针对生物恐怖主义的预防性疫苗：疗效与安全性评估。

Preventive vaccines against bioterrorism: evaluation of efficacy and safety.

作者信息

Horne Amelia Dale, Clifford Julianne, Goldenthal Karen L, Kleppinger Cynthia, Lachenbruch Peter A

机构信息

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.

出版信息

Vaccine. 2004 Nov 15;23(1):84-90. doi: 10.1016/j.vaccine.2004.04.037.

DOI:10.1016/j.vaccine.2004.04.037

PMID:15519711

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.

摘要

本文讨论了美国食品药品监督管理局评估疫苗的一般方法，特别是针对生物恐怖主义疾病的疫苗。我们总结了疫苗研发和批准的科学依据，然后讨论了针对可能被用作生物恐怖主义武器的致病生物体的疫苗的具体问题。