Vaccine Supply and Innovation -- Copyright -- Preface -- Contents -- Vaccine Supply and Innovation -- 1 Summary -- OVERVIEW -- VACCINE AVAILABILITY: MAJOR BARRIERS AND IMPEDIMENTS -- Impediments to Vaccine Innovation -- 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 -- Development of Vaccines and Recommendations for Vaccine Use -- THE FUTURE -- REFERENCES AND NOTES -- 3 Vaccine Availability: Concerns, Barriers, and Impediments -- CONCERNS ABOUT THE CURRENT SITUATION -- Supply -- Stockpiling of Vaccines -- Problems with Sole Reliance on Foreign Manufacturers -- Federal Action to Ensure Vaccine Supply -- BARRIERS AND IMPEDIMENTS TO VACCINE INNOVATION -- Identification of Need and Establishing Priorities -- Establishing the Technical Feasibility of Vaccine Development -- Economic Disincentives to Innovation and Production -- Factors Influencing the Market for Vaccines -- VACCINE UTILIZATION -- System Factors -- Client Factors -- Provider Factors -- CONCLUSIONS -- Barriers and Impediments to Vaccine Innovation -- REFERENCES AND NOTES -- 4 Economic Aspects of Vaccine Innovation and Manufacturing -- POTENTIAL CAUSES OF INDUSTRY DECLINE -- Property Rights and Innovation -- Regulation -- Market Size -- Liability and Risk -- DESCRIPTIVE STATISTICS -- The Market and Participants -- Pricing -- Research and Development -- CONCLUSIONS -- REFERENCES AND NOTES -- 5 Vaccine Injury -- The Pertussis Controversy -- Identifying Individuals at High Risk of Adverse Effects -- VACCINES USED IN CHILDHOOD.

Pertussis Vaccine -- Diphtheria Toxoid -- Tetanus Toxoid -- Poliomyelitis Vaccines -- Measles Vaccine -- Rubella Vaccine -- Mumps Vaccine -- VACCINES FOR ADULTS -- Influenza Vaccines -- Pneumococcal Vaccines -- Meningococcal Vaccines -- Rabies Vaccine -- Hepatitis B Vaccine -- SUMMARY -- REFERENCES AND NOTES -- 6 Liability for the Production and Sale of Vaccines -- STATE OF THE LAW -- Experience From the Swine Flu Vaccination Program -- Recent Trends -- The Issue of Punitive Damages -- Summary of the Legal Situation -- 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 -- Federal Agency Interactions -- Public-Private Sector Interactions -- Provider and Recipient Perceptions -- PROBLEMS WITH THE PRESENT SITUATION -- RECOMMENDATION FOR A VACCINE COMMISSION -- Rationale for Establishment -- Purpose and Functions -- Reporting -- Location, Establishment, Membership -- Funding -- Possible Areas of Activity -- CONCLUSIONS -- REFERENCES AND NOTES -- 8 Vaccine Injury Compensation and Liability Remedies -- COMPENSATION AND LIABILITY OPTIONS -- The Rationale for Providing Compensation for Vaccine-Related Injury -- THE COMPENSATION MECHANISM -- Provision of Payments -- The Amount and Nature of Payments -- Defining Compensable Events -- Establishing an Schedule of Payments -- Source of Funding -- Informed Consent -- Administrative Location -- Additional Issues -- SUMMARY AND CONCLUSIONS -- REFERENCES AND NOTES -- Appendix A Product License Holders -- Appendix B A Vaccine Supply Public Insurance Option -- REFERENCES -- Appendix C No-Fault Vaccine Injury Insurance -- Appendix D Injury Compensation Systems in the United States -- VACCINE INJURY.

Federal Legislation -- State Legislation -- COMPENSATION FOR OTHER INJURIES -- Black Lung Compensation -- Social Security Disability Compensation -- REFERENCES -- Appendix E Vaccine-Injury Compensation in Other Countries -- DENMARK -- FEDERAL REPUBLIC OF GERMANY -- FRANCE -- JAPAN -- SWITZERLAND -- UNITED KINGDOM -- Appendix F Proposed Vaccine-Injury Compensation Systems -- S. 827-NATIONAL CHILDHOOD VACCINE-INJURY COMPENSATION ACT -- Other Major Points -- Revisions -- H.R. 1780-THE NATIONAL CHILDHOOD VACCINE-INJURY COMPENSATION ACT -- Compensation -- AMA'S PROPOSED NATIONAL PEDIATRIC VACCINE-INJURY COMPENSATION ACT -- A PROPOSAL BY THE AMERICAN ACADEMY OF PEDIATRICS -- Need for Legislation to Establish a Federal Compensation Program for Vaccine-Related Injuries in Childhood Immunization… -- PROPOSED VACCINE-INJURY COMPENSATION ACT OF 1983 -- AMA'S PROPOSED MODEL STATE LEGISLATION ON VACCINE COMPENSATION -- PROPOSED FEDERAL IMMUNIZATION INSURANCE CORPORATION -- REFERENCES -- Appendix G Mechanisms Used in Other Countries to Ensure Vaccine Supply -- Appendix H Background Papers -- CASE HISTORIES -- ISSUES -- PUBLIC SECTOR PERSPECTIVES -- PRIVATE SECTOR PERSPECTIVES -- Appendix I Biographical Notes on Committee Members and Consultants -- Appendix J Recommendations for the Proposed Vaccine Commission -- Index.