title: Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration.
abstract: The public health community faces increasing demands for improving vaccine safety while simultaneously increasing the number of vaccines available to prevent infectious diseases. The passage of the US Food and Drug Administration (FDA) Amendment Act of 2007 formalized the concept of life-cycle management of the risks and benefits of vaccines, from early clinical development through many years of use in large numbers of people. Harnessing scientific and technologic advances is necessary to improve vaccine-safety evaluation. The Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research is working to improve the FDA's ability to monitor vaccine safety by improving statistical, epidemiologic, and risk-assessment methods, gaining access to new sources of data, and exploring the use of genomics data. In this article we describe the current approaches, new resources, and future directions that the FDA is taking to improve the evaluation of vaccine safety.
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, USA. robert.ball@fda.hhs.gov
authors.forename: Robert
authors.initials: R
authors.lastname: Ball
authors.forename: Dale
authors.initials: D
authors.lastname: Horne
authors.forename: Hector
authors.initials: H
authors.lastname: Izurieta
authors.forename: Andrea
authors.initials: A
authors.lastname: Sutherland
authors.forename: Mark
authors.initials: M
authors.lastname: Walderhaug
authors.forename: Henry
authors.initials: H
authors.lastname: Hsu
mesh_terms: D003140:Communicable Disease Control / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015195:Drug Design; D004341:Drug Evaluation; D004353:Drug Evaluation, Preclinical; D004355:Drug Stability; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011358:Product Surveillance, Postmarketing; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D017751:Safety Management; D014481:United States; D014486:United States Food and Drug Administration; D014611:Vaccination / Q000009:adverse effects / Q000706:statistics & numerical data*; D014612:Vaccines / Q000009:adverse effects / Q000494:pharmacology*
chemical_list: D014612:Vaccines