An assessment of the CDC anthrax vaccine safety and efficacy research program
著者
書誌事項
An assessment of the CDC anthrax vaccine safety and efficacy research program
National Academies Press, c2003
- タイトル別名
-
CDC anthrax vaccine safety and efficacy research program
大学図書館所蔵 全2件
  青森
  岩手
  宮城
  秋田
  山形
  福島
  茨城
  栃木
  群馬
  埼玉
  千葉
  東京
  神奈川
  新潟
  富山
  石川
  福井
  山梨
  長野
  岐阜
  静岡
  愛知
  三重
  滋賀
  京都
  大阪
  兵庫
  奈良
  和歌山
  鳥取
  島根
  岡山
  広島
  山口
  徳島
  香川
  愛媛
  高知
  福岡
  佐賀
  長崎
  熊本
  大分
  宮崎
  鹿児島
  沖縄
  韓国
  中国
  タイ
  イギリス
  ドイツ
  スイス
  フランス
  ベルギー
  オランダ
  スウェーデン
  ノルウェー
  アメリカ
注記
Includes bibliographies
内容説明・目次
内容説明
In 1998, the Department of Defense (DoD) began a program of mandatory immunization against anthrax for all military personnel. As the program proceeded, however, some military personnel and their families raised concerns about the safety and efficacy of the anthrax vaccine. Acknowledging both the need to protect military personnel and the concerns about the anthrax vaccine, congress directed the Centers for Disease Control and Prevention (CDC) to carry out a research program on its safety and efficacy. To assist in the development of this program, CDC requested the Institute of Medicine (IOM) to convene a committee to review the completeness and appropriateness of the research program. In An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program, the committee makes an overall assessment of the CDD research plan and reviews the specific studies proposed by CDC in the three areas of efficacy, safety and acceptability. The committee also notes additional research needs that became evident following the bioterrorist events of 2001 and makes recommendations about the leadership of the research program.
Table of Contents
Front Matter
Executive Summary
1 Introduction
2 Background
3 The CDC Anthrax Vaccine Research Plan
4 Proposed Studies on the Efficacy of the Anthrax Vaccine
5 Proposed Studies on the Safety of the Anthrax Vaccine
6 Proposed Studies on the Acceptability of the Anthrax Vaccine
7 Summary Assessment of the CDC Anthrax Vaccine Research Plan
Appendix A Biographical Sketches
Appendix B Information-Gathering Meeting Agendas
Appendix C Anthrax Vaccine Safety & Efficacy Research Plan
Appendix D Food and Drug Administration Final Rule: New Drug and
Biological Drug Products; Evidence Needed to Demonstrate
Effectiveness of New Drugs When Human Efficacy Studies Are Not
Ethical or Feasible
Appendix E Department of Defense Memorandum: Reintroduction of the
Anthrax Vaccine Immunization Program
Appendix F Institute of Medicine: CDC Anthrax Vaccine Safety &
Efficacy Research Program. Interim Report Findings and
Recommendations1
Appendix G Institute of Medicine: The Anthrax Vaccine: Is It Safe?
Does It Work? Findings and Recommendations1
目次
- 1 Front Matter
- 2 Executive Summary
- 3 1 Introduction
- 4 2 Background
- 5 3 The CDC Anthrax Vaccine Research Plan
- 6 4 Proposed Studies on the Efficacy of the Anthrax Vaccine
- 7 5 Proposed Studies on the Safety of the Anthrax Vaccine
- 8 6 Proposed Studies on the Acceptability of the Anthrax Vaccine
- 9 7 Summary Assessment of the CDC Anthrax Vaccine Research Plan
- 10 Appendix A Biographical Sketches
- 11 Appendix B Information-Gathering Meeting Agendas
- 12 Appendix C Anthrax Vaccine Safety & Efficacy Research Plan
- 13 Appendix D Food and Drug Administration Final Rule: New Drug and Biological Drug Products
- Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible
- 14 Appendix E Department of Defense Memorandum: Reintroduction of the Anthrax Vaccine Immunization Program
- 15 Appendix F Institute of Medicine: CDC Anthrax Vaccine Safety & Efficacy Research Program. Interim Report Findings and Recommendations1
- 16 Appendix G Institute of Medicine: The Anthrax Vaccine: Is It Safe? Does It Work? Findings and Recommendations1
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