An Assessment of the Safety of the Anthrax Vaccine

A Letter Report

March 30, 2000

Major General Randall L. West,


Special Advisor for Biological Defense Affairs

Under Secretary of Defense for Personnel and Readiness Department of Defense 4000 Defense Pentagon Washington, DC 20301-4000

Dear General West:

In February of this year, the Department of Defense (DoD) requested that the Institute of Medicine (IOM) provide a report on the safety and efficacy of the anthrax vaccine that could be used to answer questions raised by Congress. The IOM has agreed to undertake this comprehensive study, which will require approximately 24 months to complete. The questions include the types and severity of adverse reactions, including gender differences; long-term health implications; efficacy of the vaccine against inhalational anthrax; correlation of animal models to safety and effectiveness in humans; validation of the manufacturing process; definition of vaccine components in terms of the protective antigen and other bacterial products and constituents; and identification of gaps in existing research.

Because of immediate concern over anthrax vaccine safety issues, the IOM offered to draw relevant information from an ongoing study of Gulf War exposures funded by the Department of Veterans Affairs. The opportunity to provide limited information relating to the safety of anthrax vaccine is possible due to the ongoing work of the IOM Committee on Health Effects Associated with Exposures During the Gulf War, which was tasked with conducting literature reviews on six Gulf War exposures (including the anthrax vaccine). This committee began its work in January 1999, and it is scheduled to provide its report in August of this year. With the agreement of the Department of Veterans Affairs, the IOM was able to produce this letter report that summarizes the committee’s literature review on the safety of the anthrax vaccine. This information, while very narrowly focused, may be helpful now to Congress, the DoD, and others before the IOM begins its comprehensive assessment of the anthrax vaccine. Although DoD requested the IOM’s consideration of safety and efficacy, the current IOM committee was not tasked with issues of vaccine efficacy. The report that follows therefore addresses only the limited peer-reviewed literature on the safety of the anthrax vaccine.

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