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1 Introduction
Pages 18-22

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From page 18...
... The committee's evaluation of the CDC anthrax safety and efficacy research program has necessarily been affected by this change in context. In particular, the timeline for the CDC research plan must be viewed in the context of plans for tremendously accelerated development of a new anthrax vaccine.
From page 19...
... AN ASSESSMENT OF THE CDC Anthrax Vaccine Safely and Efficacy Research Program e
From page 20...
... The committee found that the CDC had not yet developed—or not communicated a comprehensive plan for the anthrax vaccine safety and efficacy research program. Nevertheless, the committee concluded that despite the absence of a comprehensive plan, the CDC program included appropriate and well-conceived scientific projects generally responsive to the congressional mandate.
From page 21...
... optimizing the vaccination schedule and routes of administration to assure efficacy while minimizing the number of doses required and the occurrence of adverse events."2 The program has been furrier at $~8 million annually for fiscal years 2000, 2001, and 2002.3 In this report, the Institute of Medicine (TOM) Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program reviews the completeness and appropriateness of the research program developed by CDC.
From page 22...
... The committee also acknowledges that the bioterrorist events have put great demands upon CDC and hopes that this report will provide adv~ce that will help optimize the usefulness of the research program. STUDY PROCESS In response to a request from CDC, TOM convened the Committee to Renew the CDC Anthrax Vaccine Safety and Efficacy Research Program in fall 2000.4 The TOM committee members brought expertise in microbiology; infectious diseases; vaccine research, development, and evaluation; postmarketing surveiliance of adverse events; regulatory and licensing procedures; epidemiology; biostatistics; survey research and design; immunology; differences in disease between men and women; and health surveillance (see Appendix A for biographical sketches of the committee members)

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