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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 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 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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