The vaccine used to protect humans against the anthrax disease, called Anthrax Vaccine Adsorbed (AVA), was licensed in 1970. It was initially used to protect people who might be exposed to anthrax where they worked, such as veterinarians and textile plant workers who process animal hair. When the U. S. military began to administer the vaccine, then extended a plan for the mandatory vaccination of all U. S. service members, some raised concerns about the safety and efficacy of AVA and the manufacture of the vaccine. In response to these and other concerns, Congress directed the Department of Defense to support an independent examination of AVA.


The Anthrax Vaccine: Is It Safe? Does It Work? reports the study's conclusion that the vaccine is acceptably safe and effective in protecting humans against anthrax. The book also includes a description of advances needed in main areas: improving the way the vaccine is now used, expanding surveillance efforts to detect side effects from its use, and developing a better vaccine.




Table of Contents


Front Matter
Executive Summary
1 Introduction
2 Background
3 Anthrax Vaccine Efficacy
4 Safety: Introduction
5 Safety: Case Reports
6 Safety: Epidemiologic Studies
7 Anthrax Vaccine Manufacture
8 Future Needs
Appendix A Statement of Task
Appendix B Biographical Sketches
Appendix C Information-Gathering Meeting Agendas
Appendix D Anthrax Vaccine Adsorbed Package Inserts
Appendix E Vaccine Adverse Event Reporting System (VAERS) Form
Appendix F Anthrax Vaccine Expert Committee (AVEC) Case Assessment Form
Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine
Appendix H An Assessment of the Safety of the Anthrax Vaccine: A Letter Report