PRIORITIES FOR THE NATIONAL VACCINE PLAN

Committee on Review of Priorities in the National Vaccine Plan

Board on Population Health and Public Health Practice

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
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PRIORITIES FOR THE NATIONAL VACCINE PLAN Committee on Review of Priorities in the National Vaccine Plan Board on Population Health and Public Health Practice

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 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 study was supported by Contract HHSP23320042509XI, Task Order HHSP23320070005T, between the National Academy of Sciences and the Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project. Library of Congress Cataloging-in-Publication Data Priorities for the national vaccine plan / Committee on Review of Priorities in the National Vaccine Plan, Board on Population Health and Public Health Practice. p. ; cm. Includes bibliographical references. ISBN 978-0-309-14653-1 (pbk.) 1. National Vaccine Plan (U.S.) 2. Vaccination—Government policy—United States. I. Institute of Medicine (U.S.). Committee on the Review of Priorities in the National Vaccine Plan. II. Institute of Medicine (U.S.). Board on Population Health and Public Health Practice. [DNLM: 1. National Vaccine Plan (U.S.) 2. Vaccines—United States—Guideline. 3. Drug Discovery—United States—Guideline. 4. Immunization Programs—United States—Guideline. QW 805 P958 2010] RA638.P75 2010 614.4’7—dc22 2010009225 Additional copies of this report are available from the National Academies Press, 500 Fifth Street NW, Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www. iom.edu. Copyright 2010 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2010. Priorities for the National Vaccine Plan. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” — Goethe Advising the Nation. Improving Health.

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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. Ralph J. Cicerone 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 en- gineers. 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent 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 Insti- tute 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. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences 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. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON REVIEW OF PRIORITIES IN THE NATIONAL VACCINE PLAN CLAIRE V. BROOME (Chair), Adjunct Professor, Department of Global Health, Rollins School of Public Health, Emory University ÉLAINE CHATIGNY, Director General of Communications, Public Health Agency of Canada, Communications Directorate JOCELYN GUYER, Co-Executive Director, Center for Children and Families, Health Policy Institute, Georgetown University TIMOTHY J. HOFF, Associate Professor of Health Policy and Management, Department of Health Policy, Management and Behavior, State University of New York at Albany GRACE M. LEE, Assistant Professor of Population Medicine and Pediatrics, Harvard Medical School, Harvard Pilgrim Health Care Institute, and Children’s Hospital Boston RICHARD MANDSAGER, Chief Executive, Providence Alaska Medical Center, Anchorage EDGAR K. MARCUSE, Professor of Pediatrics, Adjunct Professor of Epidemiology, University of Washington, Schools of Medicine and Public Health; Associate Medical Director (QI), Seattle Children’s A. DAVID PALTIEL, Professor, Schools of Medicine and Management, Yale University ARTHUR L. REINGOLD, Edward Penhoet Distinguished Professor of Global Health and Infectious Disease, Associate Dean for Research, School of Public Health, University of California, Berkeley DAVID B. REUBEN, Archstone Professor of Medicine, Director, Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine, University of California, Los Angeles SARA ROSENBAUM, Harold and Jane Hirsh Professor of Health Law and Policy, Chair, Department of Health Policy, The George Washington University School of Public Health and Health Services MILAGRITOS D. TAPIA, Assistant Professor, Pediatric Infectious Diseases, University of Maryland Study Staff ALINA BACIU, Study Director AMY GELLER, Program Officer RAINA SHARMA, Senior Program Assistant LOUISE JORDAN, Senior Program Assistant (through February 2009) SANDHYA POLU, Christine Mirzayan Science and Technology Fellow ROSE MARIE MARTINEZ, Director, Board on Population Health and Public Health Practice 

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Reviewers 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 its 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 review of this report: Constance A. Benson, Antiviral Research Center, University of California, San Diego Glenna Crooks, Strategic Health Policy International, Inc. Robert Davis, Center for Health Research, Southeast, Kaiser Permanente R. Gordon Douglas, Jr., Cornell University Medical College Walter R. Dowdle, Task Force for Global Health Sean Hennessy, University of Pennsylvania School of Medicine Lisa Jackson, Group Health Center for Health Studies Arthur Levin, Center for Medical Consumers Orin S. Levine, Johns Hopkins Bloomberg School of Public Health Tracy Lieu, Harvard Pilgrim Health Care and Harvard Medical School Adel Mahmoud, Princeton University Poki Namkung, County of Santa Cruz Health Services Agency ii

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iii REVIEWERS Georges Peter, Alpert Medical School of Brown University John Robbins, National Institutes of Health Patricia Stinchfield, Children’s Hospitals and Clinics of Minnesota David Sundwall, Utah Department of Health Roy Widdus, Global Health Futures Peg Willingham, AERAS Global TB Vaccine Foundation Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Linda Rosenstock, Dean, UCLA School of Public Health. Appointed by the National Research Coun- cil she was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Contents Summary 1 Introduction 17 Charge to the Committee, 17 Methods, 20 General Comments About the 2008 Draft Plan, 21 The Purpose of Immunization, 22 References, 29 1 Development of New and Improved Vaccines 31 Context: The Current State of Vaccine Research and Development, 32 Themes from Information Gathering, 34 Regulatory Enhancements to Support Innovation While Protecting Health, 34 Priority Setting in Vaccine Research and Development, 39 Coordination and Oversight of Vaccine Development, 43 The Meaning of “Vaccine” in the 21st Century, 45 Global Vaccines, 47 References, 48 2 The Safety of Vaccines and Vaccination Practices 51 A Case Study of Vaccine Safety System Functioning, 54 Part I: Components of the 1986 Legislation, 57 Part II: Recommendations About Priority Actions in the Plan, 64 ix

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 CONTENTS Concluding Observations, 75 References, 75 3 Informed Vaccine Decision Making 79 The Changing Social Context of Vaccine Communication, 81 A National Vaccine Communication Strategy, 87 References, 93 4 Vaccine Supply and Use 97 Overview of the Nation’s Immunization Services, 98 Framing of Goal 4, 99 Sub-goal 1: Supply, 103 Sub-goal 2: Financing Barriers in the United States, 104 Sub-goal 3: Access and Practice, 108 Sub-goal 4: Information Systems, 110 Sub-goal 5: Public Health Infrastructure, 115 References, 117 5 Vaccines and Global Health 121 Challenges and Opportunities in a Changing Landscape, 123 Developing Novel Vaccines, 126 Infrastructure and Capacity to Provide Immunization, 127 Financing Vaccine Development and Purchase, 128 Surveillance, 132 References, 135 6 Coordination 139 Coordination: Essential to Plan Success, 140 Factors Contributing to the Problem, 146 Fixing the Coordination Gap, 149 Concluding Observations, 151 References, 151

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i CONTENTS APPENDIXES* A Draft Strategic National Vaccine Plan 153 B Letter to the Committee from the National Vaccine Advisory Committee 239 C 1986 National Childhood Vaccine Injury Act (Public Law 99-660) 243 D Initial Guidance for an Update of the National Vaccine Plan: A Letter Report to the National Vaccine Program Office 273 E History of Public Engagement at the National Vaccine Program Office 313 F Agendas of Stakeholder Meetings Held by the Committee on Review of Priorities in the National Vaccine Plan (July 2008- June 2009) 317 G Acronyms 345 H Committee Biographies 349 *Appendixes A-F are available on the CD in the back of the book and at http://www.nap. edu/catalog.php?record_id=12796. Appendixes G and H are printed in the book and are also available online at the URL provided.

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