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Appendix A Study Activities As contracted with the sponsor, the Centers for Disease Control and Prevention (CDC), the Institute of Medicine convened a committee that was charged with reviewing the CDC's anthrax vaccine safety ant} efficacy research program. In particular, the committee was to address risk factors for adverse reactions, including gentler differences, immunologic correlates of protection and the documentation of vaccine efficacy, and the optimization of the vaccination schedule and routes of administration to assure efficacy while minimizing the number of closes required and the occurrence of adverse events. The CDC requested this interim report 10 months after the project was initiated. The entire project leading to production of a full report reviewing the CDC's anthrax vaccine research program was planned for 24 months, to be completed contingent upon funding for the second year. The committee included members with expertise in infectious disease epidemiology; vaccinology; drug/vaccine research, development, testing, and evaluation; post-marketing surveillance of adverse events, inclucling the Vaccine Aclverse Events Reporting System (VAERS); regulatory and licensing procedures; gender differences in adverse events reporting; and health surveillance. The committee met on October 3 I, 2000; on February ~ and 9, 2001, and on April I~ and 19, 2001. The meeting of April 18, 2001 included a public hearing, held jointly with the related Committee to Assess the Safety and Efficacy of the Anthrax Vaccine (sponsored by the Department of Defense), so that interested members of the public could address the committees. All open meetings were announced in the lOM's Current Project System, pursuant to the Fecleral Advisory Committee Act as amended in 1997, and all materials submitted to the committee were made available through the fOM's Public Access File. 41

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