An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program

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National Academies Press, Nov 25, 2002 - Medical - 144 pages
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In 1998, the Department of Defense (DoD) began a program of mandatory immunization against anthrax for all military personnel. As the program proceeded, however, some military personnel and their families raised concerns about the safety and efficacy of the anthrax vaccine. Acknowledging both the need to protect military personnel and the concerns about the anthrax vaccine, congress directed the Centers for Disease Control and Prevention (CDC) to carry out a research program on its safety and efficacy. To assist in the development of this program, CDC requested the Institute of Medicine (IOM) to convene a committee to review the completeness and appropriateness of the research program. In An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program, the committee makes an overall assessment of the CDD research plan and reviews the specific studies proposed by CDC in the three areas of efficacy, safety and acceptability. The committee also notes additional research needs that became evident following the bioterrorist events of 2001 and makes recommendations about the leadership of the research program.
 

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Contents

Executive Summary
1
1 Introduction
18
2 Background
23
3 The CDC Anthrax Vaccine Research Plan
33
4 Proposed Studies on the Efficacy of the Anthrax Vaccine
43
5 Proposed Studies on the Safety of the Anthrax Vaccine
56
6 Proposed Studies on the Acceptability of the Anthrax Vaccine
82
7 Summary Assessment of the CDC Anthrax Vaccine Research Plan
91
Appendix A Biographical Sketches
101
Appendix B InformationGathering Meeting Agendas
105
Appendix C Anthrax Vaccine Safety Efficacy Research Plan
113
New Drug and Biological Drug Products Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethic...
137
Reintroduction of the Anthrax Vaccine Immunization Program
149
CDC Anthrax Vaccine Safety Efficacy Research Program Interim Report Findings and Recommendations1
153
The Anthrax Vaccine Is It Safe? Does It Work? Findings and Recommendations1
155
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