arterburn, David; Rimland, David; Ribner, Bruce; Meier, Jeff; Buchanan, Wendy; Chang, Soju; Lambert, Linda; Murray, Suzanne; Riddle, Valerie; Spiro, David

    2015-01-01

    Background Variant influenza A(H3N2) viruses (H3N2v) have transmitted recently from pigs to humans in the United States. Vaccines strategies are needed. Methods Healthy adults received 2 doses of subvirion H3N2v vaccine (15 µg of hemagglutinin/dose) 21 days apart in this open-label trial. Serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody (Ab) titers were measured before and 8 and 21 days after each dose. Memory B-cell (MBC) responses were assessed. Results Vaccine was well tolerated. A total of 40% of subjects had an HAI Ab titer of ≥40 before vaccination. Eight-seven percent (95% confidence interval [CI], 79%–93%) and 73% (95% CI, 63%–81%) of subjects 18–64 years old (98 subjects) and ≥65 years old (90 subjects), respectively, had an HAI titer of ≥40 21 days after dose 1 (P = .01); 51% (95% CI, 41%–61%) and 52% (95% CI, 41%–62%) of younger and older subjects, respectively, developed ≥4-fold rises in titer (P = not significant). Neut Ab response patterns were similar. Geometric mean titers were higher in younger subjects. Dose 2 provided no significant enhancement in responses. Cross-reactive MBCs were detected before vaccination and expanded after vaccination. Preexisting H3N2v-specific MBCs positively correlated with early increases in vaccine-induced Ab. Conclusions In most healthy adults, one 15-µg dose of vaccine elicited levels of HAI Abs associated with protection. Studies in children and elderly individuals are indicated to define the immunization needs of these groups. Clinical Trials Registration NCT01746082. PMID:25649171

  1. Safety and immunogenicity of a recombinant protein influenza A vaccine in adult human volunteers and protective efficacy against wild-type H1N1 virus challenge.

    PubMed

    Fries, L F; Dillon, S B; Hildreth, J E; Karron, R A; Funkhouser, A W; Friedman, C J; Jones, C S; Culleton, V G; Clements, M L

    1993-03-01

    A recombinant influenza A vaccine (D protein), comprising a carboxy-terminal sequence from the hemagglutinin HA2 subunit of A/Puerto Rico/8/34 virus (H1N1, A/PR/34) fused to 81 amino-terminal residues of the NS1 nonstructural protein, has previously protected mice against influenza A challenge by inducing H1N1/H2N2 cross-reactive cytotoxic T cells (CTL) without hemagglutination-inhibiting (HI) or neutralizing antibody. In our dose-escalating study, the vaccine was safe in humans and induced both IgG and T cell proliferative responses to D protein but little antibody to A/PR/34 or A/Kawasaki/8/86 (H1N1, A/KW/86) viruses. Among an additional group of A/KW/86-seronegative volunteers immunized with 500 micrograms of D protein, none had a rise in serum HI or neutralizing antibody to A/KW/86, 20% had minimal IgG responses to A/KW/86 by EIA, and a minority had any increase in A/KW/86-specific CTL activity. However, viral shedding and clinical illness score were reduced in vaccines relative to A/KW/86-seronegative unimmunized controls after intranasal challenge with wild-type A/KW/86. D protein immunization conferred significant protective immunity not currently explained by any of the immune parameters measured.

  2. A phase II study of an investigational tetravalent influenza vaccine formulation combining MF59®

    PubMed Central

    Herbinger, Karl-Heinz; von Sonnenburg, Frank; Nothdurft, Hans Dieter; Perona, Pamela; Borkowski, Astrid; Fragapane, Elena; Nicolay, Uwe; Clemens, Ralf

    2014-01-01

    An investigational tetravalent vaccine combining pre-pandemic, MF59®-adjuvanted A/H5N1 vaccine with non-adjuvanted, trivalent, seasonal influenza vaccine has been developed, which has the potential to be used for pre-pandemic priming and to improve levels of compliance and coverage. It is important to determine whether the safety and immunogenicity of the combination vaccine is equivalent to that of the two separate vaccines when administered concomitantly. Healthy adults (n = 601) were randomly assigned to three vaccination groups to receive either: (1) tetravalent vaccine and placebo concomitantly (in separate arms) on Day 1, followed by A/H5N1 vaccine on Day 22; (2) A/H5N1 vaccine and placebo concomitantly on Day 1, followed by tetravalent vaccine on Day 22; or (3) A/H5N1 and seasonal vaccines concomitantly on Day 1, followed by A/H5N1 vaccine on Day 22. Antibody responses were measured using single radial hemolysis (SRH), haemagglutination inhibition (HI), and microneutralization (MN) assays on Days 1, 22, and 43. Solicited adverse reactions were recorded for seven days after vaccination. Spontaneous adverse events were recorded throughout the study. The tetravalent vaccine elicited antibody titers equivalent to those for separate A/H5N1 and seasonal vaccines, and sufficient to meet the European licensure criteria against A/H5N1 and all three seasonal strains. Local and systemic reactions were mainly mild to moderate. No vaccine-related serious adverse events occurred. These findings demonstrate that MF59-adjuvanted A/H5N1 and seasonal influenza vaccines had an acceptable safety profile and could be effectively administered as a tetravalent formulation, supporting the possibility of integrating pre-pandemic priming into seasonal influenza vaccination programs. PMID:24047817

  3. Influenza vaccination coverage among medical residents: an Italian multicenter survey.

    PubMed

    Costantino, Claudio; Mazzucco, Walter; Azzolini, Elena; Baldini, Cesare; Bergomi, Margherita; Biafiore, Alessio Daniele; Bianco, Manuela; Borsari, Lucia; Cacciari, Paolo; Cadeddu, Chiara; Camia, Paola; Carluccio, Eugenia; Conti, Andrea; De Waure, Chiara; Di Gregori, Valentina; Fabiani, Leila; Fallico, Roberto; Filisetti, Barbara; Flacco, Maria E; Franco, Elisabetta; Furnari, Roberto; Galis, Veronica; Gallea, Maria R; Gallone, Maria F; Gallone, Serena; Gelatti, Umberto; Gilardi, Francesco; Giuliani, Anna R; Grillo, Orazio C; Lanati, Niccolò; Mascaretti, Silvia; Mattei, Antonella; Micò, Rocco; Morciano, Laura; Nante, Nicola; Napoli, Giuseppe; Nobile, Carmelo Giuseppe; Palladino, Raffaele; Parisi, Salvatore; Passaro, Maria; Pelissero, Gabriele; Quarto, Michele; Ricciardi, Walter; Romano, Gabriele; Rustico, Ennio; Saponari, Anita; Schioppa, Francesco S; Signorelli, Carlo; Siliquini, Roberta; Trabacchi, Valeria; Triassi, Maria; Varetta, Alessia; Ziglio, Andrea; Zoccali, Angela; Vitale, Francesco; Amodio, Emanuele

    2014-01-01

    Although influenza vaccination is recognized to be safe and effective, recent studies have confirmed that immunization coverage among health care workers remain generally low, especially among medical residents (MRs). Aim of the present multicenter study was to investigate attitudes and determinants associated with acceptance of influenza vaccination among Italian MRs. A survey was performed in 2012 on MRs attending post-graduate schools of 18 Italian Universities. Each participant was interviewed via an anonymous, self-administered, web-based questionnaire including questions on attitudes regarding influenza vaccination. A total of 2506 MRs were recruited in the survey and 299 (11.9%) of these stated they had accepted influenza vaccination in 2011-2012 season. Vaccinated MRs were older (P = 0.006), working in clinical settings (P = 0.048), and vaccinated in the 2 previous seasons (P<0.001 in both seasons). Moreover, MRs who had recommended influenza vaccination to their patients were significantly more compliant with influenza vaccination uptake in 2011-2012 season (P<0.001). "To avoid spreading influenza among patients" was recognized as the main reason for accepting vaccination by less than 15% of vaccinated MRs. Italian MRs seem to have a very low compliance with influenza vaccination and they seem to accept influenza vaccination as a habit that is unrelated to professional and ethical responsibility. Otherwise, residents who refuse vaccination in the previous seasons usually maintain their behaviors. Promoting correct attitudes and good practice in order to improve the influenza immunization rates of MRs could represent a decisive goal for increasing immunization coverage among health care workers of the future.

  4. Avian influenza: genetic evolution under vaccination pressure

    PubMed Central

    Escorcia, Magdalena; Vázquez, Lourdes; Méndez, Sara T; Rodríguez-Ropón, Andrea; Lucio, Eduardo; Nava, Gerardo M

    2008-01-01

    Antigenic drift of avian influenza viruses (AIVs) has been observed in chickens after extended vaccination program, similar to those observed with human influenza viruses. To evaluate the evolutionary properties of endemic AIV under high vaccination pressure (around 2 billion doses used in the last 12 years), we performed a pilot phylogenic analysis of the hemagglutinin (HA) gene of AIVs isolated from 1994 to 2006. This study demonstrates that Mexican low pathogenicity (LP) H5N2-AIVs are constantly undergoing genetic drifts. Recent AIV isolates (2002–2006) show significant molecular drifts when compared with the H5N2 vaccine-strain or other field isolates (1994–2000). This study also demonstrates that molecular drifts in the HA gene lineages follow a yearly trend, suggesting gradually cumulative sequence mutations. These findings might explain the increasing incidence of LP H5N2 AIV isolated from commercial avian farms. These findings support recent concerns about the challenge of AIV antigenic drift and influenza epidemics. PMID:18218105

  5. Vaccine Safety Resources for Nurses

    PubMed Central

    Shimabukuro, Tom T.; Hibbs, Beth F.; Moro, Pedro L.; Broder, Karen R.; Vellozzi, Claudia

    2015-01-01

    Overview Nurses are on the front lines of health care delivery, and many of them routinely administer immunizations. The authors describe the Centers for Disease Control and Prevention’s (CDC) vaccine safety monitoring systems, explaining how nurses can access inquiry channels and other immunization information resources. Examples of recent vaccine safety inquiries are also provided. PMID:26222474

  6. Prevention and Control of Seasonal Influenza with Vaccines.

    PubMed

    Grohskopf, Lisa A; Sokolow, Leslie Z; Broder, Karen R; Olsen, Sonja J; Karron, Ruth A; Jernigan, Daniel B; Bresee, Joseph S

    2016-01-01

    This report updates the 2015-16 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines (Grohskopf LA, Sokolow LZ, Olsen SJ, Bresee JS, Broder KR, Karron RA. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices, United States, 2015-16 influenza season. MMWR Morb Mortal Wkly Rep 2015;64:818-25). Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For the 2016-17 influenza season, inactivated influenza vaccines (IIVs) will be available in both trivalent (IIV3) and quadrivalent (IIV4) formulations. Recombinant influenza vaccine (RIV) will be available in a trivalent formulation (RIV3). In light of concerns regarding low effectiveness against influenza A(H1N1)pdm09 in the United States during the 2013-14 and 2015-16 seasons, for the 2016-17 season, ACIP makes the interim recommendation that live attenuated influenza vaccine (LAIV4) should not be used. Vaccine virus strains included in the 2016-17 U.S. trivalent influenza vaccines will be an A/California/7/2009 (H1N1)-like virus, an A/Hong Kong/4801/2014 (H3N2)-like virus, and a B/Brisbane/60/2008-like virus (Victoria lineage). Quadrivalent vaccines will include an additional influenza B virus strain, a B/Phuket/3073/2013-like virus (Yamagata lineage).Recommendations for use of different vaccine types and specific populations are discussed. A licensed, age-appropriate vaccine should be used. No preferential recommendation is made for one influenza vaccine product over another for persons for whom more than one licensed, recommended product is otherwise appropriate. This information is intended for vaccination providers, immunization program personnel, and public health personnel. Information in this report reflects discussions during public meetings of ACIP held on October 21, 2015; February 24, 2016; and June 22, 2016

  7. Cochrane re-arranged: support for policies to vaccinate elderly people against influenza.

    PubMed

    Beyer, Walter E P; McElhaney, Janet; Smith, Derek J; Monto, Arnold S; Nguyen-Van-Tam, Jonathan S; Osterhaus, Albert D M E

    2013-12-01

    The 2010 Cochrane review on efficacy, effectiveness and safety of influenza vaccination in the elderly by Jefferson et al. covering dozens of clinical studies over a period of four decades, confirmed vaccine safety, but found no convincing evidence for vaccine effectiveness (VE) against disease thus challenging the ongoing efforts to vaccinate the elderly. However, the Cochrane review analyzed and presented the data in a way that may itself have hampered the desired separation of real vaccine benefits from inevitable 'background noise'. The data are arranged in more than one hundred stand-alone meta-analyses, according to various vaccine types, study designs, populations, and outcome case definitions, and then further subdivided according to virus circulation and antigenic match. In this way, general vaccine effects could not be separated from an abundance of environmental and operational, non vaccine-related variation. Furthermore, expected impacts of changing virus circulation and antigenic drift on VE could not be demonstrated. We re-arranged the very same data according to a biological and conceptual framework based on the basic sequence of events throughout the 'patient journey' (exposure, infection, clinical outcome, observation) and using broad outcome definitions and simple frequency distributions of VE values. This approach produced meaningful predictions for VE against influenza-related fatal and non-fatal complications (average ~30% with large dispersion), typical influenza-like illness (~40%), disease with confirmed virus infection (~50%), and biological vaccine efficacy against infection (~60%), under conditions of virus circulation. We could also demonstrate a VE average around zero in the absence of virus circulation, and decreasing VE values with decreasing virus circulation and increasing antigenic drift. We regard these findings as substantial evidence for the ability of influenza vaccine to reduce the risk of influenza infection and influenza

  8. Safety and Immunogenicity of Cell Culture-Derived A/H3N2 Variant Influenza Vaccines: A Phase I Randomized, Observer-Blind, Dose-Ranging Study

    PubMed Central

    Johnson, Casey; Hohenboken, Matthew; Poling, Terry; Jaehnig, Peter; Kanesa-thasan, Niranjan

    2015-01-01

    Background. A/H3N2 variant (H3N2v) influenza may sustain human-to-human transmission, and an available candidate vaccine would be important. Methods. In this phase I, randomized, observer-blind, dose-ranging study, 627 healthy subjects ≥3 years of age were randomized to receive 2 vaccinations with H3N2c cell-culture-derived vaccine doses containing 3.75 µg, 7.5 µg, or 15 µg hemagglutinin antigen of H3N2v with or without MF59 (registered trademark of Novartis AG) adjuvant (an oil-in-water emulsion). This paper reports Day 43 planned interim data. Results. Single MF59-adjuvanted H3N2c doses elicited immune responses in almost all subjects regardless of antigen and adjuvant dose; the Center for Biologics Evaluation Research and Review (CBER) licensure criteria were met for all groups. Subjects with prevaccination hemagglutination inhibition titers <10 and children 3–<9 years achieve CBER criteria only after receiving 2 doses of nonadjuvanted H3N2c vaccine. Highest antibody titers were observed in the 7.5 µg + 0.25 mL MF59 groups in all age cohorts. MF59-adjuvanted H3N2c vaccines showed the highest rates of solicited local and systemic events, predominately mild or moderate. Conclusions. A single dose of H3N2c vaccine may be immunogenic and supports further development of MF59-adjuvanted H3N2c vaccines, especially for pediatric populations. Clinical Trials Registration. ClinicalTrials.gov identifier NCT01855945 (http://clinicaltrials.gov/ct2/show/NCT01855945). PMID:25538277

  9. Aflunov(®): a prepandemic influenza vaccine.

    PubMed

    Gasparini, Roberto; Amicizia, Daniela; Lai, Piero Luigi; Panatto, Donatella

    2012-02-01

    Influenza viruses are adept in human populations. Indeed, they have the capacity to evade the immune system through mechanisms of mutations (antigenic drift) and major variations in surface protein expression (antigenic shift). When a major change occurs, the risk of a human pandemic arises. Three influenza pandemics occurred during the 20th century, the most serious being the Spanish influenza. The last pandemic of the past century occurred in 1968, and the responsible virus infected an estimated 1-3 million people throughout the world. The first pandemic of the present century occurred in 2009 and was sustained by a H1N1 strain (A/California/07/09). In 1997, a novel avian influenza virus, H5N1, first infected humans in China. Since its emergence, the H5N1 virus has spread from Asia to Europe and Africa, resulting in the infection of millions of poultry and wild birds. So far, 522 human cases and 322 deaths have been reported by the WHO. Many studies have therefore been performed to obtain efficacious and safe H5N1 vaccines. One of these is Aflunov(®). Aflunov is a prepandemic monovalent A/H5N1 influenza vaccine adjuvanted with MF59 produced by Novartis Vaccines and Diagnostics. In nonclinical studies conducted in rabbits, Aflunov proved to be well-tolerated, did not cause maternal or embryo-fetal toxicity, was not teratogenic, and had no effects on postnatal development. In clinical studies, Aflunov proved safe and well-tolerated in infants, children, adolescents, adults and the elderly. In the same subjects, the vaccine elicited robust immunogenicity against both homologous (A/Vietnam/1194/2004 clade 1) and heterologous viral strains (for instance, A/Indonesia/05/2005 or A/Turkey/15/2006) and induced immunologic memory. Thus, in 2010, the CHMP issued a positive opinion on Aflunov and in January 2011 Aflunov was given marketing authorization. This vaccine could be very useful in the event of adaptation of the H5N1 virus to humans, which could cause a new

  10. Influenza vaccination for healthcare workers in the UK: appraisal of systematic reviews and policy options

    PubMed Central

    Kliner, Merav; Keenan, Alex; Sinclair, David; Ghebrehewet, Sam; Garner, Paul

    2016-01-01

    Background The UK Department of Health recommends annual influenza vaccination for healthcare workers, but uptake remains low. For staff, there is uncertainty about the rationale for vaccination and evidence underpinning the recommendation. Objectives To clarify the rationale, and evidence base, for influenza vaccination of healthcare workers from the occupational health, employer and patient safety perspectives. Design Systematic appraisal of published systematic reviews. Results The quality of the 11 included reviews was variable; some included exactly the same trials but made conflicting recommendations. 3 reviews assessed vaccine effects in healthcare workers and found 1 trial reporting a vaccine efficacy (VE) of 88%. 6 reviews assessed vaccine effects in healthy adults, and VE was consistent with a median of 62% (95% CI 56 to 67). 2 reviews assessed effects on working days lost in healthcare workers (3 trials), and 3 reported effects in healthy adults (4 trials). The meta-analyses presented by the most recent reviews do not reach standard levels of statistical significance, but may be misleading as individual trials suggest benefit with wide variation in size of effect. The 2013 Cochrane review reported absolute effects close to 0 for laboratory-confirmed influenza, and hospitalisation for patients, but excluded data on clinically suspected influenza and all-cause mortality, which had shown potentially important effects in previous editions. A more recent systematic review reports these effects as a 42% reduction in clinically suspected influenza (95% CI 27 to 54) and a 29% reduction in all-cause mortality (95% CI 15 to 41). Conclusions The evidence for employer and patient safety benefits of influenza vaccination is not straightforward and has been interpreted differently by different systematic review authors. Future uptake of influenza vaccination among healthcare workers may benefit from a fully transparent guideline process by a panel representing all

  11. Oculo-respiratory syndrome following influenza vaccination: evidence for occurrence with more than one influenza vaccine.

    PubMed

    De Serres, Gaston; Boulianne, Nicole; Duval, Bernard; Rochette, Louis; Grenier, Jean Luc; Roussel, Renée; Donaldson, Danièle; Tremblay, Michèle; Toth, Eveline; Ménard, Suzanne; Landry, Monique; Robert, Yves

    2003-06-01

    We assessed the occurrence of oculo-respiratory syndrome (ORS) following two influenza vaccines: Fluviral (Shire Biologics) or Vaxigrip (Aventis Pasteur). ORS was identified amongst 5.3 and 4.6% of recipients, respectively (P=0.54). With both vaccines, the risk of ORS was much greater in individuals who had ORS the previous year (2000) than in those without such history. In multivariate analysis, the odds ratio for ORS for patients with a prior history of ORS varied between 9.4 and 9.6 (P<0.001) whereas that comparing Fluviral and Vaxigrip varied between 1.5 and 1.9 (P=0.02-0.05). ORS is an adverse event that is present with more than one vaccine and may be present with any influenza vaccines to a greater or lesser degree. PMID:12744865

  12. The economic value of a quadrivalent versus trivalent influenza vaccine.

    PubMed

    Lee, Bruce Y; Bartsch, Sarah M; Willig, Alyssa M

    2012-12-14

    The recently licensed quadrivalent seasonal influenza vaccine (QIV) may provide better protection than the traditional trivalent influenza vaccine (TIV) as it includes one more influenza B strain. We developed a Monte Carlo simulation model to determine the economic value of a QIV compared to the TIV for 10 influenza seasons (1999-2009). The addition of the influenza B strain to convert the TIV into a QIV could result in substantial cost-savings to society (median of $3.1 billion) and third party payers (median of $292 million), even when the cost of QIV is significantly higher.

  13. Influence of sources of information about influenza vaccine on parental attitudes and adolescent vaccine receipt

    PubMed Central

    Gargano, Lisa M; Underwood, Natasha L; Sales, Jessica M; Seib, Katherine; Morfaw, Christopher; Murray, Dennis; DiClemente, Ralph J; Hughes, James M

    2015-01-01

    In 2011–2012, only 34% of 13–17 years olds in the United States (US) received seasonal influenza vaccine. Little is known about the link between parents' sources of health information, their vaccine-related attitudes, and vaccination of their adolescent against influenza. This study seeks to determine the relationship between number of sources of information on influenza vaccine, parental attitudes toward influenza vaccine, and influenza vaccine uptake in adolescents. We conducted a telephone and web-based survey among US parents of students enrolled in 6 middle and 5 high schools in Georgia. Bivariate and multivariable analyses were conducted to examine associations between the number of information sources about influenza vaccine and vaccine receipt and whether parent vaccine-related attitudes act as a mediator. The most commonly reported sources of information were: a physician/medical professional (95.0%), a family member or friend (80.6%), and television (77.2%). Parents who had higher attitude scores toward influenza vaccine were 5 times as likely to report their adolescent had ever received influenza vaccine compared to parents who had lower attitude scores (adjusted odds ratio (aOR) 5.1; 95% confidence intervals (CI) 3.1–8.4; P < 0.01). Parent vaccine-related attitudes were a significant mediator of the relationship between sources of information and vaccine receipt. In light of the low response rate and participation in an adolescent vaccination intervention, findings may not be generalizable to other populations. This study shows the importance of multiple sources of information in influencing parental decision-making about influenza vaccine for adolescents. Harnessing the power of mass media and family members and friends as health advocates for influenza vaccination can potentially help increase vaccination coverage of adolescents. PMID:25996686

  14. Influence of sources of information about influenza vaccine on parental attitudes and adolescent vaccine receipt.

    PubMed

    Gargano, Lisa M; Underwood, Natasha L; Sales, Jessica M; Seib, Katherine; Morfaw, Christopher; Murray, Dennis; DiClemente, Ralph J; Hughes, James M

    2015-01-01

    In 2011-2012, only 34% of 13-17 years olds in the United States (US) received seasonal influenza vaccine. Little is known about the link between parents' sources of health information, their vaccine-related attitudes, and vaccination of their adolescent against influenza. This study seeks to determine the relationship between number of sources of information on influenza vaccine, parental attitudes toward influenza vaccine, and influenza vaccine uptake in adolescents. We conducted a telephone and web-based survey among US parents of students enrolled in 6 middle and 5 high schools in Georgia. Bivariate and multivariable analyses were conducted to examine associations between the number of information sources about influenza vaccine and vaccine receipt and whether parent vaccine-related attitudes act as a mediator. The most commonly reported sources of information were: a physician/medical professional (95.0%), a family member or friend (80.6%), and television (77.2%). Parents who had higher attitude scores toward influenza vaccine were 5 times as likely to report their adolescent had ever received influenza vaccine compared to parents who had lower attitude scores (adjusted odds ratio (aOR) 5.1; 95% confidence intervals (CI) 3.1-8.4; P < 0.01). Parent vaccine-related attitudes were a significant mediator of the relationship between sources of information and vaccine receipt. In light of the low response rate and participation in an adolescent vaccination intervention, findings may not be generalizable to other populations. This study shows the importance of multiple sources of information in influencing parental decision-making about influenza vaccine for adolescents. Harnessing the power of mass media and family members and friends as health advocates for influenza vaccination can potentially help increase vaccination coverage of adolescents. PMID:25996686

  15. Influenza and pneumococcal vaccination of the elderly in Taiwan.

    PubMed

    Chen, Yeong-Hwang; Liou, Saou-Hsing; Chou, Chih-Chieh; Su, Wen-Lin; Loh, Ching-Hui; Lin, Shih-Ha

    2004-07-29

    In 1998, Taiwan became the first country in Asia to provide free influenza vaccination to high-risk groups, mainly the elderly. The purpose of this study is to determine: (1) the annual mortality rate from influenza and pneumococcal-related illnesses such as pneumonia, chronic bronchitis, pulmonary emphysema and asthma and (2) the effectiveness of and adverse events associated with the influenza vaccination. In the elderly, influenza vaccination caused the annual death rate due chronic bronchitis, pulmonary emphysema, and asthma to decline steadily but had no effect on the annual pneumonia death rate. The only adverse effect of concern was vertigo (in approximately 2-3%).

  16. 75 FR 2049 - National Influenza Vaccination Week, 2010

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-13

    ...-fourth. (Presidential Sig.) [FR Doc. 2010-650 Filed 1-12-10; 11:15 am] Billing code 3195-W0-P ... Proclamation 8472--National Influenza Vaccination Week, 2010 #0; #0; #0; Presidential Documents #0; #0; #0;#0...;Title 3-- #0;The President ] Proclamation 8472 of January 8, 2010 National Influenza Vaccination...

  17. 75 FR 77517 - National Influenza Vaccination Week, 2010

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-10

    ... and thirty-fifth. (Presidential Sig.) [FR Doc. 2010-31292 Filed 12-9-10; 11:15 am] Billing code 3195... Proclamation 8615--National Influenza Vaccination Week, 2010 #0; #0; #0; Presidential Documents #0; #0; #0;#0...;Title 3-- #0;The President ] Proclamation 8615 of December 7, 2010 National Influenza Vaccination...

  18. Development of pandemic influenza vaccine production capacity in Viet Nam.

    PubMed

    Hoa, L K; Hiep, L V; Be, L V

    2011-07-01

    The Institute of Vaccines and Medical Biologicals (IVAC), a state-owned vaccine manufacturer, initiated research into avian influenza vaccines in the early 1990 s in response to the threat of a highly pathogenic avian influenza pandemic. Successful results from laboratory studies on A(H5N1) influenza virus attracted seed funds and led to participation in the WHO technology transfer project to enhance influenza vaccine production in developing countries. IVAC's goal is to produce 500,000 doses of inactivated monovalent whole-virion influenza vaccine per year by 2012, and progressively increase capacity to more than 1 million doses to protect essential populations in Viet Nam in the event of an influenza pandemic. The WHO seed grants, supplemented by other international partner support, enabled IVAC to build in a very short time an influenza vaccine manufacturing plant under Good Manufacturing Practice and relevant biosafety standards, a waste treatment system and a dedicated chicken farm for high-quality eggs. Much of the equipment and instrumentation required for vaccine production has been installed and tested for functional operation. Staff have been trained on site and at specialized courses which provided comprehensive manuals on egg-based manufacturing processes and biosafety. Following process validation, clinical trials will start in 2011 and the first domestic influenza vaccine doses are expected in 2012.

  19. Phase III, randomized controlled trial to evaluate lot consistency of a trivalent subunit egg-based influenza vaccine in adults.

    PubMed

    Rivera, Luis; Mazara, Sonia; Vargas, Maria; Fragapane, Elena; Casula, Daniela; Groth, Nicola

    2012-07-27

    Vaccination is the most effective preventive strategy to control influenza. The demonstration of lot-to-lot consistency to confirm the reliability of the manufacturing process has become a mandatory step in vaccine development. This phase III, observer-blind, controlled trial assessed lot-to-lot consistency, immunogenicity, and safety of a subunit trivalent influenza vaccine (Agrippal®, Novartis Vaccines and Diagnostics) in healthy adults aged 18-49 years. The immunogenicity and safety profile of Agrippal was compared with a control vaccine (Fluvirin®, Novartis Vaccines and Diagnostics). A total of 1507 subjects were randomized 2:2:2:1 to receive one vaccination of one of the three lots of influenza vaccine or control vaccine. Antibody levels were measured by hemagglutination inhibition assay on days 1 and 22. Adverse reactions were solicited via diary cards for 7 days after vaccination, and unsolicited adverse events were collected throughout the study period. Equivalence of day 22 immune responses to the three lots was shown for each of the three strains. Robust immunogenic responses after one dose were observed for all vaccine groups, and both Center for Biologics Evaluation and Research criteria for licensure of influenza vaccines were met for all three virus strains. Both vaccines exhibited a robust safety profile and were well tolerated, with no differences in local and systemic solicited reactions or in unsolicited adverse events. The demonstration of consistency between manufacturing lots confirms for purposes of clinical development the reliability of the production process. The robust immunogenic responses and favorable safety profiles further support the use of trivalent subunit influenza vaccines Agrippal and Fluvirin for active immunization against influenza. PMID:22659448

  20. Acceptability of live attenuated influenza vaccine by vaccine providers in Quebec, Canada.

    PubMed

    Dubé, Eve; Gagnon, Dominique; Kiely, Marilou; Boulianne, Nicole; Landry, Monique

    2015-01-01

    A live attenuated influenza vaccine (LAIV) was offered during the 2012-13 influenza season in Quebec, Canada, to children aged between 2 and 17 years with chronic medical conditions. Despite the offer, uptake of the vaccine was low. We assessed the perceptions and opinions about seasonal influenza vaccination and LAIV use among vaccine providers who participated in the 2012-13 campaign. More than 70% of them thought that LAIV was safe and effective and more than 90% considered that the vaccine was well-received by parents and healthcare professionals. According to respondents, the most frequent concerns of parents about LAIV were linked to vaccine efficacy. LAIV is well-accepted by vaccine providers involved in influenza vaccination clinics, but more information about the vaccine and the recommendations for its use are needed to increase vaccine uptake.

  1. Influenza virus surveillance, vaccine strain selection, and manufacture.

    PubMed

    Stöhr, Klaus; Bucher, Doris; Colgate, Tony; Wood, John

    2012-01-01

    As outlined in other chapters, the influenza virus, existing laboratory diagnostic abilities, and disease epidemiology have several peculiarities that impact on the timing and processes for the annual production of influenza vaccines. The chapter provides an overview on the key biological and other factors that influence vaccine production. They are the reason for an "annual circle race" beginning with global influenza surveillance during the influenza season in a given year to the eventual supply of vaccines 12 months later in time before the next seasonal outbreak and so on. As influenza vaccines are needed for the Northern and Southern Hemisphere outbreaks in fall and spring, respectively, global surveillance and vaccine production has become a year round business. Its highlights are the WHO recommendations on vaccine strains in February and September and the eventual delivery of vaccine doses in time before the coming influenza season. In between continues vaccine strain and epidemiological surveillance, preparation of new high growth reassortments, vaccine seed strain preparation and development of standardizing reagents, vaccine bulk production, fill-finishing and vaccine release, and in some regions, clinical trials for regulatory approval.

  2. M2e-Based Universal Influenza A Vaccines

    PubMed Central

    Deng, Lei; Cho, Ki Joon; Fiers, Walter; Saelens, Xavier

    2015-01-01

    The successful isolation of a human influenza virus in 1933 was soon followed by the first attempts to develop an influenza vaccine. Nowadays, vaccination is still the most effective method to prevent human influenza disease. However, licensed influenza vaccines offer protection against antigenically matching viruses, and the composition of these vaccines needs to be updated nearly every year. Vaccines that target conserved epitopes of influenza viruses would in principle not require such updating and would probably have a considerable positive impact on global human health in case of a pandemic outbreak. The extracellular domain of Matrix 2 (M2e) protein is an evolutionarily conserved region in influenza A viruses and a promising epitope for designing a universal influenza vaccine. Here we review the seminal and recent studies that focused on M2e as a vaccine antigen. We address the mechanism of action and the clinical development of M2e-vaccines. Finally, we try to foresee how M2e-based vaccines could be implemented clinically in the future. PMID:26344949

  3. Prospects of HA-Based Universal Influenza Vaccine

    PubMed Central

    Hashem, Anwar M.

    2015-01-01

    Current influenza vaccines afford substantial protection in humans by inducing strain-specific neutralizing antibodies (Abs). Most of these Abs target highly variable immunodominant epitopes in the globular domain of the viral hemagglutinin (HA). Therefore, current vaccines may not be able to induce heterosubtypic immunity against the divergent influenza subtypes. The identification of broadly neutralizing Abs (BnAbs) against influenza HA using recent technological advancements in antibody libraries, hybridoma, and isolation of single Ab-secreting plasma cells has increased the interest in developing a universal influenza vaccine as it could provide life-long protection. While these BnAbs can serve as a source for passive immunotherapy, their identification represents an important step towards the design of such a universal vaccine. This review describes the recent advances and approaches used in the development of universal influenza vaccine based on highly conserved HA regions identified by BnAbs. PMID:25785268

  4. Pandemic influenza A(H1N1) 2009 vaccines in the European Union.

    PubMed

    Johansen, K; Nicoll, A; Ciancio, B C; Kramarz, P

    2009-01-01

    Pandemic vaccines from four manufacturers are now available for use within the European Union (EU). Use of these vaccines will protect individuals and reduce the impact on health services to more manageable levels. The majority of the severely ill will be from known risk groups and the best strategy will be to start vaccinating in line with the recommendation from the European Union Health Security Committee prioritizing adults and children with chronic conditions, pregnant women and healthcare workers. The composition of authorized vaccines is reviewed in this article. The vaccine strain in all authorized pandemic vaccines worldwide is based on the same initial isolate of influenza A/California/7/2009 (H1N1)v but the vaccines differ in conditions for virus propagation, antigen preparation, antigen content and whether they are adjuvanted or not. The vaccines are likely to be effective since no significant genetic or antigenic drift has occurred and there are already mechanisms for estimating clinical effectiveness. Influenza vaccines have good safety records and no safety concerns have so far been encountered with any of the vaccines developed. However, special mechanisms have been devised for the early detection and rigorous investigation of possible significant side effects in Europe through post-marketing surveillance and analysis. Delivery of the vaccines to the risk groups will pose difficulties where those with chronic illnesses are not readily identifiable to the healthcare services. There is considerable scope for European added value through Member States with excess vaccines making them available to other states. PMID:19883538

  5. Effectiveness of 2010/2011 seasonal influenza vaccine in Ireland.

    PubMed

    Barret, A S; Donnell, J O; O'Hora, A; Collins, C; Coughlan, S; Joyce, M; Moran, J; Waters, A; O'Malley, A; Domegan, L; O'Flanagan, D

    2012-02-01

    We conducted a case-control study to estimate the 2010/2011 trivalent influenza vaccine effectiveness (TIVE) using the Irish general practitioners' influenza sentinel surveillance scheme. Cases were influenza-like illness (ILI) patients with laboratory-confirmed influenza. Controls were ILI patients who tested negative for influenza. Participating sentinel general practitioners (GP) collected swabs from patients presenting with ILI along with their vaccination history and other individual characteristics. The TIVE was computed as (1 - odds ratiofor vaccination) x100%. Of 60 sentinel GP practices, 22 expressed interest in participating in the study and 17 (28%) recruited at least one ILI patient. In the analysis, we included 106 cases and 85 controls. Seven controls (8.2%) and one influenza case (0.9%) had been vaccinated in 2010/2011. The estimated TIVE against any influenza subtype was 89.4% [95% CI: 13.8; 99.8%], suggesting a protective effect against GP-attended laboratory confirmed influenza. This study design could be used to monitor influenza vaccine effectiveness annually but sample size and vaccination coverage should be increased to obtain precise and adjusted estimates. PMID:22455236

  6. An approach to monitoring influenza vaccination uptake across Europe.

    PubMed

    Kroneman, M; Paget, W J; Meuwissen, L E; Joseph, C; Kennedy, H

    2008-05-15

    Currently, the monitoring of influenza vaccination uptake is mainly a national issue. As influenza infection easily crosses international borders, it is in the interest of all countries to have a high vaccine uptake in people who may be vulnerable when influenza spreads. A Europe-wide monitoring system can provide insight into the strengths and weaknesses of uptake rates in countries and, on ce sufficient levels are achieved, can safeguard the continuation of the achieved levels. This paper aims to address the following issues: a) How is influenza vaccination uptake monitored in Europe? b) What methods to monitor vaccination uptake are available and what are their limitations? c) What steps should be taken to implement a European-wide influenza vaccination uptake monitoring system? Based on existing literature and experiences in monitoring influenza vaccination uptake, an approach to set up a European-wide monitoring system is proposed. The following issues were identified as relevant for influenza vaccination uptake monitoring: a) Agreement on the population groups in which vaccination uptake should be monitored; b) The frequency of data collection; c) The importance of sharing experiences regarding existing influenza vaccination campaigns in order to learn from each other, and develop 'best practices'; d) The need to publish uptake data in close relation with influenza surveillance data and other European efforts on dissemination of vaccination knowledge. To stimulate the discussion on implementing a pan-European influenza uptake monitoring scheme the following recommendations were suggested : a) Develop a common set of variables; b) Build on experience from individual countries; c) Create a coordinating body; d) Create or identify a platform to publish the data; e) Start small and expand rapidly. PMID:18761972

  7. [Epidemiological effect of influenza vaccination (author's transl)].

    PubMed

    Hennessen, W; Mauler, R; Gruschkau, H; Hinz, J; Ullrich, C

    1977-07-29

    No influenza-A virus epidemic occurred in the Federal Republic of Germany during 1971-1975. The neighbouring countries, however, reported up to three such epidemics. The vaccines used had differences: contrary to neighbouring countries, in the FRG largely those were used which had mineral adjuvants, and they more frequently had viral subgroups. Comparison between the USA and FRG with respect to influenza death-rates over 20 years revealed a strict correlation from 1956 up to 1965. But since 1966 the death-rate has decreased progressively in the FRG while it has remained unchanged in the USA. Immunisation methods in the two countries have differed since 1966 in that the Public Health Authorities of the two countries have recommended immunisation of different population groups: in the USA it has been only for patients at risk, while in the FRG the rest of the population has also been urged to be immunised. As a result, immunisation rates differ markedly between the two countries. Absence of an influenza epidemic, accompanied by a reduction in death-rate due to influenza, strongly suggests that the two phenomena are the result of a break in the infection chain. This seems to be more successful when both part of the total population and the risk groups are immunised.

  8. Getting vaccinated or not getting vaccinated? Different reasons for getting vaccinated against seasonal or pandemic influenza

    PubMed Central

    2013-01-01

    Background A large number of studies have investigated the motivation behind health care workers (HCWs) taking the influenza vaccine. But with the appearance of pandemic influenza, it became important to better analyse the reasons why workers get vaccinated against seasonal and/or pandemic influenza. Methods Three main categories of reasons were identified with an Exploratory Factor Analysis. An analysis of variance (ANOVA) was used to verify the existence of differences between three categories of choices (taking of seasonal and pandemic vaccine, only the seasonal vaccine or none). In addition, a multinomial logistic regression analysis was performed to analyse the association between stated intentions and update of seasonal and pandemic vaccine. Questionnaires were returned from 168 HCWs (67.3% women). Results The results showed that age and being well-informed about vaccination topics are the most important variables in determining the choice to take the vaccine. Conclusions The results highlight the importance of enhancing education programs to improve awareness among HCWs concerning the benefits of taking the influenza vaccination, with particular attention paid to younger workers. PMID:24359091

  9. Influenza vaccination of pregnant women protects them over two consecutive influenza seasons in a randomized controlled trial

    PubMed Central

    Mutsaerts, Eleonora; Madhi, Shabir A.; Cutland, Clare L.; Jones, Stephanie; Hugo, Andrea; Trenor, Siobhan; Treurnicht, Florette K.; Klipstein-Grobusch, Kerstin; Weinberg, Adriana; Nunes, Marta C.

    2016-01-01

    ABSTRACT Background: We assessed the persistence of hemagglutinin inhibition (HAI) antibodies and the vaccine efficacy (VE) of trivalent inactivated influenza vaccine (IIV3) following vaccination of a cohort of pregnant South African women during a second influenza season. Methods: A cohort of women who participated in a randomized placebo-controlled trial on the safety, immunogenicity and efficacy of IIV3 in 2011 had HAI titers measured in 2012 and were monitored for influenza illness until the end of 2012. Results: The proportion of women with HAI titers ≥1:40 was significantly greater in vaccinees (63%) compared to placebo-recipients (22%; p < 0.001). VE in 2012 was 63.8% (95% confidence interval [95%CI]: −33.7%, 90.2%); combined VE for 2011 and 2012 was 58.3% (95%CI: 0.2%, 82.6%). Conclusion: The majority of women who received IIV3 during pregnancy had HAI titers above the putative threshold for protection against influenza illness one year after vaccination and showed a trend towards protection against influenza disease. PMID:27212228

  10. Influenza virus vaccination and kidney graft rejection: causality or coincidence.

    PubMed

    Fischer, Anne Sophie Lind; Møller, Bjarne Kuno; Krag, Søren; Jespersen, Bente

    2015-06-01

    Influenza can cause significant morbidity and mortality in renal transplant recipients especially with a high rate of lower respiratory disease. Annual influenza vaccination is therefore recommended to renal transplant recipients. We report the first three cases of acute kidney injury in renal transplant recipients following influenza vaccination that all led to graft loss. They all had different native diseases and were all vaccinated in the same season of 2009-10. The time span from vaccination to decline of kidney function is shorter than the time to diagnosis since the three patients only had blood tests every 3 months or when symptoms became severe. These reports do not justify a change of current recommendations regarding influenza vaccination in renal transplant recipients, but they support the continued attention and registration of vaccinations to monitor side effects. PMID:26034595

  11. Influenza virus vaccination and kidney graft rejection: causality or coincidence

    PubMed Central

    Fischer, Anne Sophie Lind; Møller, Bjarne Kuno; Krag, Søren; Jespersen, Bente

    2015-01-01

    Influenza can cause significant morbidity and mortality in renal transplant recipients especially with a high rate of lower respiratory disease. Annual influenza vaccination is therefore recommended to renal transplant recipients. We report the first three cases of acute kidney injury in renal transplant recipients following influenza vaccination that all led to graft loss. They all had different native diseases and were all vaccinated in the same season of 2009–10. The time span from vaccination to decline of kidney function is shorter than the time to diagnosis since the three patients only had blood tests every 3 months or when symptoms became severe. These reports do not justify a change of current recommendations regarding influenza vaccination in renal transplant recipients, but they support the continued attention and registration of vaccinations to monitor side effects. PMID:26034595

  12. Optimising vaccination strategies in equine influenza.

    PubMed

    Park, A W; Wood, J L N; Newton, J R; Daly, J; Mumford, J A; Grenfell, B T

    2003-06-20

    A stochastic model of equine influenza (EI) is constructed to assess the risk of an outbreak in a Thoroughbred population at a typical flat race training yard. The model is parameterised using data from equine challenge experiments conducted by the Animal Health Trust (relating to the latent and infectious period of animals) and also published data on previous epidemics (to estimate the transmission rate for equine influenza). Using 89 ponies, an empirical relationship between pre-challenge antibody and the probability of becoming infectious is established using logistic regression. Changes in antibody level over time are quantified using published and unpublished studies comprising 618 ponies and horses. A plausible Thoroughbred population is examined over the course of a year and the model is used to assess the risk of an outbreak of EI in the yard under the current minimum vaccination policy in the UK. The model is adapted to consider an alternative vaccination programme where the frequency of vaccination in older horses (2-year-olds and upwards) is increased. Model results show that this practical alternative would offer a significant increase in protection. Spread of infection between yards is also considered to ascertain the risk of secondary outbreaks.

  13. Translating vaccine policy into action: a report from the Bill & Melinda Gates Foundation Consultation on the prevention of maternal and early infant influenza in resource-limited settings.

    PubMed

    Ortiz, Justin R; Neuzil, Kathleen M; Ahonkhai, Vincent I; Gellin, Bruce G; Salisbury, David M; Read, Jennifer S; Adegbola, Richard A; Abramson, Jon S

    2012-11-26

    Immunization of pregnant women against influenza is a promising strategy to protect the mother, fetus, and young infant from influenza-related diseases. The burden of influenza during pregnancy, the vaccine immunogenicity during this period, and the robust influenza vaccine safety database underpin recommendations that all pregnant women receive the vaccine to decrease complications of influenza disease during their pregnancies. Recent data also support maternal immunization for the additional purpose of preventing disease in the infant during the first six months of life. In April 2012, the WHO Strategic Advisory Group of Experts (SAGE) on Immunization recommended revisions to the WHO position paper on influenza vaccines. For the first time, SAGE recommended pregnant women should be made the highest priority for inactivated seasonal influenza vaccination. However, the variable maternal influenza vaccination coverage in countries with pre-existing maternal influenza vaccine recommendations underscores the need to understand and to address the discrepancy between recommendations and implementation success. We present the outcome of a multi-stakeholder expert consultation on inactivated influenza vaccination in pregnancy. The creation and implementation of vaccine policies and regulations require substantial resources and capacity. As with all public health interventions, the existence of perceived and real risks of vaccination will necessitate effective and transparent risk communication. Potential risk allocation and sharing mechanisms should be addressed by governments, vaccine manufacturers, and other stakeholders. In resource-limited settings, vaccine-related issues concerning supply, formulation, regulation, evidence evaluation, distribution, cost-utility, and post-marketing safety surveillance need to be addressed. Lessons can be learned from the Maternal and Neonatal Tetanus Elimination Initiative as well as efforts to increase vaccine coverage among pregnant

  14. Effect of Statin Use on Influenza Vaccine Effectiveness

    PubMed Central

    McLean, Huong Q.; Chow, Brian D. W.; VanWormer, Jeffrey J.; King, Jennifer P.; Belongia, Edward A.

    2016-01-01

    Background. Recent studies suggest that statin use may reduce influenza vaccine effectiveness (VE), but laboratory-confirmed influenza was not assessed. Methods. Patients ≥45 years old presenting with acute respiratory illness were prospectively enrolled during the 2004–2005 through 2014–2015 influenza seasons. Vaccination and statin use were extracted from electronic records. Respiratory samples were tested for influenza virus. Results. The analysis included 3285 adults: 1217 statin nonusers (37%), 903 unvaccinated statin nonusers (27%), 847 vaccinated statin users (26%), and 318 unvaccinated statin users (10%). Statin use modified VE and the risk of influenza A(H3N2) virus infection (P = .002) but not 2009 pandemic influenza A(H1N1) virus (A[H1N1]pdm09) or influenza B virus infection (P = .2 and .4, respectively). VE against influenza A(H3N2) was 45% (95% confidence interval [CI], 27%–59%) among statin nonusers and −21% (95% CI, −84% to 20%) among statin users. Vaccinated statin users had significant protection against influenza A(H1N1)pdm09 (VE, 68%; 95% CI, 19%–87%) and influenza B (VE, 48%; 95% CI, 1%–73%). Statin use did not significantly modify VE when stratified by prior season vaccination. In validation analyses, the use of other cardiovascular medications did not modify influenza VE. Conclusions. Statin use was associated with reduced VE against influenza A(H3N2) but not influenza A(H1N1)pdm09 or influenza B. Further research is needed to assess biologic plausibility and confirm these results. PMID:27471318

  15. Awareness of Influenza and Attitude Toward Influenza Vaccination Among Medical Students.

    PubMed

    Banaszkiewicz, A; Talarek, E; Śliwka, J; Kazubski, F; Małecka, I; Stryczyńska-Kazubska, J; Dziubak, W; Kuchar, E

    2016-01-01

    In Poland, influenza vaccination coverage among both the general population and healthcare workers is low. The aim of the study was to evaluate attitudes towards influenza vaccination among final-year medical students compared with first-year students at medical schools in Poland. Students were asked about the last season's influenza vaccination and what the reasons were for having, or not having, the vaccination. The knowledge of influenza was assessed using a 10-point visual analog scale. The study group consisted of 712 medical students, 404 in the first year and 308 in the final year (35 % and 31 % of all students in those years, respectively). Final-year students believed they had a better knowledge of influenza (OR = 3.33; CI95 %: 2.54-4.39). They answered questions about influenza immunizations (OR = 0.59; CI95 %: 0.44-0.78) and vaccination recommendations in pregnant women correctly more frequently (OR = 0.21; CI95 %: 0.16-0.28). The influenza vaccination rate among students in the 2014/2015 season was similar (17.1 % in the first vs. 15.9 % in the final year, NS). Among the final-year students, the reason for not having the vaccination was mainly financial and not any other. We conclude that although medical students' knowledge about influenza increases in the course of study, it did not much affect their unwilling attitude toward vaccination. PMID:27241508

  16. Influenza vaccine effectiveness against hospitalisation with influenza in adults in Australia in 2014.

    PubMed

    Cheng, Allen C; Kotsimbos, Tom; Kelly, Paul M

    2015-12-16

    We provide estimates of the influenza vaccine protection against hospitalisation with laboratory-confirmed influenza in the 2014 Australian season where the A/H1N1/pdm09 strain predominated. This was performed using a case-test negative study design as part of a national sentinel surveillance system in Australia. Vaccine effectiveness was estimated as (1-OR)×100% where the odds ratio of vaccination in cases vs test negative participants was estimated from a conditional logistic regression. Between April and November, 1692 adult patients were admitted with laboratory-confirmed influenza. Vaccine effectiveness was estimated from 1283 patients with influenza and 1116 test negative patients where vaccination status was ascertained. Vaccination was associated with a reduction in the risk of hospitalisation with influenza of 51.5% (95% CI: 41.6%, 59.7%) in all patients, and a reduction of 50.7% (95% CI: 40.1%, 59.3%) in the target population for vaccination. We estimate that the influenza vaccine was moderately protective against hospitalisation with laboratory-confirmed influenza during the 2014 influenza season in Australia.

  17. Improving Influenza and Pneumococcal Vaccination Rates in Ambulatory Specialty Practices

    PubMed Central

    Pennant, Keyana N.; Costa, John J.; Fuhlbrigge, Anne L.; Sax, Paul E.; Szent-Gyorgyi, Lara E.; Coblyn, Jonathan; Desai, Sonali P.

    2015-01-01

    Background. Influenza and pneumococcal vaccinations are recommended for elderly and high-risk patients; however, rates of adherence are low. We sought to implement influenza and pneumococcal vaccine initiatives in 4 different ambulatory specialty practices, using 3 unique approaches. Methods. Four specialties with high-risk patient populations were selected for intervention: allergy (asthma), infectious disease (ID) (human immunodeficiency virus), pulmonary (chronic lung disease), and rheumatology (immunocompromised). Allergy and ID focused on influenza vaccination, and pulmonary and rheumatology focused on pneumococcal vaccination. We used 3 strategies for quality improvement: physician reminders, patient letters, and a nurse-driven model. Physicians were provided their performance data on a monthly basis and presented trended data on a quarterly basis at staff meetings. Results. All 4 specialties developed processes for improving vaccination rates with all showing some increase. Higher rates were achieved with pneumococcal vaccine than influenza. Pneumococcal vaccine rates showed steady improvement from year to year while influenza vaccine rates remained relatively constant. Allergy's influenza rate was 59% in 2011 and 64% in the 2014 flu season. Infectious disease influenza rates moved from 74% in the 2011 flu season to 86% for the 2014 season. Pneumococcal vaccine in pulmonary patients' rate was 52% at the start of intervention in February 2009 and 79% as of January 2015. Rheumatology rates rose from 50% in February 2009 to 87% in January 2015. Conclusions. Integrated routine workflow and performance data sharing can effectively engage specialists and staff in vaccine adherence improvement. Influenza vaccination may require other approaches to achieve the rates seen with pneumococcal vaccine. PMID:26430697

  18. Methylglycol chitosan and a synthetic TLR4 agonist enhance immune responses to influenza vaccine administered sublingually.

    PubMed

    Spinner, Justin L; Oberoi, Hardeep S; Yorgensen, Yvonne M; Poirier, Danielle S; Burkhart, David J; Plante, Martin; Evans, Jay T

    2015-10-26

    Influenza is a vaccine-preventable contagious respiratory illness caused by influenza (flu) viruses which can lead to hospitalization and sometimes even death. Current flu vaccines delivered intramuscularly (IM) or intradermally (ID) are less effective at eliciting protective mucosal immune responses and vaccines delivered intranasally (IN) possess potential safety concerns. Sublingual (SL) vaccination is a promising alternative route for vaccine delivery which has been indicated as safe and effective at inducing protective immune responses in both systemic and mucosal compartments. We evaluated the efficacy of methylglycol chitosan (MGC) and a synthetic toll-like receptor 4 agonist (CRX-601), alone or in combination, for improving systemic and mucosal immune responses to a monovalent detergent-split flu virus vaccine delivered SL. SL vaccination of mice with split-flu vaccine formulated with either MGC or CRX-601 resulted in specific serum IgG and mucosal IgA titers that were significantly greater than titers from non-adjuvanted vaccination and equivalent to or greater than titers in mice vaccinated IM. Our results demonstrate that SL vaccination utilizing MGC or CRX-601 as adjuvants is a viable alternative route of vaccination for flu which can elicit systemic immune responses equivalent to or greater than IM vaccination with the added benefit of stimulating a robust specific mucosal immune response.

  19. Methylglycol chitosan and a synthetic TLR4 agonist enhance immune responses to influenza vaccine administered sublingually.

    PubMed

    Spinner, Justin L; Oberoi, Hardeep S; Yorgensen, Yvonne M; Poirier, Danielle S; Burkhart, David J; Plante, Martin; Evans, Jay T

    2015-10-26

    Influenza is a vaccine-preventable contagious respiratory illness caused by influenza (flu) viruses which can lead to hospitalization and sometimes even death. Current flu vaccines delivered intramuscularly (IM) or intradermally (ID) are less effective at eliciting protective mucosal immune responses and vaccines delivered intranasally (IN) possess potential safety concerns. Sublingual (SL) vaccination is a promising alternative route for vaccine delivery which has been indicated as safe and effective at inducing protective immune responses in both systemic and mucosal compartments. We evaluated the efficacy of methylglycol chitosan (MGC) and a synthetic toll-like receptor 4 agonist (CRX-601), alone or in combination, for improving systemic and mucosal immune responses to a monovalent detergent-split flu virus vaccine delivered SL. SL vaccination of mice with split-flu vaccine formulated with either MGC or CRX-601 resulted in specific serum IgG and mucosal IgA titers that were significantly greater than titers from non-adjuvanted vaccination and equivalent to or greater than titers in mice vaccinated IM. Our results demonstrate that SL vaccination utilizing MGC or CRX-601 as adjuvants is a viable alternative route of vaccination for flu which can elicit systemic immune responses equivalent to or greater than IM vaccination with the added benefit of stimulating a robust specific mucosal immune response. PMID:26392012

  20. Influenza Vaccination among Pregnant Women: Patient Beliefs and Medical Provider Practices

    PubMed Central

    Samelson, Renee; Siddiqui, Maryam M.; Paglia, Michael J.; Strassberg, Emmie R.; Kelly, Elizabeth; Murtough, Katie L.; Schulkin, Jay

    2016-01-01

    ACOG's research department recruited four medical centers to participate in a study on the attitudes and practices of medical providers and pregnant patients regarding influenza vaccination. Medical providers and patients were given voluntary surveys and medical record data was collected over two flu seasons, from 2013 to 2015. Discrepancies between self-reports of medical providers and patients and medical records were observed. Nearly 80% of patients self-reported accepting the influenza vaccine, but medical record data only reported 36% of patients accepting the vaccine. Similarly, all medical providers reported giving recommendations for the vaccine, but only 85% of patients reported receiving a recommendation. Age, education, a medical provider's recommendation, and educational materials were found to positively influence patient beliefs about the influenza vaccine. Accepting the vaccine was influenced by a patient's previous actions, beliefs, and a medical provider's recommendation. Patients who reported previously not accepting the vaccine and had negative feelings towards the vaccine but accepted it while pregnant reported concern for the health and safety of their baby. Future research should focus on groups that may be less likely to accept the vaccine and ways to dispel negative myths. Medical provider should continue to strongly recommend the vaccine and provide educational materials. PMID:27559272

  1. Influenza Vaccination among Pregnant Women: Patient Beliefs and Medical Provider Practices.

    PubMed

    Stark, Lauren M; Power, Michael L; Turrentine, Mark; Samelson, Renee; Siddiqui, Maryam M; Paglia, Michael J; Strassberg, Emmie R; Kelly, Elizabeth; Murtough, Katie L; Schulkin, Jay

    2016-01-01

    ACOG's research department recruited four medical centers to participate in a study on the attitudes and practices of medical providers and pregnant patients regarding influenza vaccination. Medical providers and patients were given voluntary surveys and medical record data was collected over two flu seasons, from 2013 to 2015. Discrepancies between self-reports of medical providers and patients and medical records were observed. Nearly 80% of patients self-reported accepting the influenza vaccine, but medical record data only reported 36% of patients accepting the vaccine. Similarly, all medical providers reported giving recommendations for the vaccine, but only 85% of patients reported receiving a recommendation. Age, education, a medical provider's recommendation, and educational materials were found to positively influence patient beliefs about the influenza vaccine. Accepting the vaccine was influenced by a patient's previous actions, beliefs, and a medical provider's recommendation. Patients who reported previously not accepting the vaccine and had negative feelings towards the vaccine but accepted it while pregnant reported concern for the health and safety of their baby. Future research should focus on groups that may be less likely to accept the vaccine and ways to dispel negative myths. Medical provider should continue to strongly recommend the vaccine and provide educational materials. PMID:27559272

  2. Requiring elderly patients to give signed consent for influenza vaccine. Does it affect acceptance?

    PubMed Central

    Charles, J.; Lewis, J.

    1994-01-01

    This study aimed to determine whether requiring signed consent before influenza vaccination affected vaccine acceptance by elderly patients. Previous influenza vaccination was determined by chart review. All subjects agreed to sign the consent. Requiring signed consent did not affect influenza vaccine acceptance in this population. Mailed reminder letters and information packages in patients' charts significantly increased vaccination rates. PMID:8199503

  3. Effective influenza vaccines for children: a critical unmet medical need and a public health priority.

    PubMed

    Banzhoff, Angelika; Stoddard, Jeffrey J

    2012-03-01

    Seasonal influenza causes clinical illness and hospitalization in all age groups; however, conventional inactivated vaccines have only limited efficacy in young children. MF59(®), an oil-in-water emulsion adjuvant, has been used since the 1990s to enhance the immunogenicity of influenza vaccines in the elderly, a population with waning immune function due to immunosenescence. Clinical trials now provide information to support a favorable immunogenicity and safety profile of MF59-adjuvanted influenza vaccine in young children. Published data indicate that Fluad(®), a trivalent seasonal influenza vaccine with MF59, was immunogenic and well tolerated in young children, with a benefit/risk ratio that supports routine clinical use. A recent clinical trial also shows that Fluad provides high efficacy against PCR-confirmed influenza. Based on the results of clinical studies in children, the use of MF59-adjuvanted vaccine offers the potential to enhance efficacy and make vaccination a viable prevention and control strategy in this population.

  4. Association of State Laws and Healthcare Workers' Influenza Vaccination Rates.

    PubMed

    Lin, Chyongchiou Jeng; Nowalk, Mary Patricia; Raymund, Mahlon; Sweeney, Patricia M; Zimmerman, Richard K

    2016-02-01

    State laws are being used to increase healthcare worker (HCW) influenza vaccine uptake. Approximately 40% of states have enacted such laws but their effectiveness has been infrequently studied. Data sources for this study were the 2000-2011 U.S. National Health Interview Survey Adult Sample File and a summary of U.S. state HCW influenza vaccination laws. Hierarchical linear modeling was used for two time periods: 1) 2000-2005 (before enactment of many state laws) and 2) 2006-2011 (a time of increased enactment of state HCW influenza vaccination legislation). During 2000-2005, two states had HCW influenza vaccination laws and HCW influenza vaccination rates averaged 22.5%. In 2006-2011, 19 states had such laws and vaccination rates averaged 50.9% (p < 0.001). The likelihood of HCW vaccination increased with the scope and breadth, measured by a law score. Although laws varied widely in scope and applicability, states with HCW influenza vaccination laws reported higher HCW vaccination rates. PMID:26928494

  5. Influenza virus neuraminidase (NA): a target for antivirals and vaccines.

    PubMed

    Jagadesh, Anitha; Salam, Abdul Ajees Abdul; Mudgal, Piya Paul; Arunkumar, Govindakarnavar

    2016-08-01

    Influenza, the most common infectious disease, poses a great threat to human health because of its highly contagious nature and fast transmissibility, often leading to high morbidity and mortality. Effective vaccination strategies may aid in the prevention and control of recurring epidemics and pandemics associated with this infectious disease. However, antigenic shifts and drifts are major concerns with influenza virus, requiring effective global monitoring and updating of vaccines. Current vaccines are standardized primarily based on the amount of hemagglutinin, a major surface antigen, which chiefly constitutes these preparations along with the varying amounts of neuraminidase (NA). Anti-influenza drugs targeting the active site of NA have been in use for more than a decade now. However, NA has not been approved as an effective antigenic component of the influenza vaccine because of standardization issues. Although some studies have suggested that NA antibodies are able to reduce the severity of the disease and induce a long-term and cross-protective immunity, a few major scientific issues need to be addressed prior to launching NA-based vaccines. Interestingly, an increasing number of studies have shown NA to be a promising target for future influenza vaccines. This review is an attempt to consolidate studies that reflect the strength of NA as a suitable vaccine target. The studies discussed in this article highlight NA as a potential influenza vaccine candidate and support taking the process of developing NA vaccines to the next stage. PMID:27255748

  6. Association of State Laws and Healthcare Workers' Influenza Vaccination Rates.

    PubMed

    Lin, Chyongchiou Jeng; Nowalk, Mary Patricia; Raymund, Mahlon; Sweeney, Patricia M; Zimmerman, Richard K

    2016-02-01

    State laws are being used to increase healthcare worker (HCW) influenza vaccine uptake. Approximately 40% of states have enacted such laws but their effectiveness has been infrequently studied. Data sources for this study were the 2000-2011 U.S. National Health Interview Survey Adult Sample File and a summary of U.S. state HCW influenza vaccination laws. Hierarchical linear modeling was used for two time periods: 1) 2000-2005 (before enactment of many state laws) and 2) 2006-2011 (a time of increased enactment of state HCW influenza vaccination legislation). During 2000-2005, two states had HCW influenza vaccination laws and HCW influenza vaccination rates averaged 22.5%. In 2006-2011, 19 states had such laws and vaccination rates averaged 50.9% (p < 0.001). The likelihood of HCW vaccination increased with the scope and breadth, measured by a law score. Although laws varied widely in scope and applicability, states with HCW influenza vaccination laws reported higher HCW vaccination rates.

  7. The Safety of Adjuvanted Vaccines Revisited: Vaccine-Induced Narcolepsy.

    PubMed

    Ahmed, S Sohail; Montomoli, Emanuele; Pasini, Franco Laghi; Steinman, Lawrence

    2016-01-01

    Despite the very high benefit-to-risk ratio of vaccines, the fear of negative side effects has discouraged many people from getting vaccinated, resulting in the reemergence of previously controlled diseases such as measles, pertussis and diphtheria. This fear has been amplified more recently by multiple epidemiologic studies that confirmed the link of an AS03-adjuvanted pandemic influenza vaccine (Pandemrix, GlaxoSmithKline Biologicals, Germany) used in Europe during the 2009 H1N1 influenza pandemic [A(H1N1) pdm09] with the development of narcolepsy, a chronic sleep disorder, in children and adolescents. However, public misperceptions of what adjuvants are and why they are used in vaccines has created in some individuals a closed "black box" attitude towards all vaccines. The focus of this review article is to revisit this "black box" using the example of narcolepsy associated with the European AS03-adjuvanted pandemic influenza vaccine. PMID:27228647

  8. The Safety of Adjuvanted Vaccines Revisited: Vaccine-Induced Narcolepsy.

    PubMed

    Ahmed, S Sohail; Montomoli, Emanuele; Pasini, Franco Laghi; Steinman, Lawrence

    2016-01-01

    Despite the very high benefit-to-risk ratio of vaccines, the fear of negative side effects has discouraged many people from getting vaccinated, resulting in the reemergence of previously controlled diseases such as measles, pertussis and diphtheria. This fear has been amplified more recently by multiple epidemiologic studies that confirmed the link of an AS03-adjuvanted pandemic influenza vaccine (Pandemrix, GlaxoSmithKline Biologicals, Germany) used in Europe during the 2009 H1N1 influenza pandemic [A(H1N1) pdm09] with the development of narcolepsy, a chronic sleep disorder, in children and adolescents. However, public misperceptions of what adjuvants are and why they are used in vaccines has created in some individuals a closed "black box" attitude towards all vaccines. The focus of this review article is to revisit this "black box" using the example of narcolepsy associated with the European AS03-adjuvanted pandemic influenza vaccine.

  9. Usage of quadrivalent influenza vaccine among children in the United States, 2013-14.

    PubMed

    Rodgers, Loren; Pabst, Laura J; Zhu, Liping; Chaves, Sandra S

    2015-11-27

    Annual influenza vaccination is recommended for everyone ≥ 6 months in the U.S. During the 2013-14 influenza season, in addition to trivalent influenza vaccines, quadrivalent vaccines were available, protecting against two influenza A and two influenza B viruses. We analyzed 1,976,443 immunization records from six sentinel sites to compare influenza vaccine usage among children age 6 months-18 years. A total of 983,401 (49.8%) influenza vaccine doses administered were trivalent and 920,333 (46.6%) were quadrivalent (unknown type: 72,709). Quadrivalent vaccine administration varied by age and was least frequent among those <2 years of age.

  10. Vaccines for Nontypeable Haemophilus influenzae: the Future Is Now.

    PubMed

    Murphy, Timothy F

    2015-05-01

    Infections due to nontypeable Haemophilus influenzae result in enormous global morbidity in two clinical settings: otitis media in children and respiratory tract infections in adults with chronic obstructive pulmonary disease (COPD). Recurrent otitis media affects up to 20% of children and results in hearing loss, delays in speech and language development and, in developing countries, chronic suppurative otitis media. Infections in people with COPD result in clinic and emergency room visits, hospital admissions, and respiratory failure. An effective vaccine would prevent morbidity, help control health care costs, and reduce antibiotic use, a major contributor to the global crisis in bacterial antibiotic resistance. The widespread use of the pneumococcal conjugate vaccines is causing a relative increase in H. influenzae otitis media. The partial protection against H. influenzae otitis media induced by the pneumococcal H. influenzae protein D conjugate vaccine represents a proof of principle of the feasibility of a vaccine for nontypeable H. influenzae. An ideal vaccine antigen should be conserved among strains, have abundant epitopes on the bacterial surface, be immunogenic, and induce protective immune responses. Several surface proteins of H. influenzae have been identified as potential vaccine candidates and are in various stages of development. With continued research, progress toward a broadly effective vaccine to prevent infections caused by nontypeable H. influenzae is expected over the next several years. PMID:25787137

  11. Vaccines for Nontypeable Haemophilus influenzae: the Future Is Now

    PubMed Central

    2015-01-01

    Infections due to nontypeable Haemophilus influenzae result in enormous global morbidity in two clinical settings: otitis media in children and respiratory tract infections in adults with chronic obstructive pulmonary disease (COPD). Recurrent otitis media affects up to 20% of children and results in hearing loss, delays in speech and language development and, in developing countries, chronic suppurative otitis media. Infections in people with COPD result in clinic and emergency room visits, hospital admissions, and respiratory failure. An effective vaccine would prevent morbidity, help control health care costs, and reduce antibiotic use, a major contributor to the global crisis in bacterial antibiotic resistance. The widespread use of the pneumococcal conjugate vaccines is causing a relative increase in H. influenzae otitis media. The partial protection against H. influenzae otitis media induced by the pneumococcal H. influenzae protein D conjugate vaccine represents a proof of principle of the feasibility of a vaccine for nontypeable H. influenzae. An ideal vaccine antigen should be conserved among strains, have abundant epitopes on the bacterial surface, be immunogenic, and induce protective immune responses. Several surface proteins of H. influenzae have been identified as potential vaccine candidates and are in various stages of development. With continued research, progress toward a broadly effective vaccine to prevent infections caused by nontypeable H. influenzae is expected over the next several years. PMID:25787137

  12. Increasing influenza vaccination coverage in recommended population groups in Europe.

    PubMed

    Blank, Patricia R; Szucs, Thomas D

    2009-04-01

    The clinical and economic burden of seasonal influenza is frequently underestimated. The cornerstone of controlling and preventing influenza is vaccination. National and international guidelines aim to implement immunization programs and targeted vaccination-coverage rates, which should help to enhance the vaccine uptake, especially in the at-risk population. This review purposes to highlight the vaccination guidelines and the actual vaccination situation in four target groups (the elderly, people with underlying chronic conditions, healthcare workers and children) from a European point of view.

  13. Recurrence of Panic Attacks after Influenza Vaccination: Two Case Reports

    PubMed Central

    Kim, Han-Joon; Jeon, Sang-Won; Yoon, Ho-Kyoung

    2016-01-01

    Human influenza is a contagious respiratory illness caused by the influenza virus. The influenza vaccination is recommended annually, but several adverse effects related to allergic reactions have been reported. Panic attacks are also known to occur, but no case of a panic attack adverse effect has been reported in South Korea. We present two cases of panic disorder patients whose symptoms were aggravated by the influenza vaccination. We assumed that dysregulation of T-lymphocytes in panic disorder patients could have a role in activating various kinds of cytokines and chemokines, which then can lead to panic attack aggravation. PMID:27776395

  14. Assessment of the safety and efficacy of low pathogenic avian influenza (H9N2) virus in inactivated oil emulsion vaccine in laying hens

    PubMed Central

    Shin, Jeong-Hwa; Mo, Jong Seo; Kim, Jong-Nyeo; Mo, In-pil

    2016-01-01

    In Korea, several outbreaks of low pathogenic AI (H9N2) viral infections leading to decreased egg production and increased mortality have been reported on commercial farms since 1996, resulting in severe economic losses. To control the H9N2 LPAI endemic, the Korea Veterinary Authority has permitted the use of the inactivated H9N2 LPAI vaccine since 2007. In this study, we developed a killed vaccine using a low pathogenic H9N2 AI virus (A/chicken/Korea/ADL0401) and conducted safety and efficacy tests in commercial layer farms while focusing on analysis of factors that cause losses to farms, including egg production rate, egg abnormality, and feed efficiency. The egg production rate of the control group declined dramatically 5 days after the challenge. There were no changes in feed consumption of all three groups before the challenge, but rates of the control declined afterward. Clinical signs in the vaccinated groups were similar, and a slight decline in feed consumption was observed after challenge; however, this returned to normal more rapidly than the control group and commercial layers. Overall, the results of this study indicate that the safety and efficacy of the vaccine are adequate to provide protection against the AI field infection (H9N2) epidemic in Korea. PMID:27051337

  15. Influenza vaccination and humoral alloimmunity in solid organ transplant recipients.

    PubMed

    Vermeiren, Pieter; Aubert, Vincent; Sugamele, Rocco; Aubert, John-David; Venetz, Jean-Pierre; Meylan, Pascal; Pascual, Manuel; Manuel, Oriol

    2014-09-01

    Annual influenza vaccination is recommended in solid organ transplant (SOT) recipients. However, concerns have been raised about the impact of vaccination on antigraft alloimmunity. We evaluated the humoral alloimmune responses to influenza vaccination in a cohort of SOT recipients between October 2008 and December 2011. Anti-HLA antibodies were measured before and 4-8 weeks after influenza vaccination using a solid-phase assay. Overall, 169 SOT recipients were included (kidney = 136, lung = 26, liver = 3, and combined = 4). Five (2.9%) of 169 patients developed de novo anti-HLA antibodies after vaccination, including one patient who developed donor-specific antibodies (DSA) 8 months after vaccination. In patients with pre-existing anti-HLA antibodies, median MFI was not significantly different before and after vaccination (P = 0.73 for class I and P = 0.20 for class II anti-HLA antibodies) and no development of de novo DSA was observed. Five episodes of rejection (2.9%) were observed within 12 months after vaccination, and only one patient had de novo anti-HLA antibodies. The incidence of development of anti-HLA antibodies after influenza vaccination in our cohort of SOT recipients was very low. Our findings indicate that influenza vaccination is safe and does not trigger humoral alloimmune responses in SOT recipients.

  16. Influenza vaccination in children with cancer receiving chemotherapy.

    PubMed

    Esposito, Susanna; Cecinati, Valerio; Russo, Fabio Giovanni; Principi, Nicola

    2009-06-01

    Influenza has a significant clinical impact on pediatric cancer patients because it causes frequent febrile episodes and respiratory tract infections, possibly severe complications, delays in chemotherapy administration and even death, all of which supports the importance of prevention and the widespread use of influenza vaccination. Results from clinical studies show that influenza vaccination can be considered safe in children undergoing chemotherapy and, although weaker than in healthy children, the immune response seems to be sufficient in patients with leukemia or solid tumors even if it is less in children receiving chemotherapy than in those who are not. However, there is an urgent need for universally accepted guidelines concerning the type of vaccine that leads to the best immunological results, the number of administrations, and their timing in relation to the severity of immunosuppression and chemotherapy schedules. Such recommendations, together with a clear demonstration of vaccine efficacy, are also needed to increase influenza vaccination coverage in this high-risk category of patients.

  17. 2008-2009 Influenza update: a better vaccine match.

    PubMed

    Mossad, Sherif B

    2008-12-01

    Last year, the influenza vaccine did not match the circulating strains very well, and its overall protective efficacy was only 40%. All three antigens contained in the 2008-2009 vaccine are new. Surveillance data from the Southern Hemisphere during the summer of 2008 show that this vaccine is expected to match well the circulating strains in the Northern Hemisphere. PMID:19088005

  18. Successful methodology for large-scale surveillance of severe events following influenza vaccination in Canada, 2011 and 2012.

    PubMed

    Bettinger, J A; Rouleau, I; Gariepy, M C; Bowie, W R; Valiquette, L; Vanderkooi, O G; Kellner, J D; Coleman, B L; McNeil, S A; McCarthy, A; De Serres, G

    2015-01-01

    In 2011 and 2012, a nationwide Canadian vaccine safety surveillance network rapidly collected safety data from healthcare workers (HCW) during the first weeks of the annual influenza vaccination campaign. This network provided the first available post-marketing safety data on seasonal influenza vaccines with information on background rates as a comparator. In 2012, these data were used to investigate a possible safety concern regarding a particular vaccine. An online questionnaire was provided to participating HCW two weeks before the annual influenza vaccination campaign for controls, and eight days after influenza vaccination for vaccinees. Control and vaccinees were requested to report health events occurring in the seven days prior to receiving the questionnaire. Control data were used to calculate background rates. HCW reporting a severe event were followed-up by telephone within 48 hours of the online report to validate the report and check on their health status. More than 22,000 vaccinated HCW were enrolled and surveyed over two seasons and > 90% reported no severe event following vaccination. Validated severe event rates were similar in vaccinated HCW and unvaccinated HCW (2.2% vs 2.3%; p < 0.70). The questionnaire was accurately completed for most reported symptoms, matched the validated report and was able to detect events of interest. Prior to the safety concern, the implicated vaccine was in use at one centre. Reassuring safety data were provided to public health authorities 48 hours after the vaccine was temporarily suspended. Data from this and similar networks can be used for rapid evaluation of vaccine safety and for safety assessment as required by the European Medicines Agency in 2015. PMID:26227369

  19. Making evidence-based selections of influenza vaccines.

    PubMed

    Childress, Billy-Clyde; Montney, Joshua D; Albro, Elise A

    2014-01-01

    Years ago, intramuscular influenza vaccines were the only option for those who wanted to arm themselves against the flu. Today there are alternatives, including intradermal injections and intranasal sprays. In order to select the right influenza vaccine for their patients, pharmacists, and other healthcare professionals must have a basic understanding of the immune system. Influenza vaccines elicit different levels of immune response involving innate and adaptive immunity, which are critical to fighting infection. For the 2013-2014 flu season, there were 13 different formulations of influenza vaccines on the market with vast differences in indications, contraindications, and effectiveness. The CDC does not recommend one vaccine over another, but recommends that all patients be vaccinated against the flu. Preventing the spread of influenza is no simple task; however, the most recent evidence on influenza vaccines and sufficient knowledge of the immune system will allow pharmacists and other healthcare providers to better advocate for vaccines, determine which are most appropriate, and ensure their proper administration. PMID:25483499

  20. Willingness to receive a hypothetical avian influenza vaccine among US military personnel in mid-deployment.

    PubMed

    Porter, Chad K; Fitamaurice, Gina; Tribble, David R; Armstrong, Adam W; Mostafa, Manal; Riddle, Mark S

    2013-12-01

    Though no avian influenza vaccine currently exists, development efforts have increased. Given recent reports of suboptimal vaccination rates among US military personnel, we sought to assess factors associated with a willingness to receive a hypothetical avian influenza vaccine. A self-administered questionnaire was completed by US military personnel during mid-deployment to Iraq, Afghanistan, and surrounding regions. Respondents were predominately male (86.2%), Army (72.1%), and enlisted (86.3%) with a mean age of 29.6 y. The majority (77.1%) agreed to receive an avian influenza vaccine if available. Exploratory factor analysis (EFA) identified two factors, vaccine importance and disease risk, that best described the individual perceptions and both were associated with an increased willingness to receive the hypothetical vaccine (OR: 8.2 and 1.6, respectively). Importantly, after controlling for these factors differences in the willingness to receive this hypothetical vaccine were observed across gender and branch of service. These results indicated that targeted education on vaccine safety and efficacy as well as disease risk may modify vaccination patterns in this population.

  1. Influenza vaccination is safe and effective in patients suffering from fibromyalgia syndrome.

    PubMed

    Ablin, J N; Aloush, V; Brill, A; Berman, M; Barzilai, M; Caspi, D; Mandelboim, M; Levartovsky, D; Polachek, A; Wolman, Y; Paran, D; Barkagan, M; Elkayam, O

    2015-01-01

    The fibromyalgia syndrome (FMS) is considered to result from the exposure of a genetically susceptible individual to various triggers, such as physical trauma, stress, viral infections etc. A possible role of vaccination in FMS etiology has been suspected. Our objective was to evaluate the efficacy and safety of influenza vaccination in FMS patients. Nineteen FMS patients underwent physical and dolorimetric examinations and answered the fibromyalgia impact questionnaire (FIQ), the widespread pain index (WPI) checklist and the symptoms severity scale (SSS), which are part of the 2010 diagnostic criteria. Thirty-eight healthy subjects were recruited as controls. All participants were vaccinated with the inactivated split virion influenza vaccine. Serum was collected for antibody titration. Six weeks after vaccination, sera were tested by hemagglutination (HI) against A/California (H1N1), A/Perth (H3N2) and B/Brisbane. Humoral response was defined as either a fourfold or greater increase in titer, or an increase from a non-protective baseline level of <1/40 to a level of 1/40. No severe vaccination reactions were observed. No significant change was observed between WPI, SSS and FIQ values before and after vaccination, indicating no worsening of FMS symptoms. Vaccine immunogenicity: Six weeks after vaccination, FMS patients showed a significant increase in geometric mean titers of HI antibody. The rates of sero-protection increased from 22.9% for H1N1 to 89.5% post-vaccination. A significant increase in HI antibody titers was also demonstrated among healthy controls. Influenza vaccination was both safe and effective in FMS patients. In view of these results, FMS patients should be encouraged to undergo influenza vaccination according to the standard WHO recommendations.

  2. An innovative influenza vaccination policy: targeting last season's patients.

    PubMed

    Yamin, Dan; Gavious, Arieh; Solnik, Eyal; Davidovitch, Nadav; Balicer, Ran D; Galvani, Alison P; Pliskin, Joseph S

    2014-05-01

    Influenza vaccination is the primary approach to prevent influenza annually. WHO/CDC recommendations prioritize vaccinations mainly on the basis of age and co-morbidities, but have never considered influenza infection history of individuals for vaccination targeting. We evaluated such influenza vaccination policies through small-world contact networks simulations. Further, to verify our findings we analyzed, independently, large-scale empirical data of influenza diagnosis from the two largest Health Maintenance Organizations in Israel, together covering more than 74% of the Israeli population. These longitudinal individual-level data include about nine million cases of influenza diagnosed over a decade. Through contact network epidemiology simulations, we found that individuals previously infected with influenza have a disproportionate probability of being highly connected within networks and transmitting to others. Therefore, we showed that prioritizing those previously infected for vaccination would be more effective than a random vaccination policy in reducing infection. The effectiveness of such a policy is robust over a range of epidemiological assumptions, including cross-reactivity between influenza strains conferring partial protection as high as 55%. Empirically, our analysis of the medical records confirms that in every age group, case definition for influenza, clinical diagnosis, and year tested, patients infected in the year prior had a substantially higher risk of becoming infected in the subsequent year. Accordingly, considering individual infection history in targeting and promoting influenza vaccination is predicted to be a highly effective supplement to the current policy. Our approach can also be generalized for other infectious disease, computer viruses, or ecological networks.

  3. Examining Perceptions about Mandatory Influenza Vaccination of Healthcare Workers through Online Comments on News Stories

    PubMed Central

    Lei, Yang; Pereira, Jennifer A.; Quach, Susan; Bettinger, Julie A.; Kwong, Jeffrey C.; Corace, Kimberly; Garber, Gary; Feinberg, Yael; Guay, Maryse

    2015-01-01

    Background The aim of this study was to understand online public perceptions of the debate surrounding the choice of annual influenza vaccinations or wearing masks as a condition of employment for healthcare workers, such as the one enacted in British Columbia in August 2012. Methods Four national and 82 local (British Columbia) Canadian online news sites were searched for articles posted between August 2012 and May 2013 containing the words “healthcare workers” and “mandatory influenza vaccinations/immunizations” or “mandatory flu shots and healthcare workers.” We included articles from sources that predominantly concerned our topic of interest and that generated reader comments. Two researchers coded the unedited comments using thematic analysis, categorizing codes to allow themes to emerge. In addition to themes, the comments were categorized by: 1) sentiment towards influenza vaccines; 2) support for mandatory vaccination policies; 3) citing of reference materials or statistics; 4) self-identified health-care worker status; and 5) sharing of a personal story. Results 1163 comments made by 648 commenters responding to 36 articles were analyzed. Popular themes included concerns about freedom of choice, vaccine effectiveness, patient safety, and distrust in government, public health, and the pharmaceutical industry. Almost half (48%) of commenters expressed a negative sentiment toward the influenza vaccine, 28% were positive, 20% were neutral, and 4% expressed mixed sentiment. Of those who commented on the policy, 75% did not support the condition to work policy, while 25% were in favour. Of the commenters, 11% self-identified as healthcare workers, 13% shared personal stories, and 18% cited a reference or statistic. Interpretation The perception of the influenza vaccine in the comment sections of online news sites is fairly poor. Public health agencies should consider including online forums, comment sections, and social media sites as part of their

  4. Phase I/II Randomized Double-Blind Study of the Safety and Immunogenicity of a Nonadjuvanted Vero Cell Culture-Derived Whole-Virus H9N2 Influenza Vaccine in Healthy Adults

    PubMed Central

    Grohmann-Izay, Barbara; van der Velden, Maikel V. W.; Fritsch, Sandor; Koska, Manuela; Portsmouth, Daniel; Hart, Mary Kate; El-Amin, Wael; Kistner, Otfried; Barrett, P. Noel

    2014-01-01

    Studies on candidate pandemic vaccines against avian influenza viruses have focused on H5N1, but viruses of other subtypes, such as A/H9N2, are also considered to have pandemic potential. We investigated the safety and immunogenicity of two immunizations with one of five different antigen doses (ranging from 3.75 to 45 μg of hemagglutinin antigen) of a nonadjuvanted whole-virus G9 lineage H9N2 influenza virus vaccine in healthy adults aged 18 to 49 years. The antibody responses were measured by hemagglutination inhibition (HI), microneutralization (MN), and single radial hemolysis (SRH) assays. To investigate a hypothesis that previous exposure to H2N2 viruses in subjects born in or before 1968 might prime for more robust antibody responses to H9N2 vaccination than that in subjects born after 1968, a post hoc age-stratified analysis of antibody responses was done. Both vaccinations in all dose groups were safe and well tolerated. No vaccine-related serious adverse events were reported, and the majority of the adverse reactions were rated as mild. The rates of injection site reactions were lower in the 3.75-μg- and 7.5-μg-dose groups than those in the higher-dose groups; the rates of systemic reactions were similar across all dose groups. The seroprotection rates among the different dose groups 21 days after the second immunization ranged from 52.8% to 88.9% as measured by HI assay, from 88.7% to 98.1% or 82.7% to 96.2% as measured by MN assay (MN titer cutoffs, 1:40 and 1:80, respectively), and from 94.2% to 100% as measured by SRH assay. Higher antibody responses were not induced in subjects born in or before 1968. These data indicate that a nonadjuvanted whole-virus H9N2 vaccine is well tolerated and immunogenic in healthy adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01320696.) PMID:25355797

  5. Phase I/II randomized double-blind study of the safety and immunogenicity of a nonadjuvanted vero cell culture-derived whole-virus H9N2 influenza vaccine in healthy adults.

    PubMed

    Aichinger, Gerald; Grohmann-Izay, Barbara; van der Velden, Maikel V W; Fritsch, Sandor; Koska, Manuela; Portsmouth, Daniel; Hart, Mary Kate; El-Amin, Wael; Kistner, Otfried; Barrett, P Noel

    2015-01-01

    Studies on candidate pandemic vaccines against avian influenza viruses have focused on H5N1, but viruses of other subtypes, such as A/H9N2, are also considered to have pandemic potential. We investigated the safety and immunogenicity of two immunizations with one of five different antigen doses (ranging from 3.75 to 45 μg of hemagglutinin antigen) of a nonadjuvanted whole-virus G9 lineage H9N2 influenza virus vaccine in healthy adults aged 18 to 49 years. The antibody responses were measured by hemagglutination inhibition (HI), microneutralization (MN), and single radial hemolysis (SRH) assays. To investigate a hypothesis that previous exposure to H2N2 viruses in subjects born in or before 1968 might prime for more robust antibody responses to H9N2 vaccination than that in subjects born after 1968, a post hoc age-stratified analysis of antibody responses was done. Both vaccinations in all dose groups were safe and well tolerated. No vaccine-related serious adverse events were reported, and the majority of the adverse reactions were rated as mild. The rates of injection site reactions were lower in the 3.75-μg- and 7.5-μg-dose groups than those in the higher-dose groups; the rates of systemic reactions were similar across all dose groups. The seroprotection rates among the different dose groups 21 days after the second immunization ranged from 52.8% to 88.9% as measured by HI assay, from 88.7% to 98.1% or 82.7% to 96.2% as measured by MN assay (MN titer cutoffs, 1:40 and 1:80, respectively), and from 94.2% to 100% as measured by SRH assay. Higher antibody responses were not induced in subjects born in or before 1968. These data indicate that a nonadjuvanted whole-virus H9N2 vaccine is well tolerated and immunogenic in healthy adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01320696.). PMID:25355797

  6. Phase I/II randomized double-blind study of the safety and immunogenicity of a nonadjuvanted vero cell culture-derived whole-virus H9N2 influenza vaccine in healthy adults.

    PubMed

    Aichinger, Gerald; Grohmann-Izay, Barbara; van der Velden, Maikel V W; Fritsch, Sandor; Koska, Manuela; Portsmouth, Daniel; Hart, Mary Kate; El-Amin, Wael; Kistner, Otfried; Barrett, P Noel

    2015-01-01

    Studies on candidate pandemic vaccines against avian influenza viruses have focused on H5N1, but viruses of other subtypes, such as A/H9N2, are also considered to have pandemic potential. We investigated the safety and immunogenicity of two immunizations with one of five different antigen doses (ranging from 3.75 to 45 μg of hemagglutinin antigen) of a nonadjuvanted whole-virus G9 lineage H9N2 influenza virus vaccine in healthy adults aged 18 to 49 years. The antibody responses were measured by hemagglutination inhibition (HI), microneutralization (MN), and single radial hemolysis (SRH) assays. To investigate a hypothesis that previous exposure to H2N2 viruses in subjects born in or before 1968 might prime for more robust antibody responses to H9N2 vaccination than that in subjects born after 1968, a post hoc age-stratified analysis of antibody responses was done. Both vaccinations in all dose groups were safe and well tolerated. No vaccine-related serious adverse events were reported, and the majority of the adverse reactions were rated as mild. The rates of injection site reactions were lower in the 3.75-μg- and 7.5-μg-dose groups than those in the higher-dose groups; the rates of systemic reactions were similar across all dose groups. The seroprotection rates among the different dose groups 21 days after the second immunization ranged from 52.8% to 88.9% as measured by HI assay, from 88.7% to 98.1% or 82.7% to 96.2% as measured by MN assay (MN titer cutoffs, 1:40 and 1:80, respectively), and from 94.2% to 100% as measured by SRH assay. Higher antibody responses were not induced in subjects born in or before 1968. These data indicate that a nonadjuvanted whole-virus H9N2 vaccine is well tolerated and immunogenic in healthy adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01320696.).

  7. Vitamins as influenza vaccine adjuvant components.

    PubMed

    Quintilio, Wagner; de Freitas, Fábio Alessandro; Rodriguez, Dunia; Kubrusly, Flavia Saldanha; Yourtov, Dimitri; Miyaki, Cosue; de Cerqueira Leite, Luciana Cezar; Raw, Isaias

    2016-10-01

    A number of adjuvant formulations were assayed in mice immunized with 3.75 µg of A/California/7/2009 (H1N1) pdm09 influenza vaccine with vitamins A, D and/or E in emulsions or B2 and/or B9 combined with Bordetella pertussis MPLA and/or alum as adjuvants. Squalene was used as positive control, as well as MPLA with alum. The immune response was evaluated by a panel of tests, including a hemagglutination inhibition (HAI) test, ELISA for IgG, IgG1, and IgG2a and IFN-γ, IL-2, IL-6 and IL-10 quantification in splenocyte culture supernatant after stimulus with influenza antigen. Immunological memory was evaluated using a 1/10 dose booster 60 days after the first immunization followed by assessment of the response by HAI, IgG ELISA, and determination of the antibody affinity index. The highest increases in HAI, IgG1 and IgG2a titers were obtained with the adjuvant combinations containing vitamin E, or the hydrophilic combinations containing MPLA and alum or B2 and alum. The IgG1/IgG2a ratio indicates that the response to the combination of B2 with alum would have more Th2 character than the combination of MPLA with alum. In an assay to investigate the memory response, a significant increase in HAI titer was observed with a booster vaccine dose at 60 days after immunization with vaccines containing MPLA with alum or B2 with alum. Overall, of the 27 adjuvant combinations, MPLA with alum and B2 with alum were the most promising adjuvants to be evaluated in humans. PMID:27449155

  8. Vitamins as influenza vaccine adjuvant components.

    PubMed

    Quintilio, Wagner; de Freitas, Fábio Alessandro; Rodriguez, Dunia; Kubrusly, Flavia Saldanha; Yourtov, Dimitri; Miyaki, Cosue; de Cerqueira Leite, Luciana Cezar; Raw, Isaias

    2016-10-01

    A number of adjuvant formulations were assayed in mice immunized with 3.75 µg of A/California/7/2009 (H1N1) pdm09 influenza vaccine with vitamins A, D and/or E in emulsions or B2 and/or B9 combined with Bordetella pertussis MPLA and/or alum as adjuvants. Squalene was used as positive control, as well as MPLA with alum. The immune response was evaluated by a panel of tests, including a hemagglutination inhibition (HAI) test, ELISA for IgG, IgG1, and IgG2a and IFN-γ, IL-2, IL-6 and IL-10 quantification in splenocyte culture supernatant after stimulus with influenza antigen. Immunological memory was evaluated using a 1/10 dose booster 60 days after the first immunization followed by assessment of the response by HAI, IgG ELISA, and determination of the antibody affinity index. The highest increases in HAI, IgG1 and IgG2a titers were obtained with the adjuvant combinations containing vitamin E, or the hydrophilic combinations containing MPLA and alum or B2 and alum. The IgG1/IgG2a ratio indicates that the response to the combination of B2 with alum would have more Th2 character than the combination of MPLA with alum. In an assay to investigate the memory response, a significant increase in HAI titer was observed with a booster vaccine dose at 60 days after immunization with vaccines containing MPLA with alum or B2 with alum. Overall, of the 27 adjuvant combinations, MPLA with alum and B2 with alum were the most promising adjuvants to be evaluated in humans.

  9. The Effect of Influenza Vaccination on Birth Outcomes in a Cohort of Pregnant Women in Lao PDR, 2014–2015

    PubMed Central

    Olsen, Sonja J.; Mirza, Sara A.; Vonglokham, Phouvanh; Khanthamaly, Viengphone; Chitry, Bounlap; Pholsena, Vathsana; Chitranonh, Visith; Omer, Saad B.; Moen, Ann; Bresee, Joseph S.; Corwin, Andrew; Xeuatvongsa, Anonh

    2016-01-01

    Background Some studies suggest that maternal influenza vaccination can improve birth outcomes. However, there are limited data from tropical settings, particularly Southeast Asia. We conducted an observational study in Laos to assess the effect of influenza vaccination in pregnant women on birth outcomes. Methods We consented and enrolled a cohort of pregnant woman who delivered babies at 3 hospitals during April 2014–February 2015. We collected demographic and clinical information on mother and child. Influenza vaccination status was ascertained by vaccine card. Primary outcomes were the proportion of live births born small for gestational age (SGA) or preterm and mean birth weight. Multivariate models controlled for differences between vaccinated and unvaccinated women and influenza virus circulation. Results We enrolled 5103 women (2172 [43%] were vaccinated). Among the 4854 who had a live birth, vaccinated women were statistically significantly less likely than unvaccinated women to have an infant born preterm during the period of high influenza virus circulation (risk ratio [RR] = 0.56, 95% confidence interval [CI], .45–.70), and the effect remained after adjusting for covariates (adjusted RR, 0.69; 95% CI, .55–.87). There was no effect of vaccine on SGA or mean birth weight. The population-prevented fraction was 18.0%. Conclusions In this observational study, we found indirect evidence of influenza vaccine safety during pregnancy, and women who received vaccine had a reduced risk of delivering a preterm infant during times of high influenza virus circulation. Vaccination may prevent 1 in 5 preterm births that occur during periods of high influenza circulation. PMID:27143672

  10. First estimates of influenza vaccine effectiveness among severe influenza cases, France, 2011/12.

    PubMed

    Bonmarin, I; Belchior, E; Le Strat, Y; Levy-Bruhl, D

    2012-01-01

    Following a suspected virus-vaccine mismatch, the screening method was used to estimate in almost real time the influenza vaccine effectiveness (VE) against severe cases in high-risk individuals. Data on vaccination status were provided by the influenza severe surveillance system and data on vaccination coverage by the National Social Security Scheme. The analysis showed a decline of the vaccine effectiveness in 2011/12 (VE: 30% (95% CI: 22-39)) compared to 2010/11 (VE: 53% (95% CI: 40-67)). PMID:22587956

  11. THE AUSTRIAN VACCINATION PARADOX: TICK-BORNE ENCEPHALITIS VACCINATION VERSUS INFLUENZA VACCINATION.

    PubMed

    Kunze, Ursula; Kunze, Michael

    2015-09-01

    This paper describes a paradoxical situation in Austria. The vaccination rate against tick-borne encephalitis (TBE) in the general population is 82%, which is the highest worldwide, whereas the vaccination rate against influenza is about 8% and is among the lowest worldwide. A high awareness of TBE among the Austrian population achieved by an annual social marketing programme and the wide use of effective and well-tolerated vaccines have led to a successful containment of that disease. The vaccination coverage increased from 6% in 1980 to 82% in 2013 and exceeds 90% in some high-risk areas. This has led to a steady decline in the number of TBE cases from several hundred cases to 50 to 100 cases per year. The situation in regard to influenza vaccination is the opposite. Although Austria has issued one of the most extensive recommendations for influenza vaccination worldwide, the vaccination rate of the general population is extremely low. The possible reasons for the failure in the implementation of recommendations are ignorance, lack of social marketing and the predominance of a distinct discordance within the health system in general, and the Austrian medical fraternity in particular. PMID:26615654

  12. Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China.

    PubMed

    Li, Rong Cheng; Li, Feng Xiang; Li, Yan Ping; Hou, Qi Ming; Li, Chang Gui; Li, Ya Nan; Chen, Fu Sheng; Hu, Xue Zhong; Su, Wen Bin; Zhang, Shu Min; Fang, Han Hua; Ye, Qiang; Zeng, Tian De; Liu, Tao Xuan; Li, Xiu Bi; Huang, Yun Neng; Deng, Man Ling; Zhang, Yan Ping; Ortiz, Esteban

    2011-02-24

    The aim was to demonstrate the immunogenicity and safety of a DTaP-IPV//PRP-T combined vaccine (Pentaxim(®)) compared to individual vaccines in infants in the People's Republic of China. Infants (N=792) were randomly assigned to receive DTaP-IPV//PRP-T at 2, 3 and 4 months of age (Group A) or 3, 4 and 5 months of age (Group B), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib(®)) and IPV (Imovax(®) Polio) at 3, 4 and 5 months of age (Group C). Antibody titers were measured pre- and 1 month after the third vaccination; non-inferiority analyses were performed for seroprotection/seroconversion (SP/SC) rates. Safety was assessed 1 month after the primary series. SP/SC rates for the DTaP-IPV//PRP-T vaccine were high and non-inferior to the controls. Reactogenicity was low for each group and no hypotonic hyporesponsive episode or seizure was reported. In conclusion, the DTaP-IPV//PRP-T vaccine was highly immunogenic, non-inferior to the commercially available control vaccines and had a good safety profile for both primary administration schedules.

  13. Influenza virus vaccine for neglected hosts: horses and dogs

    PubMed Central

    2016-01-01

    This study provides information regarding vaccine research and the epidemiology of influenza virus in neglected hosts (horses and dogs). Equine influenza virus (EIV) causes a highly contagious disease in horses and other equids, and outbreaks have occurred worldwide. EIV has resulted in costly damage to the horse industry and has the ability of cross the host species barrier from horses to dogs. Canine influenza is a virus of equine or avian origin and infects companion animals that live in close contact with humans; this results in possible exposure to the seasonal epizootic influenza virus. There have been case reports of genetic reassortment between human and canine influenza viruses, which results in high virulence and the ability of transmission to ferrets. This emphasizes the need for vaccine research on neglected hosts to update knowledge on current strains and to advance technology for controlling influenza outbreaks for public health. PMID:27489801

  14. Influenza virus vaccine for neglected hosts: horses and dogs.

    PubMed

    Na, Woonsung; Yeom, Minjoo; Yuk, Huijoon; Moon, Hyoungjoon; Kang, Bokyu; Song, Daesub

    2016-07-01

    This study provides information regarding vaccine research and the epidemiology of influenza virus in neglected hosts (horses and dogs). Equine influenza virus (EIV) causes a highly contagious disease in horses and other equids, and outbreaks have occurred worldwide. EIV has resulted in costly damage to the horse industry and has the ability of cross the host species barrier from horses to dogs. Canine influenza is a virus of equine or avian origin and infects companion animals that live in close contact with humans; this results in possible exposure to the seasonal epizootic influenza virus. There have been case reports of genetic reassortment between human and canine influenza viruses, which results in high virulence and the ability of transmission to ferrets. This emphasizes the need for vaccine research on neglected hosts to update knowledge on current strains and to advance technology for controlling influenza outbreaks for public health.

  15. Influenza virus vaccine for neglected hosts: horses and dogs.

    PubMed

    Na, Woonsung; Yeom, Minjoo; Yuk, Huijoon; Moon, Hyoungjoon; Kang, Bokyu; Song, Daesub

    2016-07-01

    This study provides information regarding vaccine research and the epidemiology of influenza virus in neglected hosts (horses and dogs). Equine influenza virus (EIV) causes a highly contagious disease in horses and other equids, and outbreaks have occurred worldwide. EIV has resulted in costly damage to the horse industry and has the ability of cross the host species barrier from horses to dogs. Canine influenza is a virus of equine or avian origin and infects companion animals that live in close contact with humans; this results in possible exposure to the seasonal epizootic influenza virus. There have been case reports of genetic reassortment between human and canine influenza viruses, which results in high virulence and the ability of transmission to ferrets. This emphasizes the need for vaccine research on neglected hosts to update knowledge on current strains and to advance technology for controlling influenza outbreaks for public health. PMID:27489801

  16. Vaxtracker: Active on-line surveillance for adverse events following inactivated influenza vaccine in children.

    PubMed

    Cashman, Patrick; Moberley, Sarah; Dalton, Craig; Stephenson, Jody; Elvidge, Elissa; Butler, Michelle; Durrheim, David N

    2014-09-22

    Vaxtracker is a web based survey for active post marketing surveillance of Adverse Events Following Immunisation. It is designed to efficiently monitor vaccine safety of new vaccines by early signal detection of serious adverse events. The Vaxtracker system automates contact with the parents or carers of immunised children by email and/or sms message to their smart phone. A hyperlink on the email and text messages links to a web based survey exploring adverse events following the immunisation. The Vaxtracker concept was developed during 2011 (n=21), and piloted during the 2012 (n=200) and 2013 (n=477) influenza seasons for children receiving inactivated influenza vaccine (IIV) in the Hunter New England Local Health District, New South Wales, Australia. Survey results were reviewed by surveillance staff to detect any safety signals and compare adverse event frequencies among the different influenza vaccines administered. In 2012, 57% (n=113) of the 200 participants responded to the online survey and 61% (290/477) in 2013. Vaxtracker appears to be an effective method for actively monitoring adverse events following influenza vaccination in children.

  17. Vaxtracker: Active on-line surveillance for adverse events following inactivated influenza vaccine in children.

    PubMed

    Cashman, Patrick; Moberley, Sarah; Dalton, Craig; Stephenson, Jody; Elvidge, Elissa; Butler, Michelle; Durrheim, David N

    2014-09-22

    Vaxtracker is a web based survey for active post marketing surveillance of Adverse Events Following Immunisation. It is designed to efficiently monitor vaccine safety of new vaccines by early signal detection of serious adverse events. The Vaxtracker system automates contact with the parents or carers of immunised children by email and/or sms message to their smart phone. A hyperlink on the email and text messages links to a web based survey exploring adverse events following the immunisation. The Vaxtracker concept was developed during 2011 (n=21), and piloted during the 2012 (n=200) and 2013 (n=477) influenza seasons for children receiving inactivated influenza vaccine (IIV) in the Hunter New England Local Health District, New South Wales, Australia. Survey results were reviewed by surveillance staff to detect any safety signals and compare adverse event frequencies among the different influenza vaccines administered. In 2012, 57% (n=113) of the 200 participants responded to the online survey and 61% (290/477) in 2013. Vaxtracker appears to be an effective method for actively monitoring adverse events following influenza vaccination in children. PMID:25077424

  18. Efficacy Studies of Influenza Vaccines: Effect of End Points Used and Characteristics of Vaccine Failures

    PubMed Central

    Petrie, Joshua G.; Ohmit, Suzanne E.; Johnson, Emileigh; Cross, Rachel T.

    2011-01-01

    Background. End points used to detect influenza in vaccine efficacy trials have varied. Both the inactivated and live attenuated influenza vaccines are efficacious; however, failure to protect occurs. Methods. We compared characteristics of influenza A (H3N2) and B cases from 3 years of a comparative placebo-controlled trial of inactivated and live attenuated vaccines, and we evaluated the laboratory end points used to determine efficacy. Results. Although illness duration and reported symptoms did not differ by intervention, subjects with influenza in the inactivated vaccine group were less likely than those in the placebo group to report medically attended illnesses. All influenza type A (H3N2) and B cases isolated in cell culture were also identified by real-time polymerase chain reaction (rtPCR). However, only 69% of type A (H3N2) cases identified by rtPCR also were isolated in cell culture. Isolation frequency was lowest among live attenuated vaccine failures, a reflection of lower specimen viral loads. Among cases of rtPCR identified influenza A (H3N2), 90% of placebo and 87% of live attenuated vaccine recipients but only 23% of inactivated vaccine recipients demonstrated serologic confirmation of infection. Conclusions. In influenza vaccine efficacy studies, virus identification using rtPCR is the ideal end point. Isolation in cell culture will miss cases, and a serologic end point alone will overestimate inactivated vaccine efficacy. PMID:21378375

  19. Influenza Vaccination Coverage among School Employees: Assessing Knowledge, Attitudes, and Behaviors

    ERIC Educational Resources Information Center

    de Perio, Marie A.; Wiegand, Douglas M.; Brueck, Scott E.

    2014-01-01

    Background: Influenza can spread among students, teachers, and staff in school settings. Vaccination is the most effective method to prevent influenza. We determined 2012-2013 influenza vaccination coverage among school employees, assessed knowledge and attitudes regarding the vaccine, and determined factors associated with vaccine receipt.…

  20. Influenza vaccine effectiveness in preventing inpatient and outpatient cases in a season dominated by vaccine-matched influenza B virus

    PubMed Central

    Martínez-Baz, Iván; Navascués, Ana; Pozo, Francisco; Chamorro, Judith; Albeniz, Esther; Casado, Itziar; Reina, Gabriel; Cenoz, Manuel García; Ezpeleta, Carmen; Castilla, Jesús

    2015-01-01

    Studies that have evaluated the influenza vaccine effectiveness (VE) to prevent laboratory-confirmed influenza B cases are uncommon, and few have analyzed the effect in preventing hospitalized cases. We have evaluated the influenza VE in preventing outpatient and hospitalized cases with laboratory-confirmed influenza in the 2012–2013 season, which was dominated by a vaccine-matched influenza B virus. In the population covered by the Navarra Health Service, all hospitalized patients with influenza-like illness (ILI) and all ILI patients attended by a sentinel network of general practitioners were swabbed for influenza testing, and all were included in a test-negative case-control analysis. VE was calculated as (1-odds ratio)×100. Among 744 patients tested, 382 (51%) were positive for influenza virus: 70% for influenza B, 24% for A(H1N1)pdm09, and 5% for A(H3N2). The overall estimate of VE in preventing laboratory-confirmed influenza was 63% (95% confidence interval (CI): 34 to 79), 55% (1 to 80) in outpatients and 74% (33 to 90) in hospitalized patients. The VE was 70% (41 to 85) against influenza B and 43% (−45 to 78) against influenza A. The VE against virus B was 87% (52 to 96) in hospitalized patients and 56% in outpatients (−5 to 81). Adjusted comparison of vaccination status between inpatient and outpatient cases with influenza B did not show statistically significant differences (odds ratio: 1.13; p = 0.878). These results suggest a high protective effect of the vaccine in the 2012–2013 season, with no differences found for the effect between outpatient and hospitalized cases. PMID:25996366

  1. Are we ready for universal influenza vaccination in paediatrics?

    PubMed

    Principi, Nicola; Esposito, Susanna

    2004-02-01

    Recent studies have suggested that paediatric influenza is a greater medical problem than usually thought because it can cause excess hospitalisations, medical visits, and antibiotic prescriptions even in healthy children, especially those under 2 years. Furthermore, influenza in otherwise healthy children may have substantial socioeconomic consequences for the children and their household contacts. These findings have led many experts to encourage the more widespread use of influenza vaccine in childhood. Although the immunogenicity of the available vaccines is good and they are safe, well-tolerated, and highly effective in preventing influenza and its complications, economic data support universal vaccination only when indirect effectiveness is considered. However, infants aged 6-23 months, children with recurrent acute otitis media or respiratory-tract infections, and healthy children attending day-care centres or elementary schools should be included among the paediatric groups requiring vaccination. PMID:14871631

  2. Prevention and control of influenza and dengue through vaccine development.

    PubMed

    Greenberg, David P; Robertson, Corwin A; Gordon, Daniel M

    2013-08-01

    Influenza and dengue are viral illnesses of global public health importance, especially among children. Accordingly, these diseases have been the focus of efforts to improve their prevention and control. Influenza vaccination offers the best protection against clinical disease caused by strains contained within the specific year's formulation. It is not uncommon for there to be a mismatch between vaccine strains and circulating strains, particularly with regards to the B lineages. For more than a decade, two distinct lineages of influenza B (Yamagata and Victoria) have co-circulated in the US with varying frequencies, but trivalent influenza vaccines contain only one B-lineage strain and do not offer adequate protection against the alternate B-lineage. Quadrivalent influenza vaccines (QIVs), containing two A strains (H1N1 and H3N2) and two B strains (one from each lineage) have been developed to help protect against the four strains predicted to be the most likely to be circulating. The QIV section of this article discusses epidemiology of pediatric influenza, importance of influenza B in children, potential benefits of QIV, and new quadrivalent vaccines. In contrast to influenza, a vaccine against dengue is not yet available in spite of many decades of research and development. A global increase in reports of dengue fever (DF) and its more severe presentations, dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS), suggest that US physicians will increasingly encounter patients with this disease. Similarities of the early signs and symptoms of influenza and dengue and the differences in disease management necessitates a better understanding of the epidemiology, clinical presentation, management, and prevention of DF by US physicians, including pediatricians. The article also provides a brief overview of dengue and discusses dengue vaccine development.

  3. Pityriasis lichenoides et varioliformis acuta after influenza vaccine.

    PubMed

    Castro, Breno Augusto Campos de; Pereira, Juliana Milagres Macedo; Meyer, Renata Leal Bregunci; Trindade, Fernanda Marques; Pedrosa, Moises Salgado; Piancastelli, André Costa Cruz

    2015-01-01

    The etiology of pityriasis lichenoides is unknown. One of the accepted theories admits that PL is an inflammatory response to extrinsic antigens such as infectious agents, drugs and vaccines. In recent medical literature, only the MMR vaccine (Measles, Mumps and Rubella) was associated with the occurrence of this disease. We present a case of a male, 12 year old healthy patient who, five days after Influenza vaccination, developed erythematous papules on the trunk, abdomen and limbs, some with adherent crusts and associated systemic symptoms. This case report is notable for describing the first case of pityriasis lichenoides et varioliformis acuta associated with the vaccine against Influenza. PMID:26312710

  4. Pityriasis lichenoides et varioliformis acuta after influenza vaccine.

    PubMed

    Castro, Breno Augusto Campos de; Pereira, Juliana Milagres Macedo; Meyer, Renata Leal Bregunci; Trindade, Fernanda Marques; Pedrosa, Moises Salgado; Piancastelli, André Costa Cruz

    2015-01-01

    The etiology of pityriasis lichenoides is unknown. One of the accepted theories admits that PL is an inflammatory response to extrinsic antigens such as infectious agents, drugs and vaccines. In recent medical literature, only the MMR vaccine (Measles, Mumps and Rubella) was associated with the occurrence of this disease. We present a case of a male, 12 year old healthy patient who, five days after Influenza vaccination, developed erythematous papules on the trunk, abdomen and limbs, some with adherent crusts and associated systemic symptoms. This case report is notable for describing the first case of pityriasis lichenoides et varioliformis acuta associated with the vaccine against Influenza.

  5. Improving pandemic H5N1 influenza vaccines by combining different vaccine platforms.

    PubMed

    Luke, Catherine J; Subbarao, Kanta

    2014-07-01

    A variety of platforms are being explored for the development of vaccines for pandemic influenza. Observations that traditional inactivated subvirion vaccines and live-attenuated vaccines against H5 and some H7 influenza viruses were poorly immunogenic spurred efforts to evaluate new approaches, including whole virus vaccines, higher doses of antigen, addition of adjuvants and combinations of different vaccine modalities in heterologous prime-boost regimens to potentiate immune responses. Results from clinical trials of prime-boost regimens have been very promising. Further studies are needed to determine optimal combinations of platforms, intervals between doses of vaccines and the logistics of deployment in pre-pandemic and early pandemic settings.

  6. Acceptance of intradermal inactivated influenza vaccines among hospital staff following 2 seasonal vaccination campaigns

    PubMed Central

    Goodliffe, Laura; Coleman, Brenda L; McGeer, Allison J

    2015-01-01

    After a Canadian hospital's official influenza vaccination campaign concluded in the 2011–2012 and 2012–2013 influenza seasons, study nurses provided additional vaccination mobile cart hours and the added choice of an intradermal injection. An additional 2.1% of staff in the first and 1.4% in the second season were vaccinated during the study with 90–99% preferring the intradermal injection or having no preference. All 13 staff who attempted self-injection with the intradermal vaccine in 2012–2013 were successful on their first attempt. Offering alternatives to intramuscular vaccines may increase rates of vaccination. PMID:26378778

  7. Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with Advax™ delta inulin adjuvant.

    PubMed

    Gordon, David L; Sajkov, Dimitar; Honda-Okubo, Yoshikazu; Wilks, Samuel H; Aban, Malet; Barr, Ian G; Petrovsky, Nikolai

    2016-07-19

    Influenza vaccines are usually non-adjuvanted but addition of adjuvant may improve immunogenicity and permit dose-sparing, critical for vaccine supply in the event of an influenza pandemic. The aim of this first-in-man study was to determine the effect of delta inulin adjuvant on the safety and immunogenicity of a reduced dose seasonal influenza vaccine. Healthy male and female adults aged 18-65years were recruited to participate in a randomized controlled study to compare the safety, tolerability and immunogenicity of a reduced-dose 2007 Southern Hemisphere trivalent inactivated influenza vaccine formulated with Advax™ delta inulin adjuvant (LTIV+Adj) when compared to a full-dose of the standard TIV vaccine which does not contain an adjuvant. LTIV+Adj provided equivalent immunogenicity to standard TIV vaccine as assessed by hemagglutination inhibition (HI) assays against each vaccine strain as well as against a number of heterosubtypic strains. HI responses were sustained at 3months post-immunisation in both groups. Antibody landscapes against a large panel of H3N2 influenza viruses showed distinct age effects whereby subjects over 40years old had a bimodal baseline HI distribution pattern, with the highest HI titers against the very oldest H3N2 isolates and with a second HI peak against influenza isolates from the last 5-10years. By contrast, subjects >40years had a unimodal baseline HI distribution with peak recognition of H3N2 isolates from approximately 20years ago. The reduced dose TIV vaccine containing Advax adjuvant was well tolerated and no safety issues were identified. Hence, delta inulin may be a useful adjuvant for use in seasonal or pandemic influenza vaccines. Australia New Zealand Clinical Trial Registry: ACTRN12607000599471. PMID:27342914

  8. Human Phase 1 trial of low-dose inactivated seasonal influenza vaccine formulated with Advax™ delta inulin adjuvant.

    PubMed

    Gordon, David L; Sajkov, Dimitar; Honda-Okubo, Yoshikazu; Wilks, Samuel H; Aban, Malet; Barr, Ian G; Petrovsky, Nikolai

    2016-07-19

    Influenza vaccines are usually non-adjuvanted but addition of adjuvant may improve immunogenicity and permit dose-sparing, critical for vaccine supply in the event of an influenza pandemic. The aim of this first-in-man study was to determine the effect of delta inulin adjuvant on the safety and immunogenicity of a reduced dose seasonal influenza vaccine. Healthy male and female adults aged 18-65years were recruited to participate in a randomized controlled study to compare the safety, tolerability and immunogenicity of a reduced-dose 2007 Southern Hemisphere trivalent inactivated influenza vaccine formulated with Advax™ delta inulin adjuvant (LTIV+Adj) when compared to a full-dose of the standard TIV vaccine which does not contain an adjuvant. LTIV+Adj provided equivalent immunogenicity to standard TIV vaccine as assessed by hemagglutination inhibition (HI) assays against each vaccine strain as well as against a number of heterosubtypic strains. HI responses were sustained at 3months post-immunisation in both groups. Antibody landscapes against a large panel of H3N2 influenza viruses showed distinct age effects whereby subjects over 40years old had a bimodal baseline HI distribution pattern, with the highest HI titers against the very oldest H3N2 isolates and with a second HI peak against influenza isolates from the last 5-10years. By contrast, subjects >40years had a unimodal baseline HI distribution with peak recognition of H3N2 isolates from approximately 20years ago. The reduced dose TIV vaccine containing Advax adjuvant was well tolerated and no safety issues were identified. Hence, delta inulin may be a useful adjuvant for use in seasonal or pandemic influenza vaccines. Australia New Zealand Clinical Trial Registry: ACTRN12607000599471.

  9. Refining the approach to vaccines against influenza A viruses with pandemic potential

    PubMed Central

    Czako, Rita; Subbarao, Kanta

    2015-01-01

    Vaccination is the most effective strategy for prevention and control of influenza. Timely production and deployment of seasonal influenza vaccines is based on an understanding of the epidemiology of influenza and on global disease and virologic surveillance. Experience with seasonal influenza vaccines guided the initial development of pandemic influenza vaccines. A large investment in pandemic influenza vaccines in the last decade has resulted in much progress and a body of information that can now be applied to refine the established paradigm. Critical and complementary considerations for pandemic influenza vaccines include improved assessment of the pandemic potential of animal influenza viruses, proactive development and deployment of pandemic influenza vaccines, and application of novel platforms and strategies for vaccine production and administration. PMID:26587050

  10. Efficient vaccine against pandemic influenza: combining DNA vaccination and targeted delivery to MHC class II molecules.

    PubMed

    Grødeland, Gunnveig; Bogen, Bjarne

    2015-06-01

    There are two major limitations to vaccine preparedness in the event of devastating influenza pandemics: the time needed to generate a vaccine and rapid generation of sufficient amounts. DNA vaccination could represent a solution to these problems, but efficacy needs to be enhanced. In a separate line of research, it has been established that targeting of vaccine molecules to antigen-presenting cells enhances immune responses. We have combined the two principles by constructing DNA vaccines that encode bivalent fusion proteins; these target hemagglutinin to MHC class II molecules on antigen-presenting cells. Such DNA vaccines rapidly induce hemagglutinin-specific antibodies and T cell responses in immunized mice. Responses are long-lasting and protect mice against challenge with influenza virus. In a pandemic situation, targeted DNA vaccines could be produced and tested within a month. The novel DNA vaccines could represent a solution to pandemic preparedness in the advent of novel influenza pandemics.

  11. Economic evaluations of childhood influenza vaccination: a critical review.

    PubMed

    Newall, Anthony T; Jit, Mark; Beutels, Philippe

    2012-08-01

    The potential benefits of influenza vaccination programmes targeted at children have gained increasing attention in recent years. We conducted a literature search of economic evaluations of influenza vaccination in those aged ≤18 years. The search revealed 20 relevant articles, which were reviewed. The studies differed widely in terms of the costs and benefits that were included. The conclusions were generally favourable for vaccination, but often applied a wider perspective (i.e. including productivity losses) than the reference case for economic evaluations used in many countries. Several evaluations estimated outcomes from a single-year epidemiological study, which may limit their validity given the year-to-year variation in influenza transmissibility, virulence, vaccine match and prior immunity. Only one study used a dynamic transmission model able to fully incorporate the indirect herd protection to the wider community. The use of dynamic models offers great scope to capture the population-wide implications of seasonal vaccination efforts, particularly those targeted at children.

  12. Possible Triggering Effect of Influenza Vaccination on Psoriasis.

    PubMed

    Gunes, Ali Tahsin; Fetil, Emel; Akarsu, Sevgi; Ozbagcivan, Ozlem; Babayeva, Lale

    2015-01-01

    Psoriasis is a chronic, recurrent, immune-mediated inflammatory disease and it can be provoked or exacerbated by a variety of different environmental factors, particularly infections and drugs. In addition, a possible association between vaccination and the new onset and/or exacerbation of psoriasis has been reported by a number of different authors. The aim of this study is to investigate the effects of influenza vaccination on patients with psoriasis. Here, we report the findings from 43 patients suffering from psoriasis (clinical phenotypes as mixed guttate/plaque lesions, palmoplantar or scalp psoriasis) whose diseases had been triggered after influenza vaccination applied in the 2009-2010 season. The short time intervals between vaccination and psoriasis flares in our patients and the lack of other possible triggers suggest that influenza vaccinations may have provocative effects on psoriasis. However, further large and controlled studies need to be carried out to confirm this relationship.

  13. Chemical-free inactivated whole influenza virus vaccine prepared by ultrashort pulsed laser treatment

    NASA Astrophysics Data System (ADS)

    Tsen, Shaw-Wei David; Donthi, Nisha; La, Victor; Hsieh, Wen-Han; Li, Yen-Der; Knoff, Jayne; Chen, Alexander; Wu, Tzyy-Choou; Hung, Chien-Fu; Achilefu, Samuel; Tsen, Kong-Thon

    2015-05-01

    There is an urgent need for rapid methods to develop vaccines in response to emerging viral pathogens. Whole inactivated virus (WIV) vaccines represent an ideal strategy for this purpose; however, a universal method for producing safe and immunogenic inactivated vaccines is lacking. Conventional pathogen inactivation methods such as formalin, heat, ultraviolet light, and gamma rays cause structural alterations in vaccines that lead to reduced neutralizing antibody specificity, and in some cases, disastrous T helper type 2-mediated immune pathology. We have evaluated the potential of a visible ultrashort pulsed (USP) laser method to generate safe and immunogenic WIV vaccines without adjuvants. Specifically, we demonstrate that vaccination of mice with laser-inactivated H1N1 influenza virus at about a 10-fold lower dose than that required using conventional formalin-inactivated influenza vaccines results in protection against lethal H1N1 challenge in mice. The virus, inactivated by the USP laser irradiation, has been shown to retain its surface protein structure through hemagglutination assay. Unlike conventional inactivation methods, laser treatment did not generate carbonyl groups in protein, thereby reducing the risk of adverse vaccine-elicited T helper type 2 responses. Therefore, USP laser treatment is an attractive potential strategy to generate WIV vaccines with greater potency and safety than vaccines produced by current inactivation techniques.

  14. Chemical-free inactivated whole influenza virus vaccine prepared by ultrashort pulsed laser treatment.

    PubMed

    Tsen, Shaw-Wei David; Donthi, Nisha; La, Victor; Hsieh, Wen-Han; Li, Yen-Der; Knoff, Jayne; Chen, Alexander; Wu, Tzyy-Choou; Hung, Chien-Fu; Achilefu, Samuel; Tsen, Kong-Thon

    2015-05-01

    There is an urgent need for rapid methods to develop vaccines in response to emerging viral pathogens. Whole inactivated virus (WIV) vaccines represent an ideal strategy for this purpose; however, a universal method for producing safe and immunogenic inactivated vaccines is lacking. Conventional pathogen inactivation methods such as formalin, heat, ultraviolet light, and gamma rays cause structural alterations in vaccines that lead to reduced neutralizing antibody specificity, and in some cases, disastrous T helper type 2-mediated immune pathology. We have evaluated the potential of a visible ultrashort pulsed (USP) laser method to generate safe and immunogenic WIV vaccines without adjuvants. Specifically, we demonstrate that vaccination of mice with laser-inactivated H1N1 influenza virus at about a 10-fold lower dose than that required using conventional formalin-inactivated influenza vaccines results in protection against lethal H1N1 challenge in mice. The virus, inactivated by the USP laser irradiation, has been shown to retain its surface protein structure through hemagglutination assay. Unlike conventional inactivation methods, laser treatment did not generate carbonyl groups in protein, thereby reducing the risk of adverse vaccine-elicited T helper type 2 responses. Therefore, USP laser treatment is an attractive potential strategy to generate WIV vaccines with greater potency and safety than vaccines produced by current inactivation techniques.

  15. Influenza Vaccination Guidelines and Vaccine Sales in Southeast Asia: 2008–2011

    PubMed Central

    Gupta, Vinay; Dawood, Fatimah S.; Muangchana, Charung; Lan, Phan Trong; Xeuatvongsa, Anonh; Sovann, Ly; Olveda, Remigio; Cutter, Jeffery; Oo, Khin Yi; Ratih, Theresia Sandra Diah; Kheong, Chong Chee; Kapella, Bryan K.; Kitsutani, Paul; Corwin, Andrew; Olsen, Sonja J.

    2012-01-01

    Background Southeast Asia is a region with great potential for the emergence of a pandemic influenza virus. Global efforts to improve influenza surveillance in this region have documented the burden and seasonality of influenza viruses and have informed influenza prevention strategies, but little information exists about influenza vaccination guidelines and vaccine sales. Methods To ascertain the existence of influenza vaccine guidelines and define the scope of vaccine sales, we sent a standard three-page questionnaire to the ten member nations of the Association of Southeast Asian Nations. We also surveyed three multinational manufacturers who supply influenza vaccines in the region. Results Vaccine sales in the private sector were <1000 per 100,000 population in the 10 countries. Five countries reported purchasing vaccine for use in the public sector. In 2011, Thailand had the highest combined reported rate of vaccine sales (10,333 per 100,000). In the 10 countries combined, the rate of private sector sales during 2010–2011 (after the A(H1N1)2009pdm pandemic) exceeded 2008 pre-pandemic levels. Five countries (Indonesia, Malaysia, Singapore, Thailand and Vietnam) had guidelines for influenza vaccination but only two were consistent with global guidelines. Four recommended vaccination for health care workers, four for elderly persons, three for young children, three for persons with underlying disease, and two for pregnant women. Conclusions The rate of vaccine sales in Southeast Asia remains low, but there was a positive impact in sales after the A(H1N1)2009pdm pandemic. Low adherence to global vaccine guidelines suggests that more work is needed in the policy arena. PMID:23285200

  16. A surface antigen influenza vaccine. 2. Pyrogenicity and antigenicity.

    PubMed Central

    Brady, M. I.; Furminger, I. G.

    1976-01-01

    Conventional influenza vaccine containing whole virus particles purified on a zonal centrifuge is pyrogenic and can cause systemic and local adverse side effects. An improved vaccine was therefore prepared which contained only the surface antigens of the virus adsorbed to aluminium hydroxide. The antigenicity of this vaccine was compared with conventional vaccine in chickens. Both vaccines induced similar titres of serum haemagglutination-inhibition and neuraminidase inhibition antibody. The dose response curves, however, were different. The surface antigens at vaccine strength without aluminium hydroxide were of negligible pyrogenicity in rabbits. PMID:1068196

  17. Avian influenza vaccines against H5N1 'bird flu'.

    PubMed

    Li, Chengjun; Bu, Zhigao; Chen, Hualan

    2014-03-01

    H5N1 avian influenza viruses (AIVs) have spread widely to more than 60 countries spanning three continents. To control the disease, vaccination of poultry is implemented in many of the affected countries, especially in those where H5N1 viruses have become enzootic in poultry and wild birds. Recently, considerable progress has been made toward the development of novel avian influenza (AI) vaccines, especially recombinant virus vector vaccines and DNA vaccines. Here, we will discuss the recent advances in vaccine development and use against H5N1 AIV in poultry. Understanding the properties of the available, novel vaccines will allow for the establishment of rational vaccination protocols, which in turn will help the effective control and prevention of H5N1 AI.

  18. Phase IV: randomized controlled trial to evaluate lot consistency of trivalent split influenza vaccines in healthy adults.

    PubMed

    Song, Joon Young; Cheong, Hee Jin; Lee, Jacob; Wie, Seong-Heon; Park, Kyung-Hwa; Kee, Sae Yoon; Jeong, Hye Won; Kim, Yeon-Sook; Noh, Ji Yun; Choi, Won Suk; Park, Dae Won; Sohn, Jang Wook; Kim, Woo Joo

    2014-01-01

    Influenza vaccines are the primary method for preventing influenza and its complications. Considering the increasing demand for influenza vaccines, vaccine manufacturers are required to establish large-scale production systems. This phase IV randomized trial was conducted to evaluate the lot consistency of trivalent split influenza vaccines regarding immunogenicity and safety. A total of 1,023 healthy adults aged 18-64 y were enrolled in the study. Subjects were randomly assigned in a 1:1 ratio to receive the GC FLU® Prefilled Syringe or the GC FLU® Injection, and they were further randomized to one of 3 lots of each vaccine in a 1:1:1 ratio. In both GC FLU® Injection and GC FLU® Prefilled Syringe groups, immune responses were equivalent between lots for each of the 3 vaccine strains on day 21. The 2-sided 95% CI of GMT ratios between pairs of lots were between 0.67 and 1.5, meeting the equivalence criteria. After vaccination, all 3 criteria of the European Medicines Agency were met in both GC FLU® Injection and GC FLU® Prefilled Syringe groups. The vaccines showed tolerable safety profiles without serious adverse events. The demonstration of lot consistency, robust immunogenic responses and favorable safety profiles support the reliability of mass-manufacturing systems for the GC FLU® Injection and GC FLU® Prefilled Syringe.

  19. Responses of volunteers to inactivated influenza virus vaccines.

    PubMed Central

    Jennings, R.; Potter, C. W.; Massey, P. M.; Duerden, B. I.; Martin, J.; Bevan, A. M.

    1981-01-01

    Three different types of bivalent influenza virus vaccine, a whole virus, an aqueous-surface-antigen vaccine and an adsorbed-surface-antigen vaccine were tested at three dosage levels in volunteers primed with respect to only one of the haemagglutinin antigens present in the vaccines. The local and systemic reactions to all three vaccine types were mild in nature and, following first immunization, the aqueous-surface-antigen vaccine was the least reactogenic. The serum haemagglutination-inhibiting antibody response to the A/Victoria/75 component of the vaccines to which the volunteer population was primed, was greatest following immunization with the aqueous-surface-antigen vaccine; the greatest antibody response to the A/New Jersey/76 component of the vaccines was observed following immunization with whole virus vaccine. PMID:7007488

  20. Influenza Vaccination Coverage Among Health Care Personnel - United States, 2015-16 Influenza Season.

    PubMed

    Black, Carla L; Yue, Xin; Ball, Sarah W; Donahue, Sara M A; Izrael, David; de Perio, Marie A; Laney, A Scott; Williams, Walter W; Lindley, Megan C; Graitcer, Samuel B; Lu, Peng-Jun; DiSogra, Charles; Devlin, Rebecca; Walker, Deborah K; Greby, Stacie M

    2016-09-30

    The Advisory Committee on Immunization Practices recommends annual influenza vaccination for all health care personnel to reduce influenza-related morbidity and mortality among both health care personnel and their patients (1-4). To estimate influenza vaccination coverage among U.S. health care personnel for the 2015-16 influenza season, CDC conducted an opt-in Internet panel survey of 2,258 health care personnel during March 28-April 14, 2016. Overall, 79.0% of survey participants reported receiving an influenza vaccination during the 2015-16 season, similar to the 77.3% coverage reported for the 2014-15 season (5). Coverage in long-term care settings increased by 5.3 percentage points compared with the previous season. Vaccination coverage continued to be higher among health care personnel working in hospitals (91.2%) and lower among health care personnel working in ambulatory (79.8%) and long-term care settings (69.2%). Coverage continued to be highest among physicians (95.6%) and lowest among assistants and aides (64.1%), and highest overall among health care personnel who were required by their employer to be vaccinated (96.5%). Among health care personnel working in settings where vaccination was neither required, promoted, nor offered onsite, vaccination coverage continued to be low (44.9%). An increased percentage of health care personnel reporting a vaccination requirement or onsite vaccination availability compared with earlier influenza seasons might have contributed to the overall increase in vaccination coverage during the past 6 influenza seasons.

  1. Influenza Vaccination Coverage Among Health Care Personnel - United States, 2015-16 Influenza Season.

    PubMed

    Black, Carla L; Yue, Xin; Ball, Sarah W; Donahue, Sara M A; Izrael, David; de Perio, Marie A; Laney, A Scott; Williams, Walter W; Lindley, Megan C; Graitcer, Samuel B; Lu, Peng-Jun; DiSogra, Charles; Devlin, Rebecca; Walker, Deborah K; Greby, Stacie M

    2016-01-01

    The Advisory Committee on Immunization Practices recommends annual influenza vaccination for all health care personnel to reduce influenza-related morbidity and mortality among both health care personnel and their patients (1-4). To estimate influenza vaccination coverage among U.S. health care personnel for the 2015-16 influenza season, CDC conducted an opt-in Internet panel survey of 2,258 health care personnel during March 28-April 14, 2016. Overall, 79.0% of survey participants reported receiving an influenza vaccination during the 2015-16 season, similar to the 77.3% coverage reported for the 2014-15 season (5). Coverage in long-term care settings increased by 5.3 percentage points compared with the previous season. Vaccination coverage continued to be higher among health care personnel working in hospitals (91.2%) and lower among health care personnel working in ambulatory (79.8%) and long-term care settings (69.2%). Coverage continued to be highest among physicians (95.6%) and lowest among assistants and aides (64.1%), and highest overall among health care personnel who were required by their employer to be vaccinated (96.5%). Among health care personnel working in settings where vaccination was neither required, promoted, nor offered onsite, vaccination coverage continued to be low (44.9%). An increased percentage of health care personnel reporting a vaccination requirement or onsite vaccination availability compared with earlier influenza seasons might have contributed to the overall increase in vaccination coverage during the past 6 influenza seasons. PMID:27684642

  2. Preclinical evaluation of a Haemophilus influenzae type b conjugate vaccine process intended for technology transfer

    PubMed Central

    Hamidi, Ahd; Verdijk, Pauline; Kreeftenberg, Hans

    2014-01-01

    Introduction of Haemophilus influenzae type b (Hib) vaccine in low- and middle-income countries has been limited by cost and availability of Hib conjugate vaccines for a long time. It was previously recognized by the Institute for Translational Vaccinology (Intravacc, originating from the former Vaccinology Unit of the National Institute of Public Health [RIVM] and the Netherlands Vaccine Institute [NVI]) that local production of a Hib conjugate vaccine would increase the affordability and sustainability of the vaccine and thereby help to speed up Hib introduction in these countries. A new affordable and a non-infringing production process for a Hib conjugate vaccine was developed, including relevant quality control tests, and the technology was transferred to a number of vaccine manufacturers in India, Indonesia, and China. As part of the Hib technology transfer project managed by Intravacc, a preclinical toxicity study was conducted in the Netherlands to test the safety and immunogenicity of this new Hib conjugate vaccine. The data generated by this study were used by the technology transfer partners to accelerate the clinical development of the new Hib conjugate vaccine. A repeated dose toxicity and local tolerance study in rats was performed to assess the reactogenicity and immunogenicity of a new Hib conjugate vaccine compared to a licensed vaccine. The results showed that the vaccine was well tolerated and immunogenic in rats, no major differences in both safety and immunogenicity in rats were found between the vaccine produced according to the production process developed by Intravacc and the licensed one. Rats may be useful to verify the immunogenicity of Hib conjugate vaccines and for preclinical evaluation. In general, nonclinical evaluation of the new Hib conjugate vaccine, including this proof of concept (safety and immunogenicity study in rats), made it possible for technology transfer partners, having implemented the original process with no changes

  3. Preclinical evaluation of a Haemophilus influenzae type b conjugate vaccine process intended for technology transfer.

    PubMed

    Hamidi, Ahd; Verdijk, Pauline; Kreeftenberg, Hans

    2014-01-01

    Introduction of Haemophilus influenzae type b (Hib) vaccine in low- and middle-income countries has been limited by cost and availability of Hib conjugate vaccines for a long time. It was previously recognized by the Institute for Translational Vaccinology (Intravacc, originating from the former Vaccinology Unit of the National Institute of Public Health [RIVM] and the Netherlands Vaccine Institute [NVI]) that local production of a Hib conjugate vaccine would increase the affordability and sustainability of the vaccine and thereby help to speed up Hib introduction in these countries. A new affordable and a non-infringing production process for a Hib conjugate vaccine was developed, including relevant quality control tests, and the technology was transferred to a number of vaccine manufacturers in India, Indonesia, and China. As part of the Hib technology transfer project managed by Intravacc, a preclinical toxicity study was conducted in the Netherlands to test the safety and immunogenicity of this new Hib conjugate vaccine. The data generated by this study were used by the technology transfer partners to accelerate the clinical development of the new Hib conjugate vaccine. A repeated dose toxicity and local tolerance study in rats was performed to assess the reactogenicity and immunogenicity of a new Hib conjugate vaccine compared to a licensed vaccine. The results showed that the vaccine was well tolerated and immunogenic in rats, no major differences in both safety and immunogenicity in rats were found between the vaccine produced according to the production process developed by Intravacc and the licensed one. Rats may be useful to verify the immunogenicity of Hib conjugate vaccines and for preclinical evaluation. In general, nonclinical evaluation of the new Hib conjugate vaccine, including this proof of concept (safety and immunogenicity study in rats), made it possible for technology transfer partners, having implemented the original process with no changes

  4. Prospective surveillance study of acute respiratory infections, influenza-like illness and seasonal influenza vaccine in a cohort of juvenile idiopathic arthritis patients

    PubMed Central

    2013-01-01

    Background Acute respiratory infections (ARI) are frequent in children and complications can occur in patients with chronic diseases. We evaluated the frequency and impact of ARI and influenza-like illness (ILI) episodes on disease activity, and the immunogenicity and safety of influenza vaccine in a cohort of juvenile idiopathic arthritis (JIA) patients. Methods Surveillance of respiratory viruses was conducted in JIA patients during ARI season (March to August) in two consecutive years: 2007 (61 patients) and 2008 (63 patients). Patients with ARI or ILI had respiratory samples collected for virus detection by real time PCR. In 2008, 44 patients were immunized with influenza vaccine. JIA activity index (ACRPed30) was assessed during both surveillance periods. Influenza hemagglutination inhibition antibody titers were measured before and 30-40 days after vaccination. Results During the study period 105 ARI episodes were reported and 26.6% of them were ILI. Of 33 samples collected, 60% were positive for at least one virus. Influenza and rhinovirus were the most frequently detected, in 30% of the samples. Of the 50 JIA flares observed, 20% were temporally associated to ARI. Influenza seroprotection rates were higher than 70% (91-100%) for all strains, and seroconversion rates exceeded 40% (74-93%). In general, response to influenza vaccine was not influenced by therapy or disease activity, but patients using anti-TNF alpha drugs presented lower seroconversion to H1N1 strain. No significant differences were found in ACRPed30 after vaccination and no patient reported ILI for 6 months after vaccination. Conclusion ARI episodes are relatively frequent in JIA patients and may have a role triggering JIA flares. Trivalent split influenza vaccine seems to be immunogenic and safe in JIA patients. PMID:23510667

  5. Immunogenicity and safety of a combined hepatitis A and B vaccine administered concomitantly with either a measles-mumps-rubella or a diphtheria-tetanus-acellular pertussis-inactivated poliomyelitis vaccine mixed with a Haemophilus influenzae type b conjugate vaccine in infants aged 12-18 months.

    PubMed

    Usonis, V; Meriste, S; Bakasenas, V; Lutsar, I; Collard, F; Stoffel, M; Tornieporth, N

    2005-04-01

    Two studies were undertaken to investigate the concomitant administration of combined hepatitis A/B vaccine with a diphtheria-tetanus-acellular pertussis-inactivated poliomyelitis vaccine mixed with Haemophilus influenzae vaccine (DTPa-IPV/Hib), or with a measles-mumps-rubella vaccine (MMR), during the second year of life. On completion of the vaccination course, all subjects were seropositive or seroprotected against all antigens except for one subject who was seronegative for anti-PT. Seropositivity and seroprotection rates for all other antibodies were comparable to reference values for each vaccine component, indicating that the immunogenicity of MMR, DTPa-IPV/Hib and combined hepatitis A/B vaccines is not impaired by co-administration. All vaccines were well tolerated.

  6. Seasonal trivalent inactivated influenza vaccine protects against 1918 Spanish influenza virus in ferrets

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The influenza H1N1 pandemic of 1918 was one of the worst medical disasters in human history. Recent studies have demonstrated that the hemagglutinin (HA) protein of the 1918 virus and 2009 H1N1 pandemic virus, the latter now a component of the seasonal trivalent inactivated influenza vaccine (TIV),...

  7. Influenza virus hemagglutinin stalk-based antibodies and vaccines

    PubMed Central

    Krammer, Florian; Palese, Peter

    2013-01-01

    Antibodies against the conserved stalk domain of the hemagglutinin are currently being discussed as promising therapeutic tools against influenza virus infections. Due to the conservation of the stalk domain these antibodies are able to broadly neutralize a wide spectrum of influenza virus strains and subtypes. Broadly protective vaccine candidates based on the epitopes of these antibodies, e.g. chimeric and headless hemagglutinin structures, are currently under development and show promising results in animals models. These candidates could be developed into universal influenza virus vaccines that protect from infection with drifted seasonal as well as novel pandemic influenza virus strains therefore obviating the need for annual vaccination, and enhancing our pandemic preparedness. PMID:23978327

  8. State law and influenza vaccination of health care personnel.

    PubMed

    Stewart, Alexandra M; Cox, Marisa A

    2013-01-21

    Nosocomial influenza outbreaks, attributed to the unvaccinated health care workforce, have contributed to patient complications or death, worker illness and absenteeism, and increased economic costs to the health care system. Since 1981, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has recommended that all HCP receive an annual influenza vaccination. Health care employers (HCE) have adopted various strategies to encourage health care personnel (HCP) to voluntarily receive influenza vaccination, including: sponsoring educational and promotional campaigns, increasing access to seasonal influenza vaccine, permitting the use of declination statements, and combining multiple approaches. However, these measures failed to significantly increase uptake among HCP. As a result, beginning in 2004, health care facilities and local health departments began to require certain HCP to receive influenza vaccination as a condition of employment and annually. Today, hundreds of facilities throughout the country have developed and implemented similar policies. Mandatory vaccination programs have been endorsed by professional and non-profit organizations, state health departments, and public health. These programs have been more effective at increasing coverage rates than any voluntary strategy, with some health systems reporting coverage rates up to 99.3%. Several states have enacted laws requiring HCEs to implement vaccination programs for the workforce. These laws present an example of how states will respond to threats to the public's health and constrain personal choice in order to protect vulnerable populations. This study analyzes laws in twenty states that address influenza vaccination requirements for HCP who practice in acute or long-term care facilities in the United States. The laws vary in the extent to which they incorporate the six elements of a mandatory HCP influenza vaccination program. Four of the

  9. State law and influenza vaccination of health care personnel.

    PubMed

    Stewart, Alexandra M; Cox, Marisa A

    2013-01-21

    Nosocomial influenza outbreaks, attributed to the unvaccinated health care workforce, have contributed to patient complications or death, worker illness and absenteeism, and increased economic costs to the health care system. Since 1981, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has recommended that all HCP receive an annual influenza vaccination. Health care employers (HCE) have adopted various strategies to encourage health care personnel (HCP) to voluntarily receive influenza vaccination, including: sponsoring educational and promotional campaigns, increasing access to seasonal influenza vaccine, permitting the use of declination statements, and combining multiple approaches. However, these measures failed to significantly increase uptake among HCP. As a result, beginning in 2004, health care facilities and local health departments began to require certain HCP to receive influenza vaccination as a condition of employment and annually. Today, hundreds of facilities throughout the country have developed and implemented similar policies. Mandatory vaccination programs have been endorsed by professional and non-profit organizations, state health departments, and public health. These programs have been more effective at increasing coverage rates than any voluntary strategy, with some health systems reporting coverage rates up to 99.3%. Several states have enacted laws requiring HCEs to implement vaccination programs for the workforce. These laws present an example of how states will respond to threats to the public's health and constrain personal choice in order to protect vulnerable populations. This study analyzes laws in twenty states that address influenza vaccination requirements for HCP who practice in acute or long-term care facilities in the United States. The laws vary in the extent to which they incorporate the six elements of a mandatory HCP influenza vaccination program. Four of the

  10. Control of Influenza and Poliomyelitis with Killed Virus Vaccines

    ERIC Educational Resources Information Center

    Salk, Jonas; Salk, Darrell

    1977-01-01

    Discusses control of poliomyelitis and influenza by live and killed virus vaccines. Considered are the etiological agents, pathogenic mechanisms and epidemiology of each disease. Reviews recent scientific studies of the diseases. Recommends use of killed virus vaccines in controlling both diseases. (CS)

  11. School-Located Influenza Vaccination Clinics: Local Health Department Perspectives

    ERIC Educational Resources Information Center

    Ransom, James

    2009-01-01

    Universal childhood influenza vaccination presents challenges and opportunities for health care and public health systems to vaccinate the children who fall under the new recommendation. Advisory Committee on Immunization Practices (ACIP) recommendations and guidelines are helpful, but they do not provide strategies on how to deliver immunization…

  12. Influenza (flu) vaccine (Inactivated or Recombinant): What you need to know

    MedlinePlus

    ... taken in its entirety from the CDC Inactivated Influenza Vaccine Information Statement (VIS) www.cdc.gov/vaccines/hcp/vis/vis-statements/flu.html CDC review information for Inactivated Influenza VIS: ...

  13. Timeliness of Pediatric Influenza Vaccination Compared With Seasonal Influenza Activity in an Urban Community, 2004–2008

    PubMed Central

    Hofstetter, Annika M.; Natarajan, Karthik; Rabinowitz, Daniel; Martinez, Raquel Andres; Vawdrey, David; Arpadi, Stephen

    2013-01-01

    Objectives. We assessed pediatric influenza vaccination in relation to community influenza activity. Methods. We examined seasonal influenza vaccination in 34 012 children aged 6 months through 18 years from 5 academically affiliated clinics in northern Manhattan, New York (an urban low-income community) during the 2004–2008 seasons using hospital and city immunization registries. We calculated the cumulative number of administered influenza vaccine doses and proportion of children with any (≥ 1 dose) or full (1–2 doses per age recommendations) vaccination at the onset and peak of community polymerase chain reaction–confirmed influenza activity according to state surveillance reports and by March 31 each season. Results. Influenza vaccine administration began before October 1, peaked before influenza activity onset, and declined gradually over each season. Coverage at influenza activity onset, peak, and by March 31 increased over the 5 seasons. However, most children lacked full vaccination at these time points, particularly adolescents, minorities, and those requiring 2 doses. Conclusions. Despite early initiation of influenza vaccination, few children were fully vaccinated when influenza began circulating. Interventions should address factors negatively affecting timely influenza vaccination, especially in high-risk populations. PMID:23678935

  14. Increased defibrillator therapies during influenza season in patients without influenza vaccines

    PubMed Central

    Singh, Sheldon M.; de Souza, Russell J.; Kumareswaran, Ramanan

    2015-01-01

    Background The association between influenza vaccination and implantable cardiac defibrillator (ICD) therapies during influenza season is not known and is described in this study. Understanding this association is important since reduction in ICD therapies during influenza season via use of influenza vaccination would benefit patients physically and psychologically. Methods Patients presenting to the Sunnybrook Health Sciences Center ICD clinic between September 1st, 2011 and November 31st, 2011 were asked to complete a survey evaluating their use of the influenza vaccine. The number of patients with any ICD therapy and the total number of ICD therapies in the six months before and the three months during the 2010–2011 influenza season were determined. Poisson regression analysis was employed to assess differences in the average number of ICD therapies received during the influenza season based on vaccine status (vaccinated vs. unvaccinated). The analysis was repeated after limiting the cohort to patients with a left ventricular ejection fraction ≤35%. Results A total of 229 patients completed the survey, 78% of whom received the influenza vaccine. Four patients had more than one ICD shock during the study period. Electrical storm was rare (n=2). A trend toward more ICD therapies (unadjusted incident rate ratio (IRR)=3.2; P=0.07) and appropriate ICD shocks (unadjusted IRR=9.0; P=0.17) was noted for unvaccinated compared to vaccinated patients. This association persisted when analysis was limited to patients with a left ventricular ejection fraction ≤35% (all ICD therapies: unadjusted IRR=5.8; P=0.045; adjusted IRR=2.6; P=0.33). No patient who received the influenza vaccine, and had a reduced ejection fraction, received an approprite ICD shock during influenza season (unadjusted P<0.002). Conclusion A trend toward more ICD therapies during influenza season was observed in patients who did not receive the influenza vaccine compared to those who did. The

  15. Conformationally selective biophysical assay for influenza vaccine potency determination.

    PubMed

    Wen, Yingxia; Han, Liqun; Palladino, Giuseppe; Ferrari, Annette; Xie, Yuhong; Carfi, Andrea; Dormitzer, Philip R; Settembre, Ethan C

    2015-10-01

    Influenza vaccines are the primary intervention for reducing the substantial health burden from pandemic and seasonal influenza. Hemagglutinin (HA) is the most important influenza vaccine antigen. Subunit and split influenza vaccines are formulated, released for clinical use, and tested for stability based on an in vitro potency assay, single-radial immunodiffusion (SRID), which selectively detects HA that is immunologically active (capable of eliciting neutralizing or hemagglutination inhibiting antibodies in an immunized subject). The time consuming generation of strain-specific sheep antisera and calibrated antigen standards for SRID can delay vaccine release. The limitation in generating SRID reagents was evident during the early days of the 2009 pandemic, prompting efforts to develop more practical, alternative, quantitative assays for immunologically active HA. Here we demonstrate that, under native conditions, trypsin selectively digests HA produced from egg or mammalian cell in monovalent vaccines that is altered by stress conditions such as reduced pH, elevated temperature, or deamidation, leaving native, pre-fusion HA, intact. Subsequent reverse-phase high pressure liquid chromatography (RP-HPLC) can separate trypsin-resistant HA from the digested HA. Integration of the resulting RP-HPLC peak yields HA quantities that match well the values obtained by SRID. Therefore, trypsin digestion, to pre-select immunologically active HA, followed by quantification by RP-HPLC is a promising alternative in vitro potency assay for influenza vaccines. PMID:26348403

  16. Workplace Vaccination and Other Factors Impacting Influenza Vaccination Decision among Employees in Israel

    PubMed Central

    Shahrabani, Shosh; Benzion, Uri

    2010-01-01

    The study examined the factors affecting the decision to be vaccinated against influenza among employees in Israel. The research, conducted in 2007/2008, included 616 employees aged 18−65 at various workplaces in Israel, among them companies that offered their employees influenza vaccination. The research questionnaire included socio-demographic characteristics, and the Health Belief Model principles. The results show that the significant factors affecting vaccination compliance include a vaccination program at workplaces, vaccinations in the past, higher levels of vaccine’s perceived benefits, and lower levels of barriers to getting the vaccine. We conclude that vaccine compliance is larger at companies with workplace vaccination programs providing easier accessibility to vaccination. PMID:20617008

  17. Influenza vaccines in low and middle income countries

    PubMed Central

    Ott, Jördis J.; Klein Breteler, Janna; Tam, John S.; Hutubessy, Raymond C.W.; Jit, Mark; de Boer, Michiel R.

    2013-01-01

    Objectives: Economic evaluations on influenza vaccination from low resource settings are scarce and have not been evaluated using a systematic approach. Our objective was to conduct a systematic review on the value for money of influenza vaccination in low- and middle-income countries. Methods: PubMed and EMBASE were searched for economic evaluations published in any language between 1960 and 2011. Main outcome measures were costs per influenza outcome averted, costs per quality-adjusted life years gained or disability-adjusted life years averted, costs per benefit in monetary units or cost-benefit ratios. Results: Nine economic evaluations on seasonal influenza vaccine met the inclusion criteria. These were model- or randomized-controlled-trial (RCT)-based economic evaluations from middle-income countries. Influenza vaccination provided value for money for elderly, infants, adults and children with high-risk conditions. Vaccination was cost-effective and cost-saving for chronic obstructive pulmonary disease patients and in elderly above 65 y from model-based evaluations, but conclusions from RCTs on elderly varied. Conclusion: Economic evaluations from middle income regions differed in population studied, outcomes and definitions used. Most findings are in line with evidence from high-income countries highlighting that influenza vaccine is likely to provide value for money. However, serious methodological limitations do not allow drawing conclusions on cost-effectiveness of influenza vaccination in middle income countries. Evidence on cost-effectiveness from low-income countries is lacking altogether, and more information is needed from full economic evaluations that are conducted in a standardized manner. PMID:23732900

  18. Onset of Frozen Shoulder Following Pneumococcal and Influenza Vaccinations

    PubMed Central

    Saleh, Zeina M.; Faruqui, Sami; Foad, Abdullah

    2015-01-01

    Objective Adhesive capsulitis has been suggested as an adverse effect of vaccine administration into the shoulder area. The purpose of this case series is to report 3 cases of acute onset of adhesive capsulitis following pneumococcal and influenza vaccines. Clinical Features Patients reported painful shoulder and limited motion following routine vaccination. After clinical examination, a diagnosis of adhesive capsulitis was noted. Intervention and Outcome All 3 patients were treated conservatively with physical therapy (active ranges of motion and active-assisted motion), nonsteroidal anti-inflammatory drugs, and activity modification with eventual resolution of symptoms. Conclusion Reports implicating vaccination with adhesive capsulitis are rare. This case series raises the awareness of pneumococcal and influenza vaccinations as possible causes of adhesive capsulitis that appear to respond to standard treatment. Although vaccines are of tremendous importance in the prevention of serious illness, we emphasize the importance of administering them at the appropriate depth and location for each patient. PMID:26793041

  19. [Seasonal influenza vaccination in children and adolescents. Recommendations of the CAV-AEP for the campaign].

    PubMed

    Moreno-Pérez, D; Arístegui Fernández, J; Ruiz-Contreras, J; Alvarez García, F J; Merino Moína, M; González-Hachero, J; Corretger Rauet, J M; Hernández-Sampelayo Matos, T; Ortigosa del Castillo, L; Cilleruelo Ortega, M J; Barrio Corrales, F

    2012-01-01

    The Advisory Committee on Vaccines of the Spanish Association of Paediatrics establishes annual recommendations on influenza vaccination in childhood before the onset of influenza season. Routine influenza vaccination is particularly beneficial when the strategy is aimed at children older than 6 months of age with high-risk conditions and their home contacts. The recommendation of influenza vaccination in health workers with children is also emphasized.

  20. Factors Associated with Seasonal Influenza Vaccination in Pregnant Women

    PubMed Central

    Irving, Stephanie A.; Thompson, Mark; Avalos, Lyndsay Ammon; Ball, Sarah W.; Shifflett, Pat; Naleway, Allison L.

    2015-01-01

    Abstract Background: This observational study followed a cohort of pregnant women during the 2010–2011 influenza season to determine factors associated with vaccination. Methods: Participants were 1105 pregnant women who completed a survey assessing health beliefs related to vaccination upon enrollment and were then followed to determine vaccination status by the end of the 2010–2011 influenza season. We conducted univariate and multivariate analyses to explore factors associated with vaccination status and a factor analysis of survey items to identify health beliefs associated with vaccination. Results: Sixty-three percent (n=701) of the participants were vaccinated. In the univariate analyses, multiple factors were associated with vaccination status, including maternal age, race, marital status, educational level, and gravidity. Factor analysis identified two health belief factors associated with vaccination: participant's positive views (factor 1) and negative views (factor 2) of influenza vaccination. In a multivariate logistic regression model, factor 1 was associated with increased likelihood of vaccination (adjusted odds ratio [aOR]=2.18; 95% confidence interval [CI]=1.72–2.78), whereas factor 2 was associated with decreased likelihood of vaccination (aOR=0.36; 95% CI=0.28–0.46). After controlling for the two health belief factors in multivariate analyses, demographic factors significant in univariate analyses were no longer significant. Women who received a provider recommendation were about three times more likely to be vaccinated (aOR=3.14; 95% CI=1.99–4.96). Conclusion: Pregnant women's health beliefs about vaccination appear to be more important than demographic and maternal factors previously associated with vaccination status. Provider recommendation remains one of the most critical factors influencing vaccination during pregnancy. PMID:25874550

  1. 3 CFR 8472 - Proclamation 8472 of January 8, 2010. National Influenza Vaccination Week, 2010

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Influenza Vaccination Week, 2010 8472 Proclamation 8472 Presidential Documents Proclamations Proclamation 8472 of January 8, 2010 Proc. 8472 National Influenza Vaccination Week, 2010By the President of the... complications, resulting in hospitalization or even death. We know that influenza vaccination is the best way...

  2. Influenza vaccine effectiveness among US military basic trainees, 2005-06 season.

    PubMed

    Strickler, Jennifer K; Hawksworth, Anthony W; Myers, Christopher; Irvine, Marina; Ryan, Margaret A K; Russell, Kevin L

    2007-04-01

    Virtually all US military basic trainees receive seasonal influenza vaccine. Surveillance data collected from December 2005 through March 2006 were evaluated to estimate effectiveness of the influenza vaccine at 6 US military basic training centers. Vaccine effectiveness against laboratory-confirmed influenza was 92% (95% confidence interval 85%-96%).

  3. 76 FR 81467 - Availability of an Environmental Assessment for Field Testing Swine Influenza Vaccine, RNA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... Swine Influenza Vaccine, RNA AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice... test, an unlicensed Swine Influenza Vaccine, RNA. The environmental assessment, which is based on a...: Requester: Harrisvaccines, Inc. Product: Swine Influenza Vaccine, RNA. Field Test Locations: North...

  4. [Prophylactic influenza vaccination: what is the situation in Germany?].

    PubMed

    Wutzler, P

    2006-03-01

    Vaccination is the most efficacious and cost-effective measure for the prevention of influenza. Although the vaccination rate among the population of Germany has been gradually increasing in the last few years, only 40% of chronically ill persons are vaccinated. As a third of all persons aged over 50 years have a chronic disease, vaccination of those aged 50 years and over, from the those recommended 60 years, should be considered. Such a strategy would be cost-effective both for insurance companies and society as a whole. There are at present no data on ambulatory influenza vaccination rates in children, even though this could reduce the high death rate among this age group and decrease the spread of the disease among the general population. At present all children with an underlying disease and all those in immediate contact with them should be vaccinated. Pregnant women whose expected date of delivery falls within the influenza season should also be vaccinated so that they and their newborn child are protected against influenza.

  5. Animal models for influenza viruses: implications for universal vaccine development.

    PubMed

    Margine, Irina; Krammer, Florian

    2014-10-21

    Influenza virus infections are a significant cause of morbidity and mortality in the human population. Depending on the virulence of the influenza virus strain, as well as the immunological status of the infected individual, the severity of the respiratory disease may range from sub-clinical or mild symptoms to severe pneumonia that can sometimes lead to death. Vaccines remain the primary public health measure in reducing the influenza burden. Though the first influenza vaccine preparation was licensed more than 60 years ago, current research efforts seek to develop novel vaccination strategies with improved immunogenicity, effectiveness, and breadth of protection. Animal models of influenza have been essential in facilitating studies aimed at understanding viral factors that affect pathogenesis and contribute to disease or transmission. Among others, mice, ferrets, pigs, and nonhuman primates have been used to study influenza virus infection in vivo, as well as to do pre-clinical testing of novel vaccine approaches. Here we discuss and compare the unique advantages and limitations of each model.

  6. Options and Obstacles for Designing a Universal Influenza Vaccine

    PubMed Central

    Jang, Yo Han; Seong, Baik Lin

    2014-01-01

    Since the discovery of antibodies specific to a highly conserved stalk region of the influenza virus hemagglutinin (HA), eliciting such antibodies has been considered the key to developing a universal influenza vaccine that confers broad-spectrum protection against various influenza subtypes. To achieve this goal, a prime/boost immunization strategy has been heralded to redirect host immune responses from the variable globular head domain to the conserved stalk domain of HA. While this approach has been successful in eliciting cross-reactive antibodies against the HA stalk domain, protective efficacy remains relatively poor due to the low immunogenicity of the domain, and the cross-reactivity was only within the same group, rather than among different groups. Additionally, concerns are raised on the possibility of vaccine-associated enhancement of viral infection and whether multiple boost immunization protocols would be considered practical from a clinical standpoint. Live attenuated vaccine hitherto remains unexplored, but is expected to serve as an alternative approach, considering its superior cross-reactivity. This review summarizes recent advancements in the HA stalk-based universal influenza vaccines, discusses the pros and cons of these approaches with respect to the potentially beneficial and harmful effects of neutralizing and non-neutralizing antibodies, and suggests future guidelines towards the design of a truly protective universal influenza vaccine. PMID:25196381

  7. Effectiveness of influenza vaccination in the elderly in South Africa.

    PubMed

    van Vuuren, A; Rheeder, P; Hak, E

    2009-07-01

    This study primarily aimed to estimate the association between influenza vaccination and the occurrence of hospitalization for acute respiratory or cardiovascular diseases, or all-cause death during the influenza season in an elderly population in South Africa. We conducted a nested case-control study using data from a cohort of 45 522 elderly members of a private medical funding organization during the moderate 2004 influenza season. In 1282 (2.8%) subjects the combined outcome occurred and the influenza vaccination rate in controls was 15.4%. After adjustments for measured confounders, vaccination was associated with a statistically significant reduction of 19% (95% confidence interval 3.1-32.9) in the combined outcome. Post-hoc sensitivity analysis of the potential impact of potential healthy user bias showed that confounding, if present, could have caused this finding. Our data were inconclusive regarding the benefits of influenza vaccination in elderly persons in South Africa and given the low vaccine uptake, long-term follow-up is warranted. PMID:18925986

  8. A Review of the Evidence to Support Influenza Vaccine Introduction in Countries and Areas of WHO's Western Pacific Region

    PubMed Central

    Samaan, Gina; McPherson, Michelle; Partridge, Jeffrey

    2013-01-01

    Background Immunization against influenza is considered an essential public health intervention to control both seasonal epidemics and pandemic influenza. According to the World Health Organization (WHO), there are five key policy and three key programmatic issues that decision-makers should consider before introducing a vaccine. These are (a) public health priority, (b) disease burden, (c) efficacy, quality and safety of the vaccine, (d) other inventions, (e) economic and financial issues, (f) vaccine presentation, (g) supply availability and (h) programmatic strength. We analyzed the body of evidence currently available on these eight issues in the WHO Western Pacific Region. Methodology/Principal Findings Studies indexed in PubMed and published in English between 1 January 2000 and 31 December 2010 from the 37 countries and areas of the Western Pacific Region were screened for keywords pertaining to the five policy and three programmatic issues. Studies were grouped according to country income level and vaccine target group. There were 133 articles that met the selection criteria, with most (90%) coming from high-income countries. Disease burden (n = 34), vaccine efficacy, quality and safety (n = 27) and public health priority (n = 27) were most frequently addressed by studies conducted in the Region. Many studies assessed influenza vaccine policy and programmatic issues in the general population (42%), in the elderly (24%) and in children (17%). Few studies (2%) addressed the eight issues relating to pregnant women. Conclusions/Significance The evidence for vaccine introduction in countries and areas in this Region remains limited, particularly in low- and middle-income countries that do not currently have influenza vaccination programmes. Surveillance activities and specialized studies can be used to assess the eight issues including disease burden among vaccine target groups and the cost-effectiveness of influenza vaccine. Multi-country studies

  9. Safety and immunogenicity of an oral, replicating adenovirus serotype 4 vector vaccine for H5N1 influenza: a randomised, double-blind, placebo-controlled, phase 1 study

    PubMed Central

    Gurwith, Marc; Lock, Michael; Taylor, Eve M; Ishioka, Glenn; Alexander, Jeff; Mayall, Tim; Ervin, John E; Greenberg, Richard N; Strout, Cynthia; Treanor, John J; Webby, Richard; Wright, Peter F

    2013-01-01

    Summary Background Replication-competent virus vector vaccines might have advantages compared with non-replicating vector vaccines. We tested the safety and immunogenicity of an oral adenovirus serotype 4 vector vaccine candidate (Ad4-H5-Vtn) expressing the haemagglutinin from an avian influenza A H5N1 virus. Methods We did this phase 1 study at four sites in the USA. We used a computer-generated randomisation list (block size eight, stratified by site) to assign healthy volunteers aged 18–40 years to receive one of five doses of Ad4-H5-Vtn (107 viral particles [VP], 108 VP, 109 VP, 1010 VP, 1011 VP) or placebo (3:1). Vaccine or placebo was given on three occasions, about 56 days apart. Participants, investigators, and study-site personnel were masked to assignment throughout the study. Subsequently, volunteers received a boost dose with 90 μg of an inactivated parenteral H5N1 vaccine. Primary immunogenicity endpoints were seroconversion by haemagglutination-inhibition (HAI), defined as a four-times rise compared with baseline titre, and HAI geometric mean titre (GMT). We solicited symptoms of reactogenicity daily for 7 days after each vaccination and recorded symptoms that persisted beyond 7 days as adverse events. Primary analysis was per protocol. This trial is registered with ClinicalTrials.gov, number NCT01006798. Findings We enrolled 166 participants (125 vaccine; 41 placebo) between Oct 19, 2009, and Sept 9, 2010. HAI responses were low: 13 of 123 vaccinees (11%, 95% CI 6–17) and three of 41 placebo recipients (7%, 2–20) seroconverted. HAI GMT was 6 (95% CI 5–7) for vaccinees, and 5 (5–6) for placebo recipients. However, when inactivated H5N1 vaccine became available, one H5N1 boost was offered to all participants. In this substudy, HAI seroconversion occurred in 19 of 19 participants in the 1011 VP cohort (100%; 95% CI 82–100) and eight of 22 placebo recipients (36%; 17–59); 17 of 19 participants in the 1011 VP cohort (89%; 67–99) achieved

  10. Safety of the 11-valent pneumococcal vaccine conjugated to non-typeable Haemophilus influenzae-derived protein D in the first 2 years of life and immunogenicity of the co-administered hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio virus, Haemophilus influenzae type b and control hepatitis A vaccines.

    PubMed

    Prymula, Roman; Chlibek, Roman; Splino, Miroslav; Kaliskova, Eva; Kohl, Igor; Lommel, Patricia; Schuerman, Lode

    2008-08-18

    This randomized (1:1), double-blind, multicenter study, included 4,968 healthy infants to receive either the 11-valent pneumococcal protein D (PD)-conjugate study vaccine or the hepatitis A vaccine (HAV) (control) at 3, 4, 5, and 12-15 months of age. The three-dose primary course of both vaccines was co-administered with combined hexavalent DTPa-HBV-IPV/Hib vaccine. The pneumococcal PD-conjugate study vaccine did not impact the immune response of co-administered hexavalent vaccine and the control HAV vaccine induced seropositivity (antibodies >or=15 mIU/mL) in all infants. The incidence of solicited symptoms was higher with the 11-valent pneumococcal PD-conjugate study vaccine, yet similar to that induced by concomitant DTPa-HBV-IPV/Hib vaccine. Overall, the reactogenicity and safety profile of the 11-valent pneumococcal PD-conjugate vaccine when co-administered with the hexavalent DTPa-HBV-IPV/Hib vaccine, as well as the immunogenicity of the co-administered hexavalent vaccine, were consistent with previous reports for the licensed DTPa-HBV-IPV/Hib and pneumococcal conjugate vaccines.

  11. Role of influenza vaccine for healthy children in the US.

    PubMed

    Block, Stan L

    2004-01-01

    Influenza infection is associated with significant morbidity and mortality in adults, but the highest attack rates for influenza regularly occur in children, particularly those in preschool and elementary school. The consequences of influenza in this younger population - increased rate of hospitalization in those younger than 2 years of age and serious associated morbidity - have been underestimated. Children are also the critical link for spreading influenza in the community. Recent data suggest that mass influenza vaccination of healthy children would not only protect recipients, but also may reduce the burden of influenza throughout the community. During the past 3 decades, efforts to control influenza have focused on the use of an injectable trivalent inactivated vaccine (TIV) in high-risk persons. The vaccine is 'safe' and effective, but its acceptance and uptake by patients and healthcare providers have been modest at best. A new intranasal, live-attenuated, trivalent cold-adapted influenza virus vaccine (CAIV-T) [FluMist] is 'safe', well tolerated, immunogenic, and efficacious in preventing influenza illness in healthy children. Compared with TIV, CAIV-T is easier to administer and should be more readily acceptable, particularly for mass immunization campaigns. CAIV-T also induces a broader immune response and has demonstrated protection against at least three different variant influenza strains. This vaccine is particularly well suited for routine immunization of children and thus offers the potential for greatly improved control of influenza. However, the acquisition cost per single dose of FluMist for the 2003-4 season ( approximate, equals 46 US dollars) significantly hampered its uptake both by practitioners and by managed care organizations, even despite a later approximate, equals 25 US dollars rebate offer. For the 2004-5 season, CAIV-T is likely to be only modestly more expensive (average wholesale price: 16.50 US dollars for non-returnable doses

  12. Benefits and Effectiveness of Administering Pneumococcal Polysaccharide Vaccine With Seasonal Influenza Vaccine: An Approach for Policymakers

    PubMed Central

    Nanni, Angeline; Levine, Orin

    2012-01-01

    For the influenza pandemic of 2009–2010, countries responded to the direct threat of influenza but may have missed opportunities and strategies to limit secondary pneumococcal infections. Delivering both vaccines together can potentially increase pneumococcal polysaccharide vaccine (PPV23) immunization rates and prevent additional hospitalizations and mortality in the elderly and other high-risk groups. We used PubMed to review the literature on the concomitant use of PPV23 with seasonal influenza vaccines. Eight of 9 clinical studies found that a concomitant program conferred clinical benefits. The 2 studies that compared the cost-effectiveness of different strategies found concomitant immunization to be more cost-effective than either vaccine given alone. Policymakers should consider a stepwise strategy to reduce the burden of secondary pneumococcal infections during seasonal and pandemic influenza outbreaks. PMID:22397339

  13. Safety, reactogenicity and immunogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children in the second year of life: Results from an open study

    PubMed Central

    Dicko, Alassane; Dicko, Yahia; Barry, Amadou; Sidibe, Youssoufa; Mahamar, Almahamoudou; Santara, Gaoussou; Dolo, Amagana; Diallo, Aminata; Doumbo, Ogobara; Shafi, Fakrudeen; François, Nancy; Yarzabal, Juan Pablo; Strezova, Ana; Borys, Dorota; Schuerman, Lode

    2015-01-01

    Pneumonia is still the leading cause of death among African children with pneumococcal serotypes 1 and 5 being dominant in the below 5 y of age group. The present study assessed the safety, reactogenicity and immunogenicity of a 2-dose catch-up vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae Protein D conjugate vaccine (PHiD-CV) in Malian children. This phase III, open-label study (NCT00985465) was conducted in Ouelessebougou, Mali, between November 2009 and July 2010. The study population consisted of PHiD-CV unprimed Malian children previously enrolled in the control group of study NCT00678301 receiving a 2-dose catch-up vaccination with PHiD-CV in the second year of life. Adverse events were recorded following each PHiD-CV dose. Antibody responses and opsonophagocytic activity (OPA) were measured pre-vaccination and after the second PHiD-CV catch-up dose. Swelling and fever (axillary temperature ≥ 37.5°C) were the most frequently reported solicited symptoms following either PHiD-CV dose. Few grade 3 solicited symptoms were reported. Large swelling reactions and serious adverse events were not reported. Post-catch-up vaccination, for each vaccine pneumococcal serotype, at least 94.7% of subjects had antibody concentrations ≥ 0.2 μg/ml, except for serotypes 6B (82.5%) and 23F (87.7%). At least 94.0% of subjects had OPA titres ≥ 8, except for serotype 19F (89.4%). The geometric mean concentration for antibodies against protein D was 839.3 (95% CI: 643.5-1094.6) EL.U/ml. Two-dose PHiD-CV catch-up regimen in the second year of life was well-tolerated and immunogenic for all vaccine pneumococcal serotypes and NTHi protein D when administered to Malian children PMID:26020101

  14. Impact of vitamin D administration on immunogenicity of trivalent inactivated influenza vaccine in previously unvaccinated children.

    PubMed

    Principi, Nicola; Marchisio, Paola; Terranova, Leonardo; Zampiero, Alberto; Baggi, Elena; Daleno, Cristina; Tirelli, Silvia; Pelucchi, Claudio; Esposito, Susanna

    2013-05-01

    As vitamin D (VD) has a significant regulatory effect on innate and adaptive immunity, the aim of this prospective, randomized, single-blinded, placebo-controlled study was to measure the impact of VD administration on the immune response to trivalent influenza vaccination (TIV). A total of 116 children (61 males, 52.6%; mean age 3.0 ± 1.0 y) with a history of recurrent acute otitis media (AOM), who had not been previously vaccinated against influenza, were randomized to receive daily VD 1,000 IU or placebo by mouth for four months. All of them received two doses of TIV (Fluarix, GlaxoSmithKline Biologicals) one month apart, with the first dose administered when VD supplementation was started. There was no difference in seroconversion or seroprotection rates, or antibody titers, in relation to any of the three influenza vaccine antigens between the VD and placebo groups, independently of baseline and post-treatment VD levels. The safety profile was also similar in the two groups. These data indicate that the daily administration of VD 1,000 IU for four months from the time of the injection of the first dose of TIV does not significantly modify the antibody response evoked by influenza vaccine.

  15. Obesity Outweighs Protection Conferred by Adjuvanted Influenza Vaccination

    PubMed Central

    Karlsson, Erik A.; Hertz, Tomer; Johnson, Cydney; Mehle, Andrew; Krammer, Florian

    2016-01-01

    ABSTRACT Obesity is a risk factor for developing severe influenza virus infection, making vaccination of utmost importance for this high-risk population. However, vaccinated obese animals and adults have decreased neutralizing antibody responses. In these studies, we tested the hypothesis that the addition of either alum or a squalene-based adjuvant (AS03) to an influenza vaccine would improve neutralizing antibody responses and protect obese mice from challenge. Our studies demonstrate that adjuvanted vaccine does increase both neutralizing and nonneutralizing antibody levels compared to vaccine alone. Although obese mice mount significantly decreased virus-specific antibody responses, both the breadth and the magnitude of the responses against hemagglutinin (HA) and neuraminidase (NA) are decreased compared to the responses in lean mice. Importantly, even with a greater than fourfold increase in neutralizing antibody levels, obese mice are not protected against influenza virus challenge and viral loads remain elevated in the respiratory tract. Increasing the antigen dose affords no added protection, and a decreasing viral dose did not fully mitigate the increased mortality seen in obese mice. Overall, these studies highlight that, while the use of an adjuvant does improve seroconversion, vaccination does not fully protect obese mice from influenza virus challenge, possibly due to the increased sensitivity of obese animals to infection. Given the continued increase in the global obesity epidemic, our findings have important implications for public health. PMID:27486196

  16. Report on the first WHO integrated meeting on development and clinical trials of influenza vaccines that induce broadly protective and long-lasting immune responses: Hong Kong SAR, China, 24-26 January 2013.

    PubMed

    Girard, Marc P; Tam, John S; Pervikov, Yuri; Katz, Jacqueline M

    2013-08-20

    On January 24-26, 2013, the World Health Organization convened the first integrated meeting on "The development and clinical trials of vaccines that induce broadly protective and long-lasting immune responses" to review the current status of development and clinical evaluation of novel influenza vaccines as well as strategies to produce and deliver vaccines in novel ways. Special attention was given to the development of possible universal influenza vaccines. Other topics that were addressed included an update on clinical trials of pandemic and seasonal influenza vaccines in high-risk groups and vaccine safety, as well as regulatory issues.

  17. Technology transfer of oil-in-water emulsion adjuvant manufacturing for pandemic influenza vaccine production in Romania: Preclinical evaluation of split virion inactivated H5N1 vaccine with adjuvant.

    PubMed

    Stavaru, Crina; Onu, Adrian; Lupulescu, Emilia; Tucureanu, Catalin; Rasid, Orhan; Vlase, Ene; Coman, Cristin; Caras, Iuliana; Ghiorghisor, Alina; Berbecila, Laurentiu; Tofan, Vlad; Bowen, Richard A; Marlenee, Nicole; Hartwig, Airn; Bielefeldt-Ohmann, Helle; Baldwin, Susan L; Van Hoeven, Neal; Vedvick, Thomas S; Huynh, Chuong; O'Hara, Michael K; Noah, Diana L; Fox, Christopher B

    2016-04-01

    Millions of seasonal and pandemic influenza vaccine doses containing oil-in-water emulsion adjuvant have been administered in order to enhance and broaden immune responses and to facilitate antigen sparing. Despite the enactment of a Global Action Plan for Influenza Vaccines and a multi-fold increase in production capabilities over the past 10 years, worldwide capacity for pandemic influenza vaccine production is still limited. In developing countries, where routine influenza vaccination is not fully established, additional measures are needed to ensure adequate supply of pandemic influenza vaccines without dependence on the shipment of aid from other, potentially impacted first-world countries. Adaptation of influenza vaccine and adjuvant technologies by developing country influenza vaccine manufacturers may enable antigen sparing and corresponding increases in global influenza vaccine coverage capacity. Following on previously described work involving the technology transfer of oil-in-water emulsion adjuvant manufacturing to a Romanian vaccine manufacturing institute, we herein describe the preclinical evaluation of inactivated split virion H5N1 influenza vaccine with emulsion adjuvant, including immunogenicity, protection from virus challenge, antigen sparing capacity, and safety. In parallel with the evaluation of the bioactivity of the tech-transferred adjuvant, we also describe the impact of concurrent antigen manufacturing optimization activities. Depending on the vaccine antigen source and manufacturing process, inclusion of adjuvant was shown to enhance and broaden functional antibody titers in mouse and rabbit models, promote protection from homologous virus challenge in ferrets, and facilitate antigen sparing. Besides scientific findings, the operational lessons learned are delineated in order to facilitate adaptation of adjuvant technologies by other developing country institutes to enhance global pandemic influenza preparedness.

  18. Virus-like particles as universal influenza vaccines.

    PubMed

    Kang, Sang-Moo; Kim, Min-Chul; Compans, Richard W

    2012-08-01

    Current influenza vaccines are primarily targeted to induce immunity to the influenza virus strain-specific hemagglutinin antigen and are not effective in controlling outbreaks of new pandemic viruses. An approach for developing universal vaccines is to present highly conserved antigenic epitopes in an immunogenic conformation such as virus-like particles (VLPs) together with an adjuvant to enhance the vaccine immunogenicity. In this review, the authors focus on conserved antigenic targets and molecular adjuvants that were presented in VLPs. Conserved antigenic targets that include the hemagglutinin stalk domain, the external domain of influenza M2 and neuraminidase are discussed in addition to molecular adjuvants that are engineered to be incorporated into VLPs in a membrane-anchored form. PMID:23002980

  19. Practical aspects of vaccination of poultry against avian influenza virus.

    PubMed

    Spackman, Erica; Pantin-Jackwood, Mary J

    2014-12-01

    Although little has changed in vaccine technology for avian influenza virus (AIV) in the past 20 years, the approach to vaccination of poultry (chickens, turkeys and ducks) for avian influenza has evolved as highly pathogenic AIV has become endemic in several regions of the world. Vaccination for low pathogenicity AIV is also becoming routine in regions where there is a high level of field challenge. In contrast, some countries will not use vaccination at all and some will only use it on an emergency basis during eradication efforts (i.e. stamping-out). There are pros and cons to each approach and, since every outbreak situation is different, no one method will work equally well in all situations. Numerous practical aspects must be considered when developing an AIV control program with vaccination as a component, such as: (1) the goals of vaccination must be defined; (2) the population to be vaccinated must be clearly identified; (3) there must be a plan to obtain and administer good quality vaccine in a timely manner and to achieve adequate coverage with the available resources; (4) risk factors for vaccine failure should be mitigated as much as possible; and, most importantly, (5) biosecurity must be maintained as much as possible, if not enhanced, during the vaccination period.

  20. Conflicts of interest in vaccine safety research.

    PubMed

    DeLong, Gayle

    2012-01-01

    Conflicts of interest (COIs) cloud vaccine safety research. Sponsors of research have competing interests that may impede the objective study of vaccine side effects. Vaccine manufacturers, health officials, and medical journals may have financial and bureaucratic reasons for not wanting to acknowledge the risks of vaccines. Conversely, some advocacy groups may have legislative and financial reasons to sponsor research that finds risks in vaccines. Using the vaccine-autism debate as an illustration, this article details the conflicts of interest each of these groups faces, outlines the current state of vaccine safety research, and suggests remedies to address COIs. Minimizing COIs in vaccine safety research could reduce research bias and restore greater trust in the vaccine program. PMID:22375842

  1. The Saudi Thoracic Society guidelines for influenza vaccinations

    PubMed Central

    Zeitouni, Mohammed O.; Al Barrak, Ali M.; Al-Moamary, Mohamed S.; Alharbi, Nasser S.; Idrees, Majdy M.; Al Shimemeri, Abdullah A.; Al-Hajjaj, Mohamed S.

    2015-01-01

    Influenza viruses are responsible for the influenza outbreaks that lead to significant burden and cause significant morbidity and mortality worldwide. Based on the core proteins, influenza viruses are classified into three types, A, B, and C, of which only A and B cause significant human disease and so the vaccine is directed against these two subtypes only. The effectiveness of the vaccine depends on boosting the immune system against the serotypes included within it. As influenza viruses undergo periodic changes in their antigen, the vaccine is modified annually to ensure susceptibility. In contrast to other countries, Saudi Arabia faces a unique and challenging situation due to Hajj and Umrah seasons, when millions of people gather at the holy places in Mecca and Madinah, during which influenza outbreaks are commonly found. Such challenges making the adoption of strict vaccination strategy in Saudi Arabia is of great importance. All efforts were made to develop this guideline in an easy-to-read form, making it very handy and easy to use by health care workers. The guideline was designed to provide recommendations for problems frequently encountered in real life, with special consideration for special situations such as Hajj and Umrah seasons and pregnancy. PMID:26664559

  2. The Association between Influenza Vaccination and Other Preventative Health Behaviors in a Cohort of Pregnant Women

    ERIC Educational Resources Information Center

    Scheminske, Megan; Henninger, Michelle; Irving, Stephanie A.; Thompson, Mark; Williams, Jenny; Shifflett, Pat; Ball, Sarah W.; Avalos, Lyndsay Ammon; Naleway, Allison L.

    2015-01-01

    Objectives: Although pregnant women are a high-priority group for seasonal influenza vaccination, vaccination rates in this population remain below target levels. Previous studies have identified sociodemographic predictors of vaccine choice, but relationships between preconception heath behaviors and seasonal influenza vaccination are poorly…

  3. Global use of Haemophilus influenzae type b conjugate vaccine.

    PubMed

    Ojo, Linda R; O'Loughlin, Rosalyn E; Cohen, Adam L; Loo, Jennifer D; Edmond, Karen M; Shetty, Sharmila S; Bear, Allyson P; Privor-Dumm, Lois; Griffiths, Ulla K; Hajjeh, Rana

    2010-10-01

    Haemophilus influenzae type b (Hib) conjugate vaccines have been underutilized globally. We report progress in global use of Hib vaccines included in national immunization schedules. The number of countries using Hib vaccine increased from 89/193 (46%) in 2004 to 158/193 (82%) by the end of 2009. The increase was greatest among low-income countries eligible for financial support from the GAVI Alliance [13/75 (17%) in 2004, 60/72 (83%) by the end of 2009], and can be attributed to various factors. Additional efforts are still needed to increase vaccine adoption in lower middle income countries [20/31 (65%) by the end of 2009].

  4. Pityriasis lichenoides et varioliformis acuta after influenza vaccine*

    PubMed Central

    de Castro, Breno Augusto Campos; Pereira, Juliana Milagres Macedo; Meyer, Renata Leal Bregunci; Trindade, Fernanda Marques; Pedrosa, Moises Salgado; Piancastelli, André Costa Cruz

    2015-01-01

    The etiology of pityriasis lichenoides is unknown. One of the accepted theories admits that PL is an inflammatory response to extrinsic antigens such as infectious agents, drugs and vaccines. In recent medical literature, only the MMR vaccine (Measles, Mumps and Rubella) was associated with the occurrence of this disease. We present a case of a male, 12 year old healthy patient who, five days after Infl uenza vaccination, developed erythematous papules on the trunk, abdomen and limbs, some with adherent crusts and associated systemic symptoms. This case report is notable for describing the first case of pityriasis lichenoides et varioliformis acuta associated with the vaccine against Influenza. PMID:26312710

  5. Using physician billing claims from the Ontario Health Insurance Plan to determine individual influenza vaccination status: an updated validation study

    PubMed Central

    Schwartz, Kevin L.; Jembere, Nathaniel; Campitelli, Michael A.; Buchan, Sarah A.; Chung, Hannah; Kwong, Jeffrey C.

    2016-01-01

    Background: Owing to the absence of a vaccination registry in Ontario, administrative data are currently the best available source to determine population-based individual-level influenza vaccination status. Our objective was to validate physician billing claims for influenza vaccination in the Ontario Health Insurance Plan database against the Canadian Community Health Survey. Methods: We used self-reported seasonal influenza vaccination status of Ontario residents surveyed between 2007 and 2009 as the reference standard. The survey responses were linked to physician claims database records to validate billing codes for influenza vaccination. We calculated sensitivity, specificity, positive predictive value and negative predictive value with 95% confidence intervals (CIs). We stratified the data by several covariates and comorbidities to determine stratum-specific performance characteristics. We used these estimates to adjust an estimate of influenza vaccine effectiveness for the 2010/11 influenza season. Results: For the 47 301 patients included in the analysis, the sensitivity for the billing codes was 49.8% (95% CI 49.0%-50.5%), specificity was 95.7% (95% CI 95.5%-96.0%), positive predictive value was 88.4% (95% CI 87.8%-89.0%) and negative predictive value was 74.5% (95% CI 74.0%-74.9%). Performance measures were optimized in patients aged 65 years and older, particularly those with comorbidities. Interpretation: Although administrative data have limitations for determining influenza vaccination status, owing to the high positive predictive value, they are well suited for self-controlled study designs that are often used to assess vaccine safety. For studies of coverage and effectiveness, restricting the cohort to patients aged 65 years and older will minimize misclassification bias. Performance characteristics from this study can be used to mitigate misclassification bias. PMID:27730110

  6. Development of Cross-Protective Influenza A Vaccines Based on Cellular Responses

    PubMed Central

    Soema, Peter Christiaan; van Riet, Elly; Kersten, Gideon; Amorij, Jean-Pierre

    2015-01-01

    Seasonal influenza vaccines provide protection against matching influenza A virus (IAV) strains mainly through the induction of neutralizing serum IgG antibodies. However, these antibodies fail to confer a protective effect against mismatched IAV. This lack of efficacy against heterologous influenza strains has spurred the vaccine development community to look for other influenza vaccine concepts, which have the ability to elicit cross-protective immune responses. One of the concepts that is currently been worked on is that of influenza vaccines inducing influenza-specific T cell responses. T cells are able to lyse infected host cells, thereby clearing the virus. More interestingly, these T cells can recognize highly conserved epitopes of internal influenza proteins, making cellular responses less vulnerable to antigenic variability. T cells are therefore cross-reactive against many influenza strains, and thus are a promising concept for future influenza vaccines. Despite their potential, there are currently no T cell-based IAV vaccines on the market. Selection of the proper antigen, appropriate vaccine formulation and evaluation of the efficacy of T cell vaccines remains challenging, both in preclinical and clinical settings. In this review, we will discuss the current developments in influenza T cell vaccines, focusing on existing protein-based and novel peptide-based vaccine formulations. Furthermore, we will discuss the feasibility of influenza T cell vaccines and their possible use in the future. PMID:26029218

  7. An overview of the regulation of influenza vaccines in the United States.

    PubMed

    Weir, Jerry P; Gruber, Marion F

    2016-09-01

    Influenza virus vaccines are unique among currently licensed viral vaccines. The vaccines designed to protect against seasonal influenza illness must be updated periodically in an effort to match the vaccine strain with currently circulating viruses, and the vaccine manufacturing timeline includes multiple, overlapping processes with a very limited amount of flexibility. In the United States (U.S.), over 150 million doses of seasonal trivalent and quadrivalent vaccine are produced annually, a mammoth effort, particularly in the context of a vaccine with components that usually change on a yearly basis. In addition, emergence of an influenza virus containing an HA subtype that has not recently circulated in humans is an ever present possibility. Recently, pandemic influenza vaccines have been licensed, and the pathways for licensure of pandemic vaccines and subsequent strain updating have been defined. Thus, there are formidable challenges for the regulation of currently licensed influenza vaccines, as well as for the regulation of influenza vaccines under development. This review describes the process of licensing influenza vaccines in the U.S., the process and steps involved in the annual updating of seasonal influenza vaccines, and some recent experiences and regulatory challenges faced in development and evaluation of novel influenza vaccines. PMID:27426005

  8. An overview of the regulation of influenza vaccines in the United States.

    PubMed

    Weir, Jerry P; Gruber, Marion F

    2016-09-01

    Influenza virus vaccines are unique among currently licensed viral vaccines. The vaccines designed to protect against seasonal influenza illness must be updated periodically in an effort to match the vaccine strain with currently circulating viruses, and the vaccine manufacturing timeline includes multiple, overlapping processes with a very limited amount of flexibility. In the United States (U.S.), over 150 million doses of seasonal trivalent and quadrivalent vaccine are produced annually, a mammoth effort, particularly in the context of a vaccine with components that usually change on a yearly basis. In addition, emergence of an influenza virus containing an HA subtype that has not recently circulated in humans is an ever present possibility. Recently, pandemic influenza vaccines have been licensed, and the pathways for licensure of pandemic vaccines and subsequent strain updating have been defined. Thus, there are formidable challenges for the regulation of currently licensed influenza vaccines, as well as for the regulation of influenza vaccines under development. This review describes the process of licensing influenza vaccines in the U.S., the process and steps involved in the annual updating of seasonal influenza vaccines, and some recent experiences and regulatory challenges faced in development and evaluation of novel influenza vaccines.

  9. National seasonal influenza vaccination survey in Europe, 2008.

    PubMed

    Mereckiene, J; Cotter, S; Nicoll, A; Levy-Bruhl, D; Ferro, A; Tridente, G; Zanoni, G; Berra, P; Salmaso, S; O'Flanagan, D; O Flanagan, D

    2008-10-23

    A cross-sectional survey was undertaken with the European Union (EU) Member States and Norway and Iceland to describe seasonal influenza immunisation in the 2006-7 season, in particular to identify country-specific recommendations for risk groups, obtain vaccine uptake information and allow comparison with global recommendations. A standardised questionnaire was completed electronically by each country's project gatekeeper. Of the 29 countries surveyed, 28 recommended seasonal influenza vaccination for older age groups (22 for those aged > 65 years), and in one country vaccine was recommended for all age groups. All countries recommended vaccinating patients with chronic pulmonary and cardiovascular diseases and most countries advised to immunise patients with haematologic or metabolic disorders (n=28), immunologic disorders (n=27) and renal disease (n=27), as well as residents of long-term care facilities (n=24). Most countries recommended vaccination for staff in hospitals (n=25), long-term care facilities (n=25) and outpatient clinics (n=23), and one-third had such recommendations for workers in essential (n=10), military (n=10) and veterinary services (n=10) and poultry industry (n=13). Eight countries recommended vaccine for pregnant women; and five advised to vaccinate children (with age limits ranging from 6 months to 5 years). Twenty countries measured influenza vaccine uptake among those aged > 65 years (range 1.8%-82.1%), seven reported uptake in healthcare workers (range 14%-48%) and seven assessed coverage in persons with underlying medical conditions (range 27.6%-75.2%). The data provided by this study can assist EU states to assess and compare their influenza vaccination programme performance with other countries. The information provides a comprehensive overview of policies and programmes and their outcomes and can be used to inform joint discussions on how the national policies in the EU might be standardised in the future to achieve optimal

  10. Plasmacytoid dendritic cells delineate immunogenicity of influenza vaccine subtypes.

    PubMed

    Koyama, Shohei; Aoshi, Taiki; Tanimoto, Takeshi; Kumagai, Yutaro; Kobiyama, Kouji; Tougan, Takahiro; Sakurai, Kazuo; Coban, Cevayir; Horii, Toshihiro; Akira, Shizuo; Ishii, Ken J

    2010-03-31

    A variety of different vaccine types are available for H1N1 influenza A virus infections; however, their immunological mechanisms of action remain unclear. Here, we show that plasmacytoid dendritic cells (pDCs) and type I interferon (IFN)-mediated signaling delineate the immunogenicity of live attenuated virus, inactivated whole-virus (WV), and split-virus vaccines. Although Toll-like receptor 7 acted as the adjuvant receptor for the immunogenicity of both live virus and WV vaccines, the requirement for type I IFN production by pDCs for the immunogenicity of the vaccines was restricted to WV. A split vaccine commonly used in humans failed to immunize naïve mice, but a pDC-activating adjuvant could restore immunogenicity. In blood from human adults, however, split vaccine alone could recall memory T cell responses, underscoring the importance of this adjuvant pathway for primary, but not secondary, vaccination. PMID:20424013

  11. Considerations of strategies to provide influenza vaccine year round.

    PubMed

    Lambach, Philipp; Alvarez, Alba Maria Ropero; Hirve, Siddhivinayak; Ortiz, Justin R; Hombach, Joachim; Verweij, Marcel; Hendriks, Jan; Palkonyay, Laszlo; Pfleiderer, Michael

    2015-11-25

    There is potential for influenza vaccine programmes to make a substantial impact on severe disease in low-resource settings, however questions around vaccine composition and programmatic issues will require special attention. Some countries may benefit from immunization programmes that provide year-round supply of vaccine; however the best way to ensure adequate vaccine supply has yet to be determined. In this report, we discuss vaccine composition, availability, and programmatic issues that must be considered when developing year-round influenza immunization programmes. We then explore how these considerations have influenced immunization practices in the Latin American region as a case study. We identify three different approaches to achieve year-round supply: (1) alternating between Northern Hemisphere and Southern Hemisphere formulations, (2) extending the expiration date to permit extended use of a single hemisphere formulation, and (3) local vaccine manufacture with production timelines that align with local epidemiology. Each approach has its challenges and opportunities. The growing data suggesting high influenza disease burden in low resource countries underscores the compelling public health need to determine the best strategies for vaccine delivery.

  12. Cost-effectiveness analysis of universal influenza vaccination with quadrivalent inactivated vaccine in the United States

    PubMed Central

    Clements, Karen M; Meier, Genevieve; McGarry, Lisa J; Pruttivarasin, Narin; Misurski, Derek A

    2014-01-01

    To address influenza B lineage mismatch and co-circulation, several quadrivalent inactivated influenza vaccines (IIV4s) containing two type A strains and both type B lineages have recently been approved in the United States. Currently available trivalent inactivated vaccines (IIV3s) or trivalent live attenuated influenza vaccines (LAIV3s) comprise two influenza A strains and one of the two influenza B lineages that have co-circulated in the United States since 2001. The objective of this analysis was to evaluate the cost-effectiveness of a policy of universal vaccination with IIV4 vs. IIV3/LAIV3 during 1 year in the United States. On average per influenza season, IIV4 was predicted to result in 30 251 fewer influenza cases, 3512 fewer hospitalizations, 722 fewer deaths, 4812 fewer life-years lost, and 3596 fewer quality-adjusted life-years (QALYs) lost vs. IIV3/LAIV3. Using the Fluarix QuadrivalentTM (GlaxoSmithKline) prices and the weighted average IIV3/LAIV3 prices, the model predicts that the vaccination program costs would increase by $452.2 million, while direct medical and indirect costs would decrease by $111.6 million and $218.7 million, respectively, with IIV4. The incremental cost-effectiveness ratio (ICER) comparing IIV4 to IIV3/LAIV3 is predicted to be $90 301/QALY gained. Deterministic sensitivity analyses found that influenza B vaccine-matched and mismatched efficacies among adults aged ≥65 years had the greatest impact on the ICER. Probabilistic sensitivity analysis showed that the cost per QALY remained below $100 000 for 61% of iterations. In conclusion, vaccination with IIV4 in the US is predicted to reduce morbidity and mortality. This strategy is also predicted to be cost-effective vs. IIV3/LAIV3 at conventional willingness-to-pay thresholds. PMID:24609063

  13. Influenza vaccination in the Americas: Progress and challenges after the 2009 A(H1N1) influenza pandemic

    PubMed Central

    Ropero-Álvarez, Alba María; El Omeiri, Nathalie; Kurtis, Hannah Jane; Danovaro-Holliday, M. Carolina; Ruiz-Matus, Cuauhtémoc

    2016-01-01

    ABSTRACT Background: There has been considerable uptake of seasonal influenza vaccines in the Americas compared to other regions. We describe the current influenza vaccination target groups, recent progress in vaccine uptake and in generating evidence on influenza seasonality and vaccine effectiveness for immunization programs. We also discuss persistent challenges, 5 years after the A(H1N1) 2009 influenza pandemic. Methods: We compiled and summarized data annually reported by countries to the Pan American Health Organization/World Health Organization (PAHO/WHO) through the WHO/UNICEF joint report form on immunization, information obtained through PAHO's Revolving Fund for Vaccine Procurement and communications with managers of national Expanded Programs on Immunization (EPI). Results: Since 2008, 25 countries/territories in the Americas have introduced new target groups for vaccination or expanded the age ranges of existing target groups. As of 2014, 40 (89%) out of 45 countries/territories have policies established for seasonal influenza vaccination. Currently, 29 (64%) countries/territories target pregnant women for vaccination, the highest priority group according to WHO´s Stategic Advisory Group of Experts and PAHO/WHO's Technical Advisory Group on Vaccine-preventable Diseases, compared to only 7 (16%) in 2008. Among 23 countries reporting coverage data, on average, 75% of adults ≥60 years, 45% of children aged 6–23 months, 32% of children aged 5–2 years, 59% of pregnant women, 78% of healthcare workers, and 90% of individuals with chronic conditions were vaccinated during the 2013–14 Northern Hemisphere or 2014 Southern Hemisphere influenza vaccination activities. Difficulties however persist in the estimation of vaccination coverage, especially for pregnant women and persons with chronic conditions. Since 2007, 6 tropical countries have changed their vaccine formulation from the Northern to the Southern Hemisphere formulation and the timing of

  14. A fast track influenza virus vaccine produced in insect cells.

    PubMed

    Cox, Manon M J; Hashimoto, Yoshifumi

    2011-07-01

    The viral surface protein hemagglutinin (HA) has been recognized as a key antigen in the host response to influenza virus in both natural infection and vaccination because neutralizing antibodies directed against HA can mitigate or prevent infection. The baculovirus-insect cell system can be used for the production of recombinant HA molecules and is suitable for influenza vaccine production where annual adjustment of the vaccine is required. This expression system is generally considered safe with minimal potential for growth of human pathogens. Extensive characterization of this novel cell substrate has been performed, none of which has revealed the presence of adventitious agents. Multiple clinical studies have demonstrated that the vaccine is safe, well-tolerated and immunogenic. The baculovirus-insect cell system could, therefore, be used for the expedited production of a safe and efficacious influenza vaccine. As a result, this technology should provide a fast track worldwide solution for newly emerging influenza strains or pandemic preparedness within a few years. PMID:21784229

  15. Feasibility and Patient Acceptance of Emergency Department-Based Influenza Vaccination in a Military Medical Center.

    PubMed

    Hilger, Keren Arkin; Hilger, James R; Putnam, Shannon D; Carstairs, Shaun D; Maves, Ryan C

    2016-08-01

    Influenza vaccination rates in the United States remain low. Many emergency department (ED) patients may not routinely seek care elsewhere. In a survey of ED visitors, 36.8% of unvaccinated respondents were willing to consider influenza vaccination during their visit. Participants at high risk for influenza complications were more likely to have been previously vaccinated, but unvaccinated participants at high risk were not significantly more likely to consider ED-based vaccination compared with other participants. ED-based influenza vaccination may be an effective method to expand vaccine coverage. PMID:27483528

  16. Developing Universal Influenza Vaccines: Hitting the Nail, Not Just on the Head.

    PubMed

    Wiersma, Lidewij C M; Rimmelzwaan, Guus F; de Vries, Rory D

    2015-01-01

    Influenza viruses have a huge impact on public health. Current influenza vaccines need to be updated annually and protect poorly against antigenic drift variants or novel emerging subtypes. Vaccination against influenza can be improved in two important ways, either by inducing more broadly protective immune responses or by decreasing the time of vaccine production, which is relevant especially during a pandemic outbreak. In this review, we outline the current efforts to develop so-called "universal influenza vaccines", describing antigens that may induce broadly protective immunity and novel vaccine production platforms that facilitate timely availability of vaccines. PMID:26343187

  17. [Influenza, tetanus, and pertussis vaccination coverage among adults in Germany].

    PubMed

    Bödeker, Birte; Remschmidt, C; Müters, S; Wichmann, O

    2015-02-01

    In order to be adequately protected throughout life and to protect specific risk groups from particular diseases, regular booster or specific indicator vaccinations are also recommended during adulthood. Adults should be vaccinated against seasonal influenza (annually, e.g., persons with underlying chronic diseases and persons aged ≥ 60 years), tetanus (every 10 years), and pertussis (as a one-time vaccination with the next due tetanus vaccine and, e.g., when people have close contact to newborn babies). The aim of this study was to provide an overview of the current status of vaccination uptake among adults living in Germany, focusing on these three vaccines. In line with nationwide continuous health monitoring, the Robert Koch Institute conducted the representative study "German Health Update" (GEDA 2012) between 2012 and 2013. The survey is conducted regularly and adults are asked questions relating to their vaccination status through computer-assisted telephone interviews. Overall, 19,294 interviews were held. In 2010/2011 and 2011/2012, seasonal influenza uptake among persons aged ≥ 60 years was 54.3 and 52.6 % and among individuals with underlying chronic diseases 46.2 and 42.9 %. 7.6 and 75.6 % of participants reported up-to-date pertussis and tetanus vaccination, respectively. 22 % of people living with a baby in one household were vaccinated against pertussis. In general, vaccination rates against seasonal influenza, pertussis, and tetanus among adults are still low, but differ depending on the specific vaccination. The required aim of the European Commission to reach influenza vaccination coverage by the 2014/2015 winter season of 75 % of higher age groups has not yet been reached. The low pertussis vaccination coverage among persons in close household contact to infants poses a big challenge to the implementation of the cocooning strategy to protect the very vulnerable newborns. To emphasize the importance of a complete vaccination

  18. Does Influenza Vaccination Modify Influenza Severity? Data on Older Adults Hospitalized With Influenza During the 2012−2013 Season in the United States

    PubMed Central

    Arriola, Carmen S.; Anderson, Evan J.; Baumbach, Joan; Bennett, Nancy; Bohm, Susan; Hill, Mary; Lindegren, Mary Lou; Lung, Krista; Meek, James; Mermel, Elizabeth; Miller, Lisa; Monroe, Maya L.; Morin, Craig; Oni, Oluwakemi; Reingold, Arthur; Schaffner, William; Thomas, Ann; Zansky, Shelley M.; Finelli, Lyn; Chaves, Sandra S.

    2015-01-01

    Background. Some studies suggest that influenza vaccination might be protective against severe influenza outcomes in vaccinated persons who become infected. We used data from a large surveillance network to further investigate the effect of influenza vaccination on influenza severity in adults aged ≥50 years who were hospitalized with laboratory-confirmed influenza. Methods. We analyzed influenza vaccination and influenza severity using Influenza Hospitalization Surveillance Network (FluSurv-NET) data for the 2012−2013 influenza season. Intensive care unit (ICU) admission, death, diagnosis of pneumonia, and hospital and ICU lengths of stay served as measures of disease severity. Data were analyzed by multivariable logistic regression, parametric survival models, and propensity score matching (PSM). Results. Overall, no differences in severity were observed in the multivariable logistic regression model. Using PSM, adults aged 50−64 years (but not other age groups) who were vaccinated against influenza had a shorter length of ICU stay than those who were unvaccinated (hazard ratio for discharge, 1.84; 95% confidence interval, 1.12−3.01). Conclusions. Our findings show a modest effect of influenza vaccination on disease severity. Analysis of data from seasons with different predominant strains and higher estimates of vaccine effectiveness are needed. PMID:25821227

  19. Hepatitis B and influenza vaccines: important occupational vaccines differently perceived among medical students.

    PubMed

    Wicker, Sabine; Rabenau, Holger F; von Gierke, Laura; François, Guido; Hambach, Ramona; De Schryver, Antoon

    2013-10-17

    Healthcare personnel (HCP) are at risk from occupational exposure to airborne and bloodborne pathogens, and the risk of infection among HCP is greater than among the general population. The aim of the study was to characterize attitudes toward occupational recommended vaccines as well as the perception of risks of occupationally acquired infections. We surveyed 650 medical students to assess their perception of influenza and hepatitis B and their opinions and beliefs about influenza and hepatitis B vaccines. We found differences between pre-clinical and clinical students regarding the uptake of influenza and hepatitis B vaccines, about the chances of being occupationally infected with influenza or hepatitis B, and about the likelihood of suffering from severe side-effects following immunization. Interestingly, the risk perception varied drastically between the two vaccine-preventable diseases hepatitis B and influenza. Medical students rated the probability of contracting hepatitis B due to a work-related exposure and the severity of disease significantly higher than for influenza, and this may be an explanation for the greater acceptance of the hepatitis B vaccine. Furthermore, our findings suggest that medical students are frequently inaccurate in assessing their own risk level, and their specific knowledge about both diseases and the severity of these diseases proved to be unsatisfactory.

  20. The role of vaccines and vaccination in avian influenza control and eradication

    Technology Transfer Automated Retrieval System (TEKTRAN)

    A comprehensive review of avian influenza (AI) control methods has been completed. From 2002-2010, over 113 billion doses of AI vaccine were used in poultry in 15 countries. The majority of vaccine (over 90%) was used in China while significant amounts were used in Egypt, Indonesia, and Vietnam. ...

  1. INFLUENZA VACCINATION UPTAKE AMONG HEALTHCARE WORKERS AT A MALAYSIAN TEACHING HOSPITAL.

    PubMed

    Rashid, Zetti Zainol; Jasme, Humaira; Liang, Ho Jing; Yusof, Mardiyah Mohd; Sharani, Zatil Zahidah Mohd; Mohamad, Marlyn; Ismail, Zalina; Sulong, Anita; Jalil, Nordiah Awang

    2015-03-01

    Annual influenza vaccination is the most important preventive strategy against influenza illness in healthcare workers (HCWs), who could acquire influenza from and transmit influenza to patients and other HCWs. Despite the well established benefits and strong recommendations for influenza vaccination for all HCWs, influenza vaccination uptake at the Universiti Kebangsaan Malaysia Medical Centre (UKMMC) for the past 3 years has been low and is decreasing. We aimed to determine the factors associated with influenza vaccination uptake among HCWs at UKMMC. We conducted a cross sectional study via questionnaire among 211 randomly selected HCWs, consisting of 106 HCWs who were vaccinated in 2011 and 105 HCWs who were not vaccinated in 2010 or 2011. We had a 100% response rate. Influenza vaccination uptake was significantly associated with age and previous vaccination history, with older HCWs being more likely to be vaccinated (adjusted OR = 12.494; 95% CI:6.278-24.863; p < 0.001) and HCWs with previous vaccination history being more likely to be vaccinated (adjusted OR = 1.038; 95% CI:1.001-1.077; p = 0.045). Influenza vaccination uptake was not associated with gender (p = 0.926) or job category (p = 0.220). Publicity at the workplace was the main source of information about the vaccine (51.2% of respondents), followed by colleagues (29.9%). Despite the low uptake, 85.3% of respondents believed influenza vaccination was important for disease prevention. The most common reason given for vaccination was protection against influenza infection (73.6%). The most common reason for not having the vaccine was time constraints (56.2%). An evidenced-based strategy needs to be developed to improve vaccine uptake or having mandatory vaccination.

  2. Epidemiological study of influenza B in Shanghai during the 2009-2014 seasons: implications for influenza vaccination strategy.

    PubMed

    Zhao, B; Qin, S; Teng, Z; Chen, J; Yu, X; Gao, Y; Shen, J; Cui, X; Zeng, M; Zhang, X

    2015-07-01

    A new quadrivalent influenza vaccine has been available for influenza B, which can pose a significant global health burden. Shanghai has the highest GDP and largest metropolitan population in China. To understand the impact of influenza B in Shanghai in terms of age-related incidence and relative prevalence compared with other subtypes, we conducted this retrospective epidemiological study of influenza B in the 2009-2014 seasons. A total of 71 354 outpatients with influenza-like illness were included, and both lineages of influenza B and subtypes of influenza A were identified using real-time RT-PCR. The antigenic characteristics of influenza B isolates were analysed by sequencing and reciprocal haemagglutinin inhibition assay. On average, 33.45% of influenza strains were influenza B, and 40.20% of strains isolated from children were influenza B. The incidence of influenza B was highest (12.52 per 100 people with influenza-like illness) in children ages 6-17 years and usually peaked in this age group at the early stage of an influenza B epidemic. Overall, both matched and mismatched influenza B strains co-circulated in Shanghai annually, and 44.57% of the circulating influenza B belonged to the opposite lineage of the vaccine strains. We concluded that influenza B has caused a substantial impact in Shanghai and that school-aged children play a key role in the transmission of influenza B. Hence, it may be beneficial to prioritize influenza vaccination for school-aged children to mitigate the outbreaks of influenza B.

  3. [Attitudes and side effects related to pandemic influenza A (H1N1) vaccination in healthcare personnel].

    PubMed

    Ormen, Bahar; Türker, Nesrin; Vardar, Ilknur; Kaptan, Figen; El, Sibel; Ural, Serap; Kaya, Fatih; Coşkun, Nejat Ali

    2012-01-01

    The aims of this study were to evaluate the attitudes towards H1N1 vaccination and to determine the safety and side effects following 2009 pandemic influenza A (H1N1) vaccination. Pandemic influenza vaccine had been administered to the healthcare personnel in our research and training hospital in December 2009. The rate being vaccinated was established as 40% (800/2000). Four months following vaccination, the opinions about vaccination were asked to the healthcare workers, and also side effects were questioned to the vaccinated group. Two different questionnaires (for vaccinated and unvaccinated subjects) were delivered to the volunteers who agreed to participate in the study. Demographic features, reasons related to being vaccinated or not, were questioned. The vaccinated group was also questioned for the presence of chronic diseases, previous vaccinations (pandemic/seasonal influenza), local or systemic reactions that develop after vaccination. A total of 332 volunteers participated in the questionnaire. Of them 247 (74.4%) were vaccinated and 85 (25.6%) were unvaccinated. Male/female ratio of the participants was 1.2, and 55.7% of them were older than 30-year-old. Most of the participants (82.8%) were highly educated (high school and faculty-graduated). Vaccination rates were found statistically significant in advanced age group compared to young adults (p= 0.042); in male gender compared to females (p= 0.001) and in parents compared to subjects who didn't have children (p= 0.021). Vaccination rates were observed to be higher (57.5%) in non-medical staff (cleaning employers, administrative personnel, etc.) than the physicians (29.1%) and nurses (13.4%), and the rate was also high (54.7%) in personnel who worked in intensive care units, emergency department and administrative units than the personnel who worked in the clinics of internal medicine (22.3%) and surgery (23.1%) (p= 0.001). The most important causes of rejecting vaccination were being afraid of the

  4. Influenza vaccination: from epidemiological aspects and advances in research to dissent and vaccination policies.

    PubMed

    Gasparini, R; Amicizia, D; Lai, P L; Panatto, D

    2016-01-01

    Influenza is a serious public health problem, since seasonal epidemics affect approximately 5-10% of the population and thus give rise to a heavy social and healthcare burden. The heavy burden of disease is due to several factors, one of which is the biological features of the pathogen. Indeed influenza viruses display high mutation rates and undergo frequent genetic reassortment. Minor variations cause seasonal epidemics and major variations, which result from the hybridization of viruses typical of different animal species, can lead to pandemics. Vaccination remains the most efficacious means of mitigating the harmful healthcare and social effects of influenza. Influenza vaccines have evolved over time in order to offer broader protection against circulating strains. Trivalent vaccines containing two A viruses and one B virus are currently available. However, given the co-circulation of both B virus lineages (B/Yamagata and B/Victoria), quadrivalent vaccines have recently been developed. The new quadrivalent vaccines constitute a great advance, in that they can offer broader strain coverage. Despite the availability of effective and safe influenza vaccines, the Italian public's trust in vaccination has declined and, in the last few years, influenza vaccination coverage rates have decreased both among the elderly and among at-risk adults. It is therefore necessary that users, in their own interests, regain trust in this important means of disease prevention. In order to mitigate the damage wreaked by influenza, it seems important to: (i) improve clinical-epidemiological and virological surveillance of the disease; (ii) promote the development of new efficacious vaccines, as has recently been done through the introduction of the quadrivalent vaccine; (iii) extend free vaccination to the entire population, as in the US and Canada; (iv) ensure that general healthcare professionals are properly informed and always updated with regard to vaccination; (v) promote public

  5. Influenza vaccination: from epidemiological aspects and advances in research to dissent and vaccination policies.

    PubMed

    Gasparini, R; Amicizia, D; Lai, P L; Panatto, D

    2016-01-01

    Influenza is a serious public health problem, since seasonal epidemics affect approximately 5-10% of the population and thus give rise to a heavy social and healthcare burden. The heavy burden of disease is due to several factors, one of which is the biological features of the pathogen. Indeed influenza viruses display high mutation rates and undergo frequent genetic reassortment. Minor variations cause seasonal epidemics and major variations, which result from the hybridization of viruses typical of different animal species, can lead to pandemics. Vaccination remains the most efficacious means of mitigating the harmful healthcare and social effects of influenza. Influenza vaccines have evolved over time in order to offer broader protection against circulating strains. Trivalent vaccines containing two A viruses and one B virus are currently available. However, given the co-circulation of both B virus lineages (B/Yamagata and B/Victoria), quadrivalent vaccines have recently been developed. The new quadrivalent vaccines constitute a great advance, in that they can offer broader strain coverage. Despite the availability of effective and safe influenza vaccines, the Italian public's trust in vaccination has declined and, in the last few years, influenza vaccination coverage rates have decreased both among the elderly and among at-risk adults. It is therefore necessary that users, in their own interests, regain trust in this important means of disease prevention. In order to mitigate the damage wreaked by influenza, it seems important to: (i) improve clinical-epidemiological and virological surveillance of the disease; (ii) promote the development of new efficacious vaccines, as has recently been done through the introduction of the quadrivalent vaccine; (iii) extend free vaccination to the entire population, as in the US and Canada; (iv) ensure that general healthcare professionals are properly informed and always updated with regard to vaccination; (v) promote public

  6. A policy to promote influenza vaccination: a behavioral economic approach.

    PubMed

    Tsutsui, Yoshiro; Benzion, Uri; Shahrabani, Shosh; Din, Gregory Yom

    2010-10-01

    The aims of this study were to identify the predictors of people's willingness to be vaccinated against influenza and to determine how to improve the inoculation rate. The study was based upon the results of our original large-scale survey conducted in the USA in 2005. A model of bounded rationality can explain vaccination behavior fairly well: (a) people evaluate the costs and benefits of vaccination by applying risk aversion and time preference; (b) the 'status quo bias' of those who were vaccinated in the past affects their decision to be vaccinated in the future; and (c) overconfidence indirectly affects the decision through the moderation of perceived variables. Policy implications include: (a) dissemination of information about the vaccine is especially important among people who are inexperienced with the vaccine since they undervalue the effectiveness of vaccination; (b) lowering the total cost of vaccination, including time costs (for example, by offering the vaccine at workplaces) may raise the inoculation rate, especially among those inexperienced with the vaccine, since those who have experience with the vaccine tend to take it on a regular basis.

  7. Use of vaccination in avian influenza control and eradication.

    PubMed

    Marangon, S; Cecchinato, M; Capua, I

    2008-01-01

    Vaccination against avian influenza (AI) infections caused by viruses of the H5 and H7 subtypes has been used in several occasions in recent years with the general objective of controlling and in some cases eradicating the disease. To contain AI infections effectively, vaccination should only be used as part of a comprehensive control strategy that also includes biosecurity, quarantine, surveillance, education, and elimination of infected and at-risk poultry. Although properly used, potent AI vaccines can prevent disease and death, increase resistance to infection, reduce virus replication and shedding, and reduce viral transmission, they cannot completely prevent AI virus replication. A wide variety of vaccines against AI has been developed and tested in experimental conditions, but only inactivated whole AI virus vaccines and recombinant H5-AI vaccines have been licensed and widely used in various countries. AI vaccination programmes should be adapted to local conditions to guarantee efficacy and sustainability. In particular, vaccination programmes should be modulated in diverse situations according to the virus strain involved, the characteristics of the poultry producing sector, the capacity of the veterinary infrastructure, and the availability of adequate resources. Based on the eco-epidemiological situation in the affected region/area/compartment and the assessment of the risk of AI introduction, different vaccination strategies could be implemented to control AI: (i) routine vaccination performed in endemic areas; (ii) emergency vaccination in the face of an epidemic; and (iii) preventative vaccination carried out whenever a high risk of virus incursion is identified.

  8. New Wisdom to Defy an Old Enemy: Summary from a scientific symposium at the 4th Influenza Vaccines for the World (IVW) 2012 Congress, 11 October, Valencia, Spain.

    PubMed

    Poland, Gregory A; Fleming, Douglas M; Treanor, John J; Maraskovsky, Eugene; Luke, Thomas C; Ball, Emma M A; Poland, Caroline M

    2013-04-17

    Both seasonal and pandemic influenza cause considerable morbidity and mortality globally. In addition, the ongoing threat of new, unpredictable influenza pandemics from emerging variant strains cannot be underestimated. Recently bioCSL (previously known as CSL Biotherapies) sponsored a symposium 'New Wisdom to Defy an Old Enemy' at the 4th Influenza Vaccines for the World Congress in Valencia, Spain. This symposium brought together a renowned faculty of experts to discuss lessons from past experience, novel influenza vaccine developments, and new methods to increase vaccine acceptance and coverage. Specific topics reviewed and discussed included new vaccine development efforts focused on improving efficacy via alternative administration routes, dose modifications, improved adjuvants, and the use of master donor viruses. Improved safety was also discussed, particularly the new finding of an excess of febrile reactions isolated to children who received the 2010 Southern Hemisphere (SH) trivalent inactivated influenza vaccine (TIV). Significant work has been done to both identify the cause and minimize the risk of febrile reactions in children. Other novel prophylactic and therapeutic advances were discussed including immunotherapy. Standard IVIg and hIVIg have been used in ferret studies and human case reports with promising results. New adjuvants, such as ISCOMATRIX™ adjuvant, were noted to provide single-dose, prolonged protection with seasonal vaccine after lethal H5N1 virus challenge in a ferret model of human influenza disease. The data suggest that adjuvanted seasonal influenza vaccines may provide broader protection than unadjuvanted vaccines. The use of an antigen-formulated vaccine to induce broad protection between pandemics that could bridge the gap between pandemic declaration and the production of a homologous vaccine was also discussed. Finally, despite the availability of effective vaccines, most current efforts to increase influenza vaccine coverage

  9. New Wisdom to Defy an Old Enemy: Summary from a scientific symposium at the 4th Influenza Vaccines for the World (IVW) 2012 Congress, 11 October, Valencia, Spain.

    PubMed

    Poland, Gregory A; Fleming, Douglas M; Treanor, John J; Maraskovsky, Eugene; Luke, Thomas C; Ball, Emma M A; Poland, Caroline M

    2013-04-17

    Both seasonal and pandemic influenza cause considerable morbidity and mortality globally. In addition, the ongoing threat of new, unpredictable influenza pandemics from emerging variant strains cannot be underestimated. Recently bioCSL (previously known as CSL Biotherapies) sponsored a symposium 'New Wisdom to Defy an Old Enemy' at the 4th Influenza Vaccines for the World Congress in Valencia, Spain. This symposium brought together a renowned faculty of experts to discuss lessons from past experience, novel influenza vaccine developments, and new methods to increase vaccine acceptance and coverage. Specific topics reviewed and discussed included new vaccine development efforts focused on improving efficacy via alternative administration routes, dose modifications, improved adjuvants, and the use of master donor viruses. Improved safety was also discussed, particularly the new finding of an excess of febrile reactions isolated to children who received the 2010 Southern Hemisphere (SH) trivalent inactivated influenza vaccine (TIV). Significant work has been done to both identify the cause and minimize the risk of febrile reactions in children. Other novel prophylactic and therapeutic advances were discussed including immunotherapy. Standard IVIg and hIVIg have been used in ferret studies and human case reports with promising results. New adjuvants, such as ISCOMATRIX™ adjuvant, were noted to provide single-dose, prolonged protection with seasonal vaccine after lethal H5N1 virus challenge in a ferret model of human influenza disease. The data suggest that adjuvanted seasonal influenza vaccines may provide broader protection than unadjuvanted vaccines. The use of an antigen-formulated vaccine to induce broad protection between pandemics that could bridge the gap between pandemic declaration and the production of a homologous vaccine was also discussed. Finally, despite the availability of effective vaccines, most current efforts to increase influenza vaccine coverage

  10. Safety, efficacy, and immunogenicity of Flublok in the prevention of seasonal influenza in adults

    PubMed Central

    Cox, Manon M. J.; Izikson, Ruvim; Post, Penny; Dunkle, Lisa

    2015-01-01

    Flublok is the first recombinant hemagglutinin (HA) vaccine licensed by the US Food and Drugs Administration for the prevention of influenza in adults aged 18 and older. The HA proteins produced in insect cell culture using the baculovirus expression system technology are exact analogues of wild type circulating influenza virus HAs. The universal HA manufacturing process that has been successfully scaled to the 21,000L contributes to rapid delivery of a substantial number of doses. This review discusses the immunogenicity, efficacy and safety data from five pivotal clinical studies used to support licensure of trivalent Flublok for adults 18 years of age and older in the United States. The trial data demonstrate that the higher antigen content in Flublok results in improved immunogenicity. Data further suggest improved efficacy and a slightly lower local reactogenicity compared with standard inactivated influenza vaccine, despite the presence of more antigen (statistically significant). Flublok influenza vaccine can include HAs designed to mimic ‘drift’ in influenza viruses as the process of predicting antigenic drift advances and, at a minimum, could address late appearing influenza viruses. The implementation of the latter will require support from regulatory authorities. PMID:26478817

  11. Using game theory to examine incentives in influenza vaccination behavior.

    PubMed

    Chapman, Gretchen B; Li, Meng; Vietri, Jeffrey; Ibuka, Yoko; Thomas, David; Yoon, Haewon; Galvani, Alison P

    2012-09-01

    The social good often depends on the altruistic behavior of specific individuals. For example, epidemiological studies of influenza indicate that elderly individuals, who face the highest mortality risk, are best protected by vaccination of young individuals, who contribute most to disease transmission. To examine the conditions under which young people would get vaccinated to protect elderly people, we conducted a game-theory experiment that mirrored real-world influenza transmission, with "young" players contributing more than "elderly" players to herd immunity. Participants could spend points to get vaccinated and reduce the risk of influenza. When players were paid according to individual point totals, more elderly than young players got vaccinated, a finding consistent with the Nash equilibrium predicting self-interested behavior. When players were paid according to group point totals, however, more young than elderly players got vaccinated-a finding consistent with the utilitarian equilibrium predicting group-optimal behavior-which resulted in higher point totals than when players were paid for their individual totals. Thus, payout structure affected whether individuals got vaccinated for self-interest or group benefit.

  12. Using game theory to examine incentives in influenza vaccination behavior.

    PubMed

    Chapman, Gretchen B; Li, Meng; Vietri, Jeffrey; Ibuka, Yoko; Thomas, David; Yoon, Haewon; Galvani, Alison P

    2012-09-01

    The social good often depends on the altruistic behavior of specific individuals. For example, epidemiological studies of influenza indicate that elderly individuals, who face the highest mortality risk, are best protected by vaccination of young individuals, who contribute most to disease transmission. To examine the conditions under which young people would get vaccinated to protect elderly people, we conducted a game-theory experiment that mirrored real-world influenza transmission, with "young" players contributing more than "elderly" players to herd immunity. Participants could spend points to get vaccinated and reduce the risk of influenza. When players were paid according to individual point totals, more elderly than young players got vaccinated, a finding consistent with the Nash equilibrium predicting self-interested behavior. When players were paid according to group point totals, however, more young than elderly players got vaccinated-a finding consistent with the utilitarian equilibrium predicting group-optimal behavior-which resulted in higher point totals than when players were paid for their individual totals. Thus, payout structure affected whether individuals got vaccinated for self-interest or group benefit. PMID:22810166

  13. Development of high-yield influenza A virus vaccine viruses

    PubMed Central

    Ping, Jihui; Lopes, Tiago J.S.; Nidom, Chairul A.; Ghedin, Elodie; Macken, Catherine A.; Fitch, Adam; Imai, Masaki; Maher, Eileen A.; Neumann, Gabriele; Kawaoka, Yoshihiro

    2015-01-01

    Vaccination is one of the most cost-effective ways to prevent infection. Influenza vaccines propagated in cultured cells are approved for use in humans, but their yields are often suboptimal. Here, we screened A/Puerto Rico/8/34 (PR8) virus mutant libraries to develop vaccine backbones (defined here as the six viral RNA segments not encoding haemagglutinin and neuraminidase) that support high yield in cell culture. We also tested mutations in the coding and regulatory regions of the virus, and chimeric haemagglutinin and neuraminidase genes. A combination of high-yield mutations from these screens led to a PR8 backbone that improved the titres of H1N1, H3N2, H5N1 and H7N9 vaccine viruses in African green monkey kidney and Madin–Darby canine kidney cells. This PR8 backbone also improves titres in embryonated chicken eggs, a common propagation system for influenza viruses. This PR8 vaccine backbone thus represents an advance in seasonal and pandemic influenza vaccine development. PMID:26334134

  14. The influenza vaccine innovation system and lessons for PDPs.

    PubMed

    Huzair, Farah

    2012-03-01

    As Product Development Partnerships (PDPs) emerge and evolve in response to the need for vaccines, this paper re-examines the oldest and most successful PDP in the vaccine field; that which year after year, produces and reinvents influenza vaccines. This paper describes the influenza vaccine production and innovation system and reviews some of its most recent major innovations. Innovation in this system is a result of collaborative partnerships between various actors from both the public and private sector. It is argued that the influenza vaccine innovation system is a Product Development Partnership (PDP), be it an unconventional one, with a central coordination role allocated to the WHO rather than a private company or charitable/not for profit entity. The unusual structure of this PDP overcomes some of the organizational issues surrounding vaccine research and production faced by other documented PDPs. These are first, the need to coordinate knowledge flow via an effective knowledge broker. Second, the need to build in-house capacity and fund essential research and elements of production where private partners find involvement too risky or costly. PMID:22327495

  15. The influenza vaccine innovation system and lessons for PDPs.

    PubMed

    Huzair, Farah

    2012-03-01

    As Product Development Partnerships (PDPs) emerge and evolve in response to the need for vaccines, this paper re-examines the oldest and most successful PDP in the vaccine field; that which year after year, produces and reinvents influenza vaccines. This paper describes the influenza vaccine production and innovation system and reviews some of its most recent major innovations. Innovation in this system is a result of collaborative partnerships between various actors from both the public and private sector. It is argued that the influenza vaccine innovation system is a Product Development Partnership (PDP), be it an unconventional one, with a central coordination role allocated to the WHO rather than a private company or charitable/not for profit entity. The unusual structure of this PDP overcomes some of the organizational issues surrounding vaccine research and production faced by other documented PDPs. These are first, the need to coordinate knowledge flow via an effective knowledge broker. Second, the need to build in-house capacity and fund essential research and elements of production where private partners find involvement too risky or costly.

  16. Are medical residents a "core group" for future improvement of influenza vaccination coverage in health-care workers? A study among medical residents at the University Hospital of Palermo (Sicily).

    PubMed

    Amodio, Emanuele; Tramuto, Fabio; Maringhini, Guido; Asciutto, Rosario; Firenze, Alberto; Vitale, Francesco; Costantino, Claudio; Calamusa, Giuseppe

    2011-10-19

    Despite international recommendations, vaccination coverage among European healthcare workers, including physicians, is widely recognized as unsatisfactory. In order to plan tailored vaccination campaigns and increase future coverage, we investigated reasons for refusing vaccination and determinants associated with influenza vaccine uptake among young health care workers. A survey was carried out during September and October 2010 on medical residents attending post-graduate Schools of the Medical Faculty at the University of Palermo (Italy). Each participant completed an anonymous web-based questionnaire including items on demographic and occupational characteristics, knowledge, attitudes and behaviours with regard to influenza and influenza vaccination, and main sources of information. A total of 202 (66.9%) out of 302 medical residents participated in the survey. During the 2009-2010 influenza vaccine campaign, 44 residents (21.8%) were vaccinated against seasonal influenza and 84 (41.6%) against pandemic influenza A (H1N1) 2009. For the impending 2010-2011 influenza season, 45 (22.3%) stated their intention to get vaccinated against seasonal influenza, 40 (19.8%) were uncertain and 117 (57.9%) were opposed. Considering themselves to be a high risk group for developing influenza was significantly associated with vaccination against both 2009-2010 seasonal (adj-OR=1.46; 95% CI=1.05-2.04) and pandemic A (H1N1) influenza (adj-OR 1.38; 95% CI=1.08-1.75). Intention to get vaccinated against 2010-2011 seasonal influenza was significantly more frequent in participants who had a high perception of efficacy/safety (adj-OR=1.49; 95% CI=1.05-2.12). After adjusting for confounding, vaccinations against seasonal 2009-2010 influenza, pandemic influenza A (H1N1) 2009 and seasonal 2010-2011 influenza were significantly more frequent in residents who were vaccinated against influenza at least once in the previous five influenza seasons. Influenza vaccination among medical

  17. "Prepandemic" immunization for novel influenza viruses, "swine flu" vaccine, Guillain-Barré syndrome, and the detection of rare severe adverse events.

    PubMed

    Evans, David; Cauchemez, Simon; Hayden, Frederick G

    2009-08-01

    The availability of immunogenic, licensed H5N1 vaccines and the anticipated development of vaccines against "swine" influenza A(H1N1) have stimulated debate about the possible use of these vaccines for protection of those exposed to potential pandemic influenza viruses and for immunization or "priming" of populations in the so-called "prepandemic" (interpandemic) era. However, the safety of such vaccines is a critical issue in policy development for wide-scale application of vaccines in the interpandemic period. For example, wide-scale interpandemic use of H5N1 vaccines could lead to millions of persons receiving vaccines of uncertain efficacy potentially associated with rare severe adverse events and against a virus that may not cause a pandemic. Here, we first review aspects of the 1976 National Influenza Immunization Programme against "swine flu" and its well-documented association with Guillain-Barré syndrome as a case study illustration of a suspected vaccine-associated severe adverse event in a mass interpandemic immunization setting. This case study is especially timely, given the recent spread of a novel influenza A(H1N1) virus in humans in Mexico and beyond. Following this, we examine available safety data from clinical trials of H5N1 vaccines and briefly discuss how vaccine safety could be monitored in a postmarketing surveillance setting.

  18. Intranasal live attenuated seasonal influenza vaccine: does not challenge current practice.

    PubMed

    2013-09-01

    Influenza vaccination of children is only justified when there is a risk of serious influenza complications. In 2012, a live attenuated vaccine for intranasal administration was authorised in the European Union for influenza prevention in individuals aged from 2 to less than 18 years. This type of vaccine has been available in the United States since 2003. Clinical evaluation of this live vaccine is based on three non-inferiority trials versus an injected inactivated vaccine. There are no specific trials in children at risk of serious influenza complications. Only one of these trials was double-blinded. Two trials involved children with a history of respiratory problems. Symptomatic influenza confirmed by viral culture was less frequent in these three trials after intranasal vaccination than after injection of the conventional vaccine (about 3 to 5% and 6 to 10%, respectively). There was no difference between the vaccines in terms of clinical complications of influenza, especially asthma exacerbations. Adverse effects attributed to the intranasal vaccine mainly consisted of local reactions such as rhinorrhoea and nasal congestion, as well as flu-like syndromes. Wheezing, respiratory tract infections and hospitalisation were more frequent with the intranasal vaccine than with the injected vaccine in children aged less than 1 year and in children with a history of severe respiratory illness. The intranasal vaccine is contraindicated in these children. The intranasal vaccine contains live attenuated virus strains and is therefore contraindicated in immunocompromised patients. US pharmacovigilance data suggest that severe allergic reactions to the intranasal vaccine, Guillain-Barré syndrome, and transmission of vaccine viruses to contacts are very rare. Intranasal administration seems to be more practical, especially for children. In practice, there is no firm evidence that this live attenuated influenza vaccine has any clinical advantages over injected vaccines

  19. Vaccine recommendations for children and youth for the 2015/2016 influenza season.

    PubMed

    Moore, Dorothy L

    2015-10-01

    The Canadian Paediatric Society continues to encourage annual influenza vaccination for ALL children and youth ≥6 months of age. Recommendations from the National Advisory Committee on Immunization for the 2015/2016 influenza season include some important changes: Children and adolescents with neurological or neurodevelopmental disorders were added to the list of individuals considered to be at high risk for severe influenza.Quadrivalent influenza vaccines are recommended preferentially over trivalent vaccines for use in children and youth.An adjuvanted trivalent inactivated influenza vaccine is now available for use in children six to 23 months of age.

  20. Current status and uptake of influenza vaccination over time among senior adults in the United States

    PubMed Central

    Lu, Peng-jun; O'Halloran, Alissa; Ding, Helen; Greby, Stacie M; Williams, Walter W

    2015-01-01

    Influenza is a major cause of morbidity and mortality among older adults in the United States, who may also have chronic medical conditions that place them at high risk for complications from influenza. The U.S. Public Health Service recommended influenza vaccination of adults ≥65 y and chronically ill persons since 1961 and beginning with the 2010–11 influenza season, the Advisory Committee on Immunization Practices (ACIP) has expanded its recommendation to vaccinate all persons 6 months of age and older. Medicare coverage for influenza vaccination began in 1993. However, despite the presence of a safe and effective vaccine, long-standing recommendations on vaccination, and federal financial support for vaccination, vaccination levels among adults ≥65 y are not optimal. Studies have shown that influenza vaccination coverage among U.S. adults ≥ 65 y steadily increased from 30.1% in 1989 to 64.2% in 1997, but plateaued near 65% from 1998 to 2013. Increasing influenza vaccination coverage among older adults in the United States will require more cooperation among health-care providers, professional organizations, vaccine manufacturers, and public health departments to raise public awareness about the benefits of influenza vaccination and to ensure continued administration of vaccinations throughout the influenza season. PMID:26697974

  1. Vaccine-induced waning of Haemophilus influenzae empyema and meningitis, Angola.

    PubMed

    Peltola, Heikki; Pelkonen, Tuula; Bernardino, Luis; Monteiro, Lurdes; Silvestre, Silvia da Conceição; Anjos, Elizabete; Cruzeiro, Manuel Leite; Pitkäranta, Anne; Roine, Irmeli

    2014-11-01

    In Angola during 2003-2012, we detected Haemophilus influenzae in 18% of 2,634 and 26% of 2,996 bacteriologically positive pleural or cerebrospinal fluid samples, respectively, from children. After vaccination launch in 2006, H. influenzae empyema declined by 83% and meningitis by 86%. Severe H. influenzae pneumonia and meningitis are preventable by vaccination.

  2. A cell-based backup to speed up pandemic influenza vaccine production.

    PubMed

    Lee, Min-Shi; Hu, Alan Yung-Chih

    2012-03-01

    Influenza vaccines are currently produced through egg-based methods, with one drawback being that this system is slow to respond to the surging global demand during an influenza pandemic. Alternative influenza vaccine production strategies, such as using a cell-based strategy, should be considered in pandemic situations.

  3. Cross-sectional study on factors associated with influenza vaccine uptake and pertussis vaccination status among pregnant women in Germany.

    PubMed

    Bödeker, Birte; Walter, Dietmar; Reiter, Sabine; Wichmann, Ole

    2014-07-16

    Pregnant women and their newborns are at increased risk for influenza-related complications; the latter also have an increased risk for pertussis-related complications. In Germany, seasonal influenza vaccination is recommended for pregnant women since 2010. A dose of pertussis-containing vaccine has been recommended since 2004 for women of childbearing age if they have not been vaccinated within the past 10 years. We conducted a nationwide cross-sectional survey among pregnant women in February/March 2013 to assess knowledge, attitudes, and practices related to influenza vaccination during pregnancy and to identify factors associated with their pertussis vaccination status. In total, 1025 pregnant women participated and provided information through a self-administered questionnaire. Of these, 23.2% were vaccinated against seasonal influenza during the 2012/13 season; 15.9% during their pregnancy. Major reasons for being unvaccinated (n=686 respondents) were lack of confidence in the vaccine (60.4%) and the perception that vaccination was not necessary (40.3%). Influenza vaccination during pregnancy was independently associated with having received influenza vaccine in the previous season, having received a recommendation from a physician, a high level of vaccine-related knowledge and of perceived disease severity. In contrast, knowledge of the recommendation for regular hand-washing to prevent influenza and the perception that vaccine-related side effects were likely to occur or likely to be severe were negatively associated with vaccine uptake. Receipt of a pertussis vaccine in the past 10 years was reported by 22.5% of participants. Pertussis vaccine uptake was independently associated with living in the Eastern federal states and receiving seasonal influenza vaccination annually, while a migration background was associated with a lower uptake. To enhance vaccine uptake in pregnant women and women of childbearing age, special efforts must be undertaken to improve

  4. Mass Media Campaign Impacts Influenza Vaccine Obtainment of University Students

    ERIC Educational Resources Information Center

    Shropshire, Ali M.; Brent-Hotchkiss, Renee; Andrews, Urkovia K.

    2013-01-01

    Objective: To describe the effectiveness of a mass media campaign in increasing the rate of college student influenza vaccine obtainment. Participants/Methods: Students ("N" = 721) at a large southern university completed a survey between September 2011 and January 2012 assessing what flu clinic media sources were visualized and if they…

  5. Attitudes of the General Public and General Practitioners in Five Countries towards Pandemic and Seasonal Influenza Vaccines during Season 2009/2010

    PubMed Central

    Blank, Patricia R.; Bonnelye, Genevieve; Ducastel, Aurore; Szucs, Thomas D.

    2012-01-01

    Background Vaccination coverage rates for seasonal influenza are not meeting national and international targets. Here, we investigated whether the 2009/2010 A/H1N1 pandemic influenza affected the uptake of influenza vaccines. Methodology/Principal Findings In December 2009/January 2010 and April 2010, 500 randomly selected members of the general public in Germany, France, the United States, China, and Mexico were surveyed by telephone about vaccination for seasonal and A/H1N1 pandemic influenza. Also, in April 2010, 100 randomly selected general practitioners were surveyed. Adult vaccine coverage in December 2009/January 2010 for A/H1N1 pandemic and seasonal influenza were, respectively, 12% and 29% in France, 11% and 25% in Germany, 41% and 46% in the US, 13% and 30% in Mexico, and 12% and 10% in China. Adult uptake rates in April 2010 were higher in Mexico but similar or slightly lower in the other countries. Coverage rates in children were higher than in adults in the US, Mexico, and China but mostly lower in Germany and France. Germans and French viewed the threat of A/H1N1 pandemic influenza as low to moderate, whereas Mexicans, Americans, and Chinese viewed it as moderate to serious, opinions generally mirrored by general practitioners. The recommendation of a general practitioner was a common reason for receiving the pandemic vaccine, while not feeling at risk and concerns with vaccine safety and efficacy were common reasons for not being vaccinated. Inclusion of the A/H1N1 pandemic strain increased willingness to be vaccinated for seasonal influenza in the United States, Mexico, and China but not in Germany or France. Conclusions/Significance The 2009/2010 A/H1N1 influenza pandemic increased vaccine uptake rates for seasonal influenza in Mexico but had little effect in other countries. Accurate communication of health information, especially by general practitioners, is needed to improve vaccine coverage rates. PMID:23071519

  6. Evaluating a Standardized Measure of Healthcare Personnel Influenza Vaccination

    PubMed Central

    Lindley, Megan C.; Lorick, Suchita A.; Geevarughese, Anita; Lee, Soo-Jeong; Makvandi, Monear; Miller, Brady L.; Nace, David A.; Smith, Carmela; Ahmed, Faruque

    2015-01-01

    Background Methods of measuring influenza vaccination of healthcare personnel (HCP) vary substantially, including which groups of HCP are included in measurements. Thus, comparison of vaccination rates across healthcare facilities is difficult. Purpose The goal of the study was to determine the feasibility of implementing a standardized measure for reporting HCP influenza vaccination data in various types of healthcare facilities. Methods A total of 318 facilities recruited in four U.S. jurisdictions agreed to participate in the evaluation, including hospitals, long-term care facilities, dialysis clinics, ambulatory surgery centers, and physician practices. HCP in participating facilities were categorized as employees, credentialed non-employees, or other non-employees using standard definitions. Data were gathered using cross-sectional web-based surveys completed at three intervals between October 2010 and May 2011 and analyzed in February 2012. Results 234 facilities (74%) completed all three surveys. Most facilities could report on-site employee vaccination; almost one third could not provide complete data on HCP vaccinated outside the facility, contraindications, or declinations, primarily due to missing non-employee data. Inability to determine vaccination status of credentialed and other non-employees was cited as a major barrier to measure implementation by 24% and 27% of respondents, respectively. Conclusions Using the measure to report employee vaccination status was feasible for most facilities; tracking non-employee HCP was more challenging. Based on evaluation findings, the measure was revised to limit the types of non-employees included. Although the revised measure is less comprehensive, it is more likely to produce valid vaccination coverage estimates. Use of this standardized measure can inform quality improvement efforts and facilitate comparison of HCP influenza vaccination among facilities. PMID:23953356

  7. Communicating vaccine safety during the development and introduction of vaccines.

    PubMed

    Kochhar, Sonali

    2015-01-01

    Vaccines are the best defense available against infectious diseases. Vaccine safety is of major focus for regulatory bodies, vaccine manufacturers, public health authorities, health care providers and the public as vaccines are often given to healthy children and adults as well as to pregnant woman. Safety assessment is critical at all stages of vaccine development. Effective, clear and consistent communication of the risks and benefits of vaccines and advocacy during all stages of clinical research (including the preparation, approvals, conduct of clinical trials through the post marketing phase) is critically important. This needs to be done for all major stakeholders (e.g. community members, Study Team, Health Care Providers, Ministry of Health, Regulators, Ethics Committee members, Public Health Authorities and Policy Makers). Improved stakeholder alignment would help to address some of the concerns that may affect the clinical research, licensing of vaccines and their wide-spread use in immunization programs around the world.

  8. New USDA licensed avian influenza vaccine (rHVT-AI) for protection against H5 avian influenza and usage discussion

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Recently, a new avian influenza vaccine was licensed by USDA for use in the United States for protection of commercial poultry. The vaccine is a recombinant herpes virus of turkeys expressing the hemagglutinin gene of an H5 subtype avian influenza virus belonging to the 2.2 clade of the H5N1 highly ...

  9. Key issues and challenges in estimating the impact and cost-effectiveness of quadrivalent influenza vaccination.

    PubMed

    Quinn, Emma; Jit, Mark; Newall, Anthony T

    2014-06-01

    Evidence has shown that quadrivalent influenza vaccines containing all four subtypes are safe and immunogenic. However, to date there have been few published studies exploring the population-level clinical and economic impact of quadrivalent compared to trivalent influenza vaccines. Economic evaluation studies need to be conducted in order to inform country-level decision making about whether (and how to) introduce and replace the current trivalent influenza vaccines with quadrivalent influenza vaccination programs. Several key issues associated with estimating the clinical and economic impact of the trivalent versus quadrivalent vaccines are discussed in this article, particularly the complexities involved in estimating the incremental preventable disease and economic burden. Other factors, such as the indirect (herd) protection from quadrivalent influenza vaccination and the timing of the replacement of trivalent influenza vaccination programs are also discussed.

  10. Influenza Activity - United States, 2015-16 Season and Composition of the 2016-17 Influenza Vaccine.

    PubMed

    Davlin, Stacy L; Blanton, Lenee; Kniss, Krista; Mustaquim, Desiree; Smith, Sophie; Kramer, Natalie; Cohen, Jessica; Cummings, Charisse Nitura; Garg, Shikha; Flannery, Brendan; Fry, Alicia M; Grohskopf, Lisa A; Bresee, Joseph; Wallis, Teresa; Sessions, Wendy; Garten, Rebecca; Xu, Xiyan; Elal, Anwar Isa Abd; Gubareva, Larisa; Barnes, John; Wentworth, David E; Burns, Erin; Katz, Jacqueline; Jernigan, Daniel; Brammer, Lynnette

    2016-01-01

    During the 2015-16 influenza season (October 4, 2015-May 21, 2016) in the United States, influenza activity* was lower and peaked later compared with the previous three seasons (2012-13, 2013-14, and 2014-15). Activity remained low from October 2015 until late December 2015 and peaked in mid-March 2016. During the most recent 18 influenza seasons (including this season), only two other seasons have peaked in March (2011-12 and 2005-06). Overall influenza activity was moderate this season, with a lower percentage of outpatient visits for influenza-like illness (ILI),(†) lower hospitalization rates, and a lower percentage of deaths attributed to pneumonia and influenza (P&I) compared with the preceding three seasons. Influenza A(H1N1)pdm09 viruses predominated overall, but influenza A(H3N2) viruses were more commonly identified from October to early December, and influenza B viruses were more commonly identified from mid-April through mid-May. The majority of viruses characterized this season were antigenically similar to the reference viruses representing the recommended components of the 2015-16 Northern Hemisphere influenza vaccine (1). This report summarizes influenza activity in the United States during the 2015-16 influenza season (October 4, 2015-May 21, 2016)(§) and reports the vaccine virus components recommended for the 2016-17 Northern Hemisphere influenza vaccines. PMID:27281364

  11. Association of School-Based Influenza Vaccination Clinics and School Absenteeism--Arkansas, 2012-2013

    ERIC Educational Resources Information Center

    Gicquelais, Rachel E.; Safi, Haytham; Butler, Sandra; Smith, Nathaniel; Haselow, Dirk T.

    2016-01-01

    Background: Influenza is a major cause of seasonal viral respiratory illness among school-aged children. Accordingly, the Arkansas Department of Health (ADH) coordinates >800 school-based influenza immunization clinics before each influenza season. We quantified the relationship between student influenza vaccination in Arkansas public schools…

  12. Developing Universal Influenza Vaccines: Hitting the Nail, Not Just on the Head

    PubMed Central

    Wiersma, Lidewij C. M.; Rimmelzwaan, Guus F.; de Vries, Rory D.

    2015-01-01

    Influenza viruses have a huge impact on public health. Current influenza vaccines need to be updated annually and protect poorly against antigenic drift variants or novel emerging subtypes. Vaccination against influenza can be improved in two important ways, either by inducing more broadly protective immune responses or by decreasing the time of vaccine production, which is relevant especially during a pandemic outbreak. In this review, we outline the current efforts to develop so-called “universal influenza vaccines”, describing antigens that may induce broadly protective immunity and novel vaccine production platforms that facilitate timely availability of vaccines. PMID:26343187

  13. Influenza epidemiology, vaccine coverage and vaccine effectiveness in sentinel Australian hospitals in 2012: the Influenza Complications Alert Network (FluCAN).

    PubMed

    Cheng, Allen C; Brown, Simon; Waterer, Grant; Holmes, Mark; Senenayake, Sanjaya; Friedman, N Deborah; Hewagama, Saliya; Simpson, Graham; Wark, Peter; Upham, John; Korman, Tony; Dwyer, Dominic; Wood-Baker, Richard; Irving, Louis; Bowler, Simon; Kotsimbos, Tom; Kelly, Paul

    2013-09-01

    Influenza is mostly a mild, self-limiting infection and severe infection requiring hospitalisation is uncommon. Immunisation aims to reduce serious morbidity and mortality. The Influenza Complications Alert Network (FluCAN) is a sentinel hospital-based surveillance program that operates at 15 sites across all states and territories in Australia. This study reports on the epidemiology of hospitalisation with confirmed influenza, estimate vaccine coverage and influenza vaccine protection against hospitalisation with influenza during the 2012 influenza season. In this observational study, cases were defined as patients admitted to one of the sentinel hospitals with influenza confirmed by nucleic acid detection. Controls were patients who had acute respiratory illnesses who were test-negative for influenza. Vaccine effectiveness was estimated as 1 minus the odds ratio of vaccination in case patients compared with control patients, after adjusting for known confounders. During the period 9 April to 31 October 2012, 1,231 patients were admitted with confirmed influenza at the 15 FluCAN sentinel hospitals. Of these, 47% were more than 65 years of age, 8% were Indigenous Australians, 3% were pregnant and 76% had chronic co-morbidities. Influenza A was detected in 83% of patients. Vaccination coverage was calculated from the vaccination status of 1,216 test negative controls and was estimated at 77% in patients 65 years or over and 61% in patients with chronic comorbidities. Vaccination effectiveness was estimated at 41% (95% CI: 28%, 51%, P<0.001). Vaccine coverage was incomplete in at-risk groups, particularly non-elderly patients with medical comorbidities. The study results suggest that the seasonal influenza vaccine was moderately protective against hospitalisation with influenza during the 2012 season. PMID:24890961

  14. Cost-effectiveness analysis of quadrivalent influenza vaccine in Spain.

    PubMed

    García, Amos; Ortiz de Lejarazu, Raúl; Reina, Jordi; Callejo, Daniel; Cuervo, Jesús; Morano Larragueta, Raúl

    2016-09-01

    Influenza has a major impact on healthcare systems and society, but can be prevented using vaccination. The World Health Organization (WHO) currently recommends that influenza vaccines should include at least two virus A and one virus B lineage (trivalent vaccine; TIV). A new quadrivalent vaccine (QIV), which includes an additional B virus strain, received regulatory approval and is now recommended by several countries. The present study estimates the cost-effectiveness of replacing TIVs with QIV for risk groups and elderly population in Spain. A static, lifetime, multi-cohort Markov model with a one-year cycle time was adapted to assess the costs and health outcomes associated with a switch from TIV to QIV. The model followed a cohort vaccinated each year according to health authority recommendations, for the duration of their lives. National epidemiological data allowed the determination of whether the B strain included in TIVs matched the circulating one. Societal perspective was considered, costs and outcomes were discounted at 3% and one-way and probabilistic sensitivity analyses were performed. Compared to TIVs, QIV reduced more influenza cases and influenza-related complications and deaths during periods of B-mismatch strains in the TIV. The incremental cost-effectiveness ratio (ICER) was 8,748€/quality-adjusted life year (QALY). One-way sensitivity analysis showed mismatch with the B lineage included in the TIV was the main driver for ICER. Probabilistic sensitivity analysis shows ICER below 30,000€/QALY in 96% of simulations. Replacing TIVs with QIV in Spain could improve influenza prevention by avoiding B virus mismatch and provide a cost-effective healthcare intervention. PMID:27184622

  15. Cost–effectiveness analysis of quadrivalent influenza vaccine in Spain

    PubMed Central

    García, Amos; Ortiz de Lejarazu, Raúl; Reina, Jordi; Callejo, Daniel; Cuervo, Jesús; Morano Larragueta, Raúl

    2016-01-01

    ABSTRACT Influenza has a major impact on healthcare systems and society, but can be prevented using vaccination. The World Health Organization (WHO) currently recommends that influenza vaccines should include at least two virus A and one virus B lineage (trivalent vaccine; TIV). A new quadrivalent vaccine (QIV), which includes an additional B virus strain, received regulatory approval and is now recommended by several countries. The present study estimates the cost-effectiveness of replacing TIVs with QIV for risk groups and elderly population in Spain. A static, lifetime, multi-cohort Markov model with a one-year cycle time was adapted to assess the costs and health outcomes associated with a switch from TIV to QIV. The model followed a cohort vaccinated each year according to health authority recommendations, for the duration of their lives. National epidemiological data allowed the determination of whether the B strain included in TIVs matched the circulating one. Societal perspective was considered, costs and outcomes were discounted at 3% and one-way and probabilistic sensitivity analyses were performed. Compared to TIVs, QIV reduced more influenza cases and influenza-related complications and deaths during periods of B-mismatch strains in the TIV. The incremental cost-effectiveness ratio (ICER) was 8,748€/quality-adjusted life year (QALY). One-way sensitivity analysis showed mismatch with the B lineage included in the TIV was the main driver for ICER. Probabilistic sensitivity analysis shows ICER below 30,000€/QALY in 96% of simulations. Replacing TIVs with QIV in Spain could improve influenza prevention by avoiding B virus mismatch and provide a cost-effective healthcare intervention. PMID:27184622

  16. Influenza vaccination: key facts for general practitioners in Europe-a synthesis by European experts based on national guidelines and best practices in the United Kingdom and the Netherlands.

    PubMed

    Kassianos, George; Blank, Patricia; Falup-Pecurariu, Oana; Kuchar, Ernest; Kyncl, Jan; De Lejarazu, Raul Ortiz; Nitsch-Osuch, Aneta; van Essen, Gerrit A

    2016-01-01

    Currently there is no influenza vaccination guidance for European general practitioners. Furthermore, although the European Council recommends a target seasonal influenza vaccination rate of 75% in the elderly (65 years and above) and in anyone aged >6 months with a chronic medical condition, there remain wide discrepancies throughout Europe. A harmonised guideline regarding not only vaccination strategy but also for the consistent diagnosis of influenza across Europe is essential to support a common approach for the implementation of seasonal influenza vaccination across Europe. This document is based on pre-existing guidelines available in the UK and Netherlands and has been approved by a group of European experts for use throughout Europe. As well as providing a standardised influenza diagnosis, it also reviews the current recommendations for influenza vaccination, the types of vaccine available, the contraindications, vaccine use in special populations (in pregnancy, children, and in those with egg allergy), and concomitant administration with other vaccines. The effectiveness, safety, and timing of the seasonal influenza vaccine are also reviewed. A second section provides practical guidance for general practitioners for the implementation of a seasonal influenza vaccination program, including the selection and notification of those eligible for vaccination, as well as suggestions for the organisation of a vaccination programme. Finally, suggested responses to common patient misconceptions and frequently asked questions are included. The aim of this article is to harmonise the diagnosis of seasonal influenza and the approach of European general practitioners to seasonal influenza vaccination in order to better identify influenza outbreaks and to move towards reaching the target vaccination rate of 75% throughout Europe. PMID:27540408

  17. Influenza vaccination: key facts for general practitioners in Europe—a synthesis by European experts based on national guidelines and best practices in the United Kingdom and the Netherlands

    PubMed Central

    Kassianos, George; Blank, Patricia; Falup-Pecurariu, Oana; Kuchar, Ernest; Kyncl, Jan; De Lejarazu, Raul Ortiz; Nitsch-Osuch, Aneta; van Essen, Gerrit A

    2016-01-01

    Currently there is no influenza vaccination guidance for European general practitioners. Furthermore, although the European Council recommends a target seasonal influenza vaccination rate of 75% in the elderly (65 years and above) and in anyone aged >6 months with a chronic medical condition, there remain wide discrepancies throughout Europe. A harmonised guideline regarding not only vaccination strategy but also for the consistent diagnosis of influenza across Europe is essential to support a common approach for the implementation of seasonal influenza vaccination across Europe. This document is based on pre-existing guidelines available in the UK and Netherlands and has been approved by a group of European experts for use throughout Europe. As well as providing a standardised influenza diagnosis, it also reviews the current recommendations for influenza vaccination, the types of vaccine available, the contraindications, vaccine use in special populations (in pregnancy, children, and in those with egg allergy), and concomitant administration with other vaccines. The effectiveness, safety, and timing of the seasonal influenza vaccine are also reviewed. A second section provides practical guidance for general practitioners for the implementation of a seasonal influenza vaccination program, including the selection and notification of those eligible for vaccination, as well as suggestions for the organisation of a vaccination programme. Finally, suggested responses to common patient misconceptions and frequently asked questions are included. The aim of this article is to harmonise the diagnosis of seasonal influenza and the approach of European general practitioners to seasonal influenza vaccination in order to better identify influenza outbreaks and to move towards reaching the target vaccination rate of 75% throughout Europe. PMID:27540408

  18. Factors impacting influenza vaccination of urban low-income Latino children under nine years requiring two doses in the 2010-2011 season.

    PubMed

    Hofstetter, Annika M; Barrett, Angela; Stockwell, Melissa S

    2015-04-01

    The Advisory Committee on Immunization Practices (ACIP) recommends that certain children under 9 years of age receive two influenza vaccine doses in a season for optimal protection. Recent data indicate that many of these children fail to receive one or both of these needed doses. Contributing factors to under-vaccination of this population remain unclear. Caregivers of children aged 6 months-8 years requiring two influenza vaccine doses in the 2010-2011 season were identified from households enrolled in four urban Head Start programs. Recruitment and survey administration were conducted between March and June 2011. The impact of caregiver, provider, and practice-based factors on influenza vaccine receipt was assessed using bivariate and multivariable logistic regression analyses. Caregivers (n = 128) were predominantly mothers, Latina, Spanish-speaking, and non-U.S. born. Few children received one (31 %) or both (7 %) influenza vaccine doses. Caregivers who discussed influenza vaccination with providers were more likely to know their child needed two doses (55 vs. 35 %, p < 0.05) and have a fully vaccinated child (11 vs. 0 %, p < 0.05). Among caregivers whose child received the first dose, those who reported being told when to return for the second dose were also more likely to have a fully vaccinated child (35 vs. 0 %, p = 0.05). Belief in influenza vaccine effectiveness was positively associated with vaccination (p < 0.001), while safety concerns were negatively associated (p < 0.05). This study highlights the importance of provider-family communication about the two-dose regimen as well as influenza vaccine effectiveness and safety. PMID:25082482

  19. Factors impacting influenza vaccination of urban low-income Latino children under nine years requiring two doses in the 2010–2011 season

    PubMed Central

    Hofstetter, Annika M.; Barrett, Angela; Stockwell, Melissa S.

    2015-01-01

    Background The Advisory Committee on Immunization Practices (ACIP) recommends that certain children under nine years of age receive two influenza vaccine doses in a season for optimal protection. Recent data indicate that many of these children fail to receive one or both of these needed doses. Contributing factors to under-vaccination of this population remain unclear. Methods Caregivers of children aged 6 months-8 years requiring two influenza vaccine doses in the 2010–2011 season were identified from households enrolled in four urban Head Start programs. Recruitment and survey administration were conducted between March and June 2011. The impact of caregiver, provider, and practice-based factors on influenza vaccine receipt (0, 1, or 2 doses) was assessed using bivariate and multivariable logistic regression analyses. Results Caregivers (n=128) were predominantly mothers, Latina, Spanish-speaking, and non-U.S. born. Few children received one (31%) or both (7%) influenza vaccine doses. Caregivers who discussed influenza vaccination with providers were more likely to know their child needed two doses (55% vs. 36%, p<0.05) and have a fully vaccinated child (11% vs. 0%, p<0.05). Among caregivers whose child received the first dose, those who reported being told when to return for the second dose were also more likely to have a fully vaccinated child (35% vs. 0%, p=0.05). Belief in influenza vaccine effectiveness was positively associated with vaccination (p<0.001), while safety concerns were negatively associated (p<0.05). Discussion This study highlights the importance of provider-family communication about the two-dose regimen as well as influenza vaccine effectiveness and safety. PMID:25082482

  20. Reduction of high pathogenicity avian influenza virus in eggs from chickens once or twice vaccinated with an oil-emulsified inactivated H5 avian influenza vaccine

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The negative impact of high pathogenicity avian influenza virus (HPAIV) infection on egg production and deposition of virus in eggs, as well as any protective effect of vaccination, is unknown. Individually housed non-vaccinated, sham-vaccinated and inactivated H5N9 vaccinated once or twice adult Wh...

  1. Apoptosis and other immune biomarkers predict influenza vaccine responsiveness.

    PubMed

    Furman, David; Jojic, Vladimir; Kidd, Brian; Shen-Orr, Shai; Price, Jordan; Jarrell, Justin; Tse, Tiffany; Huang, Huang; Lund, Peder; Maecker, Holden T; Utz, Paul J; Dekker, Cornelia L; Koller, Daphne; Davis, Mark M

    2013-01-01

    Despite the importance of the immune system in many diseases, there are currently no objective benchmarks of immunological health. In an effort to identifying such markers, we used influenza vaccination in 30 young (20-30 years) and 59 older subjects (60 to >89 years) as models for strong and weak immune responses, respectively, and assayed their serological responses to influenza strains as well as a wide variety of other parameters, including gene expression, antibodies to hemagglutinin peptides, serum cytokines, cell subset phenotypes and in vitro cytokine stimulation. Using machine learning, we identified nine variables that predict the antibody response with 84% accuracy. Two of these variables are involved in apoptosis, which positively associated with the response to vaccination and was confirmed to be a contributor to vaccine responsiveness in mice. The identification of these biomarkers provides new insights into what immune features may be most important for immune health. PMID:23591775

  2. Planning influenza vaccination programs: a cost benefit model

    PubMed Central

    2012-01-01

    Background Although annual influenza vaccination could decrease the significant economic and humanistic burden of influenza in the United States, immunization rates are below recommended levels, and concerns remain whether immunization programs can be cost beneficial. The research objective was to compare cost benefit of various immunization strategies from employer, employee, and societal perspectives. Methods An actuarial model was developed based on the published literature to estimate the costs and benefits of influenza immunization programs. Useful features of the model included customization by population age and risk-level, potential pandemic risk, and projection year. Various immunization strategies were modelled for an average U.S. population of 15,000 persons vaccinated in pharmacies or doctor’s office during the 2011/12 season. The primary outcome measure reported net cost savings per vaccinated (PV) from the perspective of various stakeholders. Results Given a typical U.S. population, an influenza immunization program will be cost beneficial for employers when more than 37% of individuals receive vaccine in non-traditional settings such as pharmacies. The baseline scenario, where 50% of persons would be vaccinated in non-traditional settings, estimated net savings of $6 PV. Programs that limited to pharmacy setting ($31 PV) or targeted persons with high-risk comorbidities ($83 PV) or seniors ($107 PV) were found to increase cost benefit. Sensitivity analysis confirmed the scenario-based findings. Conclusions Both universal and targeted vaccination programs can be cost beneficial. Proper planning with cost models can help employers and policy makers develop strategies to improve the impact of immunization programs. PMID:22835081

  3. Haemophilus influenzae Type b (Hib) vaccine - what you need to know

    MedlinePlus

    ... taken in its entirety from the CDC Hib (Haemophilus Influenzae Type b) Vaccine Information Statement (VIS): www.cdc. ... statements/hib.pdf . CDC review information for Hib (Haemophilus Influenzae Type b) VIS: Page last reviewed: April 2, ...

  4. Increasing the use of influenza vaccines in children with egg allergy.

    PubMed

    Hui, Charles Ps

    2014-12-01

    Administration of inactivated trivalent or quadrivalent influenza vaccines is now believed to be safe for individuals with egg allergy. Unless children have experienced an anaphylactic reaction to a previous dose of influenza vaccine, they can and should be immunized with a full dose of trivalent or quadrivalent inactivated vaccine.

  5. Lymphocyte responses in the lungs of vaccinated pigs following homologous and heterologous influenza A virus challenge.

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Vaccine associated enhanced respiratory disease (VAERD) has been described in pigs vaccinated with whole-inactivated influenza virus (WIV) following infection with heterologous influenza A virus (IAV). WIV vaccination elicits production of non-neutralizing antibody that is cross-reactive to the chal...

  6. Responses of US College and University Student Health Services to the 2004 Influenza Vaccine Shortage

    ERIC Educational Resources Information Center

    Alfred, Norma J.; Turner, James C.; David, Felicita; DeLozier, David M.; Strikas, Raymond A.

    2005-01-01

    The United States experienced a shortage of influenza vaccine for the 2004-2005 influenza season. The authors surveyed college health programs to determine whether they had targeted vaccine to priority groups and knew how to reallocate remaining vaccine. They used an electronic message to distribute a Web-based survey to the members of 3…

  7. The epidemiological impact of childhood influenza vaccination using live-attenuated influenza vaccine (LAIV) in Germany: predictions of a simulation study

    PubMed Central

    2014-01-01

    Background Routine annual influenza vaccination is primarily recommended for all persons aged 60 and above and for people with underlying chronic conditions in Germany. Other countries have already adopted additional childhood influenza immunisation programmes. The objective of this study is to determine the potential epidemiological impact of implementing paediatric influenza vaccination using intranasally administered live-attenuated influenza vaccine (LAIV) in Germany. Methods A deterministic age-structured model is used to simulate the population-level impact of different vaccination strategies on the transmission dynamics of seasonal influenza in Germany. In our base-case analysis, we estimate the effects of adding a LAIV-based immunisation programme targeting children 2 to 17 years of age to the existing influenza vaccination policy. The data used in the model is based on published evidence complemented by expert opinion. Results In our model, additional vaccination of children 2 to 17 years of age with LAIV leads to the prevention of 23.9 million influenza infections and nearly 16 million symptomatic influenza cases within 10 years. This reduction in burden of disease is not restricted to children. About one third of all adult cases can indirectly be prevented by LAIV immunisation of children. Conclusions Our results demonstrate that vaccinating children 2–17 years of age is likely associated with a significant reduction in the burden of paediatric influenza. Furthermore, annual routine childhood vaccination against seasonal influenza is expected to decrease the incidence of influenza among adults and older people due to indirect effects of herd protection. In summary, our model provides data supporting the introduction of a paediatric influenza immunisation programme in Germany. PMID:24450996

  8. Impact of vaccines and vaccination on global control of avian influenza.

    PubMed

    Swayne, David E

    2012-12-01

    There are 30 recorded epizootics of H5 or H7 high pathogenicity avian influenza (HPAI) from 1959 to early 2012. The largest of these epizootics, affecting more birds and countries than the other 29 epizootics combined, has been the H5N1 HPAI, which began in Guangdong China in 1996, and has killed or resulted in culling of over 250 million poultry and/or wild birds in 63 countries. Most countries have used stamping-out programs in poultry to eradicate H5N1 HPAI. However, 15 affected countries have utilized vaccination as a part of the control strategy. Greater than 113 billion doses were used from 2002 to 2010. Five countries have utilized nationwide routine vaccination programs, which account for 99% of vaccine used: 1) China (90.9%), 2) Egypt (4.6%), 3) Indonesia (2.3%), 4) Vietnam (1.4%), and 5) Hong Kong Special Administrative Region (< 0.01%). Mongolia, Kazakhstan, France, The Netherlands, Cote d'Ivoire, Sudan, North Korea, Israel, Russia, and Pakistan used < 1% of the avian influenza (AI) vaccine, and the AI vaccine was targeted to either preventive or emergency vaccination programs. Inactivated AI vaccines have accounted for 95.5% of vaccine used, and live recombinant virus vaccines have accounted for 4.5% of vaccine used. The latter are primarily recombinant Newcastle disease vectored vaccine with H5 influenza gene insert. China, Indonesia, Egypt, and Vietnam implemented vaccination after H5N1 HPAI became enzootic in domestic poultry. Bangladesh and eastern India have enzootic H5N1 HPAI and have not used vaccination in their control programs. Clinical disease and mortality have been prevented in chickens, human cases have been reduced, and rural livelihoods and food security have been maintained by using vaccines during HPAI outbreaks. However, field outbreaks have occurred in vaccinating countries, primarily because of inadequate coverage in the target species, but vaccine failures have occurred following antigenic drift in field viruses within China, Egypt

  9. Detectable Risks in Studies of the Fetal Benefits of Maternal Influenza Vaccination

    PubMed Central

    Hutcheon, Jennifer A.; Fell, Deshayne B.; Jackson, Michael L.; Kramer, Michael S.; Ortiz, Justin R.; Savitz, David A.; Platt, Robert W.

    2016-01-01

    Maternal influenza vaccination prevents influenza illness in both mothers and newborns. Results from some recent studies have suggested that influenza vaccination might also prevent adverse pregnancy outcomes, such as preterm birth. However, it is challenging to conduct epidemiologic studies to evaluate the benefits to the fetus of maternal influenza vaccination because the causal benefit of vaccination is likely only experienced by the small fraction of the cohort in whom influenza illness is prevented by vaccination. The plausibility of detecting true differences in risks between groups under such conditions is rarely discussed. We aimed to inform the interpretation of studies in which the fetal benefits of maternal influenza vaccination are evaluated by estimating detectable risk ratios and necessary sample sizes for different study scenarios. Estimates of rates of influenza illness, vaccine effectiveness, vaccine uptake, and preterm birth and of the association of influenza illness with preterm birth were identified from the published literature. We calculated detectable risk ratios for preterm birth in vaccinated versus unvaccinated women and the associated sample size requirements. Our results demonstrated that under most scenarios, plausible differences between groups will be extremely challenging to detect (risk ratios for preterm birth of 0.9 to 1.0) and will require sample sizes infeasible for prospective epidemiologic research. This suggests that the large fetal benefits from influenza vaccination observed in epidemiologic studies are unlikely to be causal. PMID:27365363

  10. Extrapolating theoretical efficacy of inactivated influenza A/H5N1 virus vaccine from human immunogenicity studies.

    PubMed

    Feldstein, Leora R; Matrajt, Laura; Elizabeth Halloran, M; Keitel, Wendy A; Longini, Ira M

    2016-07-19

    Influenza A virus subtype H5N1 has been a public health concern for almost 20years due to its potential ability to become transmissible among humans. Phase I and II clinical trials have assessed safety, reactogenicity and immunogenicity of inactivated influenza A/H5N1 virus vaccines. A shortage of vaccine is likely to occur during the first months of a pandemic. Hence, determining whether to give one dose to more people or two doses to fewer people to best protect the population is essential. We use hemagglutination-inhibition antibody titers as an immune correlate for avian influenza vaccines. Using an established relationship to obtain a theoretical vaccine efficacy from immunogenicity data from thirteen arms of six phase I and phase II clinical trials of inactivated influenza A/H5N1 virus vaccines, we assessed: (1) the proportion of theoretical vaccine efficacy achieved after a single dose (defined as primary response level), and (2) whether theoretical efficacy increases after a second dose, with and without adjuvant. Participants receiving vaccine with AS03 adjuvant had higher primary response levels (range: 0.48-0.57) compared to participants receiving vaccine with MF59 adjuvant (range: 0.32-0.47), with no observed trends in primary response levels by antigen dosage. After the first and second doses, vaccine with AS03 at dosage levels 3.75, 7.5 and 15mcg had the highest estimated theoretical vaccine efficacy: Dose (1) 45% (95% CI: 36-57%), 53% (95% CI: 42-63%) and 55% (95% CI: 44-64%), respectively and Dose (2) 93% (95% CI: 89-96%), 97% (95% CI: 95-98%) and 97% (95% CI: 96-100%), respectively. On average, the estimated theoretical vaccine efficacy of lower dose adjuvanted vaccines (AS03 and MF59) was 17% higher than that of higher dose unadjuvanted vaccines, suggesting that including an adjuvant is dose-sparing. These data indicate adjuvanted inactivated influenza A/H5N1 virus vaccine produces high theoretical efficacy after two doses to protect individuals

  11. Direct and indirect impact of influenza vaccination of young children on school absenteeism.

    PubMed

    King, James C; Beckett, Dawn; Snyder, Jonathan; Cummings, Ginny E; King, Bradley S; Magder, Laurence S

    2012-01-01

    Special mass influenza vaccination programs of elementary school-aged children (ESAC) in some or all Maryland Counties were conducted during the falls of 2005-2007. From 3% to 46% of ESAC received live attenuated influenza vaccine during these county programs, which were in addition to routine influenza vaccination efforts conducted in county medical offices. Anonymous, all cause public school absentee data for all grades was available from 11 of Maryland's 24 counties. Binomial regression was used to estimate associations between the percentage of children vaccinated in each county and the degree of increase in absenteeism rates during influenza outbreaks. We estimated that, for every 20% increase in vaccination rates for ESAC during these special programs, a 4% decrease in the rise in absentee rates occurred during influenza outbreak periods in both elementary and upper schools (P<0.05). These results suggest both direct and indirect benefits of influenza vaccination of young children. PMID:22085547

  12. Direct and indirect impact of influenza vaccination of young children on school absenteeism.

    PubMed

    King, James C; Beckett, Dawn; Snyder, Jonathan; Cummings, Ginny E; King, Bradley S; Magder, Laurence S

    2012-01-01

    Special mass influenza vaccination programs of elementary school-aged children (ESAC) in some or all Maryland Counties were conducted during the falls of 2005-2007. From 3% to 46% of ESAC received live attenuated influenza vaccine during these county programs, which were in addition to routine influenza vaccination efforts conducted in county medical offices. Anonymous, all cause public school absentee data for all grades was available from 11 of Maryland's 24 counties. Binomial regression was used to estimate associations between the percentage of children vaccinated in each county and the degree of increase in absenteeism rates during influenza outbreaks. We estimated that, for every 20% increase in vaccination rates for ESAC during these special programs, a 4% decrease in the rise in absentee rates occurred during influenza outbreak periods in both elementary and upper schools (P<0.05). These results suggest both direct and indirect benefits of influenza vaccination of young children.

  13. Temporal Patterns of Influenza A and B in Tropical and Temperate Countries: What Are the Lessons for Influenza Vaccination?

    PubMed Central

    Caini, Saverio; Andrade, Winston; Badur, Selim; Balmaseda, Angel; Barakat, Amal; Bella, Antonino; Bimohuen, Abderrahman; Brammer, Lynnette; Bresee, Joseph; Bruno, Alfredo; Castillo, Leticia; Ciblak, Meral A.; Clara, Alexey W.; Cohen, Cheryl; Cutter, Jeffery; Daouda, Coulibaly; de Lozano, Celina; De Mora, Domenica; Dorji, Kunzang; Emukule, Gideon O.; Fasce, Rodrigo A.; Feng, Luzhao; Ferreira de Almeida, Walquiria Aparecida; Guiomar, Raquel; Heraud, Jean-Michel; Holubka, Olha; Huang, Q. Sue; Kadjo, Herve A.; Kiyanbekova, Lyazzat; Kosasih, Herman; Kusznierz, Gabriela; Lara, Jenny; Li, Ming; Lopez, Liza; Mai Hoang, Phuong Vu; Pessanha Henriques, Cláudio Maierovitch; Matute, Maria Luisa; Mironenko, Alla; Moreno, Brechla; Mott, Joshua A.; Njouom, Richard; Nurhayati; Ospanova, Akerke; Owen, Rhonda; Pebody, Richard; Pennington, Kate; Puzelli, Simona; Quynh Le, Mai thi; Razanajatovo, Norosoa Harline; Rodrigues, Ana; Rudi, Juan Manuel; Tzer Pin Lin, Raymond; Venter, Marietjie; Vernet, Marie-Astrid; Wangchuk, Sonam; Yang, Juan; Yu, Hongjie; Zambon, Maria; Schellevis, François; Paget, John

    2016-01-01

    Introduction Determining the optimal time to vaccinate is important for influenza vaccination programmes. Here, we assessed the temporal characteristics of influenza epidemics in the Northern and Southern hemispheres and in the tropics, and discuss their implications for vaccination programmes. Methods This was a retrospective analysis of surveillance data between 2000 and 2014 from the Global Influenza B Study database. The seasonal peak of influenza was defined as the week with the most reported cases (overall, A, and B) in the season. The duration of seasonal activity was assessed using the maximum proportion of influenza cases during three consecutive months and the minimum number of months with ≥80% of cases in the season. We also assessed whether co-circulation of A and B virus types affected the duration of influenza epidemics. Results 212 influenza seasons and 571,907 cases were included from 30 countries. In tropical countries, the seasonal influenza activity lasted longer and the peaks of influenza A and B coincided less frequently than in temperate countries. Temporal characteristics of influenza epidemics were heterogeneous in the tropics, with distinct seasonal epidemics observed only in some countries. Seasons with co-circulation of influenza A and B were longer than influenza A seasons, especially in the tropics. Discussion Our findings show that influenza seasonality is less well defined in the tropics than in temperate regions. This has important implications for vaccination programmes in these countries. High-quality influenza surveillance systems are needed in the tropics to enable decisions about when to vaccinate. PMID:27031105

  14. Relationship between Guillain-Barré syndrome, influenza-related hospitalizations, and influenza vaccine coverage.

    PubMed

    Iqbal, Shahed; Li, Rongxia; Gargiullo, Paul; Vellozzi, Claudia

    2015-04-21

    Some studies reported an increased risk of Guillain-Barré syndrome (GBS) within six weeks of influenza vaccination. It has also been suggested that this finding could have been confounded by influenza illnesses. We explored the complex relationship between influenza illness, influenza vaccination, and GBS, from an ecologic perspective using nationally representative data. We also studied seasonal patterns for GBS hospitalizations. Monthly hospitalization data (2000-2009) for GBS, and pneumonia and influenza (P&I) in the Nationwide Inpatient Sample were included. Seasonal influenza vaccination coverage for 2004-2005 through the 2008-2009 influenza seasons (August-May) was estimated from the National Health Interview Survey data. GBS seasonality was determined using Poisson regression. GBS and P&I temporal clusters were identified using scan statistics. The association between P&I and GBS hospitalizations in the same month (concurrent) or in the following month (lagged) were determined using negative binomial regression. Vaccine coverage increased over the years (from 19.7% during 2004-2005 to 35.5% during 2008-2009 season) but GBS hospitalization did not follow a similar pattern. Overall, a significant correlation between monthly P&I and GBS hospitalizations was observed (Spearman's correlation coefficient=0.7016, p<0.0001). A significant (p=0.001) cluster of P&I hospitalizations during December 2004-March 2005 overlapped a significant (p=0.001) cluster of GBS hospitalizations during January 2005-February 2005. After accounting for effects of monthly vaccine coverage and age, P&I hospitalization was significantly associated (p<0.0001) with GBS hospitalization in the concurrent month but not with GBS hospitalization in the following month. Monthly vaccine coverage was not associated with GBS hospitalization in adjusted models (both concurrent and lagged). GBS hospitalizations demonstrated a seasonal pattern with winter months having higher rates compared to the

  15. Pandemic influenza vaccines and neuraminidase inhibitors: efficacy and side effects.

    PubMed

    Bijl, D

    2011-01-01

    At the time of the outbreak of the pandemic of New Influenza A (H1N1) pandemic influenza vaccines became available via an accelerated registration procedure. In 2005 large stocks of the neuraminidase inhibitor oseltamivir were built up in the Netherlands and other western countries. There was considerable doubt about the efficacy of this medicine. Initially reported positive effects of the drug were largely based on unpublished research, which was sponsored by the manufacturer and was partially written by ghostwriters. There now have been reports of rare and serious side effects. The first reports on the severity of the pandemic in Australia and New Zealand indicated a mild course.

  16. Demystifying FluMist, a new intranasal, live influenza vaccine.

    PubMed

    Mossad, Sherif B

    2003-09-01

    FluMist--a cold-adapted, live-attenuated, trivalent, intranasal influenza virus vaccine approved by the US Food and Drug Administration on June 17, 2003--has been shown to be safe and effective, but its role in the general prevention of influenza is yet to be defined. Intranasal administration is expected to be more acceptable than parenteral, particularly in children, but the potential for the shedding of live virus may pose a risk to anyone with a compromised immune system. PMID:14518575

  17. Seasonal influenza vaccine dose distribution in 195 countries (2004-2013): Little progress in estimated global vaccination coverage.

    PubMed

    Palache, Abraham; Oriol-Mathieu, Valerie; Fino, Mireli; Xydia-Charmanta, Margarita

    2015-10-13

    Seasonal influenza is an important disease which results in 250,000-500,000 annual deaths worldwide. Global targets for vaccination coverage rates (VCRs) in high-risk groups are at least 75% in adults ≥65 years and increased coverage in other risk groups. The International Federation of Pharmaceutical Manufacturers and Associations Influenza Vaccine Supply (IFPMA IVS) International Task Force developed a survey methodology in 2008, to assess the global distribution of influenza vaccine doses as a proxy for VCRs. This paper updates the previous survey results on absolute numbers of influenza vaccine doses distributed between 2004 and 2013 inclusive, and dose distribution rates per 1000 population, and provides a qualitative assessment of the principal enablers and barriers to seasonal influenza vaccination. The two main findings from the quantitative portion of the survey are the continued negative trend for dose distribution in the EURO region and the perpetuation of appreciable differences in scale of dose distribution between WHO regions, with no observed convergence in the rates of doses distributed per 1000 population over time. The main findings from the qualitative portion of the survey were that actively managing the vaccination program in real-time and ensuring political commitment to vaccination are important enablers of vaccination, whereas insufficient access to vaccination and lack of political commitment to seasonal influenza vaccination programs are likely contributing to vaccination target failures. In all regions of the world, seasonal influenza vaccination is underutilized as a public health tool. The survey provides evidence of lost opportunity to protect populations against potentially serious influenza-associated disease. We call on the national and international public health communities to re-evaluate their political commitment to the prevention of the annual influenza disease burden and to develop a systematic approach to improve vaccine

  18. Safety of human papillomavirus vaccines: a review

    PubMed Central

    Stillo, Michela; Carrillo Santisteve, Paloma; Lopalco, Pier Luigi

    2015-01-01

    Introduction: Between 2006 and 2009, two different human papillomavirus virus (HPV) vaccines were licensed for use: a quadrivalent (qHPVv) and a bivalent (bHPVv) vaccine. Since 2008, HPV vaccination programmes have been implemented in the majority of the industrialized countries. Since 2013, HPV vaccination has been part of the national programs of 66 countries including almost all countries in North America and Western Europe. Despite all the efforts made by individual countries, coverage rates are lower than expected. Vaccine safety represents one of the main concerns associated with the lack of acceptance of HPV vaccination both in the European Union/European Economic Area and elsewhere. Areas covered: Safety data published on bivalent and quadrivalent HPV vaccines, both in pre-licensure and post-licensure phase, are reviewed. Expert opinion: Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) represent an important barrier to overcome in order to increase vaccine coverage. Passive surveillance of AEs is an important tool for detecting safety signals, but it should be complemented by activities aimed at assessing the real cause of all suspect AEs. Improved vaccine safety surveillance is the first step for effective communication based on scientific evidence. PMID:25689872

  19. WHO influenza vaccine technology transfer initiative: role and activities of the Technical Advisory Group.

    PubMed

    Francis, Donald P; Grohmann, Gary

    2011-07-01

    In May 2006, the WHO published a Global Pandemic Influenza Action Plan. A significant part of that plan involves the transfer of technology necessary to build production capacity in developing countries. The WHO influenza technology transfer initiative has been successful. Clearly the relatively small WHO investments made in these companies to develop their own influenza vaccine production facilities have had quite dramatic results. A few companies are already producing large amounts of influenza vaccine. Others will soon follow. Whether they are developing egg-based or planning non-egg based influenza vaccine production, all companies are optimistic that their efforts will come to fruition.

  20. School-based influenza vaccine delivery, vaccination rates, and healthcare use in the context of a universal influenza immunization program: an ecological study.

    PubMed

    Kwong, Jeffrey C; Ge, Hong; Rosella, Laura C; Guan, Jun; Maaten, Sarah; Moran, Kathy; Johansen, Helen; Guttmann, Astrid

    2010-03-24

    Influenza vaccines are universally funded in Ontario, Canada. Some public health units (PHUs) vaccinate children in schools. We examined the impact of school-based delivery on vaccination rates and healthcare use of the entire population over seven influenza seasons (2000-2007) using population-based survey and health administrative data. School-based vaccination was associated with higher vaccination rates in school-age children only. Doctors' office visits were lower for PHUs with school-based vaccination for children aged 12-19 but not for other age groups. Emergency department use and hospitalizations were similar between the two groups. In the context of universal influenza vaccination, school-based delivery is associated with higher vaccination rates and modest reductions in healthcare use in school-age children.

  1. Increasing influenza vaccination in New York City taxi drivers: A community driven approach.

    PubMed

    Gany, Francesca; Rau-Murthy, Rohini; Mujawar, Imran

    2015-05-21

    The Healthy People 2020 influenza immunization goal is 80% for non-institutionalized adults 18-64. However, vaccination rates remain stubbornly low. Culturally tailored approaches to communities with poor vaccine uptake are necessary. Taxi drivers are at risk for influenza and its complications, could serve as vectors for influenza infection, and could be an effective vaccination target to enhance herd immunity of the urban population. To the best of our knowledge, this is the first study related to influenza vaccination among taxi drivers. The NYC Taxi Network surveyed a convenience sample of 53 taxi drivers to understand vaccination barriers. Only 17% had been vaccinated. Results informed a pilot tailored workplace intervention, which resulted in vaccinations for 44% of unvaccinated drivers. The study revealed that older drivers were more likely to be vaccinated than younger drivers, while the most common barrier to immunization was that drivers thought vaccination was 'not necessary'.

  2. Boosting Heterosubtypic Neutralization Antibodies in Recipients of 2009 Pandemic H1N1 Influenza Vaccine

    PubMed Central

    Qiu, Chao; Huang, Yang; Wang, Qian; Tian, Di; Zhang, Wanju; Hu, Yunwen; Yuan, Zhenghong; Zhang, Xiaoyan

    2012-01-01

    Background. A mass vaccination has been implemented to prevent the spread of 2009 pandemic influenza virus in China. Highly limited information is available on whether this vaccine induces cross-reactive neutralization antibodies against other subtypes of influenza viruses. Methods. We employed pseudovirus-based assays to analyze heterosubtypic neutralization responses in serum samples of 23 recipients of 2009 pandemic influenza vaccine. Results. One dose of pandemic vaccine not only stimulated good neutralization antibodies against cognate influenza virus 2009 influenza A (H1N1), but also raised broad cross-reactive neutralization activities against seasonal H3N2 and highly pathogenic avian influenza virus H5N1 and lesser to H2N2. The cross-reactive neutralization activities were completely abolished after the removal of immunoglobin G (IgG). In contrast, H1N1 vaccination alone in influenza-naive mice elicited only vigorous homologous neutralizing activities but not cross-reactive neutralization activities. Conclusions. Our data suggest that the cross-reactive neutralization epitopes do exist in this vaccine and could elicit significant cross-reactive neutralizing IgG antibodies in the presence of preexisting responses. The exposure to H1N1 vaccine is likely to modify the hierarchical order of preexisting immune responses to influenza viruses. These findings provide insights into the evolution of human immunity to influenza viruses after experiencing multiple influenza virus infections and vaccinations. PMID:22052887

  3. [Antineuraminidase serum antibodies in natural influenza A and immunization with influenza vaccines].

    PubMed

    Naĭkhin, A N; Tsaritsyna, I M; Syrodoeva, L G; Oleĭnikova, E V; Gorev, N E

    1983-01-01

    Parallel HI and virus-elution-from-erythrocytes-inhibition (a simplified method for titration of neuraminidase antibody) tests were used for examinations of 1117 blood serum specimens from 440 adults and children under study, 5250 single serum specimens from healthy subjects from birth to 65 years of age, 38 paired serum specimens from children who experienced influenza A/Texas/1/77 disease in the epidemic of 1979-1980, and 590 paired serum specimens from subjects immunized with influenza vaccines. In 7%-23% of influenza patients and immunized subjects antibody rise was observed to only one of the influenza A virus surface antigens, hemagglutinin or neuraminidase. The protective activity of antibody to influenza A virus neuraminidase was as good as that of antihemagglutinins. Both kinds of antibody interacted in protection against the disease. Antineuraminidase antibody was found to affect the decrease in severity of the infectious process in natural infection with influenza A. The formation of immunological memory in the system of synthesis of antihemagglutinins and antineuraminidase antibodies was shown to have features in common. The pattern of heterologous immune responses in immunized subjects and patients with influenza showed all antigenic varieties of neuraminidase N2 as well as neuraminidases N1 and N2 to share common cross-reacting determinants.

  4. [Vaccination safety and media publicity strategy].

    PubMed

    Tan, Jibin; Guo, Xiaomin; Li, Keli; Zhang, Xiumin

    2016-03-01

    Due to the over negative report of adverse event following immunization (AEFI) by media, some people began to question the safety of vaccination. Date published since 2005 were collected by literature retrieval, mainly including relative AEFI date, current status of media report of AEFI, public awareness about AEFI. Public concern about the vaccination safety mainly focused on the serious diseases which might be caused, influence on immune system. Media' s over negative reactions to AEFI and lack of related knowledge in general public have led to the public' s concern about vaccination safety. Vaccination is the most economical and effective measure for the prevention of diseases and AEFI incidence rate is very low. Therefore, it is necessary for media to give more positive report about vaccination safety.

  5. [Vaccination safety and media publicity strategy].

    PubMed

    Tan, Jibin; Guo, Xiaomin; Li, Keli; Zhang, Xiumin

    2016-03-01

    Due to the over negative report of adverse event following immunization (AEFI) by media, some people began to question the safety of vaccination. Date published since 2005 were collected by literature retrieval, mainly including relative AEFI date, current status of media report of AEFI, public awareness about AEFI. Public concern about the vaccination safety mainly focused on the serious diseases which might be caused, influence on immune system. Media' s over negative reactions to AEFI and lack of related knowledge in general public have led to the public' s concern about vaccination safety. Vaccination is the most economical and effective measure for the prevention of diseases and AEFI incidence rate is very low. Therefore, it is necessary for media to give more positive report about vaccination safety. PMID:27005553

  6. Risk of Guillain–Barré syndrome following pandemic influenza A(H1N1) 2009 vaccination in Germany†

    PubMed Central

    Prestel, Jürgen; Volkers, Peter; Mentzer, Dirk; Lehmann, Helmar C; Hartung, Hans-Peter; Keller-Stanislawski, Brigitte

    2014-01-01

    Purpose A prospective, epidemiologic study was conducted to assess whether the 2009 pandemic influenza A(H1N1) vaccination in Germany almost exclusively using an AS03-adjuvanted vaccine (Pandemrix) impacts the risk of Guillain–Barré syndrome (GBS) and its variant Fisher syndrome (FS). Methods Potential cases of GBS/FS were reported by 351 participating hospitals throughout Germany. The self-controlled case series methodology was applied to all GBS/FS cases fulfilling the Brighton Collaboration (BC) case definition (levels 1–3 of diagnostic certainty) with symptom onset between 1 November 2009 and 30 September 2010 reported until end of December 2010. Results Out of 676 GBS/FS reports, in 30 cases, GBS/FS (BC levels 1–3) occurred within 150 days following influenza A(H1N1) vaccination. The relative incidence of GBS/FS within the primary risk period (days 5–42 post-vaccination) compared with the control period (days 43–150 post-vaccination) was 4.65 (95%CI [2.17, 9.98]). Similar results were found when stratifying for infections within 3 weeks prior to onset of GBS/FS and when excluding cases with additional seasonal influenza vaccination. The overall result of temporally adjusted analyses supported the primary finding of an increased relative incidence of GBS/FS following influenza A(H1N1) vaccination. Conclusions The results indicate an increased risk of GBS/FS in temporal association with pandemic influenza A(H1N1) vaccination in Germany. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. PMID:24817531

  7. Use of computational and recombinant technologies for developing novel influenza vaccines.

    PubMed

    Wong, Terianne M; Ross, Ted M

    2016-01-01

    Influenza vaccine design has changed considerably with advancements in bioinformatics and computational biology. Improved surveillance efforts provide up-to-date information about influenza sequence diversity and assist with monitoring the spread of epidemics and vaccine efficacy rates. The advent of next-generation sequencing, epitope scanning and high-throughput analysis all help decipher influenza-associated protein interactions as well as predict immune responsiveness based on host genetic diversity. Computational approaches are utilized in nearly all aspects of vaccine design, from modeling, compatibility predictions, and optimization of antigens in various platforms. This overview discusses how computational techniques strengthen vaccine efforts against highly diverse influenza species.

  8. The complicated task of monitoring vaccine safety.

    PubMed

    Ellenberg, S S; Chen, R T

    1997-01-01

    Vaccination is an essential component of modern public health programs and is among our most cost-effective medical interventions. Yet despite vaccines' clear effectiveness in reducing risks of diseases that previously attacked large proportions of the population, caused many deaths, and left many people with permanent disabilities, current vaccination policies are not without controversy. Vaccines, like all other pharmaceutical products, are not entirely risk-free; while most known side effects are minor and self-limited, some vaccines have been associated with very rare but serious adverse effects. Because such rare effects are often not evident until vaccines come into widespread use, the Federal government maintains ongoing surveillance programs to monitor vaccine safety. The interpretation of data from such programs is complex and is associated with substantial uncertainty. A continual effort to monitor these data effectively and to develop more precise ways of assessing risks of vaccines is necessary to ensure public confidence in immunization programs.

  9. Influenza Vaccination Coverage Rate for Medical Staff: Influence of Hospital-Based Vaccination Campaign.

    PubMed

    Zielonka, T M; Szymańczak, M; Jakubiak, J; Nitsch-Osuch, A; Życińska, K

    2016-01-01

    Despite intensive recommendations, influenza vaccination rate in medical staff in Poland ranges from about 20 % in physicians to 10 % in nurses. The objective of this work was to assess the influence of hospital influenza vaccination campaign directed toward health care workers, combined with dispensing free of charge vaccine, on vaccination rate. The campaign was conducted by the Hospital Infection Control Team of the Czerniakowski Hospital in Warsaw, Poland, separately for physicians, nurses, and physiotherapists. Overall, 37 % of medical staff were vaccinated, including 55 % of physicians and 21 % of nurses. Concerning physicians, the greatest vaccination rate was in the orthopedic (80 %) and ophthalmology units (73 %), whereas the lowest rate was in the intensive care (22 %) and neurology units (20 %). Concerning nurses, the greatest vaccination rate was in those working in the outpatient (40 %) and emergency units (29 %), whereas the lowest rate was in the ophthalmology (6 %) and surgery units (11 %). We conclude that the professional knowledge campaign combined with the incentive of free of charge vaccine substantially raises the vaccination rate among medical staff.

  10. Influenza Vaccination Coverage Rate for Medical Staff: Influence of Hospital-Based Vaccination Campaign.

    PubMed

    Zielonka, T M; Szymańczak, M; Jakubiak, J; Nitsch-Osuch, A; Życińska, K

    2016-01-01

    Despite intensive recommendations, influenza vaccination rate in medical staff in Poland ranges from about 20 % in physicians to 10 % in nurses. The objective of this work was to assess the influence of hospital influenza vaccination campaign directed toward health care workers, combined with dispensing free of charge vaccine, on vaccination rate. The campaign was conducted by the Hospital Infection Control Team of the Czerniakowski Hospital in Warsaw, Poland, separately for physicians, nurses, and physiotherapists. Overall, 37 % of medical staff were vaccinated, including 55 % of physicians and 21 % of nurses. Concerning physicians, the greatest vaccination rate was in the orthopedic (80 %) and ophthalmology units (73 %), whereas the lowest rate was in the intensive care (22 %) and neurology units (20 %). Concerning nurses, the greatest vaccination rate was in those working in the outpatient (40 %) and emergency units (29 %), whereas the lowest rate was in the ophthalmology (6 %) and surgery units (11 %). We conclude that the professional knowledge campaign combined with the incentive of free of charge vaccine substantially raises the vaccination rate among medical staff. PMID:26839107

  11. Safety of immunization during pregnancy: a review of the evidence of selected inactivated and live attenuated vaccines.

    PubMed

    Keller-Stanislawski, Brigitte; Englund, Janet A; Kang, Gagandeep; Mangtani, Punam; Neuzil, Kathleen; Nohynek, Hanna; Pless, Robert; Lambach, Philipp; Zuber, Patrick

    2014-12-12

    Vaccine-preventable infectious diseases are responsible for significant maternal, neonatal, and young infant morbidity and mortality. While there is emerging scientific evidence, as well as theoretical considerations, indicating that certain vaccines are safe for pregnant women and fetuses, policy formulation is challenging because of perceived potential risks to the fetus. This report presents an overview of available evidence on pregnant women vaccination safety monitoring in pregnant women, from both published literature and ongoing surveillance programs. Safety data were reviewed for vaccines against diseases which increase morbidity in pregnant women, their fetus or infant as well as vaccines which are used in mass vaccination campaigns against diseases. They include inactivated seasonal and pandemic influenza, mono- and combined meningococcal polysaccharide and conjugated vaccines, tetanus toxoid and acellular pertussis combination vaccines, as well as monovalent or combined rubella, oral poliomyelitis virus and yellow fever vaccines. No evidence of adverse pregnancy outcomes has been identified from immunization of pregnant women with these vaccines. PMID:25285883

  12. Vaccination of children with a live-attenuated, intranasal influenza vaccine – analysis and evaluation through a Health Technology Assessment

    PubMed Central

    Andersohn, Frank; Bornemann, Reinhard; Damm, Oliver; Frank, Martin; Mittendorf, Thomas; Theidel, Ulrike

    2014-01-01

    %, respectively). In children aged >7 to 17 years (= 18th year of their lives), LAIV is superior to a vaccination with TIV (RRR 32%). For this age group, no studies that compared LAIV with placebo were identified. It can be concluded that there is high evidence for superior efficacy of LAIV (compared to placebo or TIV) among children aged 6 months to ≤7 years. For children from >7 to 17 years, there is moderate evidence for superiority of LAIV for children with asthma, while direct evidence for children from the general population is lacking for this age group. Due to the efficacy of LAIV in children aged 6 months to ≤7 years (high evidence) and the efficacy of LAIV in children with asthma aged >7 to 17 years (moderate evidence), LAIV is also very likely to be efficacious among children in the general population aged >7 to 17 years (indirect evidence). In the included studies with children aged 2 to 17 years, LAIV was safe and well-tolerated; while in younger children LAIV may increase the risk of obstruction of the airways (e.g. wheezing). In the majority of the evaluated epidemiological studies, LAIV proved to be effective in the prevention of influenza among children aged 2–17 years under everyday conditions (effectiveness). The trend appears to indicate that LAIV is more effective than TIV, although this can only be based on limited evidence for methodological reasons (observational studies). In addition to a direct protective effect for vaccinated children themselves, indirect protective ("herd protection") effects were reported among non-vaccinated elderly population groups, even at relatively low vaccination coverage of children. With regard to safety, LAIV generally can be considered equivalent to TIV. This also applies to the use among children with mild chronically obstructive conditions, from whom LAIV therefore does not have to be withheld. In all included epidemiological studies, there was some risk of bias identified, e.g. due to residual confounding or other

  13. [DEVELOPMENT OF THE QUADRIVALENT LIVE ATTENUATED INFLUENZA VACCINE INCLUDING TWO INFLUENZA B LINEAGES--VICTORIA AND YAMAGATA].

    PubMed

    Desheva, Yu A; Smolonogina, T A; Doroshenko, E M; Rudenko, L G

    2016-01-01

    This work is devoted to the research of the live attenuated influenza vaccine (LAIV) comprising two reassortant B/USSR/60/69-based vaccine influenza viruses Victoria and Yamagata. The intranasal immunization of the CBA mice with both Victoria and Yamagata strains induced 100% lung protection against the subsequent infection with the wild-type influenza B viruses of any antigen lineage. The quadrivalent LAIV (qLAIV) comprising both reassortant influenza B viruses Victoria and Yamagata were safe and areactogenic in adult volunteers. Following qLAIV administration the immune response was achieved to both Victoria and Yamagata lineages. PMID:27145595

  14. [DEVELOPMENT OF THE QUADRIVALENT LIVE ATTENUATED INFLUENZA VACCINE INCLUDING TWO INFLUENZA B LINEAGES--VICTORIA AND YAMAGATA].

    PubMed

    Desheva, Yu A; Smolonogina, T A; Doroshenko, E M; Rudenko, L G

    2016-01-01

    This work is devoted to the research of the live attenuated influenza vaccine (LAIV) comprising two reassortant B/USSR/60/69-based vaccine influenza viruses Victoria and Yamagata. The intranasal immunization of the CBA mice with both Victoria and Yamagata strains induced 100% lung protection against the subsequent infection with the wild-type influenza B viruses of any antigen lineage. The quadrivalent LAIV (qLAIV) comprising both reassortant influenza B viruses Victoria and Yamagata were safe and areactogenic in adult volunteers. Following qLAIV administration the immune response was achieved to both Victoria and Yamagata lineages.

  15. Clinical and Immune Responses to Inactivated Influenza A(H1N1)pdm09 Vaccine in Children

    PubMed Central

    Kotloff, Karen L.; Halasa, Natasha B.; Harrison, Christopher J.; Englund, Janet A.; Walter, Emmanuel B.; King, James C.; Creech, C. Buddy; Healy, Sara A.; Dolor, Rowena J.; Stephens, Ina; Edwards, Kathryn M.; Noah, Diana L.; Hill, Heather; Wolff, Mark

    2014-01-01

    Background As the influenza AH1N1 pandemic emerged in 2009, children were found to experience high morbidity and mortality and were prioritized for vaccination. This multicenter, randomized, double-blind, age-stratified trial assessed the safety and immunogenicity of inactivated influenza A(H1N1)pdm09 vaccine in healthy children aged 6 months to 17 years. Methods Children received two doses of approximately 15 μg or 30 μg hemagglutin antigen 21 days apart. Reactogenicity was assessed for 8 days after each dose, adverse events through day 42, and serious adverse events or new-onset chronic illnesses through day 201. Serum hemagglutination inhibition (HAI) titers were measured on days 0 (pre-vaccination), 8, 21, 29, and 42. Results A total of 583 children received the first dose and 571 received the second dose of vaccine. Vaccinations were generally well-tolerated and no related serious adverse events were observed. The 15 μg dosage elicited a seroprotective HAI (≥1:40) in 20%, 47%, and 93% of children in the 6-35 month, 3-9 year, and 10-17 year age strata 21 days after dose 1 and in 78%, 82%, and 98% of children 21 days after dose 2, respectively. The 30 μg vaccine dosage induced similar responses. Conclusions The inactivated influenza A(H1N1)pdm09 vaccine exhibited a favorable safety profile at both dosage levels. While a single 15 or 30 μg dose induced seroprotective antibody responses in most 10-17 year olds, younger children required 2 doses, even when receiving dosages 4-6 fold higher than recommended. Well-tolerated vaccines are needed that induce immunity after a single dose for use in young children during influenza pandemics. PMID:25222307

  16. Rapid production of a H₉ N₂ influenza vaccine from MDCK cells for protecting chicken against influenza virus infection.

    PubMed

    Ren, Zhenghua; Lu, Zhongzheng; Wang, Lei; Huo, Zeren; Cui, Jianhua; Zheng, Tingting; Dai, Qing; Chen, Cuiling; Qin, Mengying; Chen, Meihua; Yang, Rirong

    2015-04-01

    H9N2 subtype avian influenza viruses are widespread in domestic poultry, and vaccination remains the most effective way to protect the chicken population from avian influenza pandemics. Currently, egg-based H9N2 influenza vaccine production has several disadvantages and mammalian MDCK cells are being investigated as candidates for influenza vaccine production. However, little research has been conducted on low pathogenic avian influenza viruses (LPAIV) such as H9N2 replicating in mammalian cells using microcarrier beads in a bioreactor. In this study, we present a systematic analysis of a safe H9N2 influenza vaccine derived from MDCK cells for protecting chickens against influenza virus infection. In 2008, we isolated two novel H9N2 influenza viruses from chickens raised in southern China, and these H9N2 viruses were adapted to MDCK cells. The H9N2 virus was produced in MDCK cells in a scalable bioreactor, purified, inactivated, and investigated for use as a vaccine. The MDCK-derived H9N2 vaccine was able to induce high titers of neutralizing antibodies in chickens of different ages. Histopathological examination, direct immunofluorescence, HI assay, CD4(+)/CD8(+) ratio test, and cytokine evaluation indicated that the MDCK-derived H9N2 vaccine evoked a rapid and effective immune response to protect chickens from influenza infection. High titers of H9N2-specific antibodies were maintained in chickens for 5 months, and the MDCK-derived H9N2 vaccine had no effects on chicken growth. The use of MDCK cells in bioreactors for LPAIV vaccine production is an attractive option to prevent outbreaks of LPAIV in poultry.

  17. Strategies for Early Vaccination During Novel Influenza Outbreaks

    PubMed Central

    Laskowski, M.; Xiao, Y.; Charland, N.; Moghadas, S. M.

    2015-01-01

    Ongoing research and technology developments hold the promise of rapid production and large-scale deployment of strain-specific or cross-protective vaccines for novel influenza viruses. We sought to investigate the impact of early vaccination on age-specific attack rates and evaluate the outcomes of different vaccination strategies that are influenced by the level of single or two-dose vaccine-induced protections. We developed and parameterized an agent-based model for two population demographics of urban and remote areas in Canada. Our results demonstrate that there is a time period before and after the onset of epidemic, during which the outcomes of vaccination strategies may differ significantly and are highly influenced by demographic characteristics. For the urban population, attack rates were lowest for children younger than 5 years of age in all vaccination strategies. However, for the remote population, the lowest attack rates were obtained for adults older than 50 years of age in most strategies. We found that the reduction of attack rates following the start of vaccination campaigns during the epidemic depends critically on the disease transmissibility, suggesting that for a sufficiently high transmissibility, vaccine delivery after the onset of epidemic has little or no effect, regardless of the population demographics. PMID:26658016

  18. Development of a universal CTL-based vaccine for influenza.

    PubMed

    Cargnelutti, Diego Esteban; Sánchez, María Victoria; Mattion, Nora Marta; Scodeller, Eduardo Alberto

    2013-01-01

    In pursuit of better influenza vaccines, many strategies are being studied worldwide. An attractive alternative is the generation of a broadly cross-reactive vaccine based on the induction of cytotoxic T-lymphocytes (CTL) directed against conserved internal antigens of influenza A virus. The feasibility of this approach using recombinant viral vectors has recently been demonstrated in mice and humans by several research groups. However, similar results might also be achieved through immunization with viral proteins expressed in a prokaryotic system formulated with the appropriate adjuvants and delivery systems. This approach would be much simpler and less expensive. Recent results from several laboratories seem to confirm this is as a valid option to be considered. PMID:23337287

  19. Development of a universal CTL-based vaccine for influenza.

    PubMed

    Cargnelutti, Diego Esteban; Sánchez, María Victoria; Mattion, Nora Marta; Scodeller, Eduardo Alberto

    2013-01-01

    In pursuit of better influenza vaccines, many strategies are being studied worldwide. An attractive alternative is the generation of a broadly cross-reactive vaccine based on the induction of cytotoxic T-lymphocytes (CTL) directed against conserved internal antigens of influenza A virus. The feasibility of this approach using recombinant viral vectors has recently been demonstrated in mice and humans by several research groups. However, similar results might also be achieved through immunization with viral proteins expressed in a prokaryotic system formulated with the appropriate adjuvants and delivery systems. This approach would be much simpler and less expensive. Recent results from several laboratories seem to confirm this is as a valid option to be considered.

  20. Development of a universal CTL-based vaccine for influenza

    PubMed Central

    Cargnelutti, Diego Esteban; Sánchez, María Victoria; Mattion, Nora Marta; Scodeller, Eduardo Alberto

    2013-01-01

    In pursuit of better influenza vaccines, many strategies are being studied worldwide. An attractive alternative is the generation of a broadly cross-reactive vaccine based on the induction of cytotoxic T-lymphocytes (CTL) directed against conserved internal antigens of influenza A virus. The feasibility of this approach using recombinant viral vectors has recently been demonstrated in mice and humans by several research groups. However, similar results might also be achieved through immunization with viral proteins expressed in a prokaryotic system formulated with the appropriate adjuvants and delivery systems. This approach would be much simpler and less expensive. Recent results from several laboratories seem to confirm this is as a valid option to be considered. PMID:23337287

  1. Does influenza vaccination improve pregnancy outcome? Methodological issues and research needs.

    PubMed

    Savitz, David A; Fell, Deshayne B; Ortiz, Justin R; Bhat, Niranjan

    2015-11-25

    Evidence that influenza vaccination during pregnancy is safe and effective at preventing influenza disease in women and their children through the first months of life is increasing. Several reports of reduced risk of adverse outcomes associated with influenza vaccination have generated interest in its potential for improving pregnancy outcome. Gavi, the Vaccine Alliance, estimates maternal influenza immunization programs in low-income countries would have a relatively modest impact on mortality compared to other new or under-utilized vaccines, however the impact would be substantially greater if reported vaccine effects on improved pregnancy outcomes were accurate. Here, we examine the available evidence and methodological issues bearing on the relationship between influenza vaccination and pregnancy outcome, particularly preterm birth and fetal growth restriction, and summarize research needs. Evidence for absence of harm associated with vaccination at a point in time is not symmetric with evidence of benefit, given the scenario in which vaccination reduces risk of influenza disease and, in turn, risk of adverse pregnancy outcome. The empirical evidence for vaccination preventing influenza in pregnant women is strong, but the evidence that influenza itself causes adverse pregnancy outcomes is inconsistent and limited in quality. Studies of vaccination and pregnancy outcome have produced mixed evidence of potential benefit but are limited in terms of influenza disease assessment and control of confounding, and their analytic methods often fail to fully address the longitudinal nature of pregnancy and influenza prevalence. We recommend making full use of results of randomized trials, re-analysis of existing observational studies to account for confounding and time-related factors, and quantitative assessment of the potential benefits of vaccination in improving pregnancy outcome, all of which should be informed by the collective engagement of experts in influenza

  2. A Viable Recombinant Rhabdovirus Lacking Its Glycoprotein Gene and Expressing Influenza Virus Hemagglutinin and Neuraminidase Is a Potent Influenza Vaccine

    PubMed Central

    Ryder, Alex B.; Buonocore, Linda; Vogel, Leatrice; Nachbagauer, Raffael; Krammer, Florian

    2014-01-01

    ABSTRACT The emergence of novel influenza viruses that cause devastating human disease is an ongoing threat and serves as an impetus for the continued development of novel approaches to influenza vaccines. Influenza vaccine development has traditionally focused on producing humoral and/or cell-mediated immunity, often against the viral surface glycoproteins hemagglutinin (HA) and neuraminidase (NA). Here, we describe a new vaccine candidate that utilizes a replication-defective vesicular stomatitis virus (VSV) vector backbone that lacks the native G surface glycoprotein gene (VSVΔG). The expression of the H5 HA of an H5N1 highly pathogenic avian influenza virus (HPAIV), A/Vietnam/1203/04 (VN1203), and the NA of the mouse-adapted H1N1 influenza virus A/Puerto Rico/8/34 (PR8) in the VSVΔG vector restored the ability of the recombinant virus to replicate in cell culture, without the requirement for the addition of trypsin. We show here that this recombinant virus vaccine candidate was nonpathogenic in mice when given by either the intramuscular or intranasal route of immunization and that the in vivo replication of VSVΔG-H5N1 is profoundly attenuated. This recombinant virus also provided protection against lethal H5N1 infection after a single dose. This novel approach to vaccination against HPAIVs may be widely applicable to other emerging strains of influenza virus. IMPORTANCE Preparation for a potentially catastrophic influenza pandemic requires novel influenza vaccines that are safe, can be produced and administered quickly, and are effective, both soon after administration and for a long duration. We have created a new influenza vaccine that utilizes an attenuated vesicular stomatitis virus (VSV) vector, to deliver and express influenza virus proteins against which vaccinated animals develop potent antibody responses. The influenza virus hemagglutinin and neuraminidase proteins, expressed on the surface of VSV particles, allowed this vaccine to grow in cell

  3. Preexisting Immunity, More Than Aging, Influences Influenza Vaccine Responses

    PubMed Central

    Reber, Adrian J.; Kim, Jin Hyang; Biber, Renata; Talbot, H. Keipp; Coleman, Laura A.; Chirkova, Tatiana; Gross, F. Liaini; Steward-Clark, Evelene; Cao, Weiping; Jefferson, Stacie; Veguilla, Vic; Gillis, Eric; Meece, Jennifer; Bai, Yaohui; Tatum, Heather; Hancock, Kathy; Stevens, James; Spencer, Sarah; Chen, Jufu; Gargiullo, Paul; Braun, Elise; Griffin, Marie R.; Sundaram, Maria; Belongia, Edward A.; Shay, David K.; Katz, Jacqueline M.; Sambhara, Suryaprakash

    2015-01-01

    Background. Influenza disproportionately impacts older adults while current vaccines have reduced effectiveness in the older population. Methods. We conducted a comprehensive evaluation of cellular and humoral immune responses of adults aged 50 years and older to the 2008–2009 seasonal trivalent inactivated influenza vaccine and assessed factors influencing vaccine response. Results. Vaccination increased hemagglutination inhibition and neutralizing antibody; however, 66.3% of subjects did not reach hemagglutination inhibition titers ≥ 40 for H1N1, compared with 22.5% for H3N2. Increasing age had a minor negative impact on antibody responses, whereas prevaccination titers were the best predictors of postvaccination antibody levels. Preexisting memory B cells declined with age, especially for H3N2. However, older adults still demonstrated a significant increase in antigen-specific IgG+ and IgA+ memory B cells postvaccination. Despite reduced frequency of preexisting memory B cells associated with advanced age, fold-rise in memory B cell frequency in subjects 60+ was comparable to subjects age 50–59. Conclusions. Older adults mounted statistically significant humoral and cell-mediated immune responses, but many failed to reach hemagglutination inhibition titers ≥40, especially for H1N1. Although age had a modest negative effect on vaccine responses, prevaccination titers were the best predictor of postvaccination antibody levels, irrespective of age. PMID:26380344

  4. [Representations of the elderly on the influenza vaccine].

    PubMed

    Costa e Silva, Susanne Pinheiro; Menandro, Maria Cristina Smith

    2013-08-01

    This study sought to understand the social representations of health and immunization for elderly individuals vaccinated and unvaccinated with influenza vaccine. The theoretical benchmark adopted was the Theory of Social Representations of a qualitative nature. The research was carried out with thirty elderly individuals, fifteen of whom were vaccinated against influenza and fifteen who were not. Individual interviews were conducted using a questionnaire for characterization and the Free Word Association of Test (TALP) as data collection instruments and analysis was conducted using Central Nucleus Theory. TALP data revealed differences between the representations for the elderly of the two groups. Those vaccinated considered health as being synonymous with well-being, permitting the conduct of daily activities and immunization as something that protects them from various evils. However, those who remained unvaccinated defined health as a product of divine will and immunization as something that protects, but has side effects, which discouraged them from taking it. The study indicated the importance of health education and demystification of misconceptions about vaccines, since healthy habits must be increasingly encouraged, thereby reducing the high rates of preventable morbidity and mortality.

  5. A structured avian influenza model with imperfect vaccination and vaccine-induced asymptomatic infection.

    PubMed

    Gulbudak, Hayriye; Martcheva, Maia

    2014-10-01

    We introduce a model of avian influenza in domestic birds with imperfect vaccination and age-since-vaccination structure. The model has four components: susceptible birds, vaccinated birds (stratified by vaccination age), asymptomatically infected birds, and infected birds. The model includes reduction in the probability of infection, decreasing severity of disease of vaccinated birds and vaccine waning. The basic reproduction number, [Formula: see text], is calculated. The disease-free equilibrium is found to be globally stable under certain conditions when [Formula: see text]. When [Formula: see text], existence of an endemic equilibrium is proved (with uniqueness for the ODE case and local stability under stricter conditions) and uniform persistence of the disease is established. The inclusion of reduction in susceptibility of vaccinated birds, reduction in infectiousness of asymptomatically infected birds and vaccine waning can have important implications for disease control. We analytically and numerically demonstrate that vaccination can paradoxically increase the total number of infected, resulting in the "silent spread" of the disease. We also study the effects of vaccine efficacy on disease prevalence and the minimum critical vaccination coverage, a threshold value for vaccination coverage to avoid an increase in total disease prevalence due to asymptomatic infection. PMID:25230802

  6. School-Located Influenza Vaccination Reduces Community Risk for Influenza and Influenza-Like Illness Emergency Care Visits

    PubMed Central

    Tran, Cuc H.; Sugimoto, Jonathan D.; Pulliam, Juliet R. C.; Ryan, Kathleen A.; Myers, Paul D.; Castleman, Joan B.; Doty, Randell; Johnson, Jackie; Stringfellow, Jim; Kovacevich, Nadia; Brew, Joe; Cheung, Lai Ling; Caron, Brad; Lipori, Gloria; Harle, Christopher A.; Alexander, Charles; Yang, Yang; Longini, Ira M.; Halloran, M. Elizabeth; Morris, J. Glenn; Small, Parker A.

    2014-01-01

    Background School-located influenza vaccination (SLIV) programs can substantially enhance the sub-optimal coverage achieved under existing delivery strategies. Randomized SLIV trials have shown these programs reduce laboratory-confirmed influenza among both vaccinated and unvaccinated children. This work explores the effectiveness of a SLIV program in reducing the community risk of influenza and influenza-like illness (ILI) associated emergency care visits. Methods For the 2011/12 and 2012/13 influenza seasons, we estimated age-group specific attack rates (AR) for ILI from routine surveillance and census data. Age-group specific SLIV program effectiveness was estimated as one minus the AR ratio for Alachua County versus two comparison regions: the 12 county region surrounding Alachua County, and all non-Alachua counties in Florida. Results Vaccination of ∼50% of 5–17 year-olds in Alachua reduced their risk of ILI-associated visits, compared to the rest of Florida, by 79% (95% confidence interval: 70, 85) in 2011/12 and 71% (63, 77) in 2012/13. The greatest indirect effectiveness was observed among 0–4 year-olds, reducing AR by 89% (84, 93) in 2011/12 and 84% (79, 88) in 2012/13. Among all non-school age residents, the estimated indirect effectiveness was 60% (54, 65) and 36% (31, 41) for 2011/12 and 2012/13. The overall effectiveness among all age-groups was 65% (61, 70) and 46% (42, 50) for 2011/12 and 2012/13. Conclusion Wider implementation of SLIV programs can significantly reduce the influenza-associated public health burden in communities. PMID:25489850

  7. Effectiveness of influenza vaccination of schoolchildren in the city of São Paulo, Brazil, 2009

    PubMed Central

    Gattás, Vera L; Cardoso, Maria Regina A; Mondini, Gabriela; Machado, Clarisse M; Luna, Expedito J A

    2015-01-01

    Background Children play an important role in maintaining the tran