The committee recommends a long-term longitudinal study of participants in the Anthrax Vaccine Immunization Program.

The committee urges DoD to actively monitor the participants of this program and systematically collect and analyze data about symptoms, and functional and disease status. Further, the committee strongly urges investigators conducting studies on the safety of anthrax and botulinum toxoid vaccines to submit their results to peer-reviewed scientific journals for publication. The process of peer review by fellow professionals, one of the hallmarks of modern science, ensures high standards of quality and will enable broad review of results.

Finally, the committee hopes that the following recommendations will complement areas of ongoing vaccine research.

The committee recommends long-term, systematic research to examine potential adverse effects of anthrax and botulinum toxoid vaccination in multiple species and strains of animals.

To date, animal studies have focused largely on the efficacy of the anthrax and botulinum toxoid vaccines, rather than on possible adverse effects of vaccination. Future research should consider issues related to potential long-term adverse effects of anthrax and botulinum toxoid vaccines; potential health effects of the combinations of these and other vaccines routinely given to armed forces personnel; and potential health effects of combinations of these vaccines and pyridostigmine bromide, exposure to organophosphate compounds, and stress.

The committee recommends a careful study of current symptoms, functional status, and disease status in cohorts of Gulf War veterans and Gulf War era veterans for whom vaccination records exist.

Although vaccination records are not available for most Gulf War veterans, cohorts might be identified for whom such records exist. It would be important to assemble several groups to study long-term adverse health outcomes of anthrax and botulinum toxoid vaccines; these cohorts should include: nonimmunized, deployed and nondeployed Gulf War veterans; and immunized, deployed and nondeployed Gulf War veterans.

This report takes its place alongside several other recent IOM reports on the health of Gulf War veterans. Although the conclusions and recommendations presented here will not end the controversy surrounding Gulf War veterans’ illnesses, this report will provide a scientific basis for consideration by the Department of Veterans Affairs as they develop a compensation program for veterans. The committee hopes that its deliberations, along with the work of many others, will add to the body of accumulating knowledge about the health of Gulf War veterans.

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