Evaluating the Safety of New Vaccines

Summary of a Workshop

Bibliographic Data

ID11020463
AuthorsSusan S Ellenberg (0000-0002-2364-5253, At the time this article was written, Susan S. Ellenberg was with the Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Md. Mary A. Foulkes, Karen Midthun, and Karen L. Goldenthal are with the Center for Biologics Evaluation and Research, US Food and Drug Administration.), Mary A Foulkes (At the time this article was written, Susan S. Ellenberg was with the Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Md. Mary A. Foulkes, Karen Midthun, and Karen L. Goldenthal are with the Center for Biologics Evaluation and Research, US Food and Drug Administration.), Karen Midthun (At the time this article was written, Susan S. Ellenberg was with the Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Md. Mary A. Foulkes, Karen Midthun, and Karen L. Goldenthal are with the Center for Biologics Evaluation and Research, US Food and Drug Administration.), Karen L Goldenthal (At the time this article was written, Susan S. Ellenberg was with the Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Md. Mary A. Foulkes, Karen Midthun, and Karen L. Goldenthal are with the Center for Biologics Evaluation and Research, US Food and Drug Administration.)
Year2005
Volume95
Issue5
Pages800-807
Publication date2005-05-01
Peer ReviewedYes
Open AccessNo
TypeARTICLE
VenueAmerican Journal of Public Health (JOURNAL)
Journal identifiersISSN: 0090-0036 • E-ISSN: 1541-0048
PublisherAmerican Public Health Association (PUBLISHER • US)
DOI10.2105/ajph.2004.039438
PMID15855455
PMCIDPMC1449258
OpenAlexW2143116106
LanguageEN
Citations received2
References cited29

Public concerns about the safety of vaccines arise on a regular basis. In November 2000, a workshop titled “Evaluation of New Vaccines: How Much Safety Data?” was convened by US Public Health Service agencies, including the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration, to discuss appropriate methods for evaluating the safety of new vaccines. Workshop presentations addressed the current standards and approaches for new vaccine evaluation and postlicensure surveillance, as well as public views about vaccine safety and alternative approaches that could be considered. The advantages and disadvantages of conducting large controlled trials before licensure or widespread use of a new vaccine were discussed. We summarize these presentations and discussions

Administration (probate law) · Advisory committee · Disease control · Environmental health · Family medicine · Food and drug administration · Immunization · Licensure · Medical education · Political science · Public health · Public relations · Vaccine safety · Immunology · Influenza Virus Research Studies · Medicine · Nursing · Public Administration · Vaccine Coverage and Hesitancy · Viral gastroenteritis research and epidemiology

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