however, some raised concerns about the safety and the efficacy of the vaccine being administered.

Responding to those concerns, the U.S. Congress included language in the conference report accompanying the 2000 DoD appropriations legislation directing DoD to enter into a contract with the National Research Council to study the effectiveness and safety of the anthrax vaccine.1 Congress called for the study to examine the safety and efficacy of the licensed vaccine, including consideration of the types and severities of adverse reactions, differences in reactions by sex, long-term health implications, its efficacy against inhalational exposure to all known anthrax strains, and correlation of the safety and efficacy of the vaccine in animal models to its safety and efficacy in humans. The study was also to address the issue of the validation of the manufacturing process, with consideration of discrepancies identified by the Food and Drug Administration in February 1998, definition of vaccine components, and identification of gaps in existing research. (See Appendix A for the Statement of Task.)

In June 2000 a contract between DoD and the Institute of Medicine (IOM) was finalized to carry out the study requested by Congress. IOM convened the Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, and this report reflects the work of that committee.

STUDY PROCESS AND INFORMATION SOURCES

Reflecting the components of the statement of task, the members of the Committee to Assess the Safety and Efficacy of the Anthrax Vaccine brought expertise in microbiology; vaccine research, development, manufacture, and evaluation; postmarketing surveillance of adverse events; regulatory and licensing procedures; epidemiology; biostatistics; immunology; and health surveillance (see Appendix B for biographical sketches of the committee members). The committee’s charge did not include evaluation of the DoD policy to vaccinate all service members, so the committee did not include an evaluation of the threat from biological warfare agents in its purview. Similarly, the committee was not asked to address the challenges in bio-weapons vaccine development and procurement generally, which have recently been discussed in a statement from the Council of the Institute of Medicine (http://www.iom.edu/IOM/IOMHome.nsf/Pages/Vaccine+Development) and in reports by the Gilmore Commission (http://www.rand.org/nsrd/terrpanel/) and DoD (http://www.defenselink.mil/pubs/ReportonBiologicalWarfareDefenseVaccineRDPrgras-July2001.pdf ).

1  

Making Appropriations for the Department of Defense for the Fiscal Year Ending September 30, 2000, and for Other Purposes, P. L. No. 106-79 (1999).



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