Appendix A
Statement of Task

The committee will analyze available information, hold workshops, and make specific recommendations on technical aspects regarding the safety and efficacy of the licensed anthrax vaccine. The issues include the types and severity of adverse reactions, including gender (sex) differences; long-term health implications; inhalational efficacy of the vaccine against all known anthrax strains; correlation of animal models to safety and effectiveness in humans; validation of the manufacturing process focusing on, but not limited to, discrepancies identified by the Food and Drug Administration in February 1998; definition of vaccine components in terms of the protective antigen and other bacterial products and constituents; and identification of gaps in existing research.



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