Vaccines for the 21st century : a tool for decisionmaking / Kathleen R. Stratton, Jane S. Durch, and Robert S. Lawrence, editors ; Committee to Study Priorities for Vaccine Development, Division of Health Promotion and Disease Prevention, Institute of Medicine.

Format:

Book

Author/Creator:

Institute of Medicine (U.S.). Committee to Study Priorities for Vaccine Development.

Contributor:

Stratton, Kathleen R.

Durch, Jane.

Lawrence, Robert S., 1938-

Language:

English

Subjects (All):

Vaccines--Research--United States--Planning.

Vaccines.

Immunization--Research--United States--Planning.

Immunization.

Physical Description:

1 online resource (472 p.)

Edition:

1st ed.

Other Title:

Vaccines for the twenty first century

Place of Publication:

Washington, D.C. : National Academy Press, c2000.

Language Note:

English

Summary:

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.

Contents:

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

Challenges

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&amp

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

Vaccine Schedule, Efficacy, and Costs

READING LIST

APPENDIX 2 Chlamydia

Disease Scenarios: Women

Disease Scenarios: Men

Disease Scenarios: Infants

COSTS INCURRED BY DISEASE

APPENDIX 3 Coccidioides immitis

APPENDIX 4 Cytomegalovirus

APPENDIX 5 Enterotoxigenic E. coli

Disease Scenarios.

COST INCURRED BY DISEASE

APPENDIX 6 Epstein-Barr Virus

APPENDIX 7 Helicobacter pylori

APPENDIX 8 Hepatitis C

APPENDIX 9 Herpes Simplex Virus

Oral Infections

Ocular Infections

Central Nervous System Infections

Genital Infections

Neonatal Infections

Oral and Ocular Infections

APPENDIX 10 Histoplasma capsulatum

APPENDIX 11 Human Papillomavirus

VACCINE DEVELOPMENT.

VACCINE PROGRAM CONSIDERATIONS

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

VACCINE PROGRAM CONSIDERATIONS.

Notes:

Bibliographic Level Mode of Issuance: Monograph

Includes bibliographical references and index.

ISBN:

9786610191840

9780309174985

0309174988

9781280191848

1280191848

9780309564434

0309564433

OCLC:

70773575