• the relationship between the vaccine dose and the resulting level of antibody in the blood of test animals that protects the animals from challenge;

• the relationship between the level of antibody that protects animals from challenge and the level of antibody present in humans vaccinated by the regimen currently recommended for the licensed product; and

• the vaccine dose that results in a level of antibody in the blood of human volunteers similar to that in the blood of protected animals.

As a result of the inhalational exposure to anthrax spores from letters mailed in the autumn of 2001, questions about the postexposure efficacy of AVA have arisen. No data from studies with humans are available, but two papers provide information from studies with rhesus monkeys.

These limited data suggest that use of the vaccine in combination with an appropriate antibiotic for 30 days could provide excellent postexposure protection against inhalational anthrax. Although the additional benefit from receiving the vaccine after a prolonged period of antibiotic use is not proven, reliance on the vaccine alone after exposure is clearly insufficient, as some protection is needed during the time required for an immune response to develop. Additional studies on the postexposure use of AVA with antibiotics are needed.

A vaccine similar to AVA was shown to be effective against cutaneous anthrax in humans in the field trial supporting the original application for

Front Matter (R1-R22)

Executive Summary (1-32)

1 Introduction (33-39)

2 Background (40-55)

3 Anthrax Vaccine Efficacy (56-82)

4 Safety: Introduction (83-101)

5 Safety: Case Reports (102-117)

6 Safety: Epidemiologic Studies (118-179)

7 Anthrax Vaccine Manufacture (180-197)

8 Future Needs (198-210)

Appendix A Statement of Task (211-213)

Appendix B Biographical Sketches (214-217)

Appendix C Information-Gathering Meeting Agendas (218-226)

Appendix D Anthrax Vaccine Adsorbed Package Inserts (227-238)

Appendix E Vaccine Adverse Event Reporting System (VAERS) Form (239-242)

Appendix F Anthrax Vaccine Expert Committee (AVEC) Case Assessment Form (243-244)

Appendix G DMSS Analyses Requested by the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine (245-252)

Appendix H An Assessment of the Safety of the Anthrax Vaccine: A Letter Report (253-266)