The United States is facing a vaccine shortage that may threaten public health. This book examines vaccine research and development, production and supply, and utilization and offers recommendations aimed at ensuring vaccine supply and promoting innovation. In addition, this comprehensive volume provides information on the adverse reactions associated with the range of vaccines used in the United States and contains the most thorough analysis ever published on the state of the law regarding vaccine-related injury and compensation for vaccine injury.

Contents

• Committee on Public-Private Sector Relations in Vaccine Innovation
• Government-Industry Liaison Panel
• Preface
• 1. Summary
  • Overview
  • Vaccine Availability: Major Barriers and Impediments
  • Economic Characteristics of the Vaccine Industry
  • Vaccine Injury
  • The Legal Situation and Its Consequences
  • Consequences of the State of Vaccine Injury Liability Law for Vaccine Production and Innovation
  • A National Vaccine Commission
  • Compensation and Liability for Vaccine-Related Injury
• 2. Vaccines: Past, Present, and Future
  • Types of Immunization
  • History of Immunization
  • The Present
  • The Future
  • References and Notes
• 3. Vaccine Availability: Concerns, Barriers, and Impediments
  • Concerns About the Current Situation
  • Barriers and Impediments to Vaccine Innovation
  • Vaccine Utilization
  • Conclusions
  • References and Notes
• 4. Economic Aspects of Vaccine Innovation and Manufacturing
  • Potential Causes of Industry Decline
  • Descriptive Statistics
  • Conclusions
  • References and Notes
• 5. Vaccine Injury
  • The Pertussis Controversy
  • Identifying Individuals at High Risk of Adverse Effects
  • Vaccines Used in Childhood
  • Vaccines for Adults
  • Summary
  • References and Notes
• 6. Liability for the Production and Sale of Vaccines
  • State of the Law
  • Consequences of the State of Vaccine Injury Liability Law for Vaccine Production and Innovation
  • References and Notes
• 7. An Approach to the Problems of Communication, Coordination, and Collaboration in Vaccine Policy
  • Historical Background
  • The Existing Structure
  • Problems with the Present Situation
  • Recommendation for a Vaccine Commission
  • Conclusions
  • References and Notes
• 8. Vaccine Injury Compensation and Liability Remedies
  • Compensation and Liability Options
  • The Compensation Mechanism
  • Summary and Conclusions
  • References and Notes
• Appendix A Product License Holders
• Appendix B A Vaccine Supply Public Insurance Option
• Appendix C No-Fault Vaccine Injury Insurance
• Appendix D Injury Compensation Systems in the United States
• Appendix E Vaccine-Injury Compensation in Other Countries
• Appendix F Proposed Vaccine-Injury Compensation Systems
• Appendix G Mechanisms Used in Other Countries to Ensure Vaccine Supply
• Appendix H Background Papers
• Appendix I Biographical Notes on Committee Members and Consultants
• Appendix J Recommendations for the Proposed Vaccine Commission

The study was supported under contracts with the Food and Drug Administration (223-83-1109), the Department of the Army (DAMD17-83-G-9558), and the Centers for Disease Control (200-83-0609), and grants from Lederle Laboratories, the Mericux Institute, Inc., and Merck Sharp & Dohme. Additional support was provided by the National Research Council (NRC) Fund, a pool of private, discretionary, nonfederal funds that is used to support a program of Academy-initiated studies of national issues in which science and technology figure significantly. The NRC Fund consists of contributions from a consortium of private foundations including the Carnegie Corporation of New York, the Charles E. Culpeper Foundation, the William and Flora Hewlett Foundation, the John D. and Catherine T. MacArthur Foundation, the Andrew W. Mellon Foundation, the Rockefeller Foundation, and the Alfred P. Sloan Foundation; the Academy Industry Program, which seeks annual contributions from companies that are concerned with the health of U.S. science and technology and with public policy issues with technological content; and the National Academy of Sciences and the National Academy of Engineering endowments.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competencies and with regard for appropriate balance.

This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education.