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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 (TM)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.

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• Executive Summary(p. 1)
• Abstract(p. 1)
• Study Process and Information Sources(p. 3)
• Anthrax and Anthrax Vaccine(p. 5)
• Anthrax Vaccine Efficacy(p. 5)
• Anthrax Vaccine Safety(p. 10)
• Anthrax Vaccine Manufacture(p. 14)
• Future Needs(p. 15)
• References(p. 28)
• 1 Introduction(p. 33)
• Study Process and Information Sources(p. 34)
• Related Reports(p. 35)
• General Principles Regarding Use of Vaccines(p. 37)
• Organization of the Report(p. 38)
• References(p. 39)
• 2 Background(p. 40)
• The Disease(p. 41)
• Anthrax Vaccine Development(p. 48)
• Use of Anthrax Vaccine(p. 49)
• Concerns About Use of AVA(p. 50)
• Available Data on AVA(p. 51)
• References(p. 53)
• 3 Anthrax Vaccine Efficacy(p. 56)
• Evaluating Efficacy of AVA for Inhalational Anthrax(p. 57)
• Efficacy of AVA Against All Known B. anthracis Strains(p. 69)
• Correlation of Protection: Animal Models and Human Immunity(p. 72)
• Postexposure Use of Anthrax Vaccine(p. 75)
• Conclusions Regarding Efficacy(p. 76)
• References(p. 78)
• 4 Safety: Introduction(p. 83)
• Safety Concerns About the Anthrax Vaccine(p. 84)
• Identifying Vaccine-Related Adverse Events(p. 85)
• Gaining Perspective on Adverse Events Following Vaccination(p. 88)
• Sources of Information Regarding the Safety of AVA(p. 93)
• Testing for Vaccine Contamination(p. 95)
• References(p. 97)
• 5 Safety: Case Reports(p. 102)
• Vaccine Adverse Event Reporting System(p. 102)
• DoD and VAERS(p. 107)
• Reports to VAERS Related to AVA(p. 112)
• References(p. 115)
• 6 Safety: Epidemiologic Studies(p. 118)
• Ad Hoc Studies(p. 119)
• Record-Linkage Studies(p. 155)
• Preliminary Information on Analysis of Data on Birth Defects(p. 171)
• Conclusions Regarding AVA Vaccination and Adverse Events(p. 172)
• Findings and Recommendations(p. 175)
• References(p. 176)
• 7 Anthrax Vaccine Manufacture(p. 180)
• Committee's Interpretation of the Charge(p. 180)
• Regulatory Oversight of Vaccine Manufacture(p. 181)
• Anthrax Vaccine Development(p. 183)
• Regulatory Actions Concerning AVA Manufacture(p. 190)
• Findings and Recommendations(p. 194)
• References(p. 195)
• 8 Future Needs(p. 198)
• Future Use of AVA(p. 199)
• Surveillance for Adverse Events(p. 201)
• New Anthrax Vaccine Development(p. 207)
• References(p. 210)
• Appendixes
• A Statement of Task(p. 213)
• B Biographical Sketches(p. 214)
• C Information-Gathering Meeting Agendas(p. 218)
• D Anthrax Vaccine Adsorbed Package Inserts(p. 227)
• E Vaccine Adverse Event Reporting System (VAERS) Form(p. 239)
• F Anthrax Vaccine Expert Committee (AVEC) Case Assessment Form(p. 243)
• G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine(p. 245)
• H An Assessment of the Safety of the Anthrax Vaccine: A Letter Report(p. 251)