title: Preventive vaccines against bioterrorism: evaluation of efficacy and safety.
abstract: This paper discusses the US Food and Drug Administration's approach to evaluation of vaccines in general, and vaccines against diseases of bioterrorism in particular. We summarize the scientific bases for development and approval of vaccines and then discuss specific issues regarding vaccines against disease organisms that could potentially be used as weapons of bioterrorism.
authors.affiliation: Division of Biostatistics, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research (CBER), FDA, HFM-217, 1401 Rockville Pike, Rockville, MD 20852-1448, USA. horne@cber.fda.gov
authors.forename: Amelia Dale
authors.initials: AD
authors.lastname: Horne
authors.forename: Julianne
authors.initials: J
authors.lastname: Clifford
authors.forename: Karen L
authors.initials: KL
authors.lastname: Goldenthal
authors.forename: Cynthia
authors.initials: C
authors.lastname: Kleppinger
authors.forename: Peter A
authors.initials: PA
authors.lastname: Lachenbruch
mesh_terms: D000818:Animals; D001694:Biological Warfare; D023482:Bioterrorism / Q000517:prevention & control*; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000331:legislation & jurisprudence; D006801:Humans; D032541:Mass Vaccination; D011634:Public Health; D014612:Vaccines / Q000627:therapeutic use*
chemical_list: D014612:Vaccines