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Biological Threats and Terrorism Assessing the Science and Response Capabilities: Workshop Summary (2002) / Chapter Skim
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Appendix I: Statement on Vaccine Development
Pages 262-268

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From page 262...
... . In a 1992 report, Emerging Infections: Microbial Threats to Health in the United States, another IOM committee recommended the development of an integrated management structure within the federal government for acquiring vaccines, as well as a facility for developing and producing vaccines with government support t23.
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From page 263...
... However, good products developed by these startups to combat infectious diseases often do not come to market because of the very large costs of testing in pilot studies and in manufacturing. Currently, the United States has a single licensed anthrax vaccine product, manufactured by a single plant.
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From page 264...
... The FDA could work closely with such an Authority to oversee vaccine development and production as well as facilitate their oversight processes and reduce regulatory complexities. In some cases, it might find mechanisms to guarantee a price for vaccines to stimulate private sector production, as has occurred with smallpox vaccine in the current situation.
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From page 265...
... Gavin III, M.D., Ph.D. Senior Scientific Officer, Howard Hughes Medical Institute, Bethesda, Maryland Ada Sue Hinshaw, Ph.D.
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From page 266...
... Warner, Ph.D. Avedis Donabedian Distinguished University Professor of Public Health Department of Health Management & Policy School of Public Health, University of Michigan, Ann Arbor Gail R
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From page 267...
... APPENDIX 1: Function of a National Vaccine Authority Define the need Assess the market Establish priorities for U.S. CVI vaccine development in conjunction with the global CVI Characterize desired vaccine products Assemble intellectual property rights Advance CVI product development through the private sector Conduct in-house vaccine-related research and development Assist companies in the production of pilot lots of vaccine Support clinical testing and field trials of candidate vaccines Transfer CVI-related vaccine technology to developing country manufacturers Train U.S.
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From page 268...
... Washington, D.C.: National Academy Press, 1993, p.
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Key Terms

  • vaccine authority
  • vaccine development
  • iom council
  • council believes
  • hughes medical

  • smallpox vaccine
  • parent company
  • medical institute
  • vaccine research
  • vaccines required

  • microbial threats
  • howard hughes
  • vaccine initiative
  • biological threats
  • pilot lots

  • current forms
  • emory university
  • vanderbilt university
  • council encourages
  • executive vice

  • accumulated substantially
  • facilitate communications
  • management structure
  • frances stern
  • broader importance

  • conducting inhouse
  • scarce supply
  • anthrax vaccine
  • work closely
  • current situation


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