Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program

Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program

• 1 Front Matter; 2 Executive Summary; 3 1 Introduction; 4 2 Background; 5 3 The CDC Anthrax Vaccine Research Plan; 6 4 Proposed Studies on the Efficacy of the Anthrax Vaccine; 7 5 Proposed Studies on the Safety of the Anthrax Vaccine; 8 6 Proposed Studies on the Acceptability of the Anthrax Vaccine; 9 7 Summary Assessment of the CDC Anthrax Vaccine Research Plan; 10 Appendix A Biographical Sketches; 11 Appendix B Information-Gathering Meeting Agendas; 12 Appendix C Anthrax Vaccine Safety & Efficacy Research Plan; 13 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; 14 Appendix E Department of Defense Memorandum: Reintroduction of the Anthrax Vaccine Immunization Program; 15 Appendix F Institute of Medicine: CDC Anthrax Vaccine Safety & Efficacy Research Program. Interim Report Findings and Recommendations1; 16 Appendix G Institute of Medicine: The Anthrax Vaccine: Is It Safe? Does It Work? Findings and Recommendations1