Vaccines for the 21st Century

Vaccines have made it possible to eradicate the scourge of smallpox, promise the same for polio, and have profoundly reduced the threat posed by other diseases such as whooping cough, measles, and meningitis.

What is next? There are many pathogens, autoimmune diseases, and cancers that may be promising targets for vaccine research and development.

This volume provides an analytic framework and quantitative model for evaluating disease conditions that can be applied by those setting priorities for vaccine development over the coming decades. The committee describes an approach for comparing potential new vaccines based on their impact on morbidity and mortality and on the costs of both health care and vaccine development. The book examines:

• Lessons to be learned from the polio experience.
• Scientific advances that set the stage for new vaccines.
• Factors that affect how vaccines are used in the population.
• Value judgments and ethical questions raised by comparison of health needs and benefits.

The committee provides a way to compare different forms of illness and set vaccine priorities without assigning a monetary value to lives. Their recommendations will be important to anyone involved in science policy and public health planning: policymakers, regulators, health care providers, vaccine manufacturers, and researchers.

Contents

• THE NATIONAL ACADEMIES
• COMMITTEE TO STUDY PRIORITIES FOR VACCINE DEVELOPMENT
• Acknowledgments
• Executive Summary
• 1 Introduction
• 2. Progress in Vaccine Development
  • PRIORITIES OF THE IOM COMMITTEE IN 1985
  • LITIGATION AS A BARRIER TO VACCINE DEVELOPMENT
  • A CASE STUDY OF SUCCESS
  • ADVANCES IN BIOTECHNOLOGY AND MOLECULAR IMMUNOLOGY AND NEW OPPORTUNITIES FOR VACCINES
• 3. Considerations of Candidate Vaccines
  • EXCLUSION CRITERIA
  • ADDITIONAL CONSIDERATIONS FOR INCLUSION
• 4. Overview of Analytic Approach and Results
  • A COST-EFFECTIVENESS APPROACH
  • MODEL OVERVIEW
  • EXAMPLES: HYPOTHETICAL VACCINE X
  • RESULTS
• 5. Review of the Analytic Model
  • UNIT OF ANALYSIS
  • IMPLEMENTING THE ANALYSIS
  • CALCULATION OF HEALTH BENEFITS
  • COST FACTORS
  • VACCINE EFFICACY AND UTILIZATION
  • COST-EFFECTIVENESS RATIOS
• 6. Ethical Considerations and Caveats
  • ETHICAL AND VALUE JUDGMENTS BUILT INTO THE MODEL
  • CONSIDERATIONS OF JUSTICE
  • CONCLUSION
• 7. Observations
  • THE FUNDING OF RESEARCH
  • NEGLECTED OPPORTUNITIES FOR VACCINE R&D
  • QUALITATIVE JUDGMENTS
  • VACCINE PROGRAM CONCERNS
• References
• APPENDIX 1 Borrelia burgdorferi
• APPENDIX 2 Chlamydia
• APPENDIX 3 Coccidioides immitis
• APPENDIX 4 Cytomegalovirus
• APPENDIX 5 Enterotoxigenic E. coli
• APPENDIX 6 Epstein-Barr Virus
• APPENDIX 7 Helicobacter pylori
• APPENDIX 8 Hepatitis C
• APPENDIX 9 Herpes Simplex Virus
• APPENDIX 10 Histoplasma capsulatum
• APPENDIX 11 Human Papillomavirus
• APPENDIX 12 Influenza A and B
• APPENDIX 13 Insulin-Dependent Diabetes Mellitus
• APPENDIX 14 Melanoma
• APPENDIX 15 Multiple Sclerosis
• APPENDIX 16 Mycobacterium tuberculosis
• APPENDIX 17 Neisseria gonorrhea
• APPENDIX 18 Neisseria meningitidis B
• APPENDIX 19 Parainfluenza Virus
• APPENDIX 20 Respiratory Syncytial Virus
• APPENDIX 21 Rheumatoid Arthritis
• APPENDIX 22 Rotavirus
• APPENDIX 23 Shigella
• APPENDIX 24 Streptococcus, Group A
• APPENDIX 25 Streptococcus, Group B
• APPENDIX 26 Streptococcus pneumoniae
• APPENDIX 27 Information on Accessing Electronic Spreadsheets
• APPENDIX 28 Summary of Workshops
• APPENDIX 29 Questions Posed to Outside Experts and List of Responders

This project has been funded in whole with federal funds from the National Institutes of Allergy and Infectious Diseases, National Institutes of Health, under Contract No. N01-AI-45237. The views presented are those of the Institute of Medicine Committee to Study Priorities for Vaccine Development and are not necessarily those of the funding organization.

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 competences and with regard for appropriate balance.