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.
- Vaccines for the 21st Century
- Copyright
- Acknowledgments
- Contents
- Executive Summary
- THE ANALYTIC FRAMEWORK
- ETHICAL ISSUES
- RESULTS
- OBSERVATIONS
- 1 Introduction
- CONSIDERATIONS RELATED TO THE MODEL AND THE STUDY
- ORGANIZATION OF THE REPORT
- Charge to the Committee
- Committee Membership and Meetings
- Organization of the Report
- 2 Progress in Vaccine Development
- PRIORITIES OF THE IOM COMMITTEE IN 1985
- LITIGATION AS A BARRIER TO VACCINE DEVELOPMENT
- Immunization of Pregnant Women
- A CASE STUDY OF SUCCESS
- Disease Burden
- Polio Vaccine Development
- Advantages of Evolving Vaccine Strategies
- ADVANCES IN BIOTECHNOLOGY AND MOLECULAR IMMUNOLOGY AND NEW OPPORTUNITIES FOR VACCINES
- Fundamental Understanding of Helper T Cells for Antibody Versus CMI Responses, and for Cytotoxicity
- Major Advances in Mucosal Immunity
- Mucosal Immune System Organization
- Molecular Aspects of Virulence and Design of Recombinant Protein Vaccines
- Novel Vaccine Delivery Systems
- Recent Advances in Development of Novel Adjuvants
- Scientific Rationale for Vaccines against Autoimmune Diseases
- Immune Tolerance Induction
- Immune Deviation
- Receptor-Centered Regulation
- Targeting Cytokines or Their Receptors
- Viral Vectors in Autoimmune Therapy
- Preventive Vaccines for Autoimmune Diseases
- 3 Considerations of Candidate Vaccines
- EXCLUSION CRITERIA
- Insufficient Basic Science Information
- Existence of Appropriate Prevention Interventions
- International Burden of Disease
- ADDITIONAL CONSIDERATIONS FOR INCLUSION
- Therapeutic Vaccines
- Programmatic Considerations
- Delivery of Vaccines to Children
- Delivery of Vaccines to Adults
- Delivery of Vaccines to Pregnant Women
- 4 Overview of Analytic Approach and Results
- A COST-EFFECTIVENESS APPROACH
- Reasons for Using Cost-Effectiveness Analysis
- Limits of Cost-Effectiveness Analysis
- Ethical Issues
- Analytic Perspectives
- Time Horizon and Discounting
- MODEL OVERVIEW
- Health Benefits: The Denominator
- Quality Adjustments: Weighting
- Morbidity Scenarios
- Quality Adjustments for Average Population Health States
- Disease Incidence and Death Rates
- Time Intervals
- QALYs Gained with Vaccine Use
- Costs: The Numerator
- Cost of Research and Development
- Cost of Vaccine Use
- Health Care Costs
- Vaccine Efficacy and Utilization
- Cost-Effectiveness Ratios
- Exclusions from the Analysis
- EXAMPLES: HYPOTHETICAL VACCINE X
- Target Population
- Program Considerations
- Disease Severity
- Discounting
- An Idealized Scenario
- Summary
- RESULTS
- 5 Review of the Analytic Model
- UNIT OF ANALYSIS
- IMPLEMENTING THE ANALYSIS
- Basic Model
- Performing the Analysis
- CALCULATION OF HEALTH BENEFITS
- Quality-Adjusted Life Years
- Quality-Adjustment Weights Based on the Health Utilities Index
- Steps in the Calculation of Anticipated Health Benefits from Vaccine Use
- Develop Morbidity Scenarios
- Calculate Quality-Adjustment Weights
- Calculate Discounted Quality-Adjusted Life Expectancies
- Establish Age-Specific Incidence and Death Rates
- Calculate Time Intervals for Discounting Future Health Benefits
- Calculate Condition-Related Life Expectancies
- Adjust for the Underlying Health Status of the Population
- Calculate Discounted QALYs for Each Health State
- Calculate Total QALYs Gained with Vaccine Use
- COST FACTORS
- Vaccine Development
- Vaccine Use
- Cost of Care
- VACCINE EFFICACY AND UTILIZATION
- COST-EFFECTIVENESS RATIOS
- 6 Ethical Considerations and Caveats
- ETHICAL AND VALUE JUDGMENTS BUILT INTO THE MODEL
- All QALYs Count Equally
- Years of Life at Different Ages Are Weighted by Quality
- The Value of Life Extension with and without Disabilities
- Discount Rates for Costs and Benefits
- Which Benefits and Costs Should Be Counted in the Prioritization Process?
- CONSIDERATIONS OF JUSTICE
- Small Benefits to Many Versus Large Benefits to a Few
- What Priority Should Be Given to the Worst-Off or Sickest?
- Fair Chances Versus Best Outcomes
- CONCLUSION
- 7 Observations
- THE FUNDING OF RESEARCH
- NEGLECTED OPPORTUNITIES FOR VACCINE R&D
- International Considerations
- Small Target Populations
- Liability Concerns
- QUALITATIVE JUDGMENTS
- VACCINE PROGRAM CONCERNS
- References
- APPENDIX 1 Borrelia burgdorferi
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 2 Chlamydia
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios: Women
- Disease Scenarios: Men
- Disease Scenarios: Infants
- COSTS INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 3 Coccidioides immitis
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 4 Cytomegalovirus
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 5 Enterotoxigenic E. coli
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 6 Epstein-Barr Virus
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 7 Helicobacter pylori
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 8 Hepatitis C
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 9 Herpes Simplex Virus
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- Oral Infections
- Ocular Infections
- Central Nervous System Infections
- Genital Infections
- Neonatal Infections
- COST INCURRED BY DISEASE
- Oral and Ocular Infections
- Central Nervous System Infections
- Genital Infections
- Neonatal Infections
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 10 Histoplasma capsulatum
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 11 Human Papillomavirus
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 12 Influenza A and B
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 13 Insulin-Dependent Diabetes Mellitus
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 14 Melanoma
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 15 Multiple Sclerosis
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 16 Mycobacterium tuberculosis
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 17 Neisseria gonorrhea
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 18 Neisseria meningitidis B
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 19 Parainfluenza Virus
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 20 Respiratory Syncytial Virus
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 21 Rheumatoid Arthritis
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 22 Rotavirus
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 23 Shigella
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 24 Streptococcus, Group A
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 25 Streptococcus, Group B
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- Immunization of Pregnant Women and At-Risk Adults
- Immunization of Girls at Puberty and At-Risk Adults
- READING LIST
- APPENDIX 26 Streptococcus pneumoniae
- DISEASE BURDEN
- Epidemiology
- Disease Scenarios
- COST INCURRED BY DISEASE
- VACCINE DEVELOPMENT
- VACCINE PROGRAM CONSIDERATIONS
- Target Population
- Vaccine Schedule, Efficacy, and Costs
- RESULTS
- READING LIST
- APPENDIX 27 Information on Accessing Electronic Spreadsheets
- APPENDIX 28 Summary of Workshops
- HERPES SIMPLEX
- EPSTEIN-BARR VIRUS
- HEPATITIS C VIRUS
- HUMAN PAPILLOMAVIRUS
- DENGUE HEMORRHAGIC FEVER
- CHLAMYDIA TRACHOMATIS
- TUBERCULOSIS
- HISTOPLASMOSIS AND COCCIDIOIDOMYCOSIS
- GROUP A STREPTOCOCCI
- HELICOBACTER PYLORI
- NEISSERIA GONORRHOEA
- ADJUVANTS
- ANTIGEN DELIVERY SYSTEMS
- DNA VACCINES
- PREVENTIVE VACCINE FOR DIABETES
- CYTOKINE MODIFICATION OF AUTOREACTIVITY
- T-CELL SUBSET CHOICE ON THE OUTCOME OF AUTOIMMUNE DISEASE
- ANTIGEN-INDUCED PROGRAMMED T-CELL DEATH AS A NEW APPROACH TO IMMUNE THERAPY
- INDUCTION, PROPAGATION, AND IMMUNOREGULATION OF AUTOIMMUNE DISEASES OF THE CENTRAL NERVOUS SYSTEM
- PEPTIDE-MEDIATED REGULATION OF AUTOIMMUNITY
- STIMULATION AND COSTIMULATION
- VIRAL THERAPEUTIC VACCINES—HEPATITIS B
- CD8 CTL TO MUTATED ONCOPROTEINS AND FUSION PROTEINS
- CTL SCREENING FOR TUMOR ANTIGENS
- IMMUNITY TO ONCOGENIC SELF-PROTEINS
- CYTOKINES AND THEIR LOCAL ENVIRONMENTS
- APPENDIX 29 Questions Posed to Outside Experts and List of Responders
- Index
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