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.


Table of Contents


Front Matter
Executive Summary
1 Introduction
2 Background
3 The CDC Anthrax Vaccine Research Plan
4 Proposed Studies on the Efficacy of the Anthrax Vaccine
5 Proposed Studies on the Safety of the Anthrax Vaccine
6 Proposed Studies on the Acceptability of the Anthrax Vaccine
7 Summary Assessment of the CDC Anthrax Vaccine Research Plan
Appendix A Biographical Sketches
Appendix B Information-Gathering Meeting Agendas
Appendix C Anthrax Vaccine Safety & Efficacy Research Plan
Appendix D Food and Drug Administration Final Rule: New Drug and
Biological Drug Products; Evidence Needed to Demonstrate
Effectiveness of New Drugs When Human Efficacy Studies Are Not
Ethical or Feasible
Appendix E Department of Defense Memorandum: Reintroduction of the
Anthrax Vaccine Immunization Program
Appendix F Institute of Medicine: CDC Anthrax Vaccine Safety &
Efficacy Research Program. Interim Report Findings and
Recommendations1
Appendix G Institute of Medicine: The Anthrax Vaccine: Is It Safe?
Does It Work? Findings and Recommendations1