9 CFR 113.200 - General requirements for killed virus vaccines.

Code of Federal Regulations, 2012 CFR

2012-01-01

... vaccines. 113.200 Section 113.200 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... REQUIREMENTS Killed Virus Vaccines § 113.200 General requirements for killed virus vaccines. When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a killed virus vaccine...

40 CFR 85.1411 - Labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 18 2010-07-01 2010-07-01 false Labeling requirements. 85.1411 Section 85.1411 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CONTROL OF AIR POLLUTION FROM MOBILE SOURCES Urban Bus Rebuild Requirements § 85.1411 Labeling...

49 CFR 583.5 - Label requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 7 2013-10-01 2013-10-01 false Label requirements. 583.5 Section 583.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.5 Label...

49 CFR 583.5 - Label requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Label requirements. 583.5 Section 583.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.5 Label...

49 CFR 583.5 - Label requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 7 2011-10-01 2011-10-01 false Label requirements. 583.5 Section 583.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.5 Label...

49 CFR 583.5 - Label requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 7 2012-10-01 2012-10-01 false Label requirements. 583.5 Section 583.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.5 Label...

49 CFR 583.5 - Label requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 7 2014-10-01 2014-10-01 false Label requirements. 583.5 Section 583.5 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AUTOMOBILE PARTS CONTENT LABELING § 583.5 Label...

9 CFR 113.300 - General requirements for live virus vaccines.

Code of Federal Regulations, 2012 CFR

2012-01-01

... vaccines. 113.300 Section 113.300 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... REQUIREMENTS Live Virus Vaccines § 113.300 General requirements for live virus vaccines. When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a live virus vaccine shall meet the...

9 CFR 113.300 - General requirements for live virus vaccines.

Code of Federal Regulations, 2011 CFR

2011-01-01

... vaccines. 113.300 Section 113.300 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... REQUIREMENTS Live Virus Vaccines § 113.300 General requirements for live virus vaccines. When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a live virus vaccine shall meet the...

9 CFR 113.300 - General requirements for live virus vaccines.

Code of Federal Regulations, 2014 CFR

2014-01-01

... vaccines. 113.300 Section 113.300 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... REQUIREMENTS Live Virus Vaccines § 113.300 General requirements for live virus vaccines. When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a live virus vaccine shall meet the...

9 CFR 113.300 - General requirements for live virus vaccines.

Code of Federal Regulations, 2013 CFR

2013-01-01

... vaccines. 113.300 Section 113.300 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... REQUIREMENTS Live Virus Vaccines § 113.300 General requirements for live virus vaccines. When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a live virus vaccine shall meet the...

40 CFR 600.301 - Labeling requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 31 2013-07-01 2013-07-01 false Labeling requirements. 600.301 Section 600.301 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy Labeling § 600.301 Labeling...

40 CFR 600.301 - Labeling requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 30 2014-07-01 2014-07-01 false Labeling requirements. 600.301 Section 600.301 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy Labeling § 600.301 Labeling...

40 CFR 600.301 - Labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 31 2012-07-01 2012-07-01 false Labeling requirements. 600.301 Section 600.301 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy Labeling § 600.301 Labeling...

30 CFR 47.41 - Requirement for container labels.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Requirement for container labels. 47.41 Section... TRAINING HAZARD COMMUNICATION (HazCom) Container Labels and Other Forms of Warning § 47.41 Requirement for container labels. (a) The operator must ensure that each container of a hazardous chemical has a label. If a...

16 CFR 300.14 - Substitute label requirement.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Substitute label requirement. 300.14 Section 300.14 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS RULES AND REGULATIONS UNDER THE WOOL PRODUCTS LABELING ACT OF 1939 Labeling § 300.14 Substitute label...

16 CFR 1201.5 - Certification and labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Certification and labeling requirements... Certification and labeling requirements. (a) Manufacturers and private labelers of glazing materials covered by... issued under section 14. (b) [Reserved] (c) Organic-coated glass that has been tested for environmental...

10 CFR 431.30 - Applicability of labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 3 2010-01-01 2010-01-01 false Applicability of labeling requirements. 431.30 Section 431.30 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY EFFICIENCY PROGRAM FOR CERTAIN COMMERCIAL AND INDUSTRIAL EQUIPMENT Electric Motors Labeling § 431.30 Applicability of labeling requirements. The...

An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11-15 years of age.

PubMed

Kosalaraksa, Pope; Mehlsen, Jesper; Vesikari, Timo; Forstén, Aino; Helm, Klaus; Van Damme, Pierre; Joura, Elmar A; Ciprero, Karen; Maansson, Roger; Luxembourg, Alain; Sobanjo-ter Meulen, Ajoke

2015-06-01

A 9-valent human papillomavirus (9vHPV) vaccine has recently been reported to be safe and highly efficacious against infection and disease related to HPV6/11/16/18/31/33/45/52/58. We evaluated the immunogenicity and safety of the 9vHPV vaccine administered concomitantly with REPEVAX (diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine). This open-label, randomized, multicenter study enrolled 1054 males and females ages 11-15 years. Subjects were randomly assigned to each group in a 1:1 ratio. Subjects received a 0.5 mL dose of 9vHPV vaccine intramuscularly at day 1, months 2 and 6 and a 0.5 mL dose of REPEVAX either on day 1 (concomitant vaccination group; n = 526) or at month 1 (nonconcomitant vaccination group, n = 528). Serologic responses for each vaccine component were tested by 1-sided tests of noninferiority between groups. Systemic and injection-site adverse experiences (AEs) and serious AEs were monitored. Noninferiority of anti-HPV geometric mean titers and seroconversion rates for all 9vHPV antigens were demonstrated for the concomitant group compared with the nonconcomitant group. Seroconversion rates for the 9vHPV vaccine types were ≥99.8% in both groups at month 7. For REPEVAX, noninferiority of immune response was established for diphtheria, tetanus, all polio and pertussis antigens for both groups. There were no vaccine-related serious AEs. Overall, concomitant administration of 9vHPV vaccine and REPEVAX was generally well tolerated and did not interfere with the immune response to either vaccine. This strategy would minimize the number of visits required to deliver each vaccine individually.

10 CFR 835.606 - Exceptions to labeling requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Exceptions to labeling requirements. 835.606 Section 835.606 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.606 Exceptions to labeling requirements. (a) Items and containers may be excepted from the radioactive material...

10 CFR 835.606 - Exceptions to labeling requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Exceptions to labeling requirements. 835.606 Section 835.606 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.606 Exceptions to labeling requirements. (a) Items and containers may be excepted from the radioactive material...

10 CFR 835.606 - Exceptions to labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Exceptions to labeling requirements. 835.606 Section 835.606 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.606 Exceptions to labeling requirements. (a) Items and containers may be excepted from the radioactive material...

10 CFR 835.606 - Exceptions to labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Exceptions to labeling requirements. 835.606 Section 835.606 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.606 Exceptions to labeling requirements. (a) Items and containers may be excepted from the radioactive material...

10 CFR 835.606 - Exceptions to labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Exceptions to labeling requirements. 835.606 Section 835.606 Energy DEPARTMENT OF ENERGY OCCUPATIONAL RADIATION PROTECTION Posting and Labeling § 835.606 Exceptions to labeling requirements. (a) Items and containers may be excepted from the radioactive material...

21 CFR 610.67 - Bar code label requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Bar code label requirements. 610.67 Section 610.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.67 Bar code label requirements...

21 CFR 610.67 - Bar code label requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Bar code label requirements. 610.67 Section 610.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.67 Bar code label requirements...

21 CFR 201.58 - Waiver of labeling requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Waiver of labeling requirements. 201.58 Section 201.58 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.58 Waiver of...

21 CFR 201.58 - Waiver of labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Waiver of labeling requirements. 201.58 Section 201.58 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.58 Waiver of...

21 CFR 201.58 - Waiver of labeling requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Waiver of labeling requirements. 201.58 Section 201.58 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.58 Waiver of...

21 CFR 201.58 - Waiver of labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Waiver of labeling requirements. 201.58 Section 201.58 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.58 Waiver of...

21 CFR 201.58 - Waiver of labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Waiver of labeling requirements. 201.58 Section 201.58 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.58 Waiver of...

21 CFR 1302.05 - Effective dates of labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Effective dates of labeling requirements. 1302.05 Section 1302.05 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.05 Effective dates of labeling requirements. All...

42 CFR 84.257 - Labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Labeling requirements. (a) A warning shall be placed on the label of each gas mask, chemical-cartridge... performance of any gas mask, chemical-cartridge respirator, or powered air-purifying respirator approved under... this subpart shall be specified as follows: Chemical-cartridge respirator 1 hour. Gas mask 4 hours...

An open-label, single arm, phase III clinical study to evaluate the efficacy and safety of CJ smallpox vaccine in previously vaccinated healthy adults.

PubMed

Kim, Nak-Hyun; Kang, Yu Min; Kim, Gayeon; Choe, Pyoeng Gyun; Song, Jin Su; Lee, Kwang-Hee; Seong, Baik-Lin; Park, Wan Beom; Kim, Nam Joong; Oh, Myoung-don

2013-10-25

The increased possibility of bioterrorism has led to reinitiation of smallpox vaccination. In Korea, more than 30 years have passed since the last smallpox vaccinations, and even people who were previously vaccinated are not regarded as adequately protected against smallpox. We evaluated the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, in healthy adults previously vaccinated against smallpox. We conducted an open label, single arm, phase III clinical trial to evaluate the efficacy and safety of CJ-50300. Healthy volunteers, previously vaccinated against smallpox, born between 1950 and 1978 were enrolled. CJ-50300 was administered with a bifurcated needle over the deltoid muscle according to the recommended method. The rate of the cutaneous take reaction, humoral immunogenicity, and safety of the vaccine was assessed. Of 145 individuals enrolled for vaccination, 139 completed the study. The overall rates of cutaneous take reactions and humoral immunogenicity were 95.0% (132/139) and 88.5% (123/139), respectively. Although 95.9% (139/145) reported adverse events related to vaccination, no serious adverse reactions were observed. CJ-50300 can be used safely and effectively in healthy adults previously vaccinated against smallpox. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

21 CFR 701.2 - Form of stating labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Form of stating labeling requirements. 701.2 Section 701.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING General Provisions § 701.2 Form of stating labeling requirements. (a...

21 CFR 701.2 - Form of stating labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Form of stating labeling requirements. 701.2 Section 701.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING General Provisions § 701.2 Form of stating labeling requirements. (a...

21 CFR 701.2 - Form of stating labeling requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Form of stating labeling requirements. 701.2 Section 701.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING General Provisions § 701.2 Form of stating labeling requirements. (a...

21 CFR 701.2 - Form of stating labeling requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Form of stating labeling requirements. 701.2 Section 701.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING General Provisions § 701.2 Form of stating labeling requirements. (a...

21 CFR 701.2 - Form of stating labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Form of stating labeling requirements. 701.2 Section 701.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING General Provisions § 701.2 Form of stating labeling requirements. (a...

40 CFR 1051.137 - What are the consumer labeling requirements?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 32 2010-07-01 2010-07-01 false What are the consumer labeling requirements? 1051.137 Section 1051.137 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... and Related Requirements § 1051.137 What are the consumer labeling requirements? Label every vehicle...

[Pertussis in fully vaccinated infants and children. Are new vaccination strategies required?].

PubMed

Moraga-Llop, Fernando A; Mendoza-Palomar, Natàlia; Muntaner-Alonso, Antoni; Codina-Grau, Gemma; Fàbregas-Martori, Anna; Campins-Martí, Magda

2014-04-01

To analyse the vaccination status of children diagnosed with pertussis and to compare the clinical manifestations of fully vaccinated with unvaccinated, or incompletely-vaccinated, children. The clinical histories and vaccination cards of patients under 16years of age seen in the Emergency Room of the University Hospital Vall d'Hebron, Barcelona (Spain), for pertussis confirmed by a microbiological study were reviewed. The study period lasted from January 1, 2009 to December 31, 2011. Two hundred and twelve cases were studied: 35 in 2009, 28 in 2010 and 149 in 2011. RT-PCR was positive in 210 patients, and 73 had a positive culture. Infants under 6months of age account for 36.8% of all cases. Forty-four patients (21.5%) were not vaccinated. Forty-four (21.5%) children were between 2 and 5months of age and had received 1-2vaccine doses. One hundred and seventeen (57%) children were fully vaccinated; 76.9% (90cases) had received the last dose less than 4years ago. When clinical manifestations of the fully vaccinated patients were compared with those of the non-vaccinated or incompletely-vaccinated children, only cyanosis was found with a higher frequency in the latter group (P<.001). The age-adjusted probability of hospitalisation was significantly associated with non-vaccination (P=.001). The case mortality rate among inpatients was 1.3%. The number of pertussis cases seen in our centre has risen significantly in the last year. More than half (57%) of the patients were fully vaccinated, and 76.9% had received the last dose in the previous 4years. Other vaccination strategies, such as vaccination of adolescents, adults, and pregnant women, as well as a cocoon strategy are required to protect infants under 6months of age. More effective vaccines need to be developed. Copyright © 2012 Elsevier España, S.L. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

16 CFR 300.5 - Required label and method of affixing.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Required label and method of affixing. 300.5 Section 300.5 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS RULES AND REGULATIONS UNDER THE WOOL PRODUCTS LABELING ACT OF 1939 Labeling § 300.5 Required label and...

21 CFR 610.67 - Bar code label requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... or to blood and blood components intended for transfusion. For blood and blood components intended...) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.67 Bar code label requirements. Biological products must comply with the bar code requirements at § 201.25 of this chapter. However, the bar...

21 CFR 610.67 - Bar code label requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... or to blood and blood components intended for transfusion. For blood and blood components intended...) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.67 Bar code label requirements. Biological products must comply with the bar code requirements at § 201.25 of this chapter. However, the bar...

21 CFR 610.67 - Bar code label requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... or to blood and blood components intended for transfusion. For blood and blood components intended...) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.67 Bar code label requirements. Biological products must comply with the bar code requirements at § 201.25 of this chapter. However, the bar...

40 CFR 211.211 - Compliance with labeling requirement.

Code of Federal Regulations, 2010 CFR

2010-07-01

... ABATEMENT PROGRAMS PRODUCT NOISE LABELING Hearing Protective Devices § 211.211 Compliance with labeling requirement. (a) All hearing protective devices manufactured after the effective date of this regulation, and... comply with the Labeled Values of mean attenuation. (b) A manufacturer must take into account both...

21 CFR 201.15 - Drugs; prominence of required label statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs; prominence of required label statements. 201.15 Section 201.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.15 Drugs; prominence of required label statements. (a) A word, statement,...

9 CFR 590.50 - Temperature and labeling requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

...) Refrigeration of Shell Eggs § 590.50 Temperature and labeling requirements. (a) No shell egg handler shall... stored and transported under refrigeration at an ambient temperature of no greater than 45 °F (7.2 °C... the ultimate consumer unless they are labeled to indicate that refrigeration is required. (c) Any...

9 CFR 590.50 - Temperature and labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

...) Refrigeration of Shell Eggs § 590.50 Temperature and labeling requirements. (a) No shell egg handler shall... stored and transported under refrigeration at an ambient temperature of no greater than 45°F (7.2°C). (b... ultimate consumer unless they are labeled to indicate that refrigeration is required. (c) Any producer...

9 CFR 590.50 - Temperature and labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

...) Refrigeration of Shell Eggs § 590.50 Temperature and labeling requirements. (a) No shell egg handler shall... stored and transported under refrigeration at an ambient temperature of no greater than 45°F (7.2°C). (b... ultimate consumer unless they are labeled to indicate that refrigeration is required. (c) Any producer...

9 CFR 590.50 - Temperature and labeling requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

...) Refrigeration of Shell Eggs § 590.50 Temperature and labeling requirements. (a) No shell egg handler shall... stored and transported under refrigeration at an ambient temperature of no greater than 45 °F (7.2 °C... the ultimate consumer unless they are labeled to indicate that refrigeration is required. (c) Any...

Parents’ Support for School-Entry Requirements for Human Papillomavirus Vaccination: A National Study

PubMed Central

Calo, William A.; Gilkey, Melissa B.; Shah, Parth D.; Moss, Jennifer L.; Brewer, Noel T.

2016-01-01

Background The number of states proposing school-entry requirements for human papillomavirus (HPV) vaccination has increased over the last decade. However, data are currently limited regarding parents' support of such laws. We sought to obtain the first national estimates of parents' support of HPV vaccination school-entry requirements. Methods A national sample of 1501 parents of 11- to 17-year-old children completed a web-based survey between November 2014 and January 2015. Analyses used multivariable logistic regression to assess correlates of support for school-entry requirements for HPV vaccination. Results Overall, 21% of parents agreed that laws requiring HPV vaccination for school attendance "are a good idea," and 54% disagreed. If school-entry requirements included opt-out provisions, agreement increased to 57%, and only 21% disagreed. Parents more often agreed with requirements without opt-out provisions if they were Hispanic (OR=1.53, 95% CI: 1.05–2.22), believed HPV vaccine was as or more important than other adolescent vaccines (OR=2.76, 95% CI: 1.98–3.83), or believed HPV vaccine was effective for preventing cervical cancer (OR=2.55, 95% CI: 1.93–3.37). Parents less often agreed if they resided in Midwest states or believed that HPV vaccine was being pushed to make money for drug companies (both p<.05). Conclusion Opt-out provisions almost tripled parents' support for HPV vaccine school-entry requirements. Our findings suggest that race/ethnicity, attitudes about HPV vaccine, and region of residence may influence support for requirements without opt-out provisions. Impact Opt-out provisions greatly increase parent support of school-entry requirements for HPV vaccination but may make them ineffective. PMID:27543621

Parents' Support for School-Entry Requirements for Human Papillomavirus Vaccination: A National Study.

PubMed

Calo, William A; Gilkey, Melissa B; Shah, Parth D; Moss, Jennifer L; Brewer, Noel T

2016-09-01

The number of states proposing school-entry requirements for human papillomavirus (HPV) vaccination has increased over the last decade. However, data are currently limited regarding parents' support of such laws. We sought to obtain the first national estimates of parents' support of HPV vaccination school-entry requirements. A national sample of 1,501 parents of 11- to 17-year-old children completed a web-based survey between November 2014 and January 2015. Analyses used multivariable logistic regression to assess correlates of support for school-entry requirements for HPV vaccination. Overall, 21% of parents agreed that laws requiring HPV vaccination for school attendance "are a good idea," and 54% disagreed. If school-entry requirements included opt-out provisions, agreement increased to 57%, and only 21% disagreed. Parents more often agreed with requirements without opt-out provisions if they were Hispanic [OR = 1.53; 95% confidence interval (CI), 1.05-2.22], believed HPV vaccine was as or more important than other adolescent vaccines (OR = 2.76; 95% CI, 1.98-3.83), or believed HPV vaccine was effective for preventing cervical cancer (OR = 2.55; 95% CI, 1.93-3.37). Parents less often agreed if they resided in Midwest states or believed that HPV vaccine was being pushed to make money for drug companies (both P < 0.05). Opt-out provisions almost tripled parents' support for HPV vaccine school-entry requirements. Our findings suggest that race/ethnicity, attitudes about HPV vaccine, and region of residence may influence support for requirements without opt-out provisions. Opt-out provisions greatly increase parent support of school-entry requirements for HPV vaccination but may make them ineffective. Cancer Epidemiol Biomarkers Prev; 25(9); 1317-25. ©2016 AACR. ©2016 American Association for Cancer Research.

21 CFR 701.9 - Exemptions from labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... (CONTINUED) COSMETICS COSMETIC LABELING General Provisions § 701.9 Exemptions from labeling requirements. (a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a cosmetic... establishment where such cosmetic is to be processed, labeled, or repacked; or (2) In case such person is not...

21 CFR 701.9 - Exemptions from labeling requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... (CONTINUED) COSMETICS COSMETIC LABELING General Provisions § 701.9 Exemptions from labeling requirements. (a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a cosmetic... establishment where such cosmetic is to be processed, labeled, or repacked; or (2) In case such person is not...

21 CFR 701.9 - Exemptions from labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... (CONTINUED) COSMETICS COSMETIC LABELING General Provisions § 701.9 Exemptions from labeling requirements. (a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a cosmetic... establishment where such cosmetic is to be processed, labeled, or repacked; or (2) In case such person is not...

21 CFR 701.9 - Exemptions from labeling requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... (CONTINUED) COSMETICS COSMETIC LABELING General Provisions § 701.9 Exemptions from labeling requirements. (a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a cosmetic... establishment where such cosmetic is to be processed, labeled, or repacked; or (2) In case such person is not...

16 CFR 1500.125 - Labeling requirements for accompanying literature.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Labeling requirements for accompanying literature. 1500.125 Section 1500.125 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.125 Labeling requirements for accompanying literature. When any accompanying literature...

16 CFR 1500.125 - Labeling requirements for accompanying literature.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Labeling requirements for accompanying literature. 1500.125 Section 1500.125 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.125 Labeling requirements for accompanying literature. When any accompanying literature...

16 CFR 1500.125 - Labeling requirements for accompanying literature.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Labeling requirements for accompanying literature. 1500.125 Section 1500.125 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.125 Labeling requirements for accompanying literature. When any accompanying literature...

16 CFR 1500.125 - Labeling requirements for accompanying literature.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Labeling requirements for accompanying literature. 1500.125 Section 1500.125 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.125 Labeling requirements for accompanying literature. When any accompanying literature...

49 CFR 172.402 - Additional labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 30, 2001, such as, a label without the hazard class or division number displayed in the lower corner... this section); and (2)For other than Class 1 or Class 2 materials (for subsidiary labeling requirements for Class 1 or Class 2 materials see paragraph (e) or paragraphs (f) and (g), respectively, of this...

16 CFR 309.21 - Labeling requirements for used covered vehicles.

Code of Federal Regulations, 2011 CFR

2011-01-01

... ACTS OF CONGRESS LABELING REQUIREMENTS FOR ALTERNATIVE FUELS AND ALTERNATIVE FUELED VEHICLES Requirements for Alternative Fueled Vehicles § 309.21 Labeling requirements for used covered vehicles. (a... ink on Hammermill Offset Opaque Vellum/S.70 Sky Blue (or equivalent) paper. (e) Contents. Headlines...

21 CFR 801.15 - Medical devices; prominence of required label statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; prominence of required label statements. 801.15 Section 801.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices; prominence of required label statements. (a...

16 CFR 309.20 - Labeling requirements for new covered vehicles.

Code of Federal Regulations, 2011 CFR

2011-01-01

... ACTS OF CONGRESS LABELING REQUIREMENTS FOR ALTERNATIVE FUELS AND ALTERNATIVE FUELED VEHICLES Requirements for Alternative Fueled Vehicles § 309.20 Labeling requirements for new covered vehicles. (a... printed in process black ink on Hammermill Offset Opaque Vellum/S.70 Sky Blue (or equivalent) paper. (e...

76 FR 35678 - SPF Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-17

... [Docket No. FDA-2011-N-0449] SPF Labeling and Testing Requirements and Drug Facts Labeling for Over-the... testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and... techniques, when appropriate, and other forms of information technology. SPF Labeling and Testing...

Current Vaccine Shortages and Delays

MedlinePlus

... value="Submit" />label> Related Links Vaccines & Immunizations Current Vaccine Shortages & Delays Recommend on Facebook Tweet Share Compartir ... vaccination are included in this update. Chart of Vaccines* in Delay or Shortage National Vaccine Supply Shortages ...

16 CFR 309.21 - Labeling requirements for used covered vehicles.

Code of Federal Regulations, 2010 CFR

2010-01-01

... visible surface of each such vehicle. (b) Layout. Figure 6 of appendix A is the prototype label that... consistent with the prototype label. The label required by this section is one-sided and rectangular in shape... label. Specific type sizes and faces to be used are indicated on the prototype label (Figure 6 of...

9 CFR 317.1 - Labels required; supervision by Program employee.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Labels required; supervision by... Labels required; supervision by Program employee. (a) When, in an official establishment, any inspected... supervision of a Program employee. ...

9 CFR 317.1 - Labels required; supervision by Program employee.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Labels required; supervision by... Labels required; supervision by Program employee. (a) When, in an official establishment, any inspected... supervision of a Program employee. ...

9 CFR 317.17 - Interpretation and statement of labeling policy for cured products; special labeling requirements...

Code of Federal Regulations, 2011 CFR

2011-01-01

... labeling policy for cured products; special labeling requirements concerning nitrate and nitrite. 317.17..., sodium phosphate, sodium nitrate, and sodium nitrite or other permitted substances which are added to any... nitrate or nitrite is permitted or required to be added may be prepared without nitrate or nitrite and...

9 CFR 317.17 - Interpretation and statement of labeling policy for cured products; special labeling requirements...

Code of Federal Regulations, 2010 CFR

2010-01-01

... labeling policy for cured products; special labeling requirements concerning nitrate and nitrite. 317.17..., sodium phosphate, sodium nitrate, and sodium nitrite or other permitted substances which are added to any... nitrate or nitrite is permitted or required to be added may be prepared without nitrate or nitrite and...

77 FR 75400 - Labeling Requirements for Commercial and Industrial Equipment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-20

.... EERE-2012-BT-NOA-0037] RIN 1904-AC84 Labeling Requirements for Commercial and Industrial Equipment... standards for certain commercial and industrial equipment, and requires the Department of Energy (DOE) to administer an energy conservation program for the equipment, including the development of labeling...

16 CFR § 1500.125 - Labeling requirements for accompanying literature.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Labeling requirements for accompanying literature. § 1500.125 Section § 1500.125 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.125 Labeling requirements for accompanying literature. When any accompanying literature...

Parents' and providers' attitudes toward school-located provision and school-entry requirements for HPV vaccines

PubMed Central

Vercruysse, Jessica; Chigurupati, Nagasudha L.; Fung, Leslie; Apte, Gauri; Pierre-Joseph, Natalie; Perkins, Rebecca B.

2016-01-01

ABSTRACT Objective: To determine parents' and providers' attitudes toward school-located provision and school-entry requirements for HPV vaccination. Methods: Parents/guardians of 11–17 y old girls and pediatric healthcare providers at one inner-city public clinic and three private practices completed semi-structured interviews in 2012-2013. Participants were asked open-ended questions regarding their attitudes toward school-located provision and school-entry requirements for HPV vaccination. Parents' answers were analyzed with relationship to whether their daughters had not initiated, initiated but not completed, or completed the HPV vaccine series. Qualitative analysis was used to identify themes related to shared views. Results: 129 parents/guardians and 34 providers participated. 61% of parents supported providing HPV vaccinations in schools, citing reasons of convenience, improved access, and positive peer pressure. Those who opposed school-located provision raised concerns related to privacy and the capacity of school nurses to manage vaccine-related reactions. Parents whose daughters had not completed the series were more likely to intend to vaccinate their daughters in schools (70%) and support requirements (64%) than parents who had not initiated vaccination (42% would vaccinate at school, 46% support requirements) or completed the series (42% would vaccinate at school, 32% support requirements; p < 0 .05 for all comparisons). 81% of providers supported offering vaccination in schools, wanting to take advantage of the captive audience, improve vaccine completion rates, and decrease the administrative burden on medical office staff, but were concerned about adequate information transfer between schools and medical offices. Only 32% of providers supported school-entry requirements, largely because they felt that a requirement might provoke a public backlash that could further hinder vaccination efforts. Conclusions: School-located provision of HPV

Parents' and providers' attitudes toward school-located provision and school-entry requirements for HPV vaccines.

PubMed

Vercruysse, Jessica; Chigurupati, Nagasudha L; Fung, Leslie; Apte, Gauri; Pierre-Joseph, Natalie; Perkins, Rebecca B

2016-06-02

To determine parents' and providers' attitudes toward school-located provision and school-entry requirements for HPV vaccination. Parents/guardians of 11-17 y old girls and pediatric healthcare providers at one inner-city public clinic and three private practices completed semi-structured interviews in 2012-2013. Participants were asked open-ended questions regarding their attitudes toward school-located provision and school-entry requirements for HPV vaccination. Parents' answers were analyzed with relationship to whether their daughters had not initiated, initiated but not completed, or completed the HPV vaccine series. Qualitative analysis was used to identify themes related to shared views. 129 parents/guardians and 34 providers participated. 61% of parents supported providing HPV vaccinations in schools, citing reasons of convenience, improved access, and positive peer pressure. Those who opposed school-located provision raised concerns related to privacy and the capacity of school nurses to manage vaccine-related reactions. Parents whose daughters had not completed the series were more likely to intend to vaccinate their daughters in schools (70%) and support requirements (64%) than parents who had not initiated vaccination (42% would vaccinate at school, 46% support requirements) or completed the series (42% would vaccinate at school, 32% support requirements; p < 0 .05 for all comparisons). 81% of providers supported offering vaccination in schools, wanting to take advantage of the captive audience, improve vaccine completion rates, and decrease the administrative burden on medical office staff, but were concerned about adequate information transfer between schools and medical offices. Only 32% of providers supported school-entry requirements, largely because they felt that a requirement might provoke a public backlash that could further hinder vaccination efforts. School-located provision of HPV vaccination was widely accepted by healthcare providers and

21 CFR 801.50 - Labeling requirements for stand-alone software.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Labeling requirements for stand-alone software....50 Labeling requirements for stand-alone software. (a) Stand-alone software that is not distributed... in packaged form, stand-alone software regulated as a medical device must provide its unique device...

40 CFR 600.306-08 - Labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... required to bear range values as required by paragraph (b) of this section, or determined by the... minimum tax-free value, the following statement must appear on the specific label: “[Manufacturer's name... sold or not or whether the vehicle has been relabeled or not. (b) Fuel economy range of comparable...

An open-label, randomized, multicenter study of the safety, tolerability, and immunogenicity of quadrivalent human papillomavirus (types 6/11/16/18) vaccine given concomitantly with diphtheria, tetanus, pertussis, and poliomyelitis vaccine in healthy adolescents 11 to 17 years of age.

PubMed

Vesikari, Timo; Van Damme, Pierre; Lindblad, Niklas; Pfletschinger, Ulrich; Radley, David; Ryan, Desmond; Vuocolo, Scott; Haupt, Richard M; Guris, Dalya

2010-04-01

GARDASIL/SILGARD is a quadrivalent human papillomavirus (HPV) vaccine with activity against HPV 6/11/16/18. In many countries, GARDASIL is recommended for routine use among adolescents at the same age as other vaccines. In this study, we evaluated the immunogenicity and safety of GARDASIL administered concomitantly with REPEVAX (diphtheria, tetanus, acellular pertussis, and poliomyelitis vaccine). This was an open-label, randomized, multicenter study. We enrolled males (n = 260) and females (n = 583) aged 11 to 17 years. All subjects received a 0.5 mL dose of GARDASIL at day 1, month 2, and month 6, and a 0.5 mL dose of REPEVAX either on day 1 (opposite limb from GARDASIL) or at month 1. Antibody levels for all vaccine components were measured. We monitored systemic and injection-site adverse experiences (AEs) and serious adverse experiences. Immune response for all GARDASIL antigens following concomitant administration of the vaccines was demonstrated noninferior to nonconcomitant administration. Seroconversion for HPV 6, 11, 16, and 18 was >99.7% in both concomitant and nonconcomitant vaccination groups. For REPEVAX, noninferiority of immune response was established for diphtheria, tetanus, and all polio and pertussis antigens. Concomitant administration of the 2 vaccines was generally well-tolerated, although there was a small increase in headache and injection-site swelling in the concomitant group. Overall, concomitant administration of GARDASIL and REPEVAX was generally well-tolerated and did not interfere with the immune response to either vaccine. Concomitant administration of vaccines would minimize the number of visits required to deliver each vaccine individually.

10 CFR 431.31 - Labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 3 2010-01-01 2010-01-01 false Labeling requirements. 431.31 Section 431.31 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY EFFICIENCY PROGRAM FOR CERTAIN COMMERCIAL AND INDUSTRIAL... be marked clearly with the following information: (i) The motor's nominal full load efficiency (as of...

16 CFR 1616.6 - Labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Labeling requirements. 1616.6 Section 1616.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE... items from agents or treatments which are known to cause significant deterioration of their flame...

16 CFR 1616.6 - Labeling requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Labeling requirements. 1616.6 Section 1616.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE... items from agents or treatments which are known to cause significant deterioration of their flame...

16 CFR 1616.6 - Labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Labeling requirements. 1616.6 Section 1616.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE... items from agents or treatments which are known to cause significant deterioration of their flame...

16 CFR 1616.6 - Labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Labeling requirements. 1616.6 Section 1616.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE... items from agents or treatments which are known to cause significant deterioration of their flame...

40 CFR 600.306-86 - Labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... labels are required to bear range values as required by paragraph (b) of this section, or determined by... requested which has a combined unadjusted fuel economy value at or below the minimum tax-free value, the... manufacturer shall include the current range of fuel economy of comparable automobiles (as described in §§ 600...

40 CFR 600.306-86 - Labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... labels are required to bear range values as required by paragraph (b) of this section, or determined by... requested which has a combined unadjusted fuel economy value at or below the minimum tax-free value, the... manufacturer shall include the current range of fuel economy of comparable automobiles (as described in §§ 600...

16 CFR 1615.5 - Labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Labeling requirements. 1615.5 Section 1615.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE... to protect the items from agents or treatments which are known to cause deterioration of their flame...

16 CFR 1615.5 - Labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Labeling requirements. 1615.5 Section 1615.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE... to protect the items from agents or treatments which are known to cause deterioration of their flame...

16 CFR 1615.5 - Labeling requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Labeling requirements. 1615.5 Section 1615.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE... to protect the items from agents or treatments which are known to cause deterioration of their flame...

47 CFR 95.1217 - Labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SERVICES Medical Device Radiocommunication Service (MedRadio) § 95.1217 Labeling requirements. (a) MedRadio... operating in the 400.150-406.000 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth... shall be identified with a serial number. The FCC ID number associated with a medical implant...

Canadian regulatory requirements for recombinant fish vaccines.

PubMed

Sethi, M S; Gifford, G A; Samagh, B S

1997-01-01

In Canada, veterinary biological products derived by using conventional and new techniques of biotechnology are licensed and regulated under the Health of Animals Act and Regulations. Biological products include vaccines, bacterins, bacterin-toxoids and diagnostic kits which are used for the prevention, treatment or diagnosis of infectious diseases in all species of animals, including fish. Veterinary biologicals are licensed on the basis of fulfillment of four criteria: purity, potency, safety and efficacy. A risk-based approach is used to evaluate the safety of the product in target species, as well as non-target species, humans and the environment. On the basis of biological characteristics, biotechnology derived veterinary biologicals have been divided into two broad categories, high and low risk products. The paper describes the regulatory framework for the licensing of veterinary biologicals in Canada, with emphasis on the regulatory considerations for recombinant fish vaccines. Stages of movement of the product from research in a contained laboratory facility to a fully licensed product for free sale are discussed. The requirements for field testing and environmental assessment involved in these stages are highlighted. Manufacturers and researchers who intend to commercialize experimental vaccines are encouraged to consult with the Veterinary Biologics and Biotechnology Section early in the product development process so that the research data and quality assurance documentation are consistent with regulatory requirements.

College and University Compliance With a Required Meningococcal Vaccination Law

PubMed Central

Castel, Amanda D.; Reed, Greg; Davenport, Marsha G.; Harrison, Lee H.; Blythe, David

2015-01-01

Objective Maryland became the first state to pass a vaccination law requiring college and university students living on campus to obtain a meningococcal vaccination or to sign a waiver refusing vaccination because college students are at increased risk for disease. The authors sought to identify how Maryland colleges addressed the law and determine whether schools were in full compliance. Participants The authors surveyed 32 college/university administrators via a self-administered questionnaire. Methods The authors calculated vaccination and waiver rates and assessed compliance with the law overall and with specific law components. Results Among 28 participating schools, annual vaccination rates and waiver rates among students during 2000–2004 ranged from 66%–76% and 12%–17%, respectively. Two (7%) schools were compliant with all components of the law. Conclusions Mandatory vaccination laws do not ensure compliance at the college and university level. Mandatory reporting, increased education, and collaboration between colleges and universities and public health agencies are needed. PMID:17967757

21 CFR 1230.40 - Required label information.

Code of Federal Regulations, 2010 CFR

2010-04-01

... FEDERAL CAUSTIC POISON ACT Imports § 1230.40 Required label information. Containers which are offered for...) (1), (2), and (3) of the Federal Caustic Poison Act and the directions for treatment in the case of...

21 CFR 1230.40 - Required label information.

Code of Federal Regulations, 2012 CFR

2012-04-01

... FEDERAL CAUSTIC POISON ACT Imports § 1230.40 Required label information. Containers which are offered for...) (1), (2), and (3) of the Federal Caustic Poison Act and the directions for treatment in the case of...

21 CFR 1230.40 - Required label information.

Code of Federal Regulations, 2014 CFR

2014-04-01

... FEDERAL CAUSTIC POISON ACT Imports § 1230.40 Required label information. Containers which are offered for...) (1), (2), and (3) of the Federal Caustic Poison Act and the directions for treatment in the case of...

21 CFR 1230.40 - Required label information.

Code of Federal Regulations, 2011 CFR

2011-04-01

... FEDERAL CAUSTIC POISON ACT Imports § 1230.40 Required label information. Containers which are offered for...) (1), (2), and (3) of the Federal Caustic Poison Act and the directions for treatment in the case of...

21 CFR 1230.40 - Required label information.

Code of Federal Regulations, 2013 CFR

2013-04-01

... FEDERAL CAUSTIC POISON ACT Imports § 1230.40 Required label information. Containers which are offered for...) (1), (2), and (3) of the Federal Caustic Poison Act and the directions for treatment in the case of...

Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects

PubMed Central

Tay, Lee; Leon, Francisco; Vratsanos, George; Raymond, Ralph; Corbo, Michael

2007-01-01

The effect of abatacept, a selective T-cell co-stimulation modulator, on vaccination has not been previously investigated. In this open-label, single-dose, randomized, parallel-group, controlled study, the effect of a single 750 mg infusion of abatacept on the antibody response to the intramuscular tetanus toxoid vaccine (primarily a memory response to a T-cell-dependent peptide antigen) and the intramuscular 23-valent pneumococcal vaccine (a less T-cell-dependent response to a polysaccharide antigen) was measured in 80 normal healthy volunteers. Subjects were uniformly randomized to receive one of four treatments: Group A (control group), subjects received vaccines on day 1 only; Group B, subjects received vaccines 2 weeks before abatacept; Group C, subjects received vaccines 2 weeks after abatacept; and Group D, subjects received vaccines 8 weeks after abatacept. Anti-tetanus and anti-pneumococcal (Danish serotypes 2, 6B, 8, 9V, 14, 19F and 23F) antibody titers were measured 14 and 28 days after vaccination. While there were no statistically significant differences between the dosing groups, geometric mean titers following tetanus or pneumococcal vaccination were generally lower in subjects who were vaccinated 2 weeks after receiving abatacept, compared with control subjects. A positive response (defined as a twofold increase in antibody titer from baseline) to tetanus vaccination at 28 days was seen, however, in ≥ 60% of subjects across all treatment groups versus 75% of control subjects. Similarly, over 70% of abatacept-treated subjects versus all control subjects (100%) responded to at least three pneumococcal serotypes, and approximately 25–30% of abatacept-treated subjects versus 45% of control subjects responded to at least six serotypes. PMID:17425783

47 CFR 95.1217 - Labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... programmer/control transmitters shall be labeled as provided in part 2 of this chapter and shall bear the... where it is not feasible to place the statement on the device. (b) Where a MedRadio programmer/control... specified in this section is required to be affixed only to the main control unit. (c) MedRadio transmitters...

Childhood vaccination requirements: Lessons from history, Mississippi, and a path forward.

PubMed

Cawkwell, Philip B; Oshinsky, David

2015-10-26

Mississippi consistently leads the United States in childhood vaccination with a greater than 99% measles-mumps-rubella vaccination rate for children entering kindergarten. The story of how this came to pass in a state that lags behind on nearly every other public health measure is pertinent given the recent outbreaks of measles in the United States, especially in pockets of the country where there is strong resistance to vaccination. The fight against compulsory vaccination law is centuries old and the enduring success of Mississippi at repelling challenges to their vaccination requirements is a testament to the public health infrastructure and legal framework established in the state. Herein we trace the anti-vaccination movement from its origins in England up until the present time in the United States and explore how Mississippi has established a model vaccination system. Seminal court cases and legislation are evaluated for their impact. Finally, contemporary battles over vaccination legislation are examined and the feasibility of national-level change is considered. Copyright © 2015 Elsevier Ltd. All rights reserved.

40 CFR 85.1510 - Maintenance instructions, warranties, emission labeling and fuel economy requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., emission labeling and fuel economy requirements. 85.1510 Section 85.1510 Protection of Environment..., warranties, emission labeling and fuel economy requirements. The provisions of this section are applicable to... for final admission. (d) Fuel economy labeling. (1) The certificate holder shall affix a fuel economy...

40 CFR 85.1510 - Maintenance instructions, warranties, emission labeling and fuel economy requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., emission labeling and fuel economy requirements. 85.1510 Section 85.1510 Protection of Environment..., warranties, emission labeling and fuel economy requirements. The provisions of this section are applicable to... for final admission. (d) Fuel economy labeling. (1) The certificate holder shall affix a fuel economy...

40 CFR 85.1510 - Maintenance instructions, warranties, emission labeling and fuel economy requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., emission labeling and fuel economy requirements. 85.1510 Section 85.1510 Protection of Environment..., warranties, emission labeling and fuel economy requirements. The provisions of this section are applicable to... for final admission. (d) Fuel economy labeling. (1) The certificate holder shall affix a fuel economy...

21 CFR 111.160 - What requirements apply to packaging and labels received?

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.160 - What requirements apply to packaging and labels received?

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.160 - What requirements apply to packaging and labels received?

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

21 CFR 111.160 - What requirements apply to packaging and labels received?

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

Feasibility and effectiveness of oral cholera vaccine in an urban endemic setting in Bangladesh: a cluster randomised open-label trial.

PubMed

Qadri, Firdausi; Ali, Mohammad; Chowdhury, Fahima; Khan, Ashraful Islam; Saha, Amit; Khan, Iqbal Ansary; Begum, Yasmin A; Bhuiyan, Taufiqur R; Chowdhury, Mohiul Islam; Uddin, Md Jasim; Khan, Jahangir A M; Chowdhury, Atique Iqbal; Rahman, Anisur; Siddique, Shah Alam; Asaduzzaman, Muhammad; Akter, Afroza; Khan, Arifuzzaman; Ae You, Young; Siddik, Ashraf Uddin; Saha, Nirod Chandra; Kabir, Alamgir; Riaz, Baizid Khoorshid; Biswas, Shwapon Kumar; Begum, Farzana; Unicomb, Leanne; Luby, Stephen P; Cravioto, Alejandro; Clemens, John D

2015-10-03

Cholera is endemic in Bangladesh with epidemics occurring each year. The decision to use a cheap oral killed whole-cell cholera vaccine to control the disease depends on the feasibility and effectiveness of vaccination when delivered in a public health setting. We therefore assessed the feasibility and protective effect of delivering such a vaccine through routine government services in urban Bangladesh and evaluated the benefit of adding behavioural interventions to encourage safe drinking water and hand washing to vaccination in this setting. We did this cluster-randomised open-label trial in Dhaka, Bangladesh. We randomly assigned 90 clusters (1:1:1) to vaccination only, vaccination and behavioural change, or no intervention. The primary outcome was overall protective effectiveness, assessed as the risk of severely dehydrating cholera during 2 years after vaccination for all individuals present at time of the second dose. This study is registered with ClinicalTrials.gov, number NCT01339845. Of 268,896 people present at baseline, we analysed 267,270: 94,675 assigned to vaccination only, 92,539 assigned to vaccination and behavioural change, and 80,056 assigned to non-intervention. Vaccine coverage was 65% in the vaccination only group and 66% in the vaccination and behavioural change group. Overall protective effectiveness was 37% (95% CI lower bound 18%; p=0·002) in the vaccination group and 45% (95% CI lower bound 24%; p=0·001) in the vaccination and behavioural change group. We recorded no vaccine-related serious adverse events. Our findings provide the first indication of the effect of delivering an oral killed whole-cell cholera vaccine to poor urban populations with endemic cholera using routine government services and will help policy makers to formulate vaccination strategies to reduce the burden of severely dehydrating cholera in such populations. Bill & Melinda Gates Foundation. Copyright © 2015 Elsevier Ltd. All rights reserved.

9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...

9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...

9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...

9 CFR 381.401 - Required nutrition labeling of ground or chopped poultry products.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Required nutrition labeling of ground or chopped poultry products. 381.401 Section 381.401 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.401 Required nutrition labeling of ground or chopped poultry products. Nutrition...

9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...

9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...

9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...

9 CFR 317.301 - Required nutrition labeling of ground or chopped meat products.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Required nutrition labeling of ground or chopped meat products. 317.301 Section 317.301 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.301 Required nutrition labeling of ground or chopped meat products. (a) Nutrition...

Defining epitope coverage requirements for T cell-based HIV vaccines: Theoretical considerations and practical applications

PubMed Central

2011-01-01

Background HIV vaccine development must address the genetic diversity and plasticity of the virus that permits the presentation of diverse genetic forms to the immune system and subsequent escape from immune pressure. Assessment of potential HIV strain coverage by candidate T cell-based vaccines (whether natural sequence or computationally optimized products) is now a critical component in interpreting candidate vaccine suitability. Methods We have utilized an N-mer identity algorithm to represent T cell epitopes and explore potential coverage of the global HIV pandemic using natural sequences derived from candidate HIV vaccines. Breadth (the number of T cell epitopes generated) and depth (the variant coverage within a T cell epitope) analyses have been incorporated into the model to explore vaccine coverage requirements in terms of the number of discrete T cell epitopes generated. Results We show that when multiple epitope generation by a vaccine product is considered a far more nuanced appraisal of the potential HIV strain coverage of the vaccine product emerges. By considering epitope breadth and depth several important observations were made: (1) epitope breadth requirements to reach particular levels of vaccine coverage, even for natural sequence-based vaccine products is not necessarily an intractable problem for the immune system; (2) increasing the valency (number of T cell epitope variants present) of vaccine products dramatically decreases the epitope requirements to reach particular coverage levels for any epidemic; (3) considering multiple-hit models (more than one exact epitope match with an incoming HIV strain) places a significantly higher requirement upon epitope breadth in order to reach a given level of coverage, to the point where low valency natural sequence based products would not practically be able to generate sufficient epitopes. Conclusions When HIV vaccine sequences are compared against datasets of potential incoming viruses important

Challenge with a hepatitis B vaccine in two cohorts of 4-7-year-old children primed with hexavalent vaccines: an open-label, randomised trial in Italy.

PubMed

Zanetti, Alessandro; Parlato, Antonino; Romanò, Luisa; Desole, Maria Giuseppina; Ferrera, Giuseppe; Giurdanella, Filippo; Zuliani, Massimo; Richard, Patrick; Thomas, Stéphane; Fiquet, Anne

2012-08-24

The anamnestic response to a challenge dose of vaccine can assess immune memory and protection against hepatitis B infection. This study investigated responses to a challenge dose of monovalent hepatitis B vaccine in children immunised with three doses of either Hexavac or Infanrix-Hexa during infancy. This open-label, randomised, controlled, four-arm study enrolled 410 healthy children aged 4-7 years who had received either Hexavac (n=201) or Infanrix-Hexa (n=209) at 3, 5 and 11 months of life. Children received a single intramuscular challenge dose of either hepatitis B vaccine, HBVaxPro (Hexavac, n=34; Infanrix-Hexa, n=28) or Engerix-B (Hexavac, n=167; Infanrix-Hexa, n=181). Hepatitis B surface antibody (anti-HBs) concentrations were measured before and 1 month after the challenge vaccine dose. The analysis was descriptive and no formal hypothesis was tested. One month post-challenge, 91.2% of children in the Hexavac group (95% confidence interval [CI] 86.3, 94.8) and 98.0% (95% CI 94.9, 99.4) in the Infanrix-Hexa group had anti-HBs concentrations ≥10 mIU/ml (primary endpoint). In a post hoc analysis, most children with pre-challenge anti-HBs concentration <10 mIU/ml achieved anti-HBs concentrations ≥10 mIU/ml (Hexavac group, 85.3% [95% CI 77.6, 91.2]; Infanrix-Hexa group, 91.9% [95% CI 78.1, 98.3]). Both challenge vaccines were well tolerated. These data suggest that immune memory persists for long-term (5 years) after a primary vaccination in infancy with a hexavalent vaccine (Hexavac or Infanrix-Hexa). Copyright © 2012 Elsevier Ltd. All rights reserved.

Uptake of Meningococcal Vaccine in Arizona Schoolchildren After Implementation of School-Entry Immunization Requirements

PubMed Central

Hills, Rebecca A.; Allwes, Deborah; Rasmussen, Lisa

2013-01-01

Objectives Meningitis and bacteremia due to Neisseria meningitidis are rare but potentially deadly diseases that can be prevented with immunization. Beginning in 2008, Arizona school immunization requirements were amended to include immunization of children aged 11 years or older with meningococcal vaccine before entering the sixth grade. We describe patterns in meningococcal vaccine uptake surrounding these school-entry requirement changes in Arizona. Methods We used immunization records from the Arizona State Immunization Information System (ASIIS) to compare immunization rates in 11- and 12-year-olds. We used principal component analysis and hierarchical cluster analysis to identify and analyze demographic variables reported by the 2010 U.S. Census. Results Adolescent meningococcal immunization rates in Arizona increased after implementation of statewide school-entry immunization requirements. The increase in meningococcal vaccination rates among 11- and 12-year-olds from 2007 to 2008 was statistically significant (p<0.0001). All demographic groups had significantly higher odds of on-schedule vaccination after the school-entry requirement change (odds ratio range = 5.57 to 12.81, p<0.0001). County demographic factors that were associated with lower odds of on-schedule vaccination included higher poverty, more children younger than 18 years of age, fewer high school graduates, and a higher proportion of Native Americans. Conclusions This analysis suggests that implementation of school immunization requirements resulted in increased meningococcal vaccination rates in Arizona, with degree of response varying by demographic profile. ASIIS was useful for assessing changes in immunization rates over time. Further study is required to identify methods to control for population overestimates in registry data. PMID:23277658

16 CFR § 1615.5 - Labeling requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Labeling requirements. § 1615.5 Section § 1615.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS... precautionary instructions to protect the items from agents or treatments which are known to cause deterioration...

16 CFR § 1616.6 - Labeling requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Labeling requirements. § 1616.6 Section § 1616.6 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS... instructions to protect the items from agents or treatments which are known to cause significant deterioration...

40 CFR 59.103 - Container labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 5 2010-07-01 2010-07-01 false Container labeling requirements. 59.103... National Volatile Organic Compound Emission Standards for Automobile Refinish Coatings § 59.103 Container... automobile refinish coating or coating component container or package, the day, month, and year on which the...

40 CFR 59.405 - Container labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 5 2010-07-01 2010-07-01 false Container labeling requirements. 59.405... National Volatile Organic Compound Emission Standards for Architectural Coatings § 59.405 Container... section on the coating container in which the coating is sold or distributed. (1) The date the coating was...

Characteristics of memory B cells elicited by a highly efficacious HPV vaccine in subjects with no pre-existing immunity.

PubMed

Scherer, Erin M; Smith, Robin A; Simonich, Cassandra A; Niyonzima, Nixon; Carter, Joseph J; Galloway, Denise A

2014-10-01

Licensed human papillomavirus (HPV) vaccines provide near complete protection against the types of HPV that most commonly cause anogenital and oropharyngeal cancers (HPV 16 and 18) when administered to individuals naive to these types. These vaccines, like most other prophylactic vaccines, appear to protect by generating antibodies. However, almost nothing is known about the immunological memory that forms following HPV vaccination, which is required for long-term immunity. Here, we have identified and isolated HPV 16-specific memory B cells from female adolescents and young women who received the quadrivalent HPV vaccine in the absence of pre-existing immunity, using fluorescently conjugated HPV 16 pseudoviruses to label antigen receptors on the surface of memory B cells. Antibodies cloned and expressed from these singly sorted HPV 16-pseudovirus labeled memory B cells were predominantly IgG (>IgA>IgM), utilized diverse variable genes, and potently neutralized HPV 16 pseudoviruses in vitro despite possessing only average levels of somatic mutation. These findings suggest that the quadrivalent HPV vaccine provides an excellent model for studying the development of B cell memory; and, in the context of what is known about memory B cells elicited by influenza vaccination/infection, HIV-1 infection, or tetanus toxoid vaccination, indicates that extensive somatic hypermutation is not required to achieve potent vaccine-specific neutralizing antibody responses.

Requirements for Hepatitis B Vaccinations among Optometry Students.

ERIC Educational Resources Information Center

Bowyer, Norma K.; And Others

1995-01-01

Data on the incidence of hepatitis B viral infection are examined, and a telephone survey of 19 schools of optometry concerning administrative policy about student immunization is reported. Results show less than one-third of schools require student vaccination. It is recommended that schools mandate immunization for all students. (MSE)

Reorganizing Nigeria's Vaccine Supply Chain Reduces Need For Additional Storage Facilities, But More Storage Is Required.

PubMed

Shittu, Ekundayo; Harnly, Melissa; Whitaker, Shanta; Miller, Roger

2016-02-01

One of the major problems facing Nigeria's vaccine supply chain is the lack of adequate vaccine storage facilities. Despite the introduction of solar-powered refrigerators and the use of new tools to monitor supply levels, this problem persists. Using data on vaccine supply for 2011-14 from Nigeria's National Primary Health Care Development Agency, we created a simulation model to explore the effects of variance in supply and demand on storage capacity requirements. We focused on the segment of the supply chain that moves vaccines inside Nigeria. Our findings suggest that 55 percent more vaccine storage capacity is needed than is currently available. We found that reorganizing the supply chain as proposed by the National Primary Health Care Development Agency could reduce that need to 30 percent more storage. Storage requirements varied by region of the country and vaccine type. The Nigerian government may want to consider the differences in storage requirements by region and vaccine type in its proposed reorganization efforts. Project HOPE—The People-to-People Health Foundation, Inc.

47 CFR 68.354 - Numbering and labeling requirements for terminal equipment.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Conformity or that is certified by a Telecommunications Certification Body shall have labels in a place and manner required by the Administrative Council for Terminal Attachments. (b) Terminal equipment labels... Terminal Attachments. (c) If the Administrative Council for Terminal Attachments chooses to continue the...

10 CFR 20.1905 - Exemptions to labeling requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Exemptions to labeling requirements. 20.1905 Section 20.1905 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary... have sufficient instruction to minimize radiation exposure while handling or working in the vicinity of...

10 CFR 20.1905 - Exemptions to labeling requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Exemptions to labeling requirements. 20.1905 Section 20.1905 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary... have sufficient instruction to minimize radiation exposure while handling or working in the vicinity of...

10 CFR 20.1905 - Exemptions to labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Exemptions to labeling requirements. 20.1905 Section 20.1905 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary... have sufficient instruction to minimize radiation exposure while handling or working in the vicinity of...

10 CFR 20.1905 - Exemptions to labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Exemptions to labeling requirements. 20.1905 Section 20.1905 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary... have sufficient instruction to minimize radiation exposure while handling or working in the vicinity of...

10 CFR 20.1905 - Exemptions to labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Exemptions to labeling requirements. 20.1905 Section 20.1905 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary... have sufficient instruction to minimize radiation exposure while handling or working in the vicinity of...

21 CFR 111.410 - What requirements apply to packaging and labels?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

21 CFR 111.410 - What requirements apply to packaging and labels?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

21 CFR 111.410 - What requirements apply to packaging and labels?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

21 CFR 111.410 - What requirements apply to packaging and labels?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

21 CFR 111.410 - What requirements apply to packaging and labels?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

16 CFR 305.10 - Ranges of comparability on the required labels.

Code of Federal Regulations, 2014 CFR

2014-01-01

... cost. The Representative Average Unit Energy Cost figures to be used on labels as required by § 305.11... Commission shall publish revised Representative Average Unit Energy Cost figures in the Federal Register in... ACTS OF CONGRESS ENERGY AND WATER USE LABELING FOR CONSUMER PRODUCTS UNDER THE ENERGY POLICY AND...

21 CFR 70.25 - Labeling requirements for color additives (other than hair dyes).

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Labeling requirements for color additives (other than hair dyes). 70.25 Section 70.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... color additives (other than hair dyes). (a) General labeling requirements. All color additives shall be...

21 CFR 70.25 - Labeling requirements for color additives (other than hair dyes).

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Labeling requirements for color additives (other than hair dyes). 70.25 Section 70.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... color additives (other than hair dyes). (a) General labeling requirements. All color additives shall be...

21 CFR 70.25 - Labeling requirements for color additives (other than hair dyes).

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Labeling requirements for color additives (other than hair dyes). 70.25 Section 70.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... color additives (other than hair dyes). (a) General labeling requirements. All color additives shall be...

Vaccine platforms to control Lassa fever.

PubMed

Lukashevich, Igor S; Pushko, Peter

2016-09-01

Lassa virus (LASV), the most prominent human pathogen of the Arenaviridae, is transmitted to humans from infected rodents and can cause Lassa Fever (LF). The sizeable disease burden in West Africa, numerous imported LF cases worldwide, and the possibility that LASV can be used as an agent of biological warfare make a strong case for vaccine development. There are no licensed LASV vaccines and the antiviral treatment is limited to an off-label use of ribavirin that is only partially effective. LASV vaccine development is hampered by high cost of biocontainment requirement, the absence of appropriate small animal models, genetic diversity of LASV species, and by high HIV-1 prevalence in LASV endemic areas. Over the past 15 years several vaccine platforms have been developed. Natural history of LASV and pathogenesis of the disease provide strong justification for replication-competent (RC) vaccine as one of the most feasible approaches to control LF. Development of LASV vaccine candidates based on reassortant, recombinant, and alphavirus replicon technologies is covered in this review. Expert commentary: Two lead RC vaccine candidates, reassortant ML29 and recombinant VSV/LASV, have been successfully tested in non-human primates and have been recommended by international vaccine experts for rapid clinical development. Both platforms have powerful molecular tools to further secure safety, improve immunogenicity, and cross-protection. These platforms are well positioned to design multivalent vaccines to protect against all LASV strains citculatrd in West Africa. The regulatory pathway of Candid #1, the first live-attenuated arenaviral vaccine against Argentine hemorrhagic, will be a reasonable guideline for LASV vaccine efficacy trials.

9 CFR 590.50 - Temperature and labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Refrigeration of Shell Eggs § 590.50 Temperature and labeling requirements. (a) No shell egg handler shall possess any shell eggs that are packed into containers destined for the ultimate consumer unless they are...

21 CFR 201.25 - Bar code label requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 (requests... Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Bar code label requirements. 201.25 Section 201.25...

VacciCost - A tool to estimate the resource requirements for implementing livestock vaccination campaigns. Application to peste des petits ruminants (PPR) vaccination in Senegal.

PubMed

Tago, Damian; Sall, Baba; Lancelot, Renaud; Pradel, Jennifer

2017-09-01

Vaccination is one of the main tools currently available to control animal diseases. In eradication campaigns, vaccination plays a crucial role by reducing the number of susceptible hosts with the ultimate goal of interrupting disease transmission. Nevertheless, mass vaccination campaigns may be very expensive and in some cases unprofitable. VacciCost is a tool designed to help decision-makers in the estimation of the resources required to implement mass livestock vaccination campaigns against regulated diseases. The tool focuses on the operational or running costs of the campaign, so acquisition of new equipment or vehicles is not considered. It takes into account different types of production systems to differentiate the vaccination productivity (number of animals vaccinated per day) in systems where animals are concentrated and easy to reach, from those characterized by small herds that are scattered and less accessible. The resource requirements are classified in eight categories: vaccines, injection supplies, personnel, transport, maintenance and overhead, training, social mobilization, and surveillance and monitoring. This categorization allows identifying the most expensive components of a vaccination campaign, which is crucial to design cost-reduction strategies. The use of the tool is illustrated using data collected in collaboration with Senegalese Veterinary Services regarding vaccination against peste des petits ruminants. The average daily number of animals vaccinated per vaccination team was found to be crucial for the costs of the campaign so significant savings can be obtained by implementing training to improve the performance of vaccination teams. Copyright © 2017 Centre de cooperation internationale en recherche agronomique pour le developpement (CIRAD). Published by Elsevier B.V. All rights reserved.

Immunogenicity and safety of Southern Hemisphere inactivated quadrivalent influenza vaccine: a Phase III, open-label study of adults in Brazil.

PubMed

Zerbini, Cristiano A F; Ribeiro Dos Santos, Rodrigo; Jose Nunes, Maria; Soni, Jyoti; Li, Ping; Jain, Varsha K; Ofori-Anyinam, Opokua

The World Health Organization influenza forecast now includes an influenza B strain from each of the influenza B lineages (B/Yamagata and B/Victoria) for inclusion in seasonal influenza vaccines. Traditional trivalent influenza vaccines include an influenza B strain from one lineage, but because two influenza B lineages frequently co-circulate, the effectiveness of trivalent vaccines may be reduced in seasons of influenza B vaccine-mismatch. Thus, quadrivalent vaccines may potentially reduce the burden of influenza compared with trivalent vaccines. In this Phase III, open-label study, we assessed the immunogenicity and safety of Southern Hemisphere inactivated quadrivalent influenza vaccine (Fluarix™ Tetra) in Brazilian adults (NCT02369341). The primary objective was to assess hemagglutination-inhibition antibody responses against each vaccine strain 21 days after vaccination in adults (aged ≥18-60 years) and older adults (aged >60 years). Solicited adverse events for four days post-vaccination, and unsolicited adverse events and serious adverse events for 21 days post-vaccination were also assessed. A total of 63 adults and 57 older adults received one dose of inactivated quadrivalent influenza vaccine at the beginning of the 2015 Southern Hemisphere influenza season. After vaccination, in adults and older adults, the hemagglutination-inhibition titers fulfilled the European licensure criteria for immunogenicity. In adults, the seroprotection rates with HI titer ≥1:40 were 100% (A/H1N1), 98.4% (A/H3N2), 100% (B/Yamagata), and 100% (B/Victoria); in older adults were 94.7% (A/H1N1), 96.5% (A/H3N2), 100% (B/Yamagata), and 100% (B/Victoria). Pain was the most common solicited local adverse events in adults (27/62) and in older adults (13/57), and the most common solicited general adverse events in adults was myalgia (9/62), and in older adults were myalgia and arthralgia (both 2/57). Unsolicited adverse events were reported by 11/63 adults and 10/57 older adults

21 CFR 201.25 - Bar code label requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD...-600), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Bar code label requirements. 201.25 Section 201.25...

Immunization requirements of the top 200 universities: Implications for vaccine-hesitant families.

PubMed

Noesekabel, Allison; Fenick, Ada M

2017-06-22

The majority of pediatricians encounter vaccine hesitancy in their practices. As part of a broad discussion about vaccination, school requirements arise as a topic yet providers may lack information about the effects of immunization on university matriculation. We surveyed the top-ranked 200 universities regarding required immunizations, medical, religious, and philosophical exemptions, and noncompliance policies. We examined the legal requirements for involved jurisdictions. Of 129 responding universities (64%), 94% had ≥1 pre-matriculation immunization requirement (PIR), with a mean of 3.53 (95%CI 3.17-3.89) requirements. In unadjusted analyses, funding, region, jurisdictional requirements, undergraduate size, and tuition were significant predictors of the number of PIRs. In multivariate modeling, jurisdictional requirements outperformed all other university demographics, but excluding these, Northeast and South region and smaller undergraduate size persisted. The most common PIR was measles (93%). 67% of involved jurisdictions have laws mandating ≥1 university PIR, and 45% of universities surpassed their jurisdiction's law. With respect to medical, religious, and philosophical exemptions, 24%, 40%, and 60% of universities with PIRs had the highest hardship category, and 2%, 2%, and 46% disallowed these outright. Frequent responses to student noncompliance were: hold on classes (89%), additional registration fees (13%), and hold on housing (11%). Requirements for pre-matriculation immunizations in top universities are common and exemptions are difficult to obtain. Conversations between providers and vaccine-hesitant families may be enriched by discussion of these future effects of their decision on immunization. Copyright © 2017 Elsevier Ltd. All rights reserved.

16 CFR 300.13 - Name or other identification required to appear on labels.

Code of Federal Regulations, 2011 CFR

2011-01-01

... appear on labels. 300.13 Section 300.13 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS RULES AND REGULATIONS UNDER THE WOOL PRODUCTS LABELING ACT OF 1939 Labeling § 300... in § 300.4 of this part (Rule 4), may be used for identification purposes in lieu of the required...

Revisions to labeling requirements for blood and blood components, including source plasma. Final rule.

PubMed

2012-01-03

The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the ``ABC Codabar'' system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling.

27 CFR 19.517 - Statements required on labels under an exemption from label approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... chapter; (d) State of distillation. In the case of whisky, the state of distillation statement on the... conform to the requirements of § 19.518; (g) Age of whisky containing no neutral spirits. In the case of whisky containing no neutral spirits, statements of age and percentage by volume on the label must...

Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Final rule.

PubMed

2014-12-04

The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the "Pregnancy," "Labor and delivery," and "Nursing mothers" subsections of the "Use in Specific Populations" section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the "Labor and delivery" subsection because information about labor and delivery is included in the "Pregnancy" subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential. These revisions will facilitate prescriber counseling for these populations.

Outstanding Questions In First Amendment Law Related To Food Labeling Disclosure Requirements For Health.

PubMed

Pomeranz, Jennifer L

2015-11-01

The federal and state governments are increasingly focusing on food labeling as a method to support good health. Many such laws are opposed by the food industry and may be challenged in court, raising the question of what is legally feasible. This article analyzes outstanding questions in First Amendment law related to commercial disclosure requirements and conducts legal analysis and policy evaluation for three current policies. These include the Food and Drug Administration's draft regulation requiring an added sugar disclosure on the Nutrition Facts panel, California's proposed sugar-sweetened beverage safety warning label bill, and Vermont's law requiring labels of genetically engineered food to disclose this information. I recommend several methods for policy makers to enact food labeling laws within First Amendment parameters, including imposing factual commercial disclosure requirements, disclosing the government entity issuing a warning, collecting evidence, and identifying legitimate governmental interests. Project HOPE—The People-to-People Health Foundation, Inc.

21 CFR 501.103 - Petitions requesting exemptions from or special requirements for label declaration of ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... ANIMAL FOOD LABELING Exemptions From Animal Food Labeling Requirements § 501.103 Petitions requesting... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Petitions requesting exemptions from or special requirements for label declaration of ingredients. 501.103 Section 501.103 Food and Drugs FOOD AND DRUG...

21 CFR 70.25 - Labeling requirements for color additives (other than hair dyes).

Code of Federal Regulations, 2010 CFR

2010-04-01

... suitable for coloring the human body, shall state: (1) The name of the straight color or the name of each... AND HUMAN SERVICES GENERAL COLOR ADDITIVES Packaging and Labeling § 70.25 Labeling requirements for...

21 CFR 70.25 - Labeling requirements for color additives (other than hair dyes).

Code of Federal Regulations, 2011 CFR

2011-04-01

... suitable for coloring the human body, shall state: (1) The name of the straight color or the name of each... AND HUMAN SERVICES GENERAL COLOR ADDITIVES Packaging and Labeling § 70.25 Labeling requirements for...

10 CFR Appendix C to Part 20 - Quantities 1 of Licensed Material Requiring Labeling

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Quantities 1 of Licensed Material Requiring Labeling C Appendix C to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. C Appendix C to Part 20—Quantities 1 of Licensed Material Requiring Labeling Radionuclide...

10 CFR Appendix C to Part 20 - Quantities 1 of Licensed Material Requiring Labeling

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Quantities 1 of Licensed Material Requiring Labeling C Appendix C to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. C Appendix C to Part 20—Quantities 1 of Licensed Material Requiring Labeling Radionuclide...

10 CFR Appendix C to Part 20 - Quantities 1 of Licensed Material Requiring Labeling

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Quantities 1 of Licensed Material Requiring Labeling C Appendix C to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. C Appendix C to Part 20—Quantities 1 of Licensed Material Requiring Labeling Radionuclide...

10 CFR Appendix C to Part 20 - Quantities 1 of Licensed Material Requiring Labeling

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Quantities 1 of Licensed Material Requiring Labeling C Appendix C to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. C Appendix C to Part 20—Quantities 1 of Licensed Material Requiring Labeling Radionuclide...

Co-administration of a meningococcal glycoconjugate ACWY vaccine with travel vaccines: a randomized, open-label, multi-center study.

PubMed

Alberer, Martin; Burchard, Gerd; Jelinek, Tomas; Reisinger, Emil; Beran, Jiri; Meyer, Seetha; Forleo-Neto, Eduardo; Gniel, Dieter; Dagnew, Alemnew F; Arora, Ashwani Kumar

2014-01-01

Potential interactions between vaccines may compromise the immunogenicity and/or safety of individual vaccines so must be assessed before concomitant administration is recommended. In this study, the immunogenicity and safety of travel vaccines against Japanese encephalitis (JEV) and rabies (PCECV) administered together with or without a quadrivalent meningococcal glycoconjugate ACWY-CRM vaccine were evaluated (NCT01466387). Healthy adults aged 18 to ≤60 years were randomized to one of four vaccine regimens: JEV + PCECV + MenACWY-CRM, JEV + PCECV, PCECV or MenACWY-CRM. Immunogenicity at baseline and 28 days post-complete vaccination was assessed by serum bactericidal assay using human complement or neutralization tests. Adverse events (AEs) were collected throughout the study period. JEV + PCECV + MenACWY-CRM was non-inferior to JEV + PCECV. Post-vaccination seroprotective neutralizing titers or concentrations were achieved in 98-99% (JE) and 100% (rabies) of subjects across the vaccine groups. Antibody responses to vaccine meningococcal serogroups were in the same range for MenACWY-CRM and JEV + PCECV + MenACWY-CRM. Rates of reporting of AEs were similar for JEV + PCECV and JEV + PCECV + MenACWY-CRM. MenACWY-CRM was administered with an inactivated adjuvanted JE and a purified chick embryo cell-culture rabies vaccine without compromising immunogenicity or safety of the individual vaccines. These data provide evidence that MenACWY-CRM could be effectively incorporated into travel vaccination programs. NCT01466387. Copyright © 2014 Elsevier Ltd. All rights reserved.

Determination of freeze damage on HPV vaccines by use of flow cytometry.

PubMed

Østergaard, Erik; Frandsen, Peer Lyng; Sandberg, Eva

2015-07-01

The human papillomavirus (HPV) vaccines Gardasil, Silgard and Cervarix were labeled with antibodies against HPV strain 6 or 16/FITC conjugated secondary antibodies and analyzed by flow cytometry. The vaccines showed distinct peaks of fluorescent particles, and a shift towards decreased fluorescent particles was observed after incubation of the vaccines over night at -20 °C. Since parallel distributed vaccines could have longer route of transportation there is an increased risk of freeze damage for these types of vaccine. Shift in fluorescence of labeled vaccine particles was used to indicate whether parallel distributed Silgard, which is a vaccine type identical to Gardasil, was exposed to freeze damage during transportation, but no shift was observed. Additional experiments showed that the HPV vaccines could be degraded to smaller particles by citric acid/phosphate buffer treatment. The majority of particles detected in degraded Gardasil were very small indicating that the particles are HPV virus like particle (VLPs) labeled with antibodies, but Cervarix could only be degraded partially due to the presence of another type adjuvant in this vaccine. The described method may be useful in characterization of adjuvanted vaccines with respect to freeze damage, and to characterize vaccines containing particles corresponding to VLPs in size. Copyright © 2015 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3b controlled study in healthy infants.

PubMed

Abdelnour, Arturo; Silas, Peter E; Lamas, Marta Raquel Valdés; Aragón, Carlos Fernándo Grazioso; Chiu, Nan-Chang; Chiu, Cheng-Hsun; Acuña, Teobaldo Herrera; Castrejón, Tirza De León; Izu, Allen; Odrljin, Tatjana; Smolenov, Igor; Hohenboken, Matthew; Dull, Peter M

2014-02-12

The highest risk for invasive meningococcal disease (IMD) is in infants aged <1 year. Quadrivalent meningococcal conjugate vaccination has the potential to prevent IMD caused by serogroups A, C, W and Y. This phase 3b, multinational, open-label, randomized, parallel-group, multicenter study evaluated the safety of a 4-dose series of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, concomitantly administered with routine vaccinations to healthy infants. Two-month-old infants were randomized 3:1 to receive MenACWY-CRM with routine vaccines or routine vaccines alone at ages 2, 4, 6 and 12 months. Adverse events (AEs) that were medically attended and serious adverse events (SAEs) were collected from all subjects from enrollment through 18 months of age. In a subset, detailed safety data (local and systemic solicited reactions and all AEs) were collected for 7 days post vaccination. The primary objective was a non-inferiority comparison of the percentages of subjects with ≥1 severe systemic reaction during Days 1-7 after any vaccination of MenACWY-CRM plus routine vaccinations versus routine vaccinations alone (criterion: upper limit of 95% confidence interval [CI] of group difference <6%). A total of 7744 subjects were randomized with 1898 in the detailed safety arm. The percentage of subjects with severe systemic reactions was 16% after MenACWY-CRM plus routine vaccines and 13% after routine vaccines alone (group difference 3.0% (95% CI -0.8, 6.4%). Although the non-inferiority criterion was not met, post hoc analysis controlling for significant center and group-by-center differences revealed that MenACWY-CRM plus routine vaccinations was non-inferior to routine vaccinations alone (group difference -0.1% [95% CI -4.9%, 4.7%]). Rates of solicited AEs, medically attended AEs, and SAEs were similar across groups. In a large multinational safety study, a 4-dose series of MenACWY-CRM concomitantly administered with routine vaccines was clinically acceptable

Reviewing the importance of the cold chain in the distribution of vaccines.

PubMed

Purssell, Edward

2015-10-01

Vaccination is an effective public health measure to prevent and control a number of infectious diseases. However, since vaccines are biological products and are sensitive to both heat and cold, they need to be maintained within a narrow range of temperatures, often referred to as the 'cold-chain'. This range, which is between +2°C and +8°C with a target +5°C, does not allow for refreezing or storage at room temperature. This paper discusses the importance of the cold chain, what should be done both to maintain it, and the actions to be taken, should a break be noted. It is important to note the product information supplied with vaccines, which is taken from the summary of product characteristics that forms part of the licensing requirements for each vaccine, and which will state how it should be stored. Using a vaccine that has not been stored according to these instructions constitutes off-label use, for which the individual practitioner must take responsibility. It also emphasises the fragile nature of many public health interventions, maintenance of which require constant vigilance and close cooperation between many groups and individuals.

Software requirements for the study of contextual classifiers and label imperfections

NASA Technical Reports Server (NTRS)

Chittineni, C. B.

1979-01-01

The software requirements for the study of contextual classifiers and imperfections in the labels are presented. In particular, the requirements are described for updating the posteriori probability of the picture element under consideration using information from its local neighborhood, designing the Fisher classifier, and other required routines. Only the necessary equations are given for the development of software.

77 FR 6463 - Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-08

... 640 [Docket No. FDA-2003-N-0097; Formerly 2003N-0211] Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma; Correction AGENCY: Food and Drug Administration, HHS. ACTION... published a final rule entitled ``Revisions to Labeling Requirements for Blood and Blood Components...

9 CFR 381.115 - Containers of inspected and passed poultry products required to be labeled.

Code of Federal Regulations, 2010 CFR

2010-01-01

... poultry products required to be labeled. 381.115 Section 381.115 Animals and Animal Products FOOD SAFETY... AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Labeling and Containers § 381.115 Containers of inspected and passed poultry products required to...

Can thermostable vaccines help address cold-chain challenges? Results from stakeholder interviews in six low- and middle-income countries.

PubMed

Kristensen, Debra D; Lorenson, Tina; Bartholomew, Kate; Villadiego, Shirley

2016-02-10

This study captures the perspectives of stakeholders at multiple levels of the vaccine supply chain regarding their assessment of challenges with storing vaccines within recommended temperature ranges and their perceptions on the benefits of having vaccines with improved stability, including the potential short-term storage and transport of vaccines in a controlled-temperature chain. Semi-structured interviews were undertaken with 158 immunization stakeholders in six countries. Interviewees included national decision-makers and advisors involved in vaccine purchasing decisions, national Expanded Programme on Immunization managers, and health and logistics personnel at national, subnational, and health facility levels. Challenges with both heat and freeze-exposure of vaccines were recognized in all countries, with heat-exposure being a greater concern. Conditions leading to freeze-exposure including ice build-up due to poor refrigerator performance and improper icepack conditioning were reported by 53% and 28% of participants, respectively. Respondents were interested in vaccine products with improved heat/freeze-stability characteristics. The majority of those involved in vaccine purchasing indicated they would be willing to pay a US$0.05 premium per dose for a freeze-stable pentavalent vaccine (68%) or a heat-stable rotavirus vaccine (59%), although most (53%) preferred not to pay the premium for a heat-stable pentavalent vaccine if the increased stability required changing from a liquid to a lyophilized product. Most respondents (73%) were also interested in vaccines labeled for short-term use in a controlled-temperature chain. The majority (115/158) recognized the flexibility this would provide during outreach or should cold-chain breaks occur. Respondents were also aware that possible confusion might arise and additional training would be required if handling conditions were changed for some, but not all vaccines. Participating immunization stakeholders

Can thermostable vaccines help address cold-chain challenges? Results from stakeholder interviews in six low- and middle-income countries

PubMed Central

Kristensen, Debra D.; Lorenson, Tina; Bartholomew, Kate; Villadiego, Shirley

2016-01-01

Introduction This study captures the perspectives of stakeholders at multiple levels of the vaccine supply chain regarding their assessment of challenges with storing vaccines within recommended temperature ranges and their perceptions on the benefits of having vaccines with improved stability, including the potential short-term storage and transport of vaccines in a controlled-temperature chain. Methods Semi-structured interviews were undertaken with 158 immunization stakeholders in six countries. Interviewees included national decision-makers and advisors involved in vaccine purchasing decisions, national Expanded Programme on Immunization managers, and health and logistics personnel at national, subnational, and health facility levels. Results Challenges with both heat and freeze-exposure of vaccines were recognized in all countries, with heat-exposure being a greater concern. Conditions leading to freeze-exposure including ice build-up due to poor refrigerator performance and improper icepack conditioning were reported by 53% and 28% of participants, respectively. Respondents were interested in vaccine products with improved heat/freeze-stability characteristics. The majority of those involved in vaccine purchasing indicated they would be willing to pay a US$0.05 premium per dose for a freeze-stable pentavalent vaccine (68%) or a heat-stable rotavirus vaccine (59%), although most (53%) preferred not to pay the premium for a heat-stable pentavalent vaccine if the increased stability required changing from a liquid to a lyophilized product. Most respondents (73%) were also interested in vaccines labeled for short-term use in a controlled-temperature chain. The majority (115/158) recognized the flexibility this would provide during outreach or should cold-chain breaks occur. Respondents were also aware that possible confusion might arise and additional training would be required if handling conditions were changed for some, but not all vaccines. Conclusion

9 CFR 113.200 - General requirements for killed virus vaccines.

Code of Federal Regulations, 2010 CFR

2010-01-01

... completed product from each serial shall be tested for safety in guinea pigs as prescribed in § 113.38 and... an applicable Standard Requirement or in the filed Outline of Production, a killed virus vaccine.... Suitable tests to assure complete inactivation shall be written into the filed Outline of Production. (b...

40 CFR 600.304-12 - Fuel economy label-special requirements for hydrogen fuel cell vehicles.

Code of Federal Regulations, 2012 CFR

2012-07-01

... requirements for hydrogen fuel cell vehicles. 600.304-12 Section 600.304-12 Protection of Environment... MOTOR VEHICLES Fuel Economy Labeling § 600.304-12 Fuel economy label—special requirements for hydrogen fuel cell vehicles. Fuel economy labels for hydrogen fuel cell vehicles must meet the specifications...

40 CFR 600.304-12 - Fuel economy label-special requirements for hydrogen fuel cell vehicles.

Code of Federal Regulations, 2014 CFR

2014-07-01

... requirements for hydrogen fuel cell vehicles. 600.304-12 Section 600.304-12 Protection of Environment... MOTOR VEHICLES Fuel Economy Labeling § 600.304-12 Fuel economy label—special requirements for hydrogen fuel cell vehicles. Fuel economy labels for hydrogen fuel cell vehicles must meet the specifications...

40 CFR 600.304-12 - Fuel economy label-special requirements for hydrogen fuel cell vehicles.

Code of Federal Regulations, 2013 CFR

2013-07-01

... requirements for hydrogen fuel cell vehicles. 600.304-12 Section 600.304-12 Protection of Environment... MOTOR VEHICLES Fuel Economy Labeling § 600.304-12 Fuel economy label—special requirements for hydrogen fuel cell vehicles. Fuel economy labels for hydrogen fuel cell vehicles must meet the specifications...

Gluten-Free Labeling of Foods

MedlinePlus

... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Food Home Food Guidance & Regulation Guidance Documents & Regulatory Information by Topic Allergens Gluten-Free Labeling of Foods Share Tweet Linkedin Pin it More sharing options ...

40 CFR 168.65 - Pesticide export label and labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... toxic pesticides. If the pesticide, device or active ingredient is highly toxic to humans, the skull and... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Pesticide export label and labeling...) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for...

40 CFR 168.65 - Pesticide export label and labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... toxic pesticides. If the pesticide, device or active ingredient is highly toxic to humans, the skull and... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Pesticide export label and labeling...) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for...

40 CFR 168.65 - Pesticide export label and labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... toxic pesticides. If the pesticide, device or active ingredient is highly toxic to humans, the skull and... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Pesticide export label and labeling...) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for...

Immunogenicity of simultaneous versus sequential administration of a 23-valent pneumococcal polysaccharide vaccine and a quadrivalent influenza vaccine in older individuals: A randomized, open-label, non-inferiority trial.

PubMed

Nakashima, Kei; Aoshima, Masahiro; Ohfuji, Satoko; Yamawaki, Satoshi; Nemoto, Masahiro; Hasegawa, Shinya; Noma, Satoshi; Misawa, Masafumi; Hosokawa, Naoto; Yaegashi, Makito; Otsuka, Yoshihito

2018-03-21

It is unclear whether simultaneous administration of a 23-valent pneumococcal polysaccharide vaccine (PPSV23) and a quadrivalent influenza vaccine (QIV) produces immunogenicity in older individuals. This study tested the hypothesis that the pneumococcal antibody response elicited by simultaneous administration of PPSV23 and QIV in older individuals is not inferior to that elicited by sequential administration of PPSV23 and QIV. We performed a single-center, randomized, open-label, non-inferiority trial comprising 162 adults aged ≥65 years randomly assigned to either the simultaneous (simultaneous injections of PPSV23 and QIV) or sequential (control; PPSV23 injected 2 weeks after QIV vaccination) groups. Pneumococcal immunoglobulin G (IgG) titers of serotypes 23F, 3, 4, 6B, 14, and 19A were assessed. The primary endpoint was the serotype 23F response rate (a ≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination). With the non-inferiority margin set at 20% fewer patients, the response rate of serotype 23F in the simultaneous group (77.8%) was not inferior to that of the sequential group (77.6%; difference, 0.1%; 90% confidence interval, -10.8% to 11.1%). None of the pneumococcal IgG serotype titers were significantly different between the groups 4-6 weeks after vaccination. Simultaneous administration did not show a significant decrease in seroprotection odds ratios for H1N1, H3N2, or B/Phuket influenza strains other than B/Texas. Additionally, simultaneous administration did not increase adverse reactions. Hence, simultaneous administration of PPSV23 and QIV shows an acceptable immunogenicity that is comparable to sequential administration without an increase in adverse reactions. (This study was registered with ClinicalTrials.gov [NCT02592486]).

Tolerability and immunogenicity of an inactivated enterovirus 71 vaccine in Chinese healthy adults and children: an open label, phase 1 clinical trial.

PubMed

Meng, Fan-Yue; Li, Jing-Xin; Li, Xiu-Ling; Chu, Kai; Zhang, Yun-Tao; Ji, Hong; Li, Liang; Liang, Zheng-Lun; Zhu, Feng-Cai

2012-05-01

In this open labeled phase 1 clinical trial with enterovirus 71 (EV71) vaccine (ClinicalTrials.gov number: NCT01267903) performed in Donghai County, Jiangsu Province, China, in January 2011. A total of 100 healthy participants, stratified by age (40 adults aged 16-22 y and 60 children aged 6-15 y), were enrolled from volunteers and sequentially received EV71 vaccines of 160U (only for children), 320U, or 640U on day 0 and 28, in a manner of dose escalation. All the participants were followed for 28 d after each shot. During the study period, 37 participants reported at least one injection-site or systemic adverse reaction. No case of grade 3 adverse reaction or serious adverse event (SAE) was observed. Also no dose-related increase in reaction rate was noticed. Pain at injection-site and fever were the most frequently reported local and systematic reaction, respectively. The studied EV71 vaccines demonstrated acceptable tolerability and no anti-nuclear antibody (ANA) seropositive was detected pre or post vaccinations in participants. Also, no clinically significant abnormal change for the liver or kidney function indexes was found. In the according-to-protocol cohort for immunogenicity, it was observed one dose of EV71 vaccine elicited good immune response in the participants, especially for the ones with sero-positive baseline. No obvious dose-response relationship for immunogenicity was found.

16 CFR 305.10 - Ranges of comparability on the required labels.

Code of Federal Regulations, 2013 CFR

2013-01-01

... modification under this section need not be relabeled. (b) Representative average unit energy cost. The Representative Average Unit Energy Cost to be used on labels as required by § 305.11 and disclosures as required... Representative Average Unit Energy Cost figures every five years beginning in 2012 in the Federal Register. When...

16 CFR 305.10 - Ranges of comparability on the required labels.

Code of Federal Regulations, 2010 CFR

2010-01-01

... modification under this section need not be relabeled. (b) Representative average unit energy cost. The Representative Average Unit Energy Cost to be used on labels as required by § 305.11 and disclosures as required... Representative Average Unit Energy Cost figures every five years beginning in 2012 in the Federal Register. When...

16 CFR 305.10 - Ranges of comparability on the required labels.

Code of Federal Regulations, 2012 CFR

2012-01-01

... modification under this section need not be relabeled. (b) Representative average unit energy cost. The Representative Average Unit Energy Cost to be used on labels as required by § 305.11 and disclosures as required... Representative Average Unit Energy Cost figures every five years beginning in 2012 in the Federal Register. When...

16 CFR 305.10 - Ranges of comparability on the required labels.

Code of Federal Regulations, 2011 CFR

2011-01-01

... modification under this section need not be relabeled. (b) Representative average unit energy cost. The Representative Average Unit Energy Cost to be used on labels as required by § 305.11 and disclosures as required... Representative Average Unit Energy Cost figures every five years beginning in 2012 in the Federal Register. When...

16 CFR 309.21 - Labeling requirements for used covered vehicles.

Code of Federal Regulations, 2012 CFR

2012-01-01

... numbers, bar codes, and vehicle identification numbers consistent with Figure 6. (c) Type size and setting... vehicles. 309.21 Section 309.21 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS LABELING REQUIREMENTS FOR ALTERNATIVE FUELS AND ALTERNATIVE FUELED VEHICLES...

16 CFR 309.21 - Labeling requirements for used covered vehicles.

Code of Federal Regulations, 2013 CFR

2013-01-01

... numbers, bar codes, and vehicle identification numbers consistent with Figure 6. (c) Type size and setting... vehicles. 309.21 Section 309.21 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS LABELING REQUIREMENTS FOR ALTERNATIVE FUELS AND ALTERNATIVE FUELED VEHICLES...

16 CFR 309.20 - Labeling requirements for new covered vehicles.

Code of Federal Regulations, 2013 CFR

2013-01-01

... numbers, bar codes, and vehicle identification numbers consistent with Figures 4, 5, and 5.1. (c) Type... vehicles. 309.20 Section 309.20 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS LABELING REQUIREMENTS FOR ALTERNATIVE FUELS AND ALTERNATIVE FUELED VEHICLES...

16 CFR 309.20 - Labeling requirements for new covered vehicles.

Code of Federal Regulations, 2012 CFR

2012-01-01

... numbers, bar codes, and vehicle identification numbers consistent with Figures 4, 5, and 5.1. (c) Type... vehicles. 309.20 Section 309.20 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS LABELING REQUIREMENTS FOR ALTERNATIVE FUELS AND ALTERNATIVE FUELED VEHICLES...

77 FR 7 - Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-03

... requirements will facilitate the use of a labeling system using machine-readable information that would be... components. Furthermore, we proposed the use of a labeling system using machine-readable information that...; Facilitates the use of a labeling system using machine- readable information that would be acceptable as a...

Flow-aggregated traffic-driven label mapping in label-switching networks

NASA Astrophysics Data System (ADS)

Nagami, Kenichi; Katsube, Yasuhiro; Esaki, Hiroshi; Nakamura, Osamu

1998-12-01

Label switching technology enables high performance, flexible, layer-3 packet forwarding based on the fixed length label information mapped to the layer-3 packet stream. A Label Switching Router (LSR) forwards layer-3 packets based on their label information mapped to the layer-3 address information as well as their layer-3 address information. This paper evaluates the required number of labels under traffic-driven label mapping policy using the real backbone traffic traces. The evaluation shows that the label mapping policy requires a large number of labels. In order to reduce the required number of labels, we propose a label mapping policy which is a traffic-driven label mapping for the traffic toward the same destination network. The evaluation shows that the proposed label mapping policy requires only about one tenth as many labels compared with the traffic-driven label mapping for the host-pair packet stream,and the topology-driven label mapping for the destination network packet stream.

Evaluating the value proposition for improving vaccine thermostability to increase vaccine impact in low and middle-income countries.

PubMed

Karp, Christopher L; Lans, Deborah; Esparza, José; Edson, Eleanore B; Owen, Katey E; Wilson, Christopher B; Heaton, Penny M; Levine, Orin S; Rao, Raja

2015-07-09

The need to keep vaccines cold in the face of high ambient temperatures and unreliable access to electricity is a challenge that limits vaccine coverage in low and middle-income countries (LMICs). Greater vaccine thermostability is generally touted as the obvious solution. Despite conventional wisdom, comprehensive analysis of the value proposition for increasing vaccine thermostability has been lacking. Further, while significant investments have been made in increasing vaccine thermostability in recent years, no vaccine products have been commercialized as a result. We analyzed the value proposition for increasing vaccine thermostability, grounding the analysis in specific vaccine use cases (e.g., use in routine immunization [RI] programs, or in campaigns) and in the broader context of cold chain technology and country level supply chain system design. The results were often surprising. For example, cold chain costs actually represent a relatively small fraction of total vaccine delivery system costs. Further, there are critical, vaccine use case-specific temporal thresholds that need to be overcome for significant benefits to be reaped from increasing vaccine thermostability. We present a number of recommendations deriving from this analysis that suggest a rational path toward unlocking the value (maximizing coverage, minimizing total system costs) of increased vaccine thermostability, including: (1) the full range of thermostability of existing vaccines should be defined and included in their labels; (2) for new vaccines, thermostability goals should be addressed up-front at the level of the target product profile; (3) improving cold chain infrastructure and supply chain system design is likely to have the largest impact on total system costs and coverage in the short term-and will influence the degree of thermostability required in the future; (4) in the long term, there remains value in monitoring the emergence of disruptive technologies that could remove the

21 CFR 201.26 - Exceptions or alternatives to labeling requirements for human drug products held by the Strategic...

Code of Federal Regulations, 2011 CFR

2011-04-01

... requirements for human drug products held by the Strategic National Stockpile. 201.26 Section 201.26 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.26 Exceptions or alternatives to labeling requirements for human...

Flublok Seasonal Influenza (Flu) Vaccination

MedlinePlus

... type="submit" value="Submit" />label> Archived Flu Emails Influenza Types Seasonal Avian Swine Variant Pandemic Other Flublok Seasonal Influenza (Flu) Vaccine Questions & Answers Language: English (US) Español ...

16 CFR 1615.5 - Labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE.... (a) Care labels. All items of children's sleepwear shall be labeled with precautionary instructions... accordance with rules and regulations established by the Consumer Product Safety Commission. (b) [Reserved...

30 CFR 47.41 - Requirement for container labels.

Code of Federal Regulations, 2011 CFR

2011-07-01

... replace an outdated label when a revised label is received from the chemical's manufacturer or supplier... container labels. (a) The operator must ensure that each container of a hazardous chemical has a label. If a... unreadable. (2) The operator must not remove or deface existing labels on containers of hazardous chemicals...

30 CFR 47.41 - Requirement for container labels.

Code of Federal Regulations, 2014 CFR

2014-07-01

... replace an outdated label when a revised label is received from the chemical's manufacturer or supplier... container labels. (a) The operator must ensure that each container of a hazardous chemical has a label. If a... unreadable. (2) The operator must not remove or deface existing labels on containers of hazardous chemicals...

30 CFR 47.41 - Requirement for container labels.

Code of Federal Regulations, 2013 CFR

2013-07-01

... replace an outdated label when a revised label is received from the chemical's manufacturer or supplier... container labels. (a) The operator must ensure that each container of a hazardous chemical has a label. If a... unreadable. (2) The operator must not remove or deface existing labels on containers of hazardous chemicals...

30 CFR 47.41 - Requirement for container labels.

Code of Federal Regulations, 2012 CFR

2012-07-01

... replace an outdated label when a revised label is received from the chemical's manufacturer or supplier... container labels. (a) The operator must ensure that each container of a hazardous chemical has a label. If a... unreadable. (2) The operator must not remove or deface existing labels on containers of hazardous chemicals...

Engineered human vaccines

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sandhu, J.S.

1994-01-01

The limitations of human vaccines in use at present and the design requirements for a new generation of human vaccines are discussed. The progress in engineering of human vaccines for bacteria, viruses, parasites, and cancer is reviewed, and the data from human studies with the engineered vaccines are discussed, especially for cancer and AIDS vaccines. The final section of the review deals with the possible future developments in the field of engineered human vaccines and the requirement for effective new human adjuvants.

Identification of IBV QX vaccine markers : Should vaccine acceptance by authorities require similar identifications for all live IBV vaccines?

PubMed

Listorti, Valeria; Laconi, Andrea; Catelli, Elena; Cecchinato, Mattia; Lupini, Caterina; Naylor, Clive J

2017-10-09

IBV genotype QX causes sufficient disease in Europe for several commercial companies to have started developing live attenuated vaccines. Here, one of those vaccines (L1148) was fully consensus sequenced alongside its progenitor field strain (1148-A) to determine vaccine markers, thereby enabling detection on farms. Twenty-eight single nucleotide substitutions were associated with the 1148-A attenuation, of which any combination can identify vaccine L1148 in the field. Sixteen substitutions resulted in amino acid coding changes of which half were in spike. One change in the 1b gene altered the normally highly conserved final 5 nucleotides of the transcription regulatory sequence of the S gene, common to all IBV QX genes. No mutations can currently be associated with the attenuation process. Field vaccination strategies would greatly benefit by such comparative sequence data being mandatorily submitted to regulators prior to vaccine release following a successful registration process. Copyright © 2017. Published by Elsevier Ltd.

76 FR 9231 - New Customs Declarations Label Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-17

...The Postal Service is revising the Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM[supreg]) 608.2.4 to require all mailpieces containing goods that enter the Customs Territory of the United States (CTUS), from outside the CTUS, to bear a customs declaration label. Additionally, the Postal Service updates the standards for items weighing 16 ounces or more when sent to, from, or between, and in some circumstances, within certain U.S. territories, possessions, and Freely Associated States.

PRN 98-6: Flammability Labeling Requirements for Total Release Fogger Pesticides

EPA Pesticide Factsheets

This notice describes new labeling requirements for total release foggers and provides the procedures and time frame for compliance. It ONLY affects total release foggers containing a propellant with a flash point at or below 20 degrees Fahrenheit.

Safety of an Escherichia coli-expressed bivalent human papillomavirus (types 16 and 18) L1 virus-like particle vaccine: an open-label phase I clinical trial.

PubMed

Hu, Yue-Mei; Huang, Shou-Jie; Chu, Kai; Wu, Ting; Wang, Zhong-Ze; Yang, Chang-Lin; Cai, Jia-Ping; Jiang, Han-Min; Wang, Yi-Jun; Guo, Meng; Liu, Xiao-Hui; Huang, Hong-Jiang; Zhu, Feng-Cai; Zhang, Jun; Xia, Ning-Shao

2014-01-01

An Escherichia coli-expressed recombinant bivalent human papillomavirus (types 16 and 18) vaccine candidate has been shown to be safe and immunogenic in preclinical trials. The safety of this vaccine was analyzed in an open-label phase I clinical trial in Jiangsu province, China. Thirty-eight healthy women from 18 to 55 y of age were enrolled and vaccinated at 0, 1, and 6 mo. Adverse events that occurred within 30 d after each injection and serious adverse events that occurred throughout the study were recorded. In addition, blood parameters were tested before and after each injection. All but one woman received all 3 doses. Thirty-two (84.2%) of the participants reported adverse events, all adverse events of which were mild, of short duration and resolved spontaneously. No serious adverse events occurred during the study. Changes in blood parameters after each injection were random, mild, and not clinically significant. These preliminary results show that a new Escherichia coli-expressed recombinant HPV 16/18 bivalent vaccine is well tolerated in healthy women and support further immunogenicity and efficacy studies for this HPV vaccine candidate.

Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy.

PubMed

Roberts, Jeffrey N; Gruber, Marion F

2015-02-18

Despite supportive public health policies (e.g., ACIP recommendations), the potential for providing clinical benefit through maternal immunization has yet to be fully realized. For vaccines already licensed and approved for use in adults, specific FDA approval for use during pregnancy to prevent disease in the mother and/or infant may have a significant impact on uptake and usage in pregnant women. In addition, for either a licensed vaccine or a novel vaccine, FDA approval for use during pregnancy would result in labeling that would serve as a resource for practitioners and would facilitate the safe and effective use of the vaccine during pregnancy. In the U.S., while many vaccines are approved for use in adults and most are not contraindicated for use in pregnant women, no vaccine is licensed for use specifically during pregnancy. Among the perceived obstacles hindering the clinical development of vaccines for use in pregnancy, regulatory issues are frequently cited. One aim of this article is to address the perceived regulatory obstacles. General concepts and regulatory considerations for clinical safety and effectiveness evaluations for vaccines indicated for use during pregnancy will be discussed. This discussion is not intended to establish data requirements or to articulate agency policy or guidance regarding specific vaccine products. Published by Elsevier Ltd.

40 CFR 600.307-95 - Fuel economy label format requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Fuel economy label format requirements. 600.307-95 Section 600.307-95 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy Regulations for 1977 and Later Model Year Automobile...

40 CFR 600.307-86 - Fuel economy label format requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Fuel economy label format requirements. 600.307-86 Section 600.307-86 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy Regulations for 1977 and Later Model Year Automobile...

40 CFR 763.171 - Labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... placed for sale, shipment, or storage. If the product has more than one layer of external wrapping or packaging, the label must be attached to the innermost layer adjacent to the product. If the innermost layer... product's innermost layer of product wrapping or packaging, or a label must be attached to the next outer...

21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...

21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...

21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...

21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...

Arenavirus reverse genetics for vaccine development

PubMed Central

Ortiz-Riaño, Emilio; Cheng, Benson Yee Hin; Carlos de la Torre, Juan

2013-01-01

Arenaviruses are important human pathogens with no Food and Drug Administration (FDA)-licensed vaccines available and current antiviral therapy being limited to an off-label use of the nucleoside analogue ribavirin of limited prophylactic efficacy. The development of reverse genetics systems represented a major breakthrough in arenavirus research. However, rescue of recombinant arenaviruses using current reverse genetics systems has been restricted to rodent cells. In this study, we describe the rescue of recombinant arenaviruses from human 293T cells and Vero cells, an FDA-approved line for vaccine development. We also describe the generation of novel vectors that mediate synthesis of both negative-sense genome RNA and positive-sense mRNA species of lymphocytic choriomeningitis virus (LCMV) directed by the human RNA polymerases I and II, respectively, within the same plasmid. This approach reduces by half the number of vectors required for arenavirus rescue, which could facilitate virus rescue in cell lines approved for human vaccine production but that cannot be transfected at high efficiencies. We have shown the feasibility of this approach by rescuing both the Old World prototypic arenavirus LCMV and the live-attenuated vaccine Candid#1 strain of the New World arenavirus Junín. Moreover, we show the feasibility of using these novel strategies for efficient rescue of recombinant tri-segmented both LCMV and Candid#1. PMID:23364194

21 CFR 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic...

Code of Federal Regulations, 2010 CFR

2010-04-01

... requirements for biological products held by the Strategic National Stockpile. 610.68 Section 610.68 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.68 Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile. (a) The appropriate FDA Center...

40 CFR 80.570 - What labeling requirements apply to retailers and wholesale purchaser-consumers of diesel fuel...

Code of Federal Regulations, 2010 CFR

2010-07-01

... retailers and wholesale purchaser-consumers of diesel fuel beginning June 1, 2006? 80.570 Section 80.570... Marine Fuel Labeling Requirements § 80.570 What labeling requirements apply to retailers and wholesale..., any retailer or wholesale purchaser-consumer who sells, dispenses, or offers for sale or dispensing...

Comparison of the Membrane Proteome of Virulent Mycobacterium tuberculosis and the Attenuated Mycobacterium bovis BCG Vaccine Strain by Label-free Quantitative Proteomics

PubMed Central

Gunawardena, Harsha P.; Feltcher, Meghan E.; Wrobel, John A.; Gu, Sheng; Braunstein, Miriam; Chen, Xian

2015-01-01

The Mycobacterium tuberculosis (MTB) membrane is rich in antigens that are potential targets for diagnostics and the development of new vaccines. To better understand the mechanisms underlying MTB virulence and identify new targets for therapeutic intervention we investigated the differential composition of membrane proteomes between virulent M. tuberculosis H37Rv (MTB) and the Mycobacterium bovis BCG vaccine strain. To compare the membrane proteomes, we used LC-MS/MS analysis in combination with label-free quantitative (LFQ) proteomics, utilizing the area-under-curve (AUC) of the extracted ion chromatograms (XIC) of peptides obtained from m/z and retention time alignment of MS1 features. With this approach, we obtained relative abundance ratios for 2,203 identified membrane-associated proteins in high confidence. Of these proteins, 294 showed statistically significant differences of at least 2 fold, in relative abundance between MTB and BCG membrane fractions. Our comparative analysis detected several proteins associated with known genomic regions of difference between MTB and BCG as being absent, which validated the accuracy of our approach. In further support of our label-free quantitative data, we verified select protein differences by immunoblotting. To our knowledge we have generated the first comprehensive and high coverage profile of comparative membrane proteome changes between virulent MTB and its attenuated relative BCG, which helps elucidate the proteomic basis of the intrinsic virulence of the MTB pathogen. PMID:24093440

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2012 CFR

2012-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2013 CFR

2013-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2011 CFR

2011-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2014 CFR

2014-04-01

..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

16 CFR Appendix A to Part 306 - Summary of Labeling Requirements for Biodiesel Fuels

Code of Federal Regulations, 2014 CFR

2014-01-01

... Biodiesel Fuels A Appendix A to Part 306 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER... Part 306—Summary of Labeling Requirements for Biodiesel Fuels (Part 1 of 2) Fuel type Blends of 5 percent or less Blends of more than 5 but not more than 20 percent Header Text Color Biodiesel No label...

16 CFR Appendix A to Part 306 - Summary of Labeling Requirements for Biodiesel Fuels

Code of Federal Regulations, 2013 CFR

2013-01-01

... Biodiesel Fuels A Appendix A to Part 306 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER... Part 306—Summary of Labeling Requirements for Biodiesel Fuels (Part 1 of 2) Fuel type Blends of 5 percent or less Blends of more than 5 but not more than 20 percent Header Text Color Biodiesel No label...

16 CFR Appendix A to Part 306 - Summary of Labeling Requirements for Biodiesel Fuels

Code of Federal Regulations, 2012 CFR

2012-01-01

... Biodiesel Fuels A Appendix A to Part 306 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER... Part 306—Summary of Labeling Requirements for Biodiesel Fuels (Part 1 of 2) Fuel type Blends of 5 percent or less Blends of more than 5 but not more than 20 percent Header Text Color Biodiesel No label...

16 CFR Appendix A to Part 306 - Summary of Labeling Requirements for Biodiesel Fuels

Code of Federal Regulations, 2011 CFR

2011-01-01

... Biodiesel Fuels A Appendix A to Part 306 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER... Part 306—Summary of Labeling Requirements for Biodiesel Fuels (Part 1 of 2) Fuel type Blends of 5 percent or less Blends of more than 5 but not more than 20 percent Header Text Color Biodiesel No label...

21 CFR 809.11 - Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human...

Code of Federal Regulations, 2011 CFR

2011-04-01

... requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile. 809.11... (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE Labeling § 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic...

21 CFR 809.11 - Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human...

Code of Federal Regulations, 2010 CFR

2010-04-01

... requirements for in vitro diagnostic products for human use held by the Strategic National Stockpile. 809.11... (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE Labeling § 809.11 Exceptions or alternatives to labeling requirements for in vitro diagnostic products for human use held by the Strategic...

Safety and efficacy of the RTS,S/AS01E candidate malaria vaccine given with expanded-programme-on-immunisation vaccines: 19 month follow-up of a randomised, open-label, phase 2 trial.

PubMed

Asante, Kwaku Poku; Abdulla, Salim; Agnandji, Selidji; Lyimo, John; Vekemans, Johan; Soulanoudjingar, Solange; Owusu, Ruth; Shomari, Mwanajaa; Leach, Amanda; Jongert, Erik; Salim, Nahya; Fernandes, Jose F; Dosoo, David; Chikawe, Maria; Issifou, Saadou; Osei-Kwakye, Kingsley; Lievens, Marc; Paricek, Maria; Möller, Tina; Apanga, Stephen; Mwangoka, Grace; Dubois, Marie-Claude; Madi, Tigani; Kwara, Evans; Minja, Rose; Hounkpatin, Aurore B; Boahen, Owusu; Kayan, Kingsley; Adjei, George; Chandramohan, Daniel; Carter, Terrell; Vansadia, Preeti; Sillman, Marla; Savarese, Barbara; Loucq, Christian; Lapierre, Didier; Greenwood, Brian; Cohen, Joe; Kremsner, Peter; Owusu-Agyei, Seth; Tanner, Marcel; Lell, Bertrand

2011-10-01

The RTS,S/AS01(E) candidate malaria vaccine is being developed for immunisation of infants in Africa through the expanded programme on immunisation (EPI). 8 month follow-up data have been reported for safety and immunogenicity of RTS,S/AS01(E) when integrated into the EPI. We report extended follow-up to 19 months, including efficacy results. We did a randomised, open-label, phase 2 trial of safety and efficacy of the RTS,S/AS01(E) candidate malaria vaccine given with EPI vaccines between April 30, 2007, and Oct 7, 2009, in Ghana, Tanzania, and Gabon. Eligible children were 6-10 weeks of age at first vaccination, without serious acute or chronic illness. All children received the EPI diphtheria, tetanus, pertussis (inactivated whole-cell), and hepatitis-B vaccines, Haemophilus influenzae type b vaccine, and oral polio vaccine at study months 0, 1, and 2, and measles vaccine and yellow fever vaccines at study month 7. Participants were randomly assigned (1:1:1) to receive three doses of RTS,S/AS01(E) at 6, 10, and 14 weeks (0, 1, 2 month schedule) or at 6 weeks, 10 weeks, and 9 months (0, 2, 7 month schedule) or placebo. Randomisation was according to a predefined block list with a computer-generated randomisation code. Detection of serious adverse events and malaria was by passive case detection. Antibodies against Plasmodium falciparum circumsporozoite protein and HBsAg were monitored for 19 months. This study is registered with ClinicalTrials.gov, number NCT00436007. 511 children were enrolled. Serious adverse events occurred in 57 participants in the RTS,S/AS01(E) 0, 1, 2 month group (34%, 95% CI 27-41), 47 in the 0, 1, 7 month group (28%, 21-35), and 49 (29%, 22-36) in the control group; none were judged to be related to study vaccination. At month 19, anticircumsporozoite immune responses were significantly higher in the RTS,S/AS01(E) groups than in the control group. Vaccine efficacy for the 0, 1, 2 month schedule (2 weeks after dose three to month 19, site

A randomized, open-label study of the immunogenicity and reactogenicity of three lots of a combined typhoid fever/hepatitis A vaccine in healthy adults.

PubMed

Loebermann, Micha; Kollaritsch, Herwig; Ziegler, Tom; Rendi-Wagner, Pamela; Chambonneau, Laurent; Dumas, Rafaele; Lafrenz, Michael

2004-07-01

Travelers are often advised to receive both the typhoid fever and hepatitis A virus (HAV) vaccines, particularly when going to areas where the 2 diseases are endemic. Thus, combined administration of these vaccines could make immunization more acceptable by reducing the number of injections needed. This study compared the safety profiles and immunogenicity of 3 batches of a combined typhoid fever/HAV vaccine administered using a dual-chamber bypass syringe. This randomized, open-label study was conducted at 2 university-based travel clinics in Germany and Austria. Subjects received a single IM injection from 1 of 3 batches of the combined vaccine. Blood samples were drawn immediately before and 28 days after vaccination to evaluate the response to the 2 antigens by assessing geometric mean titers (GMTs) and rates of seroconversion and seroprotection. Subjects recorded all adverse events (AEs) occurring during the study period in a diary. Six hundred ten healthy adults were enrolled in the study. Twenty-eight days after vaccination, 90.6% of the study population had protective typhoid Vi antibody titers (> or = 1 microg/mL) and 100% had protective HAV antibody titers (> or = 20 mIU/mL). Seroconversion rates and GMTs were not significantly different between the 3 batches. There were no differences with regard to local or systemic AEs between the 3 batches of vaccine. There were no immediate adverse reactions (within 30 minutes of vaccination) and no serious AEs related to vaccination. Of 609 evaluable subjects (1 was lost to follow-up after the first visit), 555 (91.1%) experienced > or = 1 local reaction within the first 7 days after vaccination, mainly pain at the injection site (550 [90.3%]), but only 26 (4.3%) described this pain as severe. Vaccine-related headache and mild to moderate asthenia were each reported by 54 subjects (8.9%). Symptoms resolved spontaneously in all cases. The 3 batches of the combined typhoid fever/HAV vaccine administered by dual

Determining the pneumococcal conjugate vaccine coverage required for indirect protection against vaccine-type pneumococcal carriage in low and middle-income countries: a protocol for a prospective observational study.

PubMed

Chan, Jocelyn; Nguyen, Cattram D; Lai, Jana Y R; Dunne, Eileen M; Andrews, Ross; Blyth, Christopher C; Datta, Siddhartha; Fox, Kim; Ford, Rebecca; Hinds, Jason; La Vincente, Sophie; Lehmann, Deborah; Lim, Ruth; Mungun, Tuya; Newton, Paul N; Phetsouvanh, Rattanaphone; Pomat, Willam S; Xeuatvongsa, Anonh; von Mollendorf, Claire; Dance, David A B; Satzke, Catherine; Muholland, Kim; Russell, Fiona M

2018-05-18

Pneumococcal conjugate vaccines (PCVs) prevent disease through both direct protection of vaccinated individuals and indirect protection of unvaccinated individuals by reducing nasopharyngeal (NP) carriage and transmission of vaccine-type (VT) pneumococci. While the indirect effects of PCV vaccination are well described, the PCV coverage required to achieve the indirect effects is unknown. We will investigate the relationship between PCV coverage and VT carriage among undervaccinated children using hospital-based NP pneumococcal carriage surveillance at three sites in Asia and the Pacific. We are recruiting cases, defined as children aged 2-59 months admitted to participating hospitals with acute respiratory infection in Lao People's Democratic Republic, Mongolia and Papua New Guinea. Thirteen-valent PCV status is obtained from written records. NP swabs are collected according to standard methods, screened using lytA qPCR and serotyped by microarray. Village-level vaccination coverage, for the resident communities of the recruited cases, is determined using administrative data or community survey. Our analysis will investigate the relationship between VT carriage among undervaccinated cases (indirect effects) and vaccine coverage using generalised estimating equations. Ethical approval has been obtained from the relevant ethics committees at participating sites. The results are intended for publication in open-access peer-reviewed journals and will demonstrate methods suitable for low- and middle-income countries to monitor vaccine impact and inform vaccine policy makers about the PCV coverage required to achieve indirect protection. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Safety and immune response to a challenge dose of hepatitis B vaccine in healthy children primed 10years earlier with hexavalent vaccines in a 3, 5, 11-month schedule: An open-label, controlled, multicentre trial in Italy.

PubMed

Zanetti, Alessandro; Desole, Maria Giuseppina; Romanò, Luisa; d'Alessandro, Antonio; Conversano, Michele; Ferrera, Giuseppe; Panico, Maria Grazia; Tomasi, Alberto; Zoppi, Giorgio; Zuliani, Massimo; Thomas, Stéphane; Soubeyrand, Benoît; Eymin, Cécile; Lockhart, Stephen

2017-07-13

The strategy of vaccinating infants to prevent hepatitis B virus infection in adolescence or adulthood requires durable immunity. This study investigated responses to a challenge dose of monovalent hepatitis B vaccine in children primed with three doses of either Hexavac® or Infanrix hexa® 10years earlier during infancy. This open-label, controlled, multicentre study conducted in Italy, enrolled 751 healthy pre-adolescents (aged 11-13years) who were given either Hexavac (n=409) or Infanrix hexa (n=342) at 3, 5 and 11months of life. All participants received a challenge dose of a monovalent hepatitis B vaccine (HBVaxPro® 5µg). The concentrations of antibodies to hepatitis B surface antigen (anti-HBs) were measured before and 1month after the challenge dose. The analysis was descriptive and no formal hypothesis was tested. One month post-challenge, 331 participants in the Hexavac cohort [83.6%, 95% CI: 79.6; 87.1] and 324 in the Infanrix hexa cohort [96.4%, 95% CI: 93.8; 98.1] had anti-HBs concentrations ≥10mIU/mL. Before the challenge dose, an anti-HBs concentration of ≥10mIU/mL was found in 94 children in the Hexavac cohort [23.9%, 95% CI: 19.7; 28.4] and in 232 children in the Infanrix hexa cohort [69%, 95% CI: 63.8; 74.0]. Among children with a pre-challenge anti-HBs concentration of <10mIU/mL, 236 [78.7%, 95% CI: 73.6; 83.2] in the Hexavac cohort and 92 [88.5%, 95% CI: 80.7; 93.9] in the Infanrix hexa cohort achieved protective anti-HBs antibody concentrations. No evidence of active hepatitis B disease was observed in either group, and the HBVaxPro challenge dose was well tolerated. These data confirm that immune memory persists in a high percentage of children (>80%) at least 10years after a two-dose primary and booster vaccination schedule with a hexavalent vaccine (Hexavac or Infanrix hexa). EudraCT Number: 2013-001602-28; clinicaltrials.gov: NCT02012998. Copyright © 2017 Elsevier Ltd. All rights reserved.

Challenges for the registration of vaccines in emerging countries: Differences in dossier requirements, application and evaluation processes.

PubMed

Dellepiane, Nora; Pagliusi, Sonia

2018-06-07

The divergence of regulatory requirements and processes in developing and emerging countries contributes to hamper vaccines' registration, and therefore delay access to high-quality, safe and efficacious vaccines for their respective populations. This report focuses on providing insights on the heterogeneity of registration requirements in terms of numbering structure and overall content of dossiers for marketing authorisation applications for vaccines in different areas of the world. While it also illustrates the divergence of regulatory processes in general, as well as the need to avoid redundant reviews, it does not claim to provide a comprehensive view of all processes nor existing facilitating mechanisms, nor is it intended to touch upon the differences in assessments made by different regulatory authorities. This report describes the work analysed by regulatory experts from vaccine manufacturing companies during a meeting held in Geneva in May 2017, in identifying and quantifying differences in the requirements for vaccine registration in three aspects for comparison: the dossier numbering structure and contents, the application forms, and the evaluation procedures, in different countries and regions. The Module 1 of the Common Technical Document (CTD) of 10 countries were compared. Modules 2-5 of the CTDs of two regions and three countries were compared to the CTD of the US FDA. The application forms of eight countries were compared and the registration procedures of 134 importing countries were compared as well. The analysis indicates a high degree of divergence in numbering structure and content requirements. Possible interventions that would lead to significant improvements in registration efficiency include alignment in CTD numbering structure, a standardised model-application form, and better convergence of evaluation procedures. Copyright © 2018.

Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials.

PubMed

Gaudinski, Martin R; Houser, Katherine V; Morabito, Kaitlyn M; Hu, Zonghui; Yamshchikov, Galina; Rothwell, Ro Shauna; Berkowitz, Nina; Mendoza, Floreliz; Saunders, Jamie G; Novik, Laura; Hendel, Cynthia S; Holman, LaSonji A; Gordon, Ingelise J; Cox, Josephine H; Edupuganti, Srilatha; McArthur, Monica A; Rouphael, Nadine G; Lyke, Kirsten E; Cummings, Ginny E; Sitar, Sandra; Bailer, Robert T; Foreman, Bryant M; Burgomaster, Katherine; Pelc, Rebecca S; Gordon, David N; DeMaso, Christina R; Dowd, Kimberly A; Laurencot, Carolyn; Schwartz, Richard M; Mascola, John R; Graham, Barney S; Pierson, Theodore C; Ledgerwood, Julie E; Chen, Grace L

2018-02-10

The Zika virus epidemic and associated congenital infections have prompted rapid vaccine development. We assessed two new DNA vaccines expressing premembrane and envelope Zika virus structural proteins. We did two phase 1, randomised, open-label trials involving healthy adult volunteers. The VRC 319 trial, done in three centres, assessed plasmid VRC5288 (Zika virus and Japanese encephalitis virus chimera), and the VRC 320, done in one centre, assessed plasmid VRC5283 (wild-type Zika virus). Eligible participants were aged 18-35 years in VRC19 and 18-50 years in VRC 320. Participants were randomly assigned 1:1 by a computer-generated randomisation schedule prepared by the study statistician. All participants received intramuscular injection of 4 mg vaccine. In VRC 319 participants were assigned to receive vaccinations via needle and syringe at 0 and 8 weeks, 0 and 12 weeks, 0, 4, and 8 weeks, or 0, 4, and 20 weeks. In VRC 320 participants were assigned to receive vaccinations at 0, 4, and 8 weeks via single-dose needle and syringe injection in one deltoid or split-dose needle and syringe or needle-free injection with the Stratis device (Pharmajet, Golden, CO, USA) in each deltoid. Both trials followed up volunteers for 24 months for the primary endpoint of safety, assessed as local and systemic reactogenicity in the 7 days after each vaccination and all adverse events in the 28 days after each vaccination. The secondary endpoint in both trials was immunogenicity 4 weeks after last vaccination. These trials are registered with ClinicalTrials.gov, numbers NCT02840487 and NCT02996461. VRC 319 enrolled 80 participants (20 in each group), and VRC 320 enrolled 45 participants (15 in each group). One participant in VRC 319 and two in VRC 320 withdrew after one dose of vaccine, but were included in the safety analyses. Both vaccines were safe and well tolerated. All local and systemic symptoms were mild to moderate. In both studies, pain and tenderness at the injection site

16 CFR 1500.20 - Labeling requirement for advertising toys and games.

Code of Federal Regulations, 2010 CFR

2010-01-01

... and games. 1500.20 Section 1500.20 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.20 Labeling requirement for advertising toys and games. (a) Scope. This section applies to..., that is used in various children's games, generally as a playing piece or marker. The term “marble...

16 CFR 1500.20 - Labeling requirement for advertising toys and games.

Code of Federal Regulations, 2011 CFR

2011-01-01

... and games. 1500.20 Section 1500.20 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.20 Labeling requirement for advertising toys and games. (a) Scope. This section applies to..., that is used in various children's games, generally as a playing piece or marker. The term “marble...

16 CFR 1500.20 - Labeling requirement for advertising toys and games.

Code of Federal Regulations, 2014 CFR

2014-01-01

... and games. 1500.20 Section 1500.20 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.20 Labeling requirement for advertising toys and games. (a) Scope. This section applies to..., that is used in various children's games, generally as a playing piece or marker. The term “marble...

16 CFR 1500.20 - Labeling requirement for advertising toys and games.

Code of Federal Regulations, 2012 CFR

2012-01-01

... and games. 1500.20 Section 1500.20 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL... REGULATIONS § 1500.20 Labeling requirement for advertising toys and games. (a) Scope. This section applies to..., that is used in various children's games, generally as a playing piece or marker. The term “marble...

Requirements for Access to Pesticide Labeling Information

EPA Pesticide Factsheets

Employers of pesticide handlers must make sure that the handlers are given information from the pesticide labeling and have access to the labeling itself, before they do any handling task. Learn about the information employers must provide.

Do cigarette health warning labels comply with requirements: A 14-country study.

PubMed

Cohen, Joanna E; Brown, Jennifer; Washington, Carmen; Welding, Kevin; Ferguson, Jacqueline; Smith, Katherine C

2016-12-01

The Framework Convention on Tobacco Control, a global health treaty ratified by over 175 countries, calls on countries to ensure that tobacco packages carry health warning labels (HWLs) describing the harmful effects of tobacco use. We assessed the extent of compliance with 14 countries' HWL requirements. Unique cigarette packs were purchased in 2013 using a systematic protocol in 12 distinct neighborhoods within three of the ten most populous cities in the 14 low- and middle-income countries with the greatest number (count) of smokers. HWL compliance codebooks were developed for each country based on the details of country-specific HWL requirements, with up to four common compliance indicators assessed for each country (location, size, label elements, text size). Packs (n=1859) were double coded for compliance. Compliance was examined by country and pack characteristics, including parent company and brand family. Overall, 72% of coded cigarette packs were compliant with all relevant compliance indicators, ranging from 17% in the Philippines to 94% in Mexico. Compliance was highest for location of the warning (ranging from 75%-100%) and lowest for warning size (ranging from 46%-99%). Compliance was higher for packs bought in high SES neighborhoods, and varied by parent company and brand family. This multi-country study found at least one pack in every country - and many packs in some countries - that were not compliant with key requirements for health warning labels in the country of purchase. Non-compliance may be exacerbating health disparities. Tobacco companies should be held accountable for complying with country HWL requirements. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

9 CFR 590.410 - Shell eggs and egg products required to be labeled.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Shell eggs and egg products required..., DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Identifying and Marking Product § 590.410 Shell eggs and egg products required to be labeled...

9 CFR 590.410 - Shell eggs and egg products required to be labeled.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Shell eggs and egg products required..., DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION INSPECTION OF EGGS AND EGG PRODUCTS (EGG PRODUCTS INSPECTION ACT) Identifying and Marking Product § 590.410 Shell eggs and egg products required to be labeled...

Vaccine exemptions and the kindergarten vaccination coverage gap.

PubMed

Smith, Philip J; Shaw, Jana; Seither, Ranee; Lopez, Adriana; Hill, Holly A; Underwood, Mike; Knighton, Cynthia; Zhao, Zhen; Ravanam, Megha Shah; Greby, Stacie; Orenstein, Walter A

2017-09-25

Vaccination requirements for kindergarten entry vary by state, but all states require 2 doses of measles containing vaccine (MCV) at kindergarten entry. To assess (i) national MCV vaccination coverage for children who had attended kindergarten; (ii) the extent to which undervaccination after kindergarten entry is attributable to parents' requests for an exemption; (iii) the extent to which undervaccinated children had missed opportunities to be administered missing vaccine doses among children whose parent did not request an exemption; and (iv) the vaccination coverage gap between the "highest achievable" MCV coverage and actual MCV coverage among children who had attended kindergarten. A national survey of 1465 parents of 5-7year-old children was conducted during October 2013 through March 2014. Vaccination coverage estimates are based provider-reported vaccination histories. Children have a "missed opportunity" for MCV if they were not up-to-date and if there were dates on which other vaccines were administered but not MCV. The "highest achievable" MCV vaccination coverage rate is 100% minus the sum of the percentages of (i) undervaccinated children with parents who requested an exemption; and (ii) undervaccinated children with parents who did not request an exemption and whose vaccination statuses were assessed during a kindergarten grace period or period when they were provisionally enrolled in kindergarten. Among all children undervaccinated for MCV, 2.7% were attributable to having a parent who requested an exemption. Among children who were undervaccinated for MCV and whose parent did not request an exemption, 41.6% had a missed opportunity for MCV. The highest achievable MCV coverage was 98.6%, actual MCV coverage was 90.9%, and the kindergarten vaccination gap was 7.7%. Vaccination coverage may be increased by schools fully implementing state kindergarten vaccination laws, and by providers assessing children's vaccination status at every clinic visit, and

Vaccinating parents experience vaccine anxiety too.

PubMed

Luthy, Karlen E; Beckstrand, Renea L; Asay, Whitney; Hewett, Carly

2013-12-01

To identify common causes of parental anxiety regarding childhood vaccinations among parents who vaccinate. Another purpose was to seek recommendations for healthcare providers to help parents overcome their anxiety when their children are immunized. Four 1-h focus groups were conducted, each consisting of 8-10 parents. Each focus group discussion was conducted by a moderator and an assistant moderator. The moderator facilitated discussion while the assistant moderator took notes. Each session was recorded on video. The data were transcribed and analyzed for themes. Parents identifying themselves as being compliant with childhood vaccination requirements reported anxiety that can be divided into five major themes: parental anxiety prior to vaccination, parental anxiety during the vaccination, parental anxiety after the vaccination, parental suggestions for healthcare providers, and informational issues. Making minor changes in office policies may help alleviate some parental anxiety regarding vaccinations. Providers should also create lists of credible sources about vaccination information. Because the cause of vaccine-related parental anxiety varies, targeted education is necessary to relieve common causes of vaccine anxiety, even among parents who vaccinate. ©2013 The Author(s) ©2013 American Association of Nurse Practitioners.

40 CFR 600.306-12 - Fuel economy label-special requirements for compressed natural gas vehicles.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 31 2013-07-01 2013-07-01 false Fuel economy label-special requirements for compressed natural gas vehicles. 600.306-12 Section 600.306-12 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy Labeling §...

40 CFR 600.306-12 - Fuel economy label-special requirements for compressed natural gas vehicles.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 30 2014-07-01 2014-07-01 false Fuel economy label-special requirements for compressed natural gas vehicles. 600.306-12 Section 600.306-12 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy Labeling §...

40 CFR 600.306-12 - Fuel economy label-special requirements for compressed natural gas vehicles.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 31 2012-07-01 2012-07-01 false Fuel economy label-special requirements for compressed natural gas vehicles. 600.306-12 Section 600.306-12 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy Labeling §...

Label Review Training: Module 1: Label Basics, Page 22

EPA Pesticide Factsheets

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about what labels require review.

40 CFR 88.305-94 - Clean-fuel fleet vehicle labeling requirements for heavy-duty vehicles.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 21 2012-07-01 2012-07-01 false Clean-fuel fleet vehicle labeling requirements for heavy-duty vehicles. 88.305-94 Section 88.305-94 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CLEAN-FUEL VEHICLES Clean-Fuel Fleet Program § 88.305-94 Clean-fuel fleet vehicle labeling...

40 CFR 88.305-94 - Clean-fuel fleet vehicle labeling requirements for heavy-duty vehicles.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 21 2013-07-01 2013-07-01 false Clean-fuel fleet vehicle labeling requirements for heavy-duty vehicles. 88.305-94 Section 88.305-94 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CLEAN-FUEL VEHICLES Clean-Fuel Fleet Program § 88.305-94 Clean-fuel fleet vehicle labeling...

40 CFR 88.305-94 - Clean-fuel fleet vehicle labeling requirements for heavy-duty vehicles.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 20 2014-07-01 2013-07-01 true Clean-fuel fleet vehicle labeling requirements for heavy-duty vehicles. 88.305-94 Section 88.305-94 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CLEAN-FUEL VEHICLES Clean-Fuel Fleet Program § 88.305-94 Clean-fuel fleet vehicle labeling...

40 CFR 88.305-94 - Clean-fuel fleet vehicle labeling requirements for heavy-duty vehicles.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 20 2011-07-01 2011-07-01 false Clean-fuel fleet vehicle labeling requirements for heavy-duty vehicles. 88.305-94 Section 88.305-94 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CLEAN-FUEL VEHICLES Clean-Fuel Fleet Program § 88.305-94 Clean-fuel fleet vehicle labeling...

Impact of rotavirus vaccine introduction and post-introduction etiology of diarrhea requiring hospital admission in Haydom, Tanzania, a rural African setting.

PubMed

Platts-Mills, James A; Amour, Caroline; Gratz, Jean; Nshama, Rosemary; Walongo, Thomas; Mujaga, Buliga; Maro, Athanasia; McMurry, Timothy L; Liu, Jie; Mduma, Estomih; Houpt, Eric R

2017-05-29

No data are available on the etiology of diarrhea requiring hospitalization after rotavirus vaccine introduction in Africa. The monovalent rotavirus vaccine was introduced in Tanzania on January 1, 2013. We performed a vaccine impact and effectiveness study as well as a qPCR-based etiology study at a rural Tanzanian hospital. We obtained data on admissions among children under 5 years to Haydom Lutheran Hospital between January 1, 2010 and December 31, 2015, and estimated the impact of vaccine introduction on all-cause diarrhea admissions. We then performed a vaccine effectiveness study using the test-negative design. Finally, we tested diarrheal specimens during 2015 by qPCR for a broad range of enteropathogens and calculated pathogen-specific attributable fractions. Vaccine introduction was associated with a 44.9% (95% CI 17.6 - 97.4) reduction in diarrhea admissions in 2015, as well as delay of the rotavirus season. The effectiveness of two doses of vaccine was 74.8% (-8.2 - 94.1) using an enzyme immunoassay-based case definition and 85.1% (26.5 - 97.0) using a qPCR-based case definition. Among 146 children enrolled in 2015, rotavirus remained the leading etiology of diarrhea requiring hospitalization (AF 25.8%, 95% CI: 24.4 - 26.7), followed by heat-stabile enterotoxin-producing E. coli (18.4%, 12.9 - 21.9), Shigella/enteroinvasive E. coli (14.5%, 10.2 - 22.8), and Cryptosporidium (7.9%, 6.2 - 9.3). Despite the clear impact of vaccine introduction in this setting, rotavirus remained the leading etiology of diarrhea requiring hospitalization. Further efforts to maximize vaccine coverage and improve vaccine performance in these settings are warranted. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

An open-label randomized clinical trial of prophylactic paracetamol coadministered with 7-valent pneumococcal conjugate vaccine and hexavalent diphtheria toxoid, tetanus toxoid, 3-component acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine.

PubMed

Rose, Markus A; Juergens, Christine; Schmoele-Thoma, Beate; Gruber, William C; Baker, Sherryl; Zielen, Stefan

2013-06-21

In two clinical trials, low-grade fever was observed more frequently after coadministration than after separate administration of two recommended routine pediatric vaccines. Since fever is an important issue with vaccine tolerability, we performed this open-label study on the efficacy and safety of prophylactic use of paracetamol (acetaminophen, Benuron®) in children administered routine 7-valent pneumococcal conjugate vaccine (PCV-7) coadministered with hexavalent vaccine (diphtheria-tetanus-acellular pertussis-hepatitis B, poliovirus, Haemophilus influenzae type b vaccine [DTPa-HBV-IPV/Hib]) in Germany. Healthy infants (N = 301) who received a 3-dose infant series of PCV-7 and DTPa-HBV-IPV/Hib plus a toddler dose were randomly assigned 1:1 to prophylactic paracetamol (125 mg or 250 mg suppositories, based on body weight) at vaccination, and at 6-8 hour intervals thereafter, or a control group that received no paracetamol. Rectal temperature and local and other systemic reactions were measured for 4 days post vaccination; adverse events were collected throughout the study. In the intent-to-treat population, paracetamol reduced the incidence of fever ≥38°C, but this reduction was only significant for the infant series, with computed efficacy of 43.0% (95% confidence interval [CI]: 17.4, 61.2), and not significant after the toddler dose (efficacy 15.9%; 95% CI: -19.9, 41.3); results were similar in the per protocol (PP) population. Fever >39°C was rare during the infant series, such that there were too few cases for assessment. After the toddler dose, paracetamol effectively reduced fever >39°C, reaching statistical significance in the PP population only (efficacy 79%; 95% CI: 3.9, 97.7). Paracetamol also reduced reactogenicity, but there were few significant differences between groups after any dose. No vaccine-related serious adverse events were reported. Paracetamol effectively prevented fever and other reactions, mainly during the infant series

Label Review Training: Module 1: Label Basics, Page 24

EPA Pesticide Factsheets

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. This page is about which labels require review.

Vaccination of horses with Lyme vaccines for dogs induces short-lasting antibody responses.

PubMed

Guarino, Cassandra; Asbie, Sanda; Rohde, Jennifer; Glaser, Amy; Wagner, Bettina

2017-07-24

Borrelia burgdorferi can induce Lyme disease. Approved Lyme vaccines for horses are currently not available. In an effort to protect horses, veterinarians are using Lyme vaccines licensed for dogs. However, data to assess the response of horses to, or determine the efficacy of this off-label vaccine use are missing. Here, antibodies against outer surface protein A (OspA), OspC, and OspF were quantified in diagnostic serum submissions from horses with a history of vaccination with canine Lyme vaccines. The results suggested that many horses respond with low and often short-lasting antibody responses. Subsequently, four experimental vaccination trials were performed. First, we investigated antibody responses to three canine vaccines in B. burgdorferi-naïve horses. One killed bacterin vaccine induced antibodies against OspC. OspA antibodies were low for all three vaccines and lasted less than 16weeks. The second trial tested the impact of the vaccine dose using the OspA/OspC inducing bacterin vaccine in horses. A 2mL dose produced higher OspA and OspC antibody values than a 1mL dose. However, the antibody response again quickly declined, independent of dose. Third, the horses were vaccinated with 2 doses of a recombinant OspA vaccine. Previous vaccination and/or environmental exposure enhanced the magnitude and longevity of the OspA antibody response to about 20weeks. Last, the influence of intramuscular versus subcutaneous vaccine administration was investigated for the recombinant OspA vaccine. OspA antibody responses were not influenced by injection route. The current work highlights that commercial Lyme vaccines for dogs induce only transient antibody responses in horses which can also be of low magnitude. Protection from infection with B. burgdorferi should not be automatically assumed after vaccinating horses with Lyme vaccines for dogs. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!).

PubMed

Henao-Restrepo, Ana Maria; Camacho, Anton; Longini, Ira M; Watson, Conall H; Edmunds, W John; Egger, Matthias; Carroll, Miles W; Dean, Natalie E; Diatta, Ibrahima; Doumbia, Moussa; Draguez, Bertrand; Duraffour, Sophie; Enwere, Godwin; Grais, Rebecca; Gunther, Stephan; Gsell, Pierre-Stéphane; Hossmann, Stefanie; Watle, Sara Viksmoen; Kondé, Mandy Kader; Kéïta, Sakoba; Kone, Souleymane; Kuisma, Eewa; Levine, Myron M; Mandal, Sema; Mauget, Thomas; Norheim, Gunnstein; Riveros, Ximena; Soumah, Aboubacar; Trelle, Sven; Vicari, Andrea S; Røttingen, John-Arne; Kieny, Marie-Paule

2017-02-04

rVSV-ZEBOV is a recombinant, replication competent vesicular stomatitis virus-based candidate vaccine expressing a surface glycoprotein of Zaire Ebolavirus. We tested the effect of rVSV-ZEBOV in preventing Ebola virus disease in contacts and contacts of contacts of recently confirmed cases in Guinea, west Africa. We did an open-label, cluster-randomised ring vaccination trial (Ebola ça Suffit!) in the communities of Conakry and eight surrounding prefectures in the Basse-Guinée region of Guinea, and in Tomkolili and Bombali in Sierra Leone. We assessed the efficacy of a single intramuscular dose of rVSV-ZEBOV (2×10 7 plaque-forming units administered in the deltoid muscle) in the prevention of laboratory confirmed Ebola virus disease. After confirmation of a case of Ebola virus disease, we definitively enumerated on a list a ring (cluster) of all their contacts and contacts of contacts including named contacts and contacts of contacts who were absent at the time of the trial team visit. The list was archived, then we randomly assigned clusters (1:1) to either immediate vaccination or delayed vaccination (21 days later) of all eligible individuals (eg, those aged ≥18 years and not pregnant, breastfeeding, or severely ill). An independent statistician generated the assignment sequence using block randomisation with randomly varying blocks, stratified by location (urban vs rural) and size of rings (≤20 individuals vs >20 individuals). Ebola response teams and laboratory workers were unaware of assignments. After a recommendation by an independent data and safety monitoring board, randomisation was stopped and immediate vaccination was also offered to children aged 6-17 years and all identified rings. The prespecified primary outcome was a laboratory confirmed case of Ebola virus disease with onset 10 days or more from randomisation. The primary analysis compared the incidence of Ebola virus disease in eligible and vaccinated individuals assigned to immediate

Label Review Training: Module 1: Label Basics, Page 23

EPA Pesticide Factsheets

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Lists types of labels that do not require review.

Financing children's vaccines.

PubMed

Nelson, E Anthony S; Sack, David; Wolfson, Lara; Walker, Damian G; Seng, Lim Fong; Steele, Duncan

2009-11-20

A 2006 Commonwealth Association of Paediatric Gastroenterology and Nutrition workshop on financing children's vaccines highlighted the potential for vaccines to control diarrhoea and other diseases as well as spur economic development through better health. Clear communication of vaccination value to decision-makers is required, together with sustainable funding mechanisms. GAVI and partners have made great progress providing funding for vaccines for children in the poorest countries but other solutions may be required to achieve the same gains in middle- and high-income countries. World Health Organization has a wealth of freely available country-level data on immunisation that academics and advocates can use to communicate the economic and health benefits of vaccines to decision-makers.

[Consensus position document on the child with an allergic reaction after vaccination or an allergy to vaccine components].

PubMed

Echeverría Zudaire, L; Ortigosa Del Castillo, L; Alonso Lebrero, E; Álvarez García, F J; Cortés Álvarez, N; García Sánchez, N; Martorell Aragonés, A

2015-07-01

Vaccinations are one of the main public health tools for the control of vaccine-preventable diseases. If a child is labeled to have had an allergic reaction to a vaccine, the next immunizations will probably be suspended in that child, with the risks involved in this decision. The rate of severe allergic reactions is very low, ranging between 0.5-1/100,000 doses. The causes of allergic reactions to vaccines, more than the vaccine itself, are often due to residual protein components in the manufacturing process, such as gelatin or egg, and rarely to yeast or latex. Most of vaccine reactions are mild, localized at the site of injection, but in some circumstances, severe anaphylactic reactions can occur. If an immediate-type allergic reaction is suspected when vaccinating, or a child allergic to some of the vaccine components has to be vaccinated, a correct diagnosis of the possible allergy has to be made. The usual components of each vaccine should be known, in order to determine if vaccination can be performed safely on the child. Copyright © 2014 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.

21 CFR 111.160 - What requirements apply to packaging and labels received?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to packaging and labels received? 111.160 Section 111.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

40 CFR 88.305-94 - Clean-fuel fleet vehicle labeling requirements for heavy-duty vehicles.

Code of Federal Regulations, 2010 CFR

2010-07-01

... requirements for heavy-duty vehicles. 88.305-94 Section 88.305-94 Protection of Environment ENVIRONMENTAL...-94 Clean-fuel fleet vehicle labeling requirements for heavy-duty vehicles. (a) All clean-fuel heavy... LEV, ULEV, or ZEV, and meets all of the applicable requirements of this part 88. (b) All heavy-duty...

9 CFR 381.125 - Special handling label requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... consumers, hotels, restaurants, or similar institutions and shall appear on the label. The information shall... such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as...

Development of a Preventive HIV Vaccine Requires Solving Inverse Problems Which Is Unattainable by Rational Vaccine Design

PubMed Central

Van Regenmortel, Marc H. V.

2018-01-01

Hypotheses and theories are essential constituents of the scientific method. Many vaccinologists are unaware that the problems they try to solve are mostly inverse problems that consist in imagining what could bring about a desired outcome. An inverse problem starts with the result and tries to guess what are the multiple causes that could have produced it. Compared to the usual direct scientific problems that start with the causes and derive or calculate the results using deductive reasoning and known mechanisms, solving an inverse problem uses a less reliable inductive approach and requires the development of a theoretical model that may have different solutions or none at all. Unsuccessful attempts to solve inverse problems in HIV vaccinology by reductionist methods, systems biology and structure-based reverse vaccinology are described. The popular strategy known as rational vaccine design is unable to solve the multiple inverse problems faced by HIV vaccine developers. The term “rational” is derived from “rational drug design” which uses the 3D structure of a biological target for designing molecules that will selectively bind to it and inhibit its biological activity. In vaccine design, however, the word “rational” simply means that the investigator is concentrating on parts of the system for which molecular information is available. The economist and Nobel laureate Herbert Simon introduced the concept of “bounded rationality” to explain why the complexity of the world economic system makes it impossible, for instance, to predict an event like the financial crash of 2007–2008. Humans always operate under unavoidable constraints such as insufficient information, a limited capacity to process huge amounts of data and a limited amount of time available to reach a decision. Such limitations always prevent us from achieving the complete understanding and optimization of a complex system that would be needed to achieve a truly rational design

Safety profile of a replication-deficient human adenovirus-vectored foot-and-mouth disease virus serotype A24 subunit vaccine in cattle.

PubMed

Barrera, J; Brake, D A; Kamicker, B J; Purcell, C; Kaptur, R; Schieber, T; Lechtenberg, K; Miller, T D; Ettyreddy, D; Brough, D E; Butman, B T; Colby, M; Neilan, J G

2018-04-01

The safety of a replication-deficient, human adenovirus-vectored foot-and-mouth disease virus (FMDV) serotype A24 Cruzeiro capsid-based subunit vaccine (AdtA24) was evaluated in five independent safety studies. The target animal safety studies were designed in compliance with United States (U.S.) regulatory requirements (Title 9, U.S. Code of Federal Regulation [9CFR]) and international standard guidelines (VICH Topic GL-44) for veterinary live vaccines. The first three studies were conducted in a total of 22 vaccinees and demonstrated that the AdtA24 master seed virus (MSV) was safe, did not revert to virulence and was not shed or spread from vaccinees to susceptible cattle or pigs. The fourth safety study conducted in 10 lactating cows using an AdtA24 vaccine serial showed that the vaccine was completely absent from milk. The fifth safety study was conducted under typical U.S. production field conditions in 500 healthy beef and dairy cattle using two AdtA24 vaccine serials. These results demonstrated that the vaccine was safe when used per the product label recommendations. Additional data collected during these five studies confirmed that AdtA24 vaccinees developed FMDV A24 and the HAd5 vaccine vector serum neutralization antibodies that test negative in a FMDV non-structural protein antibody test, confirming AdtA24 vaccine's capability to differentiate infected from vaccinated animals (DIVA). In conclusion, results from this comprehensive set of cattle studies demonstrated the safety of the replication-deficient AdtA24 vaccine and fulfilled safety-related requirements for U.S. regulatory requirements. © 2017 The Authors. Transboundary and Emerging Diseases Published by Blackwell Verlag GmbH.

16 CFR Appendix A to Part 306 - Summary of Labeling Requirements for Biodiesel Fuels

Code of Federal Regulations, 2010 CFR

2010-01-01

... required Either “B-XX Biodiesel Blend” or “Biodiesel Blend” contains biomass-based diesel or biodiesel in quantities between 5 percent and 20 percent Blue Biomass-Based Diesel No label required Either “XX% Biomass-Based Diesel Blend” or “Biomass-Based Diesel Blend” contains biomass-based diesel or biodiesel in...

21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

Code of Federal Regulations, 2013 CFR

2013-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

Code of Federal Regulations, 2014 CFR

2014-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

Code of Federal Regulations, 2011 CFR

2011-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

Code of Federal Regulations, 2012 CFR

2012-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

Code of Federal Regulations, 2010 CFR

2010-04-01

... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

Vaccination Policies: Requirements and Exemptions for Entering School.

PubMed

Skinner, Erik

2017-12-01

(1) According to the World Health Organization, immunization prevents between 2 million to 3 million deaths every year across the world. (2) When immunization rates are high, herd immunity develops and limits the spread of the disease, which helps protect those who cannot be vaccinated. (3) Vaccination rates for measles, mumps and rubella vary across the United States, ranging from 85.6 percent in Washington, D.C., to 99.4 percent in Mississippi.

16 CFR § 1500.20 - Labeling requirement for advertising toys and games.

Code of Federal Regulations, 2013 CFR

2013-01-01

... and games. § 1500.20 Section § 1500.20 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION... ENFORCEMENT REGULATIONS § 1500.20 Labeling requirement for advertising toys and games. (a) Scope. This section..., that is used in various children's games, generally as a playing piece or marker. The term “marble...

A randomized, open-label study to investigate the effect of belimumab on pneumococcal vaccination in patients with active, autoantibody-positive systemic lupus erythematosus

PubMed Central

Chadha, A; Fettiplace, J; Kleoudis, C; Bass, D; Roth, D; Gordon, D

2017-01-01

Objective Intravenous belimumab 10 mg/kg is approved as an add-on therapy in patients with active, autoantibody-positive systemic lupus erythematosus. This study aimed to assess the impact of belimumab on immune response to pneumococcal vaccination in patients with systemic lupus erythematosus. Methods This was a Phase 4, open-label study (GSK BEL115470; NCT01597492) conducted in the United States. Patients were randomized (7:9) to receive a 23-valent pneumococcal vaccination four weeks prior to (pre-belimumab cohort) or 24 weeks after (belimumab-concurrent cohort) commencing four-weekly belimumab 10 mg/kg intravenous treatment plus standard systemic lupus erythematosus therapy. Analyses of vaccine titers were performed on the as-treated population (received ≥1 dose of belimumab). The primary endpoint was the proportion of patients with positive antibody responses (≥2-fold increase from pre-vaccination levels, or post-vaccination level ≥ 0.6 µg/mL if pre-vaccination levels were unquantifiable) to ≥1 of 23 pneumococcal vaccine serotypes, four weeks post vaccination. Other endpoints included the proportion of patients with positive antibody responses to ≥2 to ≥10, and ≥11–23 (post hoc analysis) of serotypes. Safety was assessed by monitoring adverse events. Results Seventy-nine patients received pneumococcal vaccination (pre-belimumab cohort, n = 34; belimumab-concurrent cohort, n = 45). The majority (87.3% [69/79]) completed the study; 10 (12.7%) withdrew (patient request, n = 3; adverse event, n = 3; lost to follow-up, n = 2; other, n = 2). At Week 4 post-vaccination, 97.0% (32/33) and 97.6% (40/41) of patients (pre-belimumab and concurrent belimumab cohorts, respectively) had a positive response to ≥1 of 23 pneumococcal serotypes. Over 85% of patients in both cohorts responded to ≥10 of serotypes, approximately 80% responded to ≥12 serotypes, and approximately two-thirds responded to ≥16 serotypes. Little

A randomized, open-label study to investigate the effect of belimumab on pneumococcal vaccination in patients with active, autoantibody-positive systemic lupus erythematosus.

PubMed

Chatham, W; Chadha, A; Fettiplace, J; Kleoudis, C; Bass, D; Roth, D; Gordon, D

2017-12-01

Objective Intravenous belimumab 10 mg/kg is approved as an add-on therapy in patients with active, autoantibody-positive systemic lupus erythematosus. This study aimed to assess the impact of belimumab on immune response to pneumococcal vaccination in patients with systemic lupus erythematosus. Methods This was a Phase 4, open-label study (GSK BEL115470; NCT01597492) conducted in the United States. Patients were randomized (7:9) to receive a 23-valent pneumococcal vaccination four weeks prior to (pre-belimumab cohort) or 24 weeks after (belimumab-concurrent cohort) commencing four-weekly belimumab 10 mg/kg intravenous treatment plus standard systemic lupus erythematosus therapy. Analyses of vaccine titers were performed on the as-treated population (received ≥1 dose of belimumab). The primary endpoint was the proportion of patients with positive antibody responses (≥2-fold increase from pre-vaccination levels, or post-vaccination level ≥ 0.6 µg/mL if pre-vaccination levels were unquantifiable) to ≥1 of 23 pneumococcal vaccine serotypes, four weeks post vaccination. Other endpoints included the proportion of patients with positive antibody responses to ≥2 to ≥10, and ≥11-23 (post hoc analysis) of serotypes. Safety was assessed by monitoring adverse events. Results Seventy-nine patients received pneumococcal vaccination (pre-belimumab cohort, n = 34; belimumab-concurrent cohort, n = 45). The majority (87.3% [69/79]) completed the study; 10 (12.7%) withdrew (patient request, n = 3; adverse event, n = 3; lost to follow-up, n = 2; other, n = 2). At Week 4 post-vaccination, 97.0% (32/33) and 97.6% (40/41) of patients (pre-belimumab and concurrent belimumab cohorts, respectively) had a positive response to ≥1 of 23 pneumococcal serotypes. Over 85% of patients in both cohorts responded to ≥10 of serotypes, approximately 80% responded to ≥12 serotypes, and approximately two-thirds responded to ≥16 serotypes. Little

75 FR 82402 - Proposed Consolidated Vaccine Information Materials for Multiple Infant Vaccines

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

... number of shots your baby needs by combining several vaccines in one shot. These combination vaccines are... to any patient (or to the parent or legal representative in the case of a child) receiving vaccines... United States who intends to administer one of these covered vaccines is required to provide copies of...

Military vaccines in today's environment.

PubMed

Schmaljohn, Connie S; Smith, Leonard A; Friedlander, Arthur M

2012-08-01

The US military has a long and highly distinguished record of developing effective vaccines against pathogens that threaten the armed forces. Many of these vaccines have also been of significant benefit to civilian populations around the world. The current requirements for force protection include vaccines against endemic disease threats as well as against biological warfare or bioterrorism agents, to include novel or genetically engineered threats. The cost of vaccine development and the modern regulatory requirements for licensing vaccines have strained the ability of the program to maintain this broad mission. Without innovative vaccine technologies, streamlined regulatory strategies, and coordinating efforts for use in civilian populations where appropriate, the military vaccine development program is in jeopardy.

Immunogenicity and safety of the inactivated Japanese encephalitis vaccine IXIARO® in elderly subjects: Open-label, uncontrolled, multi-center, phase 4 study.

PubMed

Cramer, Jakob P; Dubischar, Katrin; Eder, Susanne; Burchard, Gerd D; Jelinek, Tomas; Jilma, Bernd; Kollaritsch, Herwig; Reisinger, Emil; Westritschnig, Kerstin

2016-08-31

IXIARO® is a Vero cell-derived, inactivated Japanese encephalitis (JE) vaccine licensed mainly in western countries for children and adults traveling to JE endemic areas. Limited immunogenicity and safety data in elderly travelers have been available. To evaluate safety and immunogenicity of IXIARO in elderly subjects. Open-label, single arm, multi-centered study. Two-hundred subjects with good general health, including adequately controlled chronic conditions, received two doses of IXIARO®, 28days apart. Protective levels of antibodies were tested 42days after the second dose. Systemic and local adverse events (AEs) were solicited for 7days after each dose, unsolicited AEs were collected up to day 70 and in a phone call at month 7. Subjects were aged 64-83years (median 69.0years). Nineteen percent of subjects had serious or medically attended AEs up to Day 70 (primary endpoint), none of them causally linked to IXIARO. Solicited local AEs were reported by 33.5% (most common: local tenderness) and solicited systemic AEs by 27% (most common: headache) of subjects. The seroprotection rate was 65% with a geometric mean titre (GMT) of 37. Subjects with tick borne encephalitis (TBE) vaccinations in the past 5years (N=29) had a SCR of 90% and GMT of 65. IXIARO is generally well tolerated in the elderly, and the safety profile is largely comparable with younger adults. SCR and GMT are lower compared to younger adults, but SCR is in the range reported in elderly for other vaccines e.g. against TBE, hepatitis-A virus (HAV)/hepatitis-B virus (HBV), influenza. The differences in SCR and GMT from younger to elderly adults were in the range of other vaccines. Duration of protection is uncertain in older persons, therefore a booster dose (third dose) should be considered before any further exposure to JE virus. Copyright © 2016. Published by Elsevier Ltd.

9 CFR 112.7 - Special additional requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... a biological product containing inactivated rabies virus, carton labels, enclosures, and all but... biological product containing modified live rabies virus, the carton labels, enclosures, and all but very... Any Other Animal!” (2) For other vaccines containing modified live rabies virus, the statement “For...

21 CFR 1271.90 - Are there exceptions from the requirement of determining donor eligibility, and what labeling...

Code of Federal Regulations, 2012 CFR

2012-04-01

... for reproductive use; or (3) Cryopreserved cells or tissue for reproductive use, other than embryos... recipient. (4) A cryopreserved embryo, originally exempt under paragraph (a)(2) of this section at the time... embryo to the recipient. (b) Required labeling. As applicable, you must prominently label an HCT/P...

21 CFR 1271.90 - Are there exceptions from the requirement of determining donor eligibility, and what labeling...

Code of Federal Regulations, 2013 CFR

2013-04-01

... for reproductive use; or (3) Cryopreserved cells or tissue for reproductive use, other than embryos... recipient. (4) A cryopreserved embryo, originally exempt under paragraph (a)(2) of this section at the time... embryo to the recipient. (b) Required labeling. As applicable, you must prominently label an HCT/P...

Eggshell-inspired biomineralization generates vaccines that do not require refrigeration.

PubMed

Wang, Guangchuan; Li, Xiaofeng; Mo, Lijuan; Song, Zhiyong; Chen, Wei; Deng, Yongqiang; Zhao, Hui; Qin, Ede; Qin, Chengfeng; Tang, Ruikang

2012-10-15

We're not gonna bake it: In situ biomineralization creates an egg-like shell on vaccine particles to improve their thermostability. Different from the bare vaccine (squares), the biomineralized vaccine (red circles) can be stored at ambient temperature without refrigeration for up to a week and retain biological activity both in vitro (see graph), as well as in a mouse model. Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

78 FR 20604 - Enhanced Document Requirements To Support Use of the Dolphin Safe Label on Tuna Products

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

... Commission Act for including a dolphin-safe label on tuna product in the United States that fails to meet the.... 130221153-3153-01] RIN 0648-BC78 Enhanced Document Requirements To Support Use of the Dolphin Safe Label on Tuna Products AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric...

Proton-pump inhibitors in patients requiring antiplatelet therapy: new FDA labeling.

PubMed

Johnson, David A; Chilton, Robert; Liker, Harley R

2014-05-01

Proton-pump inhibitors (PPIs) are recommended for patients who require antiplatelet therapy and have a history of upper gastrointestinal bleeding. Proton-pump inhibitors should also be considered for patients receiving antiplatelet therapy who have other risk factors for gastrointestinal bleeding, including use of aspirin. Thus, evidence of pharmacokinetic and pharmacodynamic interactions between PPIs and consequent impaired effectiveness of the antiplatelet agent clopidogrel has caused concern. Here, we discuss comparative studies suggesting that the extent to which a PPI reduces exposure to the active metabolite of clopidogrel and attenuates its antithrombotic effect differs among PPIs. Although a clinically meaningful effect of the interaction between PPIs and clopidogrel on cardiovascular outcomes has not been established, these studies provided the basis for recent changes in US Food and Drug Administration (FDA) labeling for several PPIs and clopidogrel. New labeling suggests that PPI use among patients taking clopidogrel be limited to pantoprazole, rabeprazole, lansoprazole, or dexlansoprazole. Because comparative studies indicate that omeprazole and esomeprazole have a greater effect on the CYP2C19-mediated conversion of clopidogrel to its active metabolite and, consequently, clopidogrel's effect on platelet reactivity, FDA labeling recommends avoiding omeprazole and esomeprazole in patients taking clopidogrel. Even a 12-hour separation of dosing does not appear to prevent drug interactions between omeprazole and clopidogrel.

Risk of bursitis and other injuries and dysfunctions of the shoulder following vaccinations.

PubMed

Martín Arias, L H; Sanz Fadrique, R; Sáinz Gil, M; Salgueiro-Vazquez, M E

2017-09-05

While vaccination injection site adverse reactions are usually mild and transient in nature, several cases of bursitis and other shoulder injuries have been reported in the medical literature. However, these lesions are not included in vaccine label inserts. To identify the characteristics of post-vaccination shoulder injuries and those of patients and involved vaccines, as well as their potential causes, a systematic review of the cases of vaccination-related bursitis and other shoulder injuries reported in the literature and notified to the Spanish Pharmacovigilance System database (FEDRA) have been conducted. We found 45 cases of bursitis and other shoulder injuries that appeared following the vaccine intramuscular injection given into the deltoid muscle (37 from the systematic review of the literature, and 8 from the scrutiny in the Spanish Pharmacovigilance System database, FEDRA). All the patients were adult, 71.1% females, with a mean and median age of 53.6years (range: 22-89). The most frequently involved vaccines were influenza and pneumococcal vaccines, respectively; followed by diphtheria-tetanus-pertussis, diphtheria-tetanus toxoid, human papillomavirus, and hepatitis A vaccines. The most frequent shoulder lesion was bursitis. Most of patients required medical care due to severe local pain and arm mobility restriction. In a majority of cases, symptoms started 48h post vaccination. Subdeltoid or subacromial bursitis and other shoulder lesions may be more common than suspected. Such lesions predominantly affect women. The cause may be related to antigens or adjuvants contained in the vaccines that would trigger an immune or inflammatory response. However, they are more likely to be the consequence of a poor injection technique (site, angle, needle size, and failure to take into account patient's characteristics, i. e., sex, body weight, and physical constitution). Therefore, vaccination-related shoulder injuries would be amenable to prevention. Copyright

The influenza vaccine licensing process.

PubMed

Wood, J M; Levandowski, R A

2003-05-01

Influenza vaccines are unique because they require a licensing process which includes a procedure for rapid annual updates to vaccine strains. The licensing procedures in the European Union and the USA are described as examples. In the event of an influenza pandemic, vaccines will be required urgently and licensing process should reflect such needs.

Vaccines and vaccination strategies against human cutaneous leishmaniasis.

PubMed

Okwor, Ifeoma; Uzonna, Jude

2009-05-01

One might think that the development of a vaccine against cutaneous leishmaniasis would be relatively straightforward because the type of immune response required for protection is known and natural immunity occurs following recovery from primary infection. However, there is as yet no effective vaccine against the disease in humans. Although vaccination in murine studies has yielded promising results, these vaccines have failed miserably when tested in primates or humans. The reasons behind these failures are unknown and remain a major hurdle for vaccine design and development against cutaneous leishmaniasis. In contrast, recovery from natural, deliberate or experimental infections results in development of long-lasting immunity to re-infection. This so called infection-induced resistance is the strongest anti-Leishmania immunity known. Here, we briefly review the different approaches to vaccination against cutaneous leishmaniasis and argue that vaccines composed of genetically modified (attenuated) parasites, which induce immunity akin to infection-induced resistance, may provide best protection against cutaneous leishmaniasis in humans.

Comparison of anamnestic responses to rabies vaccination in dogs and cats with current and out-of-date vaccination status.

PubMed

Moore, Michael C; Davis, Rolan D; Kang, Qing; Vahl, Christopher I; Wallace, Ryan M; Hanlon, Cathleen A; Mosier, Derek A

2015-01-15

To compare anamnestic antibody responses of dogs and cats with current versus out-of-date vaccination status. Cross-sectional study. 74 dogs and 33 cats. Serum samples were obtained from dogs and cats that had been exposed to rabies and brought to a veterinarian for proactive serologic monitoring or that had been brought to a veterinarian for booster rabies vaccination. Blood samples were collected on the day of initial evaluation (day 0) and then again 5 to 15 days later. On day 0, a rabies vaccine was administered according to label recommendations. Paired serum samples were analyzed for antirabies antibodies by means of a rapid fluorescent focus inhibition test. All animals had an antirabies antibody titer ≥ 0.5 IU/mL 5 to 15 days after booster vaccination. Dogs with an out-of-date vaccination status had a higher median increase in titer, higher median fold increase in titer, and higher median titer following booster vaccination, compared with dogs with current vaccination status. Most (26/33) cats, regardless of rabies vaccination status, had a titer ≥ 12 IU/mL 5 to 15 days after booster vaccination. Results indicated that dogs with out-of-date vaccination status were not inferior in their antibody response following booster rabies vaccination, compared with dogs with current vaccination status. Findings supported immediate booster vaccination followed by observation for 45 days of dogs and cats with an out-of-date vaccination status that are exposed to rabies, as is the current practice for dogs and cats with current vaccination status.

40 CFR 85.1510 - Maintenance instructions, warranties, emission labeling and fuel economy requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 18 2010-07-01 2010-07-01 false Maintenance instructions, warranties, emission labeling and fuel economy requirements. 85.1510 Section 85.1510 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CONTROL OF AIR POLLUTION FROM MOBILE SOURCES Importation of Motor Vehicles and...

Immunogenicity of a Japanese encephalitis chimeric virus vaccine as a booster dose after primary vaccination with SA14-14-2 vaccine in Thai children.

PubMed

Janewongwirot, Pakpoom; Puthanakit, Thanyawee; Anugulruengkitt, Suvaporn; Jantarabenjakul, Watsamon; Phasomsap, Chayapa; Chumket, Sompong; Yoksan, Sutee; Pancharoen, Chitsanu

2016-10-17

Japanese Encephalitis chimeric virus vaccine (JE-CV) and SA14-14-2 vaccine are live-attenuated JE vaccines produced from the same virus strain. Data on interchangeability is limited. To evaluate the immunogenicity and safety of JE-CV booster after primary vaccination with SA14-14-2 vaccine. This study was an open-label clinical trial in Thai children who had received a primary SA14-14-2 vaccination at 12-24monthsbefore enrollment (ClinicalTrials.gov NCT02602652). JE-CV was administered. A 50% plaque reduction neutralization test (PRNT 50 ) against three virus strains; JE-CV, SA-14-14-2andwild-type JE virus was measured before and 28-days post vaccination. The laboratory was performed at PRNT 50 titers ⩾10 (1/dil) were considered seroprotective against JE. Geometric mean titer (GMT) of PRNT 50 was calculated. Adverse events were observed for 28days. From March 2014 to June 2015, 50 children (64% male) were enrolled. Mean age and duration after primary vaccination was 26.9 (SD 4.6) and 12.8 (SD 2.7) months, respectively. The proportion of participants who had PRNT 50 pre and post-booster vaccination were 92% and 96% against JE-CV virus, 56% and 98% against SA-14-14-2 strain and 70% and 98% against wild-type JE virus, respectively. Solicited injection site reactions including erythema, pain and swelling occurred in 18%, 10% and 4% of subjects, respectively. Four children (8%) had fever (⩾37.7Celsius). Eight children (16%) had adverse events, which were not related to the vaccine. AJE-CV booster dose is highly immunogenic and safe among children who previously received SA14-14-2 vaccine. Copyright © 2016 Elsevier Ltd. All rights reserved.

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2013 CFR

2013-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2014 CFR

2014-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2012 CFR

2012-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2011 CFR

2011-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

Code of Federal Regulations, 2010 CFR

2010-04-01

... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

40 CFR 59.507 - What are the labeling requirements for aerosol coatings?

Code of Federal Regulations, 2010 CFR

2010-07-01

... in Table 1 of this subpart or a company-specific code, if that code is explained as required by § 59.511(a); (2) The applicable PWR limit for the product specified in Table 1 of this subpart; (3) The day... this subpart. (b) The label on the product must be displayed in such a manner that it is readily...

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. Copyright © 2011 Elsevier Ltd. All rights reserved.

47 CFR 15.19 - Labelling requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... material fastened to the equipment by welding, riveting, or a permanent adhesive. The label must be... intended for use with cable service or the quality of such features are acceptable so long as such...

47 CFR 15.19 - Labelling requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... material fastened to the equipment by welding, riveting, or a permanent adhesive. The label must be... intended for use with cable service or the quality of such features are acceptable so long as such...

47 CFR 15.19 - Labelling requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... material fastened to the equipment by welding, riveting, or a permanent adhesive. The label must be... intended for use with cable service or the quality of such features are acceptable so long as such...

21 CFR 201.57 - Specific requirements on content and format of labeling for human prescription drug and...

Code of Federal Regulations, 2010 CFR

2010-04-01

... § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c), except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at... to the labeling sections described in paragraphs (c)(1), (c)(2), (c)(3), (c)(5), and (c)(6) of this...

21 CFR 201.57 - Specific requirements on content and format of labeling for human prescription drug and...

Code of Federal Regulations, 2011 CFR

2011-04-01

... § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c), except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at... to the labeling sections described in paragraphs (c)(1), (c)(2), (c)(3), (c)(5), and (c)(6) of this...

US College and University Student Health Screening Requirements for Tuberculosis and Vaccine-Preventable Diseases, 2012

ERIC Educational Resources Information Center

Jewett, Amy; Bell, Teal; Cohen, Nicole J.; Buckley, Kirsten; Leino, E. Victor; Even, Susan; Beavers, Suzanne; Brown, Clive; Marano, Nina

2016-01-01

Objective: Colleges are at risk for communicable disease outbreaks because of the high degree of person-to-person interactions and relatively crowded dormitory settings. This report describes the US college student health screening requirements among US resident and international students for tuberculosis (TB) and vaccine-preventable diseases…

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2011 CFR

2011-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2013 CFR

2013-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2012 CFR

2012-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2014 CFR

2014-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

Code of Federal Regulations, 2010 CFR

2010-04-01

... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of two different reduced antigen diphtheria-tetanus-acellular pertussis-polio vaccines, when co-administered with measles-mumps-rubella vaccine in 3 and 4-year-old healthy children in the UK.

PubMed

Marlow, Robin; Kuriyakose, Sherine; Mesaros, Narcisa; Han, Htay Htay; Tomlinson, Richard; Faust, Saul N; Snape, Matthew D; Pollard, Andrew J; Finn, Adam

2018-04-19

To evaluate the immunogenicity and safety of a reduced antigen diphtheria-tetanus-acellular pertussis-inactivated poliovirus (dTap-IPV B ) vaccine (Boostrix-IPV, GSK) as a pre-school booster in 3-4 year old children as compared to dTap-IPV R (Repevax, Sanofi Pasteur), when co-administered with mumps-measles-rubella vaccine (MMRV). This phase III, open label, randomised study was conducted in the UK between April 2011 and April 2012. Children due their pre-school dTap-IPV booster vaccination were randomised 2:1 to receive one of two different dTap-IPV vaccines (dTap-IPV B or dTap-IPV R ) with blood sample for immunogenicity assessment just prior and one month after vaccination. Immune responses to diphtheria, tetanus and polio antigens were compared between the study vaccines (inferential comparison). In the absence of an accepted pertussis correlate of protection, the immunogenicity of dTap-IPV B vaccine against pertussis was compared with historical pertussis efficacy data (inferential comparison). Safety and reactogenicity of both study vaccines were evaluated. 387 children were randomised and 385 vaccinated: 255 in the dTap-IPV B group and 130 in the dTap-IPV R group. Prior to vaccination, ≥76.8% of children had anti-diphtheria and ≥65.5% had anti-tetanus titres above the protection threshold; for pertussis, the pre-vaccination seropositivity rate ranged between 18.1 and 70.6%. Both vaccines were immunogenic with 99.2-100% of children achieving titres above the pre-specified seroprotection/seropositivity thresholds. One serious adverse event not considered as causally related to the study vaccination by the study investigator was reported in the dTap-IPV B group. Non-inferiority of dTap-IPV B to dTap-IPV R was demonstrated. Both vaccines had a clinically acceptable safety and reactogenicity profile when co-administered with MMRV to children 3-4 years old. NCT01245049 (ClinicalTrials.gov). Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All

16 CFR 303.19 - Name or other identification required to appear on labels.

Code of Federal Regulations, 2010 CFR

2010-01-01

... trademark, used as a house mark, registered in the United States Patent Office, such word trademark may be used on labels in lieu of the name otherwise required: Provided, The owner of such word trademark furnishes the Commission a copy of the registration prior to its use. No trademark, trade names, or other...

75 FR 48715 - Proposed Vaccine Information Materials for Measles, Mumps, Rubella, and Varicella Vaccines

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-11

... United States who intends to administer one of these covered vaccines is required to provide copies of..., mumps, and rubella (MMR) vaccine can prevent these diseases. Most children who get their MMR shots will... one dose of MMR vaccine, unless they can show that they have had either the vaccines or the diseases...

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

PubMed Central

Libster, Romina; McNeal, Monica; Walter, Emmanuel B.; Shane, Andi L.; Winokur, Patricia; Cress, Gretchen; Berry, Andrea A.; Kotloff, Karen L.; Sarpong, Kwabena; Turley, Christine B.; Harrison, Christopher J.; Pahud, Barbara A.; Marbin, Jyothi; Dunn, John; El-Khorazaty, Jill; Barrett, Jill

2016-01-01

BACKGROUND AND OBJECTIVES: Although both licensed rotavirus vaccines are safe and effective, it is often not possible to complete the schedule by using the same vaccine formulation. The goal of this study was to investigate the noninferiority of the immune responses to the 2 licensed rotavirus vaccines when administered as a mixed schedule compared with administering a single vaccine formulation alone. METHODS: Randomized, multicenter, open-label study. Healthy infants (6–14 weeks of age) were randomized to receive rotavirus vaccines in 1 of 5 different schedules (2 using a single vaccine for all doses, and 3 using mixed schedules). The group receiving only the monovalent rotavirus vaccine received 2 doses of vaccine and the other 4 groups received 3 doses of vaccine. Serum for immunogenicity testing was obtained 1 month after the last vaccine dose and the proportion of seropositive children (rotavirus immunoglobulin A ≥20 U/mL) were compared in all the vaccine groups. RESULTS: Between March 2011 and September 2013, 1393 children were enrolled and randomized. Immune responses to all the sequential mixed vaccine schedules were shown to be noninferior when compared with the 2 single vaccine reference groups. The proportion of children seropositive to at least 1 vaccine antigen at 1 month after vaccination ranged from 77% to 96%, and was not significantly different among all the study groups. All schedules were well tolerated. CONCLUSIONS: Mixed schedules are safe and induced comparable immune responses when compared with the licensed rotavirus vaccines given alone. PMID:26823540

Chinese vaccine products go global: vaccine development and quality control.

PubMed

Xu, Miao; Liang, Zhenglun; Xu, Yinghua; Wang, Junzhi

2015-05-01

Through the continuous efforts of several generations, China has become one of the few countries in the world that is capable of independently addressing all the requirements by the Expanded Program on Immunization. Regulatory science is applied to continuously improve the vaccine regulatory system. Passing the prequalification by WHO has allowed Chinese vaccine products to go global. Chinese vaccine products not only secure disease prevention and control domestically but also serve the needs for international public health. This article describes the history of Chinese vaccine development, the current situation of Chinese vaccine industry and its contribution to the prevention and control of infectious diseases. We also share our experience of national quality control and vaccine regulation during the past decades. China's experience in vaccine development and quality control can benefit other countries and regions worldwide, including the developing countries.

Analysis of mutations in oral poliovirus vaccine by hybridization with generic oligonucleotide microchips.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Proudnikov, D.; Kirillov, E.; Chumakov, K.

2000-01-01

This paper describes use of a new technology of hybridization with a micro-array of immobilized oligonucleotides for detection and quantification of neurovirulent mutants in Oral Poliovirus Vaccine (OPV). We used a micro-array consisting of three-dimensional gel-elements containing all possible hexamers (total of 4096 probes). Hybridization of fluorescently labelled viral cDNA samples with such microchips resulted in a pattern of spots that was registered and quantified by a computer-linked CCD camera, so that the sequence of the original cDNA could be deduced. The method could reliably identify single point mutations, since each of them affected fluorescence intensity of 12 micro-array elements.more » Micro-array hybridization of DNA mixtures with varying contents of point mutants demonstrated that the method can detect as little as 10% of revertants in a population of vaccine virus. This new technology should be useful for quality control of live viral vaccines, as well as for other applications requiring identification and quantification of point mutations.« less

Repeated annual influenza vaccination and vaccine effectiveness: review of evidence.

PubMed

Belongia, Edward A; Skowronski, Danuta M; McLean, Huong Q; Chambers, Catharine; Sundaram, Maria E; De Serres, Gaston

2017-07-01

Studies in the 1970s and 1980s signaled concern that repeated influenza vaccination could affect vaccine protection. The antigenic distance hypothesis provided a theoretical framework to explain variability in repeat vaccination effects based on antigenic similarity between successive vaccine components and the epidemic strain. Areas covered: A meta-analysis of vaccine effectiveness studies from 2010-11 through 2014-15 shows substantial heterogeneity in repeat vaccination effects within and between seasons and subtypes. When negative effects were observed, they were most pronounced for H3N2, especially in 2014-15 when vaccine components were unchanged and antigenically distinct from the epidemic strain. Studies of repeated vaccination across multiple seasons suggest that vaccine effectiveness may be influenced by more than one prior season. In immunogenicity studies, repeated vaccination blunts the hemagglutinin antibody response, particularly for H3N2. Expert commentary: Substantial heterogeneity in repeated vaccination effects is not surprising given the variation in study populations and seasons, and the variable effects of antigenic distance and immunological landscape in different age groups and populations. Caution is required in the interpretation of pooled results across multiple seasons, since this can mask important variation in repeat vaccination effects between seasons. Multi-season clinical studies are needed to understand repeat vaccination effects and guide recommendations.

9 CFR 590.411 - Requirement of formulas and approval of labels for use in official egg products plants.

Code of Federal Regulations, 2014 CFR

2014-01-01

... products than for bulk packaged egg products not for sale or distribution to household consumers, label... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Requirement of formulas and approval of labels for use in official egg products plants. 590.411 Section 590.411 Animals and Animal...

9 CFR 590.411 - Requirement of formulas and approval of labels for use in official egg products plants.

Code of Federal Regulations, 2012 CFR

2012-01-01

... products than for bulk packaged egg products not for sale or distribution to household consumers, label... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Requirement of formulas and approval of labels for use in official egg products plants. 590.411 Section 590.411 Animals and Animal...

Vaccines for pandemic influenza. The history of our current vaccines, their limitations and the requirements to deal with a pandemic threat.

PubMed

Hampson, Alan W

2008-06-01

Fears of a potential pandemic due to A(H5N1) viruses have focussed new attention on our current vaccines, their shortcomings, and concerns regarding global vaccine supply in a pandemic. The bulk of current vaccines are inactivated split virus vaccines produced from egg-grown virus and have only modest improvements compared with those first introduced over 60 years ago. Splitting, which was introduced some years ago to reduce reactogenicity, also reduces the immunogenicity of vaccines in immunologically naïve recipients. The A(H5N1) viruses have been found poorly immunogenic and present other challenges for vaccine producers which further exacerbate an already limited global production capacity. There have been some recent improvements in vaccine production methods and improvements to immunogenicity by the development of new adjuvants, however, these still fall short of providing timely supplies of vaccine for all in the face of a pandemic. New approaches to influenza vaccines which might fulfil the demands of a pandemic situation are under evaluation, however, these remain some distance from clinical reality and face significant regulatory hurdles.

40 CFR 600.303-12 - Fuel economy label-special requirements for flexible-fuel vehicles.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 31 2012-07-01 2012-07-01 false Fuel economy label-special requirements for flexible-fuel vehicles. 600.303-12 Section 600.303-12 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR...

40 CFR 600.303-12 - Fuel economy label-special requirements for flexible-fuel vehicles.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 30 2014-07-01 2014-07-01 false Fuel economy label-special requirements for flexible-fuel vehicles. 600.303-12 Section 600.303-12 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR...

40 CFR 600.303-12 - Fuel economy label-special requirements for flexible-fuel vehicles.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 31 2013-07-01 2013-07-01 false Fuel economy label-special requirements for flexible-fuel vehicles. 600.303-12 Section 600.303-12 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL ECONOMY AND GREENHOUSE GAS EXHAUST EMISSIONS OF MOTOR...

Safety and Immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine in Vaccinia-Naive and Experienced Human Immunodeficiency Virus-Infected Individuals: An Open-Label, Controlled Clinical Phase II Trial.

PubMed

Overton, Edgar Turner; Stapleton, Jack; Frank, Ian; Hassler, Shawn; Goepfert, Paul A; Barker, David; Wagner, Eva; von Krempelhuber, Alfred; Virgin, Garth; Meyer, Thomas Peter; Müller, Jutta; Bädeker, Nicole; Grünert, Robert; Young, Philip; Rösch, Siegfried; Maclennan, Jane; Arndtz-Wiedemann, Nathaly; Chaplin, Paul

2015-04-01

Background.  First- and second-generation smallpox vaccines are contraindicated in individuals infected with human immunodeficiency virus (HIV). A new smallpox vaccine is needed to protect this population in the context of biodefense preparedness. The focus of this study was to compare the safety and immunogenicity of a replication-deficient, highly attenuated smallpox vaccine modified vaccinia Ankara (MVA) in HIV-infected and healthy subjects. Methods.  An open-label, controlled Phase II trial was conducted at 36 centers in the United States and Puerto Rico for HIV-infected and healthy subjects. Subjects received 2 doses of MVA administered 4 weeks apart. Safety was evaluated by assessment of adverse events, focused physical exams, electrocardiogram recordings, and safety laboratories. Immune responses were assessed using enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT). Results.  Five hundred seventy-nine subjects were vaccinated at least once and had data available for analysis. Rates of ELISA seropositivity were comparably high in vaccinia-naive healthy and HIV-infected subjects, whereas PRNT seropositivity rates were higher in healthy compared with HIV-infected subjects. Modified vaccinia Ankara was safe and well tolerated with no adverse impact on viral load or CD4 counts. There were no cases of myo-/pericarditis reported. Conclusions.  Modified vaccinia Ankara was safe and immunogenic in subjects infected with HIV and represents a promising smallpox vaccine candidate for use in immunocompromised populations.

Safety and Immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine in Vaccinia-Naive and Experienced Human Immunodeficiency Virus-Infected Individuals: An Open-Label, Controlled Clinical Phase II Trial

PubMed Central

Overton, Edgar Turner; Stapleton, Jack; Frank, Ian; Hassler, Shawn; Goepfert, Paul A.; Barker, David; Wagner, Eva; von Krempelhuber, Alfred; Virgin, Garth; Meyer, Thomas Peter; Müller, Jutta; Bädeker, Nicole; Grünert, Robert; Young, Philip; Rösch, Siegfried; Maclennan, Jane; Arndtz-Wiedemann, Nathaly; Chaplin, Paul

2015-01-01

Background. First- and second-generation smallpox vaccines are contraindicated in individuals infected with human immunodeficiency virus (HIV). A new smallpox vaccine is needed to protect this population in the context of biodefense preparedness. The focus of this study was to compare the safety and immunogenicity of a replication-deficient, highly attenuated smallpox vaccine modified vaccinia Ankara (MVA) in HIV-infected and healthy subjects. Methods. An open-label, controlled Phase II trial was conducted at 36 centers in the United States and Puerto Rico for HIV-infected and healthy subjects. Subjects received 2 doses of MVA administered 4 weeks apart. Safety was evaluated by assessment of adverse events, focused physical exams, electrocardiogram recordings, and safety laboratories. Immune responses were assessed using enzyme-linked immunosorbent assay (ELISA) and a plaque reduction neutralization test (PRNT). Results. Five hundred seventy-nine subjects were vaccinated at least once and had data available for analysis. Rates of ELISA seropositivity were comparably high in vaccinia-naive healthy and HIV-infected subjects, whereas PRNT seropositivity rates were higher in healthy compared with HIV-infected subjects. Modified vaccinia Ankara was safe and well tolerated with no adverse impact on viral load or CD4 counts. There were no cases of myo-/pericarditis reported. Conclusions. Modified vaccinia Ankara was safe and immunogenic in subjects infected with HIV and represents a promising smallpox vaccine candidate for use in immunocompromised populations. PMID:26380340

78 FR 66826 - Prior Label Approval System: Generic Label Approval

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-07

... container of a misleading form or size.\\1\\ FSIS has interpreted these provisions as requiring that the...-evaluating-labeling . Labels submitted as an extraordinary circumstance are given the highest priority for... submissions to FSIS headquarters, thus increasing the availability of FSIS labeling staff. Upon publication of...

Tools and approaches to ensure quality of vaccines throughout the cold chain.

PubMed

Kartoglu, Umit; Milstien, Julie

2014-07-01

The Expanded Program on Immunization was designed 40 years ago for two types of vaccines: those that are heat stable but freeze sensitive and those that are stable to freezing but heat labile. A cold chain was developed for transport and storage of such vaccines and established in all countries, despite limited access to resources and electricity in the poorest areas. However, cold chain problems occur in all countries. Recent changes to vaccines and vaccine handling include development and introduction of new vaccines with a wide range of characteristics, improvement of heat stability of several basic vaccines, observation of vaccine freezing as a real threat, development of regulatory pathways for both vaccine development and the supply chain, and emergence of new temperature monitoring devices that can pinpoint and avoid problems. With such tools, public health groups have now encouraged development of vaccines labeled for use in flexible cold chains and these tools should be considered for future systems.

Tools and approaches to ensure quality of vaccines throughout the cold chain

PubMed Central

Kartoglu, Umit; Milstien, Julie

2014-01-01

The Expanded Program on Immunization was designed 40 years ago for two types of vaccines: those that are heat stable but freeze sensitive and those that are stable to freezing but heat labile. A cold chain was developed for transport and storage of such vaccines and established in all countries, despite limited access to resources and electricity in the poorest areas. However, cold chain problems occur in all countries. Recent changes to vaccines and vaccine handling include development and introduction of new vaccines with a wide range of characteristics, improvement of heat stability of several basic vaccines, observation of vaccine freezing as a real threat, development of regulatory pathways for both vaccine development and the supply chain, and emergence of new temperature monitoring devices that can pinpoint and avoid problems. With such tools, public health groups have now encouraged development of vaccines labeled for use in flexible cold chains and these tools should be considered for future systems. PMID:24865112

Nine μg intradermal influenza vaccine and 15 μg intramuscular influenza vaccine induce similar cellular and humoral immune responses in adults

PubMed Central

Nougarede, Nolwenn; Bisceglia, Hélène; Rozières, Aurore; Goujon, Catherine; Boudet, Florence; Laurent, Philippe; Vanbervliet, Beatrice; Rodet, Karen; Hennino, Ana; Nicolas, Jean-François

2014-01-01

Intanza® 9 μg (Sanofi Pasteur), a trivalent split-virion vaccine administered by intradermal (ID) injection, was approved in Europe in 2009 for the prevention of seasonal influenza in adults 18 to 59 years. Here, we examined the immune responses induced in adults by the ID 9 μg vaccine and the standard trivalent intramuscular (IM) vaccine (Vaxigrip® 15 μg, Sanofi Pasteur). This trial was a randomized, controlled, single-center, open-label study in healthy adults 18 to 40 years of age during the 2007/8 influenza season. Subjects received a single vaccination with the ID 9 μg (n = 38) or IM 15 μg (n = 42) vaccine. Serum, saliva, and peripheral blood mononuclear cells were collected up to 180 days post-vaccination. Geometric mean hemagglutination inhibition titers, seroprotection rates, seroconversion rates, and pre-vaccination-to-post-vaccination ratios of geometric mean hemagglutination inhibition titers did not differ between the two vaccines. Compared with pre-vaccination, the vaccines induced similar increases in vaccine-specific circulating B cells at day 7 but did not induce significant increases in vaccine-specific memory B cells at day 180. Cell-mediated immunity to all three vaccine strains, measured in peripheral blood mononuclear cells, was high at baseline and not increased by either vaccine. Neither vaccine induced a mucosal immune response. These results show that the humoral and cellular immune responses to the ID 9 μg vaccine are similar to those to the standard IM 15 μg vaccine. PMID:25483667

Nine μg intradermal influenza vaccine and 15 μg intramuscular influenza vaccine induce similar cellular and humoral immune responses in adults.

PubMed

Nougarede, Nolwenn; Bisceglia, Hélène; Rozières, Aurore; Goujon, Catherine; Boudet, Florence; Laurent, Philippe; Vanbervliet, Beatrice; Rodet, Karen; Hennino, Ana; Nicolas, Jean-François

2014-01-01

Intanza® 9 μg (Sanofi Pasteur), a trivalent split-virion vaccine administered by intradermal (ID) injection, was approved in Europe in 2009 for the prevention of seasonal influenza in adults 18 to 59 years. Here, we examined the immune responses induced in adults by the ID 9 μg vaccine and the standard trivalent intramuscular (IM) vaccine (Vaxigrip® 15 μg, Sanofi Pasteur). This trial was a randomized, controlled, single-center, open-label study in healthy adults 18 to 40 years of age during the 2007/8 influenza season. Subjects received a single vaccination with the ID 9 μg (n=38) or IM 15 μg (n=42) vaccine. Serum, saliva, and peripheral blood mononuclear cells were collected up to 180 days post-vaccination. Geometric mean hemagglutination inhibition titers, seroprotection rates, seroconversion rates, and pre-vaccination-to-post-vaccination ratios of geometric mean hemagglutination inhibition titers did not differ between the two vaccines. Compared with pre-vaccination, the vaccines induced similar increases in vaccine-specific circulating B cells at day 7 but did not induce significant increases in vaccine-specific memory B cells at day 180. Cell-mediated immunity to all three vaccine strains, measured in peripheral blood mononuclear cells, was high at baseline and not increased by either vaccine. Neither vaccine induced a mucosal immune response. These results show that the humoral and cellular immune responses to the ID 9 μg vaccine are similar to those to the standard IM 15 μg vaccine.

A decade of vaccinating allergic travellers: a clinical audit.

PubMed

McCallum, Andrew D; Duncan, Christopher J A; MacDonald, Rona; Jones, Michael E

2011-09-01

Adverse reactions following vaccination are rare but may include potentially fatal anaphylaxis. This audit is a retrospective review of 38 patients with a history, or potential risk, of 'vaccine allergy' referred to an Infectious Diseases Unit for vaccination over a 10 year period. A total of 59 patient encounters were recorded, of which 89.8% were uneventful. Of the 6 adverse events, 3 patients had a local reaction, 1 patient developed urticaria and 1 patient had a vasovagal episode. Only 1 patient developed anaphylaxis secondary to vaccination, and she had no prior history of vaccine allergy. Of these patients 17 had a history suggesting the need for immunological investigation but only 7 had laboratory evidence of allergy. The differential diagnosis of anaphylaxis includes vasovagal reactions and non-specific mediator release and immunological work-up of such events can help avoid such patients being incorrectly labelled as allergic. The vast majority of immunisations are uncomplicated and patients with a history of allergic reactions to vaccination may be vaccinated safely in a controlled setting. Unduly conservative guidelines risk withholding vaccines providing protection against dangerous pathogens but which can be safely administered. Copyright © 2011 Elsevier Ltd. All rights reserved.

21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

Code of Federal Regulations, 2012 CFR

2012-04-01

... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

Code of Federal Regulations, 2011 CFR

2011-04-01

... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

Code of Federal Regulations, 2014 CFR

2014-04-01

... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

Code of Federal Regulations, 2013 CFR

2013-04-01

... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

16 CFR 309.20 - Labeling requirements for new covered vehicles.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... (b) Layout. Figures 4, 5, and 5.1 are prototype labels that demonstrate the proper layout. All positioning, spacing, type size, and line widths shall be similar to and consistent with the prototype labels... and 71/2 inches (19.05 cm) long. Figure 4 of appendix A represents the prototype for the labels for...

Effects of prophylactic ibuprofen and paracetamol administration on the immunogenicity and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine (PHiD-CV) co-administered with DTPa-combined vaccines in children: An open-label, randomized, controlled, non-inferiority trial.

PubMed

Falup-Pecurariu, Oana; Man, Sorin C; Neamtu, Mihai L; Chicin, Gratiana; Baciu, Ginel; Pitic, Carmen; Cara, Alexandra C; Neculau, Andrea E; Burlea, Marin; Brinza, Ileana L; Schnell, Cristina N; Sas, Valentina; Lupu, Valeriu V; François, Nancy; Swinnen, Kristien; Borys, Dorota

2017-03-04

Prophylactic paracetamol administration impacts vaccine immune response; this study ( www.clinicaltrials.gov : NCT01235949) is the first to assess PHiD-CV immunogenicity following prophylactic ibuprofen administration. In this phase IV, multicenter, open-label, randomized, controlled, non-inferiority study in Romania (November 2010-December 2012), healthy infants were randomized 3:3:3:1:1:1 to prophylactically receive immediate, delayed or no ibuprofen (IIBU, DIBU, NIBU) or paracetamol (IPARA, DPARA, NPARA) after each of 3 primary doses (PHiD-CV at age 3/4/5 months co-administered with DTPa-HBV-IPV/Hib at 3/5 and DTPa-IPV/Hib at 4 months) or booster dose (PHiD-CV and DTPa-HBV-IPV/Hib; 12-15 months). Non-inferiority of immune response one month post-primary vaccination in terms of percentage of infants with anti-pneumococcal antibody concentrations ≥0.2 µg/mL (primary objective) was demonstrated if the upper limit (UL) of the 98.25% confidence interval of difference between groups (NIBU vs IIBU, NIBU vs DIBU) was <10% for ≥7/10 serotypes. Immunogenicity and reactogenicity/safety were evaluated, including confirmatory analysis of difference in fever incidences post-primary vaccination in IBU or DIBU group compared to NIBU. Of 850 infants randomized, 812 were included in the total vaccinated cohort. Non-inferiority was demonstrated for both comparisons (UL was <10% for 9/10 vaccine serotypes; exceptions: 6B [NIBU], 23F [IIBU]). However, fever incidence post-primary vaccination in the IIBU and DIBU groups did not indicate a statistically significant reduction. Prophylactic administration (immediate or delayed) of paracetamol decreased fever incidence but seemed to reduce immune response to PHiD-CV, except when given only at booster. Twenty-seven serious adverse events were reported for 15 children; all resolved and were not vaccination-related.

A malaria vaccine for travelers and military personnel: Requirements and top candidates.

PubMed

Teneza-Mora, Nimfa; Lumsden, Joanne; Villasante, Eileen

2015-12-22

Malaria remains an important health threat to non-immune travelers with the explosive growth of global travel. Populations at high risk of acquiring malaria infections include once semi-immune travelers who visit friends and relatives, military forces, business travelers and international tourists with destinations to sub-Saharan Africa, where malaria transmission intensity is high. Most malaria cases have been associated with poor compliance with existing preventive measures, including chemoprophylaxis. High risk groups would benefit immensely from an efficacious vaccine to protect them against malaria infection and together make up a sizable market for such a vaccine. The attributes of an ideal malaria vaccine for non-immune travelers and military personnel include a protective efficacy of 80% or greater, durability for at least 6 months, an acceptable safety profile and compatibility with existing preventive measures. It is very likely that a malaria vaccine designed to effectively prevent infection and clinical disease in the non-immune traveler and military personnel will also protect semi-immune residents of malaria-endemic areas and contribute to malaria elimination by reducing or blocking malaria transmission. The RTS,S vaccine (GlaxoSmithKline) and the PfSPZ Vaccine (Sanaria Inc) are the leading products that would make excellent vaccine candidates for these vulnerable populations. Published by Elsevier Ltd.

40 CFR 156.10 - Labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

40 CFR 156.10 - Labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

40 CFR 156.10 - Labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

40 CFR 156.10 - Labeling requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

40 CFR 156.10 - Labeling requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

Vaccines and Immunization Practice.

PubMed

Hogue, Michael D; Meador, Anna E

2016-03-01

Vaccines are among most cost-effective public health strategies. Despite effective vaccines for many bacterial and viral illnesses, tens of thousands of adults and hundreds of children die each year in the United States from vaccine-preventable diseases. Underutilization of vaccines requires rethinking the approach to incorporating vaccines into practice. Arguably, immunizations could be a part all health care encounters. Shared responsibility is paramount if deaths are to be reduced. This article reviews the available vaccines in the US market, as well as practice recommendations of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. Copyright © 2016 Elsevier Inc. All rights reserved.

Unknown Risks: Parental Hesitation about Vaccination.

PubMed

Blaisdell, Laura L; Gutheil, Caitlin; Hootsmans, Norbert A M; Han, Paul K J

2016-05-01

This qualitative study of a select sample of vaccine-hesitant parents (VHPs) explores perceived and constructed personal judgments about the risks and uncertainties associated with vaccines and vaccine-preventable diseases (VPDs) and how these subjective risk judgments influence parents' decisions about childhood vaccination. The study employed semistructured focus group interviews with 42 VHPs to elicit parents' perceptions and thought processes regarding the risks associated with vaccination and nonvaccination, the sources of these perceptions, and their approach to decision making about vaccination for their children. VHPs engage in various reasoning processes and tend to perceive risks of vaccination as greater than the risks of VPDs. At the same time, VHPs engage in other reasoning processes that lead them to perceive ambiguity in information about the harms of vaccination-citing concerns about the missing, conflicting, changing, or otherwise unreliable nature of information. VHPs' refusal of vaccination may reflect their aversion to both the risk and ambiguity they perceive to be associated with vaccination. Mitigating this vaccine hesitancy likely requires reconstructing the risks and ambiguities associated with vaccination-a challenging task that requires providing parents with meaningful evidence-based information on the known risks of vaccination versus VPDs and explicitly acknowledging the risks that remain truly unknown. © The Author(s) 2015.

Preventable mix-ups of tuberculin and vaccines: reports to the US Vaccine and Drug Safety Reporting Systems.

PubMed

Chang, Soju; Pool, Vitali; O'Connell, Kathryn; Polder, Jacquelyn A; Iskander, John; Sweeney, Colleen; Ball, Robert; Braun, M Miles

2008-01-01

Errors involving the mix-up of tuberculin purified protein derivative (PPD) and vaccines leading to adverse reactions and unnecessary medical management have been reported previously. To determine the frequency of PPD-vaccine mix-ups reported to the US Vaccine Adverse Event Reporting System (VAERS) and the Adverse Event Reporting System (AERS), characterize adverse events and clusters involving mix-ups and describe reported contributory factors. We reviewed AERS reports from 1969 to 2005 and VAERS reports from 1990 to 2005. We defined a mix-up error event as an incident in which a single patient or a cluster of patients inadvertently received vaccine instead of a PPD product or received a PPD product instead of vaccine. We defined a cluster as inadvertent administration of PPD or vaccine products to more than one patient in the same facility within 1 month. Of 115 mix-up events identified, 101 involved inadvertent administration of vaccines instead of PPD. Product confusion involved PPD and multiple vaccines. The annual number of reported mix-ups increased from an average of one event per year in the early 1990s to an average of ten events per year in the early part of this decade. More than 240 adults and children were affected and the majority reported local injection site reactions. Four individuals were hospitalized (all recovered) after receiving the wrong products. Several patients were inappropriately started on tuberculosis prophylaxis as a result of a vaccine local reaction being interpreted as a positive tuberculin skin test. Reported potential contributory factors involved both system factors (e.g. similar packaging) and human errors (e.g. failure to read label before product administration). To prevent PPD-vaccine mix-ups, proper storage, handling and administration of vaccine and PPD products is necessary.

Post-vaccinal distemper encephalitis in two Border Collie cross littermates.

PubMed

Fairley, R A; Knesl, O; Pesavento, P A; Elias, B C

2015-03-01

One 4.5-month-old male Border Collie cross presented with aggression and seizures in October 2006. A 16-month-old, female, spayed Border Collie cross presented with hypersalivation and a dropped jaw and rapidly became stuporous in September 2007. The dogs were littermates and developed acute neurological signs 5 and 27 days, respectively, after vaccination with different modified live vaccines containing canine distemper virus. Sections of brain in both dogs showed evidence of encephalitis mainly centred on the grey matter of brainstem nuclei, where there was extensive and intense parenchymal and perivascular infiltration of histiocytes and lymphocytes. Intra-nuclear and intra-cytoplasmic inclusions typical of distemper were plentiful and there was abundant labelling for canine distemper virus using immunohistochemistry. Post-vaccinal canine distemper. Post-vaccinal canine distemper has mainly been attributed to virulent vaccine virus, but it may also occur in dogs whose immunologic nature makes them susceptible to disease induced by a modified-live vaccine virus that is safe and protective for most dogs.

Classification & Labelling Inventory: role of ECHA and notification requirements.

PubMed

Schöning, Gabriele

2011-01-01

The CLP Regulation introduces the criteria of the UN Globally Harmonised System of Classification and Labelling (UN GHS) in the EU. The European Chemicals Agency (ECHA) manages the CLP related tasks - such as harmonised classification and labelling, handling requests for alternative names and maintaining the Classification & Labelling Inventory (C&L) - to ensure consistent implementation in the EU. The obligations for industry depend on their role in the supply chain. Manufacturers and importers have to notify to ECHA the identity and classification and labelling of substances within one month of placing them on the market either on their own or in a mixture, and regardless of the quantitity. As of 3 January 2011 ECHA has received some 3.1 million notifications of over 107 000 substances. This information is stored in the C&L Inventory and accessible to Member State Competent Authorities. The non-confidential information will be made publicly available on ECHA's website in 2011.

Current ebola vaccines.

PubMed

Hoenen, Thomas; Groseth, Allison; Feldmann, Heinz

2012-07-01

Ebolaviruses cause severe viral hemorrhagic fever in humans and non-human primates (NHPs), with case fatality rates of up to 90%. Currently, neither a specific treatment nor a vaccine licensed for use in humans is available. However, a number of vaccine candidates have been developed in the last decade that are highly protective in NHPs, the gold standard animal model for ebola hemorrhagic fever. This review analyzes a number of scenarios for the use of ebolavirus vaccines, discusses the requirements for ebolavirus vaccines in these scenarios and describes current ebolavirus vaccines. Among these vaccines are recombinant adenoviruses, recombinant vesicular stomatitis viruses (VSVs), recombinant human parainfluenza viruses and virus-like particles. Interestingly, one of these vaccine platforms, based on recombinant VSVs, has also demonstrated post-exposure protection in NHPs. The most pressing remaining challenge is now to move these vaccine candidates forward into human trials and toward licensure. In order to achieve this, it will be necessary to establish the mechanisms and correlates of protection for these vaccines, and to continue to demonstrate their safety, particularly in potentially immunocompromised populations. However, already now there is sufficient evidence that, from a scientific perspective, a vaccine protective against ebolaviruses is possible.

9 CFR 113.308 - Encephalomyelitis Vaccine, Venezuelan.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Encephalomyelitis Vaccine, Venezuelan... REQUIREMENTS Live Virus Vaccines § 113.308 Encephalomyelitis Vaccine, Venezuelan. Encephalomyelitis Vaccine... established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All...

9 CFR 113.308 - Encephalomyelitis Vaccine, Venezuelan.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Encephalomyelitis Vaccine, Venezuelan... REQUIREMENTS Live Virus Vaccines § 113.308 Encephalomyelitis Vaccine, Venezuelan. Encephalomyelitis Vaccine... established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All...

9 CFR 113.308 - Encephalomyelitis Vaccine, Venezuelan.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Encephalomyelitis Vaccine, Venezuelan... REQUIREMENTS Live Virus Vaccines § 113.308 Encephalomyelitis Vaccine, Venezuelan. Encephalomyelitis Vaccine... established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All...

9 CFR 113.308 - Encephalomyelitis Vaccine, Venezuelan.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Encephalomyelitis Vaccine, Venezuelan... REQUIREMENTS Live Virus Vaccines § 113.308 Encephalomyelitis Vaccine, Venezuelan. Encephalomyelitis Vaccine... established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All...

9 CFR 113.308 - Encephalomyelitis Vaccine, Venezuelan.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Encephalomyelitis Vaccine, Venezuelan... REQUIREMENTS Live Virus Vaccines § 113.308 Encephalomyelitis Vaccine, Venezuelan. Encephalomyelitis Vaccine... established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All...

Physician communication about adolescent vaccination: How is human papillomavirus vaccine different?

PubMed

Gilkey, Melissa B; Moss, Jennifer L; Coyne-Beasley, Tamera; Hall, Megan E; Shah, Parth D; Brewer, Noel T

2015-08-01

Low human papillomavirus (HPV) vaccination coverage stands in stark contrast to our success in delivering other adolescent vaccines. To identify opportunities for improving physicians' recommendations for HPV vaccination, we sought to understand how the communication context surrounding adolescent vaccination varies by vaccine type. A national sample of 776 U.S. physicians (53% pediatricians, 47% family medicine physicians) completed our online survey in 2014. We assessed physicians' perceptions and communication practices related to recommending adolescent vaccines for 11- and 12-year-old patients. About three-quarters of physicians (73%) reported recommending HPV vaccine as highly important for patients, ages 11-12. More physicians recommended tetanus, diphtheria, and acellular pertussis (Tdap) (95%) and meningococcal vaccines (87%, both p<0.001) as highly important for this age group. Only 13% of physicians perceived HPV vaccine as being highly important to parents, which was far fewer than perceived parental support for Tdap (74%) and meningococcal vaccines (62%, both p<0.001). Physicians reported that discussing HPV vaccine took almost twice as long as discussing Tdap. Among physicians with a preferred order for discussing adolescent vaccines, most (70%) discussed HPV vaccine last. Our findings suggest that primary care physicians perceived HPV vaccine discussions to be burdensome, requiring more time and engendering less parental support than other adolescent vaccines. Perhaps for this reason, physicians in our national study recommended HPV vaccine less strongly than other adolescent vaccines, and often chose to discuss it last. Communication strategies are needed to support physicians in recommending HPV vaccine with greater confidence and efficiency. Copyright © 2015 Elsevier Inc. All rights reserved.

Compliance in 2017 With Federal Calorie Labeling in 90 Chain Restaurants and 10 Retail Food Outlets Prior to Required Implementation.

PubMed

Cleveland, Lauren P; Simon, Denise; Block, Jason P

2018-06-21

To examine early compliance with the delayed federal calorie labeling regulation that requires posting calories on menus and menu boards at retail food chains with 20 or more establishments nationally. We explored implementation of calorie labeling at 90 of the largest US chain restaurants and the 10 highest-grossing supermarket chains from May to December 2017. We contacted corporate offices and at least 2 locations for each chain, made site visits when possible, and supplemented these efforts with targeted Internet searches. Overall, 71 (79%) restaurant chains partially or fully implemented labeling, as did 9 (90%) supermarket chains. Fast-food and fast-casual restaurants fully implemented labeling at a modestly higher rate than did full-service restaurants. Most of the retail food chains we assessed implemented calorie labeling policies in advance of the May 2018 compliance date. Public Health Implications. Although implementation of federal calorie labeling has been delayed repeatedly in the 8 years since the passage of the legislation, retail food chains have demonstrated a high rate of compliance with calorie labeling in advance of the required May 2018 implementation date. Despite reports from some retail food industries that compliance will be difficult, current implementation shows the feasibility of complying. (Am J Public Health. Published online ahead of print June 21, 2018: e1-e4. doi:10.2105/AJPH.2018.304513).

Avian influenza vaccines and vaccination in birds.

PubMed

Capua, Ilaria; Alexander, Dennis J

2008-09-12

Although the use of vaccines against avian influenza viruses in birds has been discouraged over the years, the unprecedented occurrence of outbreaks caused by avian influenza (AI) viruses in recent times has required review of this policy. A variety of products are now available on the market, ranging from inactivated conventional to live recombinant products. The general consensus on the use of vaccination is that if complying to GMP standards and properly administered, birds will be more resistant to field challenge and will exhibit reduced shedding levels in case of infection. However, viral circulation may still occur in a clinically healthy vaccinated population. This may result in an endemic situation and in the emergence of antigenic variants. In order to limit these risks, monitoring programmes enabling the detection of field exposure in vaccinated populations are recommended by international organisations and are essential to allow the continuation of international trade. Adequate management of a vaccination campaign, including monitoring, improved biosecurity and restriction is essential for the success of any control program for AI.

9 CFR 113.325 - Avian Encephalomyelitis Vaccine.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Avian Encephalomyelitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.325 Avian Encephalomyelitis Vaccine. Avian Encephalomyelitis Vaccine... vaccine production. All serials shall be prepared from the first through the fifth passage from the Master...

9 CFR 113.310 - Bovine Rhinotracheitis Vaccine.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Bovine Rhinotracheitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.310 Bovine Rhinotracheitis Vaccine. Bovine Rhinotracheitis Vaccine shall... as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine...

9 CFR 113.310 - Bovine Rhinotracheitis Vaccine.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Bovine Rhinotracheitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.310 Bovine Rhinotracheitis Vaccine. Bovine Rhinotracheitis Vaccine shall... as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine...

9 CFR 113.315 - Feline Rhinotracheitis Vaccine.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Feline Rhinotracheitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.315 Feline Rhinotracheitis Vaccine. Feline Rhinotracheitis Vaccine shall... as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine...

9 CFR 113.325 - Avian Encephalomyelitis Vaccine.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Avian Encephalomyelitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.325 Avian Encephalomyelitis Vaccine. Avian Encephalomyelitis Vaccine... vaccine production. All serials shall be prepared from the first through the fifth passage from the Master...

9 CFR 113.315 - Feline Rhinotracheitis Vaccine.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Feline Rhinotracheitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.315 Feline Rhinotracheitis Vaccine. Feline Rhinotracheitis Vaccine shall... as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine...

9 CFR 113.315 - Feline Rhinotracheitis Vaccine.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Feline Rhinotracheitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.315 Feline Rhinotracheitis Vaccine. Feline Rhinotracheitis Vaccine shall... as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine...

9 CFR 113.315 - Feline Rhinotracheitis Vaccine.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Feline Rhinotracheitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.315 Feline Rhinotracheitis Vaccine. Feline Rhinotracheitis Vaccine shall... as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine...

9 CFR 113.325 - Avian Encephalomyelitis Vaccine.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Avian Encephalomyelitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.325 Avian Encephalomyelitis Vaccine. Avian Encephalomyelitis Vaccine... vaccine production. All serials shall be prepared from the first through the fifth passage from the Master...

9 CFR 113.315 - Feline Rhinotracheitis Vaccine.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Feline Rhinotracheitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.315 Feline Rhinotracheitis Vaccine. Feline Rhinotracheitis Vaccine shall... as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine...

9 CFR 113.325 - Avian Encephalomyelitis Vaccine.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Avian Encephalomyelitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.325 Avian Encephalomyelitis Vaccine. Avian Encephalomyelitis Vaccine... vaccine production. All serials shall be prepared from the first through the fifth passage from the Master...

9 CFR 113.310 - Bovine Rhinotracheitis Vaccine.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Bovine Rhinotracheitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.310 Bovine Rhinotracheitis Vaccine. Bovine Rhinotracheitis Vaccine shall... as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine...

9 CFR 113.310 - Bovine Rhinotracheitis Vaccine.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Bovine Rhinotracheitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.310 Bovine Rhinotracheitis Vaccine. Bovine Rhinotracheitis Vaccine shall... as pure, safe, and immunogenic shall be used for preparing the production seed virus for vaccine...

78 FR 4073 - Labeling of Pesticide Products and Devices for Export; Clarification of Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-18

... normal business operations. As such, EPA has concluded that the per firm and industry level impact of the... when the predominant or official language of the importing country is English. The regulatory text has been revised so that labeling text is only required to appear in a foreign language if English is not...

Vaccine production, distribution, access and uptake

PubMed Central

Smith, Jon; Lipsitch, Marc; Almond, Jeffrey W.

2011-01-01

Making human vaccines available on a global scale requires the use of complex production methods, meticulous quality control and reliable distribution channels that ensure the products are potent and effective at their point of use. The technologies involved in manufacturing different types of vaccines may strongly influence vaccine cost, ease of industrial scale-up, stability and ultimately world-wide availability. Manufacturing complexity is compounded by the need for different formulations for different countries and age groups. Reliable vaccine production in appropriate quantities and at affordable prices is the cornerstone of developing global vaccination policies. However, ensuring optimal access and uptake also requires strong partnerships between private manufacturers, regulatory authorities and national and international public health services. For vaccines whose supplies are limited, either due to rapidly emerging diseases or longer-term mismatch of supply and demand, prioritizing target groups can increase vaccine impact. Focusing on influenza vaccines as an example that well illustrates many of the relevant points, this article considers current production, distribution, access and other factors that ultimately impact on vaccine uptake and population-level effectiveness. PMID:21664680

Emerging human papillomavirus vaccines

PubMed Central

Ma, Barbara; Maraj, Bharat; Tran, Nam Phuong; Knoff, Jayne; Chen, Alexander; Alvarez, Ronald D; Hung, Chien-Fu; Wu, T.-C.

2013-01-01

Introduction Identification of human papillomavirus (HPV) as the etiologic factor of cervical, anogenital, and a subset of head and neck cancers has stimulated the development of preventive and therapeutic HPV vaccines to control HPV-associated malignancies. Excitement has been generated by the commercialization of two preventive L1-based vaccines, which use HPV virus-like particles (VLPs) to generate capsid-specific neutralizing antibodies. However, factors such as high cost and requirement for cold chain have prevented widespread implementation where they are needed most. Areas covered Next generation preventive HPV vaccine candidates have focused on cost-effective stable alternatives and generating broader protection via targeting multivalent L1 VLPs, L2 capsid protein, and chimeric L1/L2 VLPs. Therapeutic HPV vaccine candidates have focused on enhancing T cell-mediated killing of HPV-transformed tumor cells, which constitutively express HPV-encoded proteins, E6 and E7. Several therapeutic HPV vaccines are in clinical trials. Expert opinion Although progress is being made, cost remains an issue inhibiting the use of preventive HPV vaccines in countries that carry the majority of the cervical cancer burden. In addition, progression of therapeutic HPV vaccines through clinical trials may require combination strategies employing different therapeutic modalities. As research in the development of HPV vaccines continues, we may generate effective strategies to control HPV-associated malignancies. PMID:23163511

Economics of animal vaccination.

PubMed

McLeod, A; Rushton, J

2007-08-01

This paper describes the steps that might be used in assessing the economic justification for using vaccination to control animal disease, and the way that vaccination is financed and administered. It describes decisions that have been taken with respect to preserving international trade, and issues related to protection of livelihoods. Regardless of the motivation for vaccination, its costs can usually be shared between the public and private sectors. Cost-effective vaccination requires methods of delivery to be adapted to livestock production systems. The paper concludes by suggesting questions around the use of vaccination that would merit further economic analysis.

Vaccine hesitancy: Causes, consequences, and a call to action.

PubMed

Salmon, Daniel A; Dudley, Matthew Z; Glanz, Jason M; Omer, Saad B

2015-11-27

Vaccine hesitancy reflects concerns about the decision to vaccinate oneself or one's children. There is a broad range of factors contributing to vaccine hesitancy, including the compulsory nature of vaccines, their coincidental temporal relationships to adverse health outcomes, unfamiliarity with vaccine-preventable diseases, and lack of trust in corporations and public health agencies. Although vaccination is a norm in the U.S. and the majority of parents vaccinate their children, many do so amid concerns. The proportion of parents claiming non-medical exemptions to school immunization requirements has been increasing over the past decade. Vaccine refusal has been associated with outbreaks of invasive Haemophilus influenzae type b disease, varicella, pneumococcal disease, measles, and pertussis, resulting in the unnecessary suffering of young children and waste of limited public health resources. Vaccine hesitancy is an extremely important issue that needs to be addressed because effective control of vaccine-preventable diseases generally requires indefinite maintenance of extremely high rates of timely vaccination. The multifactorial and complex causes of vaccine hesitancy require a broad range of approaches on the individual, provider, health system, and national levels. These include standardized measurement tools to quantify and locate clustering of vaccine hesitancy and better understand issues of trust; rapid, independent, and transparent review of an enhanced and appropriately funded vaccine safety system; adequate reimbursement for vaccine risk communication in doctors' offices; and individually tailored messages for parents who have vaccine concerns, especially first-time pregnant women. The potential of vaccines to prevent illness and save lives has never been greater. Yet, that potential is directly dependent on parental acceptance of vaccines, which requires confidence in vaccines, healthcare providers who recommend and administer vaccines, and the

Effectiveness of vaccination recommendations versus mandates: Evidence from the hepatitis A vaccine.

PubMed

Lawler, Emily C

2017-03-01

I provide novel evidence on the effectiveness of two vaccination policies - simple non-binding recommendations to vaccinate versus mandates requiring vaccination prior to childcare or kindergarten attendance - in the context of the only disease whose institutional features permit a credible examination of both: hepatitis A. Using provider-verified immunization data I find that recommendations significantly increased hepatitis A vaccination rates among young children by at least 20 percentage points, while mandates increase rates by another 8 percentage points. These policies also significantly reduced population hepatitis A incidence. My results suggest a range of policy options for addressing suboptimally low population vaccination rates. Copyright © 2017 Elsevier B.V. All rights reserved.

9 CFR 113.301 - Ovine Ecthyma Vaccine.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Ovine Ecthyma Vaccine. 113.301 Section... Virus Vaccines § 113.301 Ovine Ecthyma Vaccine. Ovine Ecthyma Vaccine shall be prepared from tissue... inoculation with virulent ovine ecthyma virus. Ovine Ecthyma Vaccine is exempt from the requirements...

9 CFR 113.328 - Fowl Laryngotracheitis Vaccine.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Fowl Laryngotracheitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.328 Fowl Laryngotracheitis Vaccine. Fowl Laryngotracheitis Vaccine shall... vaccine production. All serials shall be prepared from the first through the fifth passage from the Master...

9 CFR 113.301 - Ovine Ecthyma Vaccine.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Ovine Ecthyma Vaccine. 113.301 Section... Virus Vaccines § 113.301 Ovine Ecthyma Vaccine. Ovine Ecthyma Vaccine shall be prepared from tissue... inoculation with virulent ovine ecthyma virus. Ovine Ecthyma Vaccine is exempt from the requirements...

9 CFR 113.328 - Fowl Laryngotracheitis Vaccine.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Fowl Laryngotracheitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.328 Fowl Laryngotracheitis Vaccine. Fowl Laryngotracheitis Vaccine shall... vaccine production. All serials shall be prepared from the first through the fifth passage from the Master...

9 CFR 113.328 - Fowl Laryngotracheitis Vaccine.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Fowl Laryngotracheitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.328 Fowl Laryngotracheitis Vaccine. Fowl Laryngotracheitis Vaccine shall... vaccine production. All serials shall be prepared from the first through the fifth passage from the Master...

9 CFR 113.301 - Ovine Ecthyma Vaccine.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Ovine Ecthyma Vaccine. 113.301 Section... Virus Vaccines § 113.301 Ovine Ecthyma Vaccine. Ovine Ecthyma Vaccine shall be prepared from tissue... inoculation with virulent ovine ecthyma virus. Ovine Ecthyma Vaccine is exempt from the requirements...

9 CFR 113.301 - Ovine Ecthyma Vaccine.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Ovine Ecthyma Vaccine. 113.301 Section... Virus Vaccines § 113.301 Ovine Ecthyma Vaccine. Ovine Ecthyma Vaccine shall be prepared from tissue... inoculation with virulent ovine ecthyma virus. Ovine Ecthyma Vaccine is exempt from the requirements...

9 CFR 113.301 - Ovine Ecthyma Vaccine.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Ovine Ecthyma Vaccine. 113.301 Section... Virus Vaccines § 113.301 Ovine Ecthyma Vaccine. Ovine Ecthyma Vaccine shall be prepared from tissue... inoculation with virulent ovine ecthyma virus. Ovine Ecthyma Vaccine is exempt from the requirements...

9 CFR 113.328 - Fowl Laryngotracheitis Vaccine.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Fowl Laryngotracheitis Vaccine. 113... REQUIREMENTS Live Virus Vaccines § 113.328 Fowl Laryngotracheitis Vaccine. Fowl Laryngotracheitis Vaccine shall... vaccine production. All serials shall be prepared from the first through the fifth passage from the Master...

Cost-effectiveness of vaccination against herpes zoster.

PubMed

de Boer, Pieter T; Wilschut, Jan C; Postma, Maarten J

2014-01-01

Herpes zoster (HZ) is a common disease among elderly, which may develop into a severe pain syndrome labeled postherpetic neuralgia (PHN). A live-attenuated varicella zoster virus vaccine has been shown to be effective in reducing the incidence and burden of illness of HZ and PHN, providing the opportunity to prevent significant health-related and financial consequences of HZ. In this review, we summarize the available literature on cost-effectiveness of HZ vaccination and discuss critical parameters for cost-effectiveness results. A search in PubMed and EMBASE was performed to identify full cost-effectiveness studies published before April 2013. Fourteen cost-effectiveness studies were included, all performed in western countries. All studies evaluated cost-effectiveness among elderly above 50 years and used costs per quality-adjusted life year (QALY) gained as primary outcome. The vast majority of studies showed vaccination of 60- to 75-year-old individuals to be cost-effective, when duration of vaccine efficacy was longer than 10 years. Duration of vaccine efficacy, vaccine price, HZ incidence, HZ incidence and discount rates were influential to the incremental cost-effectiveness ratio (ICER). HZ vaccination may be a worthwhile intervention from a cost-effectiveness point of view. More extensive reporting on methodology and more detailed results of sensitivity analyses would be desirable to address uncertainty and to guarantee optimal comparability between studies, for example regarding model structure, discounting, vaccine characteristics and loss of quality of life due to HZ and PHN.

Cost-effectiveness of vaccination against herpes zoster

PubMed Central

de Boer, Pieter T; Wilschut, Jan C; Postma, Maarten J

2014-01-01

Herpes zoster (HZ) is a common disease among elderly, which may develop into a severe pain syndrome labeled postherpetic neuralgia (PHN). A live-attenuated varicella zoster virus vaccine has been shown to be effective in reducing the incidence and burden of illness of HZ and PHN, providing the opportunity to prevent significant health-related and financial consequences of HZ. In this review, we summarize the available literature on cost-effectiveness of HZ vaccination and discuss critical parameters for cost-effectiveness results. A search in PubMed and EMBASE was performed to identify full cost-effectiveness studies published before April 2013. Fourteen cost-effectiveness studies were included, all performed in western countries. All studies evaluated cost-effectiveness among elderly above 50 years and used costs per quality-adjusted life year (QALY) gained as primary outcome. The vast majority of studies showed vaccination of 60- to 75-year-old individuals to be cost-effective, when duration of vaccine efficacy was longer than 10 years. Duration of vaccine efficacy, vaccine price, HZ incidence, HZ incidence and discount rates were influential to the incremental cost-effectiveness ratio (ICER). HZ vaccination may be a worthwhile intervention from a cost-effectiveness point of view. More extensive reporting on methodology and more detailed results of sensitivity analyses would be desirable to address uncertainty and to guarantee optimal comparability between studies, for example regarding model structure, discounting, vaccine characteristics and loss of quality of life due to HZ and PHN. PMID:25424815

Zolpidem prescribing practices before and after Food and Drug Administration required product labeling changes

PubMed Central

Norman, Jessica L; Fixen, Danielle R; Saseen, Joseph J; Saba, Laura M; Linnebur, Sunny A

2017-01-01

Background: Women have higher morning serum zolpidem concentrations than men after taking an evening dose, potentially leading to increased risk of harm. On 19 April 2013, the United States Food and Drug Administration required labeling changes for zolpidem, recommending an initial dose of no greater than 5 mg (immediate release) or 6.25 mg (controlled release) per night in women. Objectives: The primary objective of this study was to compare prescribing practices before and after the 2013 zolpidem labeling change. A secondary objective was to evaluate serious adverse events potentially related to zolpidem. Methods: Electronic medical records of adults receiving care through the University of Colorado Health system were accessed for study inclusion if patients were provided a first-time prescription for zolpidem either prior to or after the Food and Drug Administration labeling change. Patients were randomly chosen from eight strata based on age, gender, and date of zolpidem initiation (before/after the labeling change). Demographic and zolpidem prescribing data were collected. Low-dose zolpidem was considered 5 mg (immediate release) or 6.25 mg (controlled release) daily or less. Documentation of potentially related serious adverse events within the patients’ records was also evaluated. Results: A total of 400 patients were included in the study. The overall percentage of patients prescribed low-dose zolpidem increased from 44% to 58% after the labeling change (p = 0.0020). In a pre-specified subgroup analysis, the percentage of patients prescribed low-dose zolpidem increased in all groups, including young men (38%–50%, p = 0.23), elderly men (34%–40%, p = 0.53), and elderly women (60%–74%, p = 0.14), but the change was only significant in young women (42%–70%, p = 0.0045). Conclusion: After Food and Drug Administration–mandated labeling changes for zolpidem in 2013, the percentage of overall patients in our health system

Zolpidem prescribing practices before and after Food and Drug Administration required product labeling changes.

PubMed

Norman, Jessica L; Fixen, Danielle R; Saseen, Joseph J; Saba, Laura M; Linnebur, Sunny A

2017-01-01

Women have higher morning serum zolpidem concentrations than men after taking an evening dose, potentially leading to increased risk of harm. On 19 April 2013, the United States Food and Drug Administration required labeling changes for zolpidem, recommending an initial dose of no greater than 5 mg (immediate release) or 6.25 mg (controlled release) per night in women. The primary objective of this study was to compare prescribing practices before and after the 2013 zolpidem labeling change. A secondary objective was to evaluate serious adverse events potentially related to zolpidem. Electronic medical records of adults receiving care through the University of Colorado Health system were accessed for study inclusion if patients were provided a first-time prescription for zolpidem either prior to or after the Food and Drug Administration labeling change. Patients were randomly chosen from eight strata based on age, gender, and date of zolpidem initiation (before/after the labeling change). Demographic and zolpidem prescribing data were collected. Low-dose zolpidem was considered 5 mg (immediate release) or 6.25 mg (controlled release) daily or less. Documentation of potentially related serious adverse events within the patients' records was also evaluated. A total of 400 patients were included in the study. The overall percentage of patients prescribed low-dose zolpidem increased from 44% to 58% after the labeling change (p = 0.0020). In a pre-specified subgroup analysis, the percentage of patients prescribed low-dose zolpidem increased in all groups, including young men (38%-50%, p = 0.23), elderly men (34%-40%, p = 0.53), and elderly women (60%-74%, p = 0.14), but the change was only significant in young women (42%-70%, p = 0.0045). After Food and Drug Administration-mandated labeling changes for zolpidem in 2013, the percentage of overall patients in our health system, and specifically young women, with initial prescriptions for low

75 FR 48712 - Proposed Vaccine Information Materials for Influenza Vaccine

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-11

... the parent or legal representative in the case of a child) receiving vaccines covered under the... who intends to administer one of these covered vaccines is required to provide copies of the relevant.... In such cases, the only revision to the influenza VIS is the notation of the flu season for which the...

75 FR 48706 - Proposed Vaccine Information Materials for Rotavirus Vaccine

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-11

... the parent or legal representative in the case of a child) receiving vaccines covered under the... who intends to administer one of these covered vaccines is required to provide copies of the relevant... accompanied by vomiting and fever. Rotavirus is not the only cause of severe diarrhea, but it is one of the...

Lessons learned from a review of the development of selected vaccines. National Vaccine Advisory Committee.

PubMed

Peter, G; des Vignes-Kendrick, M; Eickhoff, T C; Fine, A; Galvin, V; Levine, M M; Maldonado, Y A; Marcuse, E K; Monath, T P; Osborn, J E; Plotkin, S; Poland, G A; Quinlisk, M P; Smith, D R; Sokol, M; Soland, D B; Whitley-Williams, P N; Williamson, D E; Breiman, R F

1999-10-01

Although the vaccine research and development network in the United States remains vibrant, its continued success requires maintaining harmonious interaction among its many components. Changing one component is likely to affect the system overall. An examination of case studies of the development of selected vaccines would allow an examination of the network as a whole. This article presents conclusions drawn from the case study review undertaken. Successful development of vaccines is a time-intensive process requiring years of commitment from a network of scientists and a continuum of regulatory and manufacturing entities. We undertook this work to shed light on how well the vaccine development system in the United States performs. The National Vaccine Advisory Committee examined the research and development pathways of several vaccines that reached licensure expeditiously (hepatitis B vaccine, Haemophilus influenzae type b conjugate vaccines); some that became licensed only after considerable delay (oral typhoid Ty21a vaccine, varicella vaccine); some that are at the point of imminent or recent licensure (reassortant Rhesus rotavirus vaccine, which was licensed by the Food and Drug Administration on August 30, 1998) or near submission for licensure (intranasal cold adapted influenza vaccine); and one for which clinical development is slow because of hurdles that must be overcome (respiratory syncytial virus vaccines). Some common themes emerged from the reviews of these vaccine "case histories": the expediting influence of a strong scientific base and rationale; the need for firm quantitation of disease burden and clear identification of target populations; the critical role played by individuals or teams who act as "champions" to overcome the inevitable obstacles; availability of relevant animal models, high-quality reagents and standardized assays to measure immune response; the absolute requirement for well designed, meticulously executed clinical trials of

Informing vaccine decision-making: A strategic multi-attribute ranking tool for vaccines-SMART Vaccines 2.0.

PubMed

Knobler, Stacey; Bok, Karin; Gellin, Bruce

2017-01-20

National Institutes of Health. We aim to demonstrate the utility of SMART Vaccines 2.0 through the engagement of a community of relevant stakeholders and to identify a limited number of pilot projects to determine explicitly defined attribute preferences and the related data and model requirements that are responsive to user needs and able to improve the use of evidence for vaccine-related decision-making and consequential priorities of vaccination options. Copyright © 2016 Elsevier Ltd. All rights reserved.

Challenges in conducting post-authorisation safety studies (PASS): A vaccine manufacturer's view.

PubMed

Cohet, Catherine; Rosillon, Dominique; Willame, Corinne; Haguinet, Francois; Marenne, Marie-Noëlle; Fontaine, Sandrine; Buyse, Hubert; Bauchau, Vincent; Baril, Laurence

2017-05-25

Post-authorisation safety studies (PASS) of vaccines assess or quantify the risk of adverse events following immunisation that were not identified or could not be estimated pre-licensure. The aim of this perspective paper is to describe the authors' experience in the design and conduct of twelve PASS that contributed to the evaluation of the benefit-risk of vaccines in real-world settings. We describe challenges and learnings from selected PASS of rotavirus, malaria, influenza, human papillomavirus and measles-mumps-rubella-varicella vaccines that assessed or identified potential or theoretical risks, which may lead to changes to risk management plans and/or to label updates. Study settings include the use of large healthcare databases and de novo data collection. PASS methodology is influenced by the background incidence of the outcome of interest, vaccine uptake, availability and quality of data sources, identification of the at-risk population and of suitable comparators, availability of validated case definitions, and the frequent need for case ascertainment in large databases. Challenges include the requirement for valid exposure and outcome data, identification of, and access to, adequate data sources, and mitigating limitations including bias and confounding. Assessing feasibility is becoming a key step to confirm that study objectives can be met in a timely manner. PASS provide critical information for regulators, public health agencies, vaccine manufacturers and ultimately, individuals. Collaborative approaches and synergistic efforts between vaccine manufacturers and key stakeholders, such as regulatory and public health agencies, are needed to facilitate access to data, and to drive optimal study design and implementation, with the aim of generating robust evidence. Copyright © 2017 GSK Biologicals SA. Published by Elsevier Ltd.. All rights reserved.

Current Ebola vaccines

PubMed Central

Hoenen, Thomas; Groseth, Allison; Feldmann, Heinz

2012-01-01

Introduction Ebolaviruses cause severe viral hemorrhagic fever in humans and non-human primates, with case fatality rates of up to 90%. Currently, neither a specific treatment nor a vaccine licensed for use in humans is available. However, a number of vaccine candidates have been developed in the last decade that are highly protective in non-human primates, the gold standard animal model for Ebola hemorrhagic fever. Areas covered This review analyzes a number of scenarios for the use of ebolavirus vaccines, discusses the requirements for ebolavirus vaccines in these scenarios, and describes current ebolavirus vaccines. Among these vaccines are recombinant Adenoviruses, recombinant Vesicular Stomatitis viruses, recombinant Human Parainfluenza viruses and virus-like particles. Interestingly, one of these vaccine platforms, based on recombinant Vesicular Stomatitis viruses, has also demonstrated post-exposure protection in non-human primates. Expert opinion The most pressing remaining challenge is now to move these vaccine candidates forward into human trials and towards licensure. In order to achieve this, it will be necessary to establish the mechanisms and correlates of protection for these vaccines, and to continue to demonstrate their safety, particularly in potentially immunocompromised populations. However, already now there is sufficient evidence that, from a scientific perspective, a vaccine protective against ebolaviruses is possible. PMID:22559078

Modes of Action for Mucosal Vaccine Adjuvants.

PubMed

Aoshi, Taiki

Vaccine adjuvants induce innate immune responses and the addition of adjuvants to the vaccine helps to induce protective immunity in the host. Vaccines utilizing live attenuated or killed whole pathogens usually contain endogenous adjuvants, such as bacterial cell wall products and their genomic nucleic acids, which act as pathogen-associated molecular patterns and are sufficient to induce adaptive immune responses. However, purified protein- or antigen-based vaccines, including component or recombinant vaccines, usually lose these endogenous innate immune stimulators, so the addition of an exogenous adjuvant is essential for the success of these vaccine types. Although this adjuvant requirement is mostly the same for parental and mucosal vaccines, the development of mucosal vaccine adjuvants requires the specialized consideration of adapting the adjuvants to characteristic mucosal conditions. This review provides a brief overview of mucosa-associated immune response induction processes, such as antigen uptake and dendritic cell subset-dependent antigen presentation. It also highlights several mucosal vaccine adjuvants from recent reports, particularly focusing on their modes of action.

Glycoconjugate Vaccines: The Regulatory Framework.

PubMed

Jones, Christopher

2015-01-01

Most vaccines, including the currently available glycoconjugate vaccines, are administered to healthy infants, to prevent future disease. The safety of a prospective vaccine is a key prerequisite for approval. Undesired side effects would not only have the potential to damage the individual infant but also lead to a loss of confidence in the respective vaccine-or vaccines in general-on a population level. Thus, regulatory requirements, particularly with regard to safety, are extremely rigorous. This chapter highlights regulatory aspects on carbohydrate-based vaccines with an emphasis on analytical approaches to ensure the consistent quality of successive manufacturing lots.

Immunology Update: New Vaccines.

PubMed

Starr, S Paul

2016-11-01

A new 9-valent human papillomavirus (HPV) vaccine is effective against more cancer-causing HPV types than previous vaccines. HPV vaccine series started with previous vaccines can be completed with the 9-valent vaccine. Two new influenza vaccines are available for adults 65 years and older: a high-dose vaccine and an enhanced adjuvant vaccine. These elicit stronger antibody responses than standard-dose vaccines. Current guidelines specify no preference for the new versus standard-dose vaccines. Two new group B meningococcal vaccines are intended for use during outbreaks and for patients with asplenia, complement deficiencies, frequent occupational meningococcus exposure, or for patients who desire protection from type B meningococcus. These are not substitutes for the quadrivalent vaccine already in use. For pneumococcus, new recommendations state that 13-valent pneumococcal conjugate vaccine (PCV13) should be administered to patients 65 years and older, followed at least 1 year later by the polyvalent pneumococcal polysaccharide vaccine (PPSV23). For patients ages 19 to 64 years with immunocompromise and not previously vaccinated against pneumococcus, administration of these two vaccines should be separated by at least 8 weeks. Rotavirus vaccine is standard for infants at age 2 months. Also, there is a new cholera vaccine approved for use in the United States. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.

The role of vaccines in the control of STDs: HPV vaccines.

PubMed Central

Frazer, I H

1996-01-01

Prophylactic vaccines for genital human papillomavirus (HPV) infection have been shown to be feasible in animal models, and suitable vaccine material based on virus-like particles can be produced in bulk at reasonable cost. Initiation of phase III clinical trials will follow definition of trial outcome measures through further epidemiological studies, and development of assays of host protective immunity. Vaccines could in principle eliminate HPV-related disease, as the human race is the only natural host for the relevant papillomaviruses (PVs). Therapeutic vaccines for genital HPV infection are also possible, but have not yet been demonstrated as feasible in practice because the choice of vaccine antigens is difficult, the method of their optimal delivery is uncertain, and the nature of the relevant antiviral immunity is unknown. PV species specificity will require trials to be conducted in man, which will slow definition of an ideal vaccine. PMID:9038634

21 CFR 1302.04 - Location and size of symbol on label and labeling.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Location and size of symbol on label and labeling. 1302.04 Section 1302.04 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.04 Location and size of symbol on label...

21 CFR 1302.04 - Location and size of symbol on label and labeling.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Location and size of symbol on label and labeling. 1302.04 Section 1302.04 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.04 Location and size of symbol on label...

21 CFR 1302.04 - Location and size of symbol on label and labeling.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Location and size of symbol on label and labeling. 1302.04 Section 1302.04 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.04 Location and size of symbol on label...

21 CFR 111.127 - What quality control operations are required for packaging and labeling operations?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What quality control operations are required for packaging and labeling operations? 111.127 Section 111.127 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING...

21 CFR 111.415 - What requirements apply to filling, assembling, packaging, labeling, and related operations?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to filling, assembling, packaging, labeling, and related operations? 111.415 Section 111.415 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD...

21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to holding components, dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD...

Vaccine adjuvant technology: from mechanistic concepts to practical applications.

PubMed

Degen, Winfried G J; Jansen, Theo; Schijns, Virgil E J C

2003-04-01

Distinct types of immune responses are required for efficient elimination of different pathogens. Programming of the desired type of immune response by safe nonreplicating vaccines requires suitable vaccine adjuvants. Adjuvants largely determine the magnitude and quality of immune responses specific for the coadministered antigen. Unfortunately, rational vaccine design requiring a rational choice of vaccine adjuvant, is hampered by a lack of knowledge about the mechanism(s) of vaccine adjuvant activity. The current review addresses different critical immunological processes possibly explaining adjuvant functions. In addition, we discuss traditional vaccine adjuvant formulations and their possible mode of action. Finally, we reflect on the latest technologies for the identification of novel adjuvants using molecular analysis of immune activation and functional genomics.

9 CFR 113.67 - Erysipelothrix Rhusiopathiae Vaccine.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Erysipelothrix Rhusiopathiae Vaccine... REQUIREMENTS Live Bacterial Vaccines § 113.67 Erysipelothrix Rhusiopathiae Vaccine. Erysipelothrix Rhusiopathiae Vaccine shall be prepared as a desiccated live culture of an avirulent or modified strain of...

9 CFR 113.67 - Erysipelothrix Rhusiopathiae Vaccine.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Erysipelothrix Rhusiopathiae Vaccine... REQUIREMENTS Live Bacterial Vaccines § 113.67 Erysipelothrix Rhusiopathiae Vaccine. Erysipelothrix Rhusiopathiae Vaccine shall be prepared as a desiccated live culture of an avirulent or modified strain of...

9 CFR 113.67 - Erysipelothrix Rhusiopathiae Vaccine.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Erysipelothrix Rhusiopathiae Vaccine... REQUIREMENTS Live Bacterial Vaccines § 113.67 Erysipelothrix Rhusiopathiae Vaccine. Erysipelothrix Rhusiopathiae Vaccine shall be prepared as a desiccated live culture of an avirulent or modified strain of...