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Published on: February 22, 2019
Preventive vaccines against bioterrorism: evaluation of efficacy and safety
Amelia Dale Horne1, Julianne Clifford, Karen L Goldenthal
1Division 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
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.
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