Since the terrorist attacks of September 11, 2001, and subsequent mail distribution of anthrax spores, interest in AVA has greatly increased. Consideration of the full range of topics concerning civilian use of the anthrax vaccine was beyond the purview of this report. However, some of the issues that the committee did address should also be of interest for civilians.
The committee gathered information for the study through several means. The committee held a total of four public workshops to collect relevant information; the dates and locations of these meetings are provided in Appendix C. At these meetings, researchers presented the committee with data gathered in studies of the safety of the vaccine. In addition, the committee heard from service members and others with concerns about the safety and efficacy of the vaccine, as well as additional information about the manufacture of the vaccine and the disease itself. The committee also commissioned a paper to review the available literature regarding the rates of adverse events associated with several vaccines routinely administered to adults. Information on the anthrax vaccine was obtained from DoD, the Food and Drug Administration, and BioPort, the current manufacturer. In addition to its four public workshops, the committee met in two additional meetings and two conference calls.
The committee sought access to all possible data, not just published data. Only a few studies on the safety of the anthrax vaccine had been published by the time the committee preparing this report began its work in October 2000. However, several studies had been conducted by DoD investigators, who were urged by IOM and DoD to publish their work. Over the course of this study, investigators made available to the committee several manuscripts submitted or planned for submission for publication. The investigators involved in many of the studies, published or unpublished, also attended open committee meetings to present their data and discuss their findings with the committee. In addition, several analyses of existing data were carried out at the committee’s request, and these provided some of the most compelling information supporting the committee’s findings on safety.
The conference report mandating the current study required that a preliminary report be submitted to Congress by April 1, 2000. At the time of the legislation, the IOM Committee on Health Effects Associated with Exposures During the Gulf War was active in its work to evaluate the published scientific literature concerning the agents to which Gulf War veterans may have been exposed. Since the anthrax vaccine was among these exposures, the committee had already reviewed the available database