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Vaccines for the 21st Century: A Tool for Decisionmaking
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
NATIONAL ACADEMY PRESS
Washington, D.C.
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Vaccines for the 21st Century: A Tool for Decisionmaking
NATIONAL ACADEMY PRESS
2101 Constitution Avenue, N.W. Washington, DC 20418
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.
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.
Library of Congress Cataloging-in-Publication Data
Institute of Medicine (U.S.). Committee to Study Priorities for Vaccine Development.
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.
p.; cm.
Includes bibliographical references and index.
ISBN 0-309-05646-2 (hard cover)
1. Vaccines—Research—United States—Planning. I. Stratton, Kathleen R. II. Durch, Jane. III. Lawrence, Robert S., 1938- IV. Title.
[DNLM: 1. Vaccines. 2. Economics, Pharmaceutical. 3. Models, Theoretical. 4. Research. QW 805 I592v 2000]
RA638 .I556 2000
615'.372'072073—dc21
00–025528
Vaccines for the 21st Century: A Tool for Decisionmaking is available for sale from the
National Academy Press,
2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055. Call (800) 624–6242 or (202) 334–3313 (in the Washington metropolitan area), or visit the NAP’s on-line bookstore at www.nap.edu. The full text of this publication is available on line at www.nap.edu.
For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu.
Copyright 2000 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
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Vaccines for the 21st Century: A Tool for Decisionmaking
“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
—Goethe
INSTITUTE OF MEDICINE
Shaping the Future for Health
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Vaccines for the 21st Century: A Tool for Decisionmaking
THE NATIONAL ACADEMIES
National Academy of Sciences
National Academy of Engineering
Institute of Medicine
National Research Council
The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M.Alberts is president of the National Academy of Sciences.
The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A.Wulf is president of the National Academy of Engineering.
The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I.Shine is president of the Institute of Medicine.
The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M.Alberts and Dr. William A.Wulf are chairman and vice chairman, respectively, of the National Research Council.
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Vaccines for the 21st Century: A Tool for Decisionmaking
COMMITTEE TO STUDY PRIORITIES FOR VACCINE DEVELOPMENT
ROBERT S.LAWRENCE, M.D. (Chair), Associate Dean for Professional Education and Programs and Professor of Health Policy and Management,
Johns Hopkins School of Hygiene and Public Health
CAROL J.BAKER, M.D.,
Texas Children’s Hospital Foundation
Chair and Professor of Pediatrics, Microbiology, and Immunology and
Head,
Section of Infectious Diseases, Baylor College of Medicine
DAN W.BROCK, Ph.D., Charles C.Tillinghast, Jr.,
University Professor of Philosophy and Biomedical Ethics,
Director,
Center for Biomedical Ethics, Brown University
K.LYNN CATES, M.D., Associate Professor of Pediatrics,
Case Western Reserve University School of Medicine
ANNE A.GERSHON, M.D., Professor of Pediatrics,
College of Physicians and Surgeons, Columbia University
PETER M.HOWLEY, M.D., George Fabyan Professor and Chairman,
Department of Pathology, Harvard Medical School
SAMUEL L.KATZ, M.D., Wilburt C.Davison Professor and Chairman Emeritus,
Department of Pediatrics, Duke University Medical Center
JEFFREY KOPLAN, M.D., M.P.H.,* Executive Vice President and Director,
Prudential Center for Health Care Research, Atlanta
F.MARC LaFORCE, M.D., Professor of Medicine,
University of Rochester School of Medicine and Dentistry
JERRY R.McGHEE, Ph.D., Director,
Immunobiology Vaccine Center and
Professor of Microbiology,
University of Alabama at Birmingham
PEARAY L.OGRA, M.D., John Sealy Distinguished Chair and Professor of Pediatrics,
Children’s Hospital, University of Texas Medical Branch at Galveston
JUNE E.OSBORN, M.D., President,
Josiah Macy, Jr. Foundation, New York City
ELI E.SERCARZ, Ph.D., Professor Emeritus,
Department of Microbiology and Molecular Genetics, University of California at Los Angeles, and
Head and Member,
Division of Immune Regulation, La Jolla Institute for Allergy and Immunology, San Diego
MILTON C.WEINSTEIN, Ph.D., Henry J.Kaiser Professor of Health Policy and Management,
Harvard School of Public Health
Staff
KATHLEEN STRATTON, Ph.D., Study Director
JANE DURCH, Program Officer
CYNTHIA HOWE, Program Officer
*
Member until September 1998. He became director of the Centers for Disease Control and Prevention in October 1998.
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Vaccines for the 21st Century: A Tool for Decisionmaking
DOROTHY MAJEWSKI, Project Assistant
HOLLY DAWKINS, Research Assistant
DONNA DUNCAN, Division Assistant
LAURIE GILL, EXCEL Consultant
ANNA MEADOWS, M.D., Scholar-in-Residence
MICHAEL A.STOTO, Ph.D., Director,
Division of Health Promotion and Disease Prevention (until January 1, 1997)
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Vaccines for the 21st Century: A Tool for Decisionmaking
Acknowledgments
This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making the published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their participation in the review of this report:
Charles C.J.Carpenter, M.D., Brown University;
Gordon DeFriese, Ph.D., University of North Carolina at Chapel Hill;
Roger D.Feldman, Ph.D., University of Minnesota;
Harvey V.Fineberg, M.D., Ph.D., Harvard University;
Fernando Guerra, M.D., M.P.H., San Antonio Metropolitan Health District;
Michael Katz, M.D., March of Dimes Birth Defects Foundation;
Louis Lasagna, M.D., Tufts University School of Medicine; and
Henry W.Riecken, Ph.D., University of Pennsylvania.
While the individuals listed above have provided constructive comments and suggestions, it must be emphasized that responsibility for the final content of this report rests entirely with the authoring committee and the institution.
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Vaccines for the 21st Century: A Tool for Decisionmaking
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Vaccines for the 21st Century: A Tool for Decisionmaking
Contents
EXECUTIVE SUMMARY
1
1
INTRODUCTION
11
Considerations Related to the Model and the Study,
12
Organization of the Report,
13
2
PROGRESS IN VACCINE DEVELOPMENT
17
Priorities of the IOM Committee in 1985,
18
Litigation as a Barrier to Vaccine Development,
20
A Case Study of Success,
23
Advances in Biotechnology and Molecular Immunology and New Opportunities for Vaccines,
26
3
CONSIDERATIONS OF CANDIDATE VACCINES
39
Exclusion Criteria,
39
Additional Considerations for Inclusion,
43
4
OVERVIEW OF ANALYTIC APPROACH AND RESULTS
53
A Cost-Effectiveness Approach,
53
Model Overview,
61
Examples: Hypothetical Vaccine X,
76
Results,
86
5
REVIEW OF THE ANALYTIC MODEL
93
Unit of Analysis,
93
Implementing the Analysis,
94
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Vaccines for the 21st Century: A Tool for Decisionmaking
Calculation of Health Benefits,
95
Cost Factors,
104
Vaccine Efficacy and Utilization,
107
Cost-Effectiveness Ratios,
108
6
ETHICAL CONSIDERATIONS AND CAVEATS
109
Ethical and Value Judgments Built into the Model,
111
Considerations of Justice,
116
Conclusion,
122
7
OBSERVATIONS
123
The Funding of Research,
123
Neglected Opportunities for Vaccine R&D,
126
Qualitative Judgments,
129
Vaccine Program Concerns,
130
REFERENCES
133
APPENDIXES
1
Borrelia burgdorferi,
143
2
Chlamydia,
149
3
Coccidioides Immitis,
159
4
Cytomegalovirus,
165
5
Enterotoxigenic E. coli,
173
6
Epstein-Barr Virus,
177
7
Helicobacter pylori,
181
8
Hepatitis C,
189
9
Herpes Simplex Virus,
195
10
Histoplasma capsulatum,
207
11
Human Papillomavirus,
213
12
Influenza A and B,
223
13
Insulin-Dependent Diabetes Mellitus,
233
14
Melanoma,
239
15
Multiple Sclerosis,
245
16
Mycobacterium tuberculosis,
251
17
Neisseria gonorrhea,
257
18
Neisseria meningitidis B,
267
19
Parainfluenza Virus,
273
20
Respiratory Syncytial Virus,
279
21
Rheumatoid Arthritis,
285
22
Rotavirus,
291
23
Shigella,
295
24
Streptococcus, Group A,
299
25
Streptococcus, Group B,
305
26
Streptococcus pneumoniae,
313
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Vaccines for the 21st Century: A Tool for Decisionmaking
27
Information on Accessing Electronic Spreadsheets,
323
28
Summary of Workshops,
325
29
Questions Posed to Outside Experts and List of Responders,
435
INDEX
443
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