Preventive vaccines against bioterrorism: evaluation of efficacy and safety.
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.
Horne
Amelia Dale
AD
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
Clifford
Julianne
J
Goldenthal
Karen L
KL
Kleppinger
Cynthia
C
Lachenbruch
Peter A
PA
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*
D014612:Vaccines