The Childhood

IMMUNIZATION SCHEDULE

and Safety

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STAKEHOLDER CONCERNS, SCIENTIFIC EVIDENCE, AND FUTURE STUDIES

Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule

Board on Population Health and Public Health Practice

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

www.nap.edu



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Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule Board on Population Health and Public Health Practice

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THE NATIONAL ACADEMIES PRESS  500 Fifth Street, NW  Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineer- ing, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropri- ate balance. This study was supported by Contract No. HHSP23337025T, Mod 2, between the National Academy of Sciences and the U.S. Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for this project. International Standard Book Number-13:  978-0-309-26702-1 International Standard Book Number-10:  0-309-26702-1 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright © 2013 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 ad- opted 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). 2013. The childhood immunization schedule and safety: Stakeholder concerns, scientific evidence, and future studies. 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 Acad- emy 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 Coun- cil 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 THE ASSESSMENT OF STUDIES OF HEALTH OUTCOMES RELATED TO THE RECOMMENDED CHILDHOOD IMMUNIZATION SCHEDULE ADA SUE HINSHAW (Chair), Uniformed Services University of the Health Sciences, Bethesda, MD TOMÁS J. ARAGÓN, San Francisco Department of Public Health, CA ALFRED BERG, University of Washington School of Medicine, Seattle STEPHEN L. BUKA, Brown University, Providence, RI R. ALTA CHARO,* University of Wisconsin Law School, Madison GERRY FAIRBROTHER, AcademyHealth, Washington, DC ELENA FUENTES-AFFLICK, University of California School of Medicine, San Francisco, CA SIDNEY M. GOSPE, JR., University of Washington School of Medicine, Seattle PAUL A. GREENBERGER, Northwestern University Feinberg School of Medicine, Chicago, IL DANIEL F. HEITJAN, University of Pennsylvania Perelman School of Medicine, Philadelphia ANNETTE C. LELAND, Independent, Washington, DC PEJMAN ROHANI, University of Michigan, Ann Arbor LAINIE FRIEDMAN ROSS, University of Chicago, IL PAULINE A. THOMAS, New Jersey Medical School, Newark Study Staff KAREN HELSING, Study Director SUZANNE LANDI, Research Associate CHELSEA FRAKES, Research Assistant HOPE HARE, Administrative Assistant ROSE MARIE MARTINEZ, Director, Board on Population Health and Public Health Practice *Until August 2012. v

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Reviewers This report has been reviewed in draft form by persons 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: Ann Bostrom, University of Washington Doug Campos-Outcalt, University of Arizona, Phoenix Louis Z. Cooper, Columbia University Rebecca Fleischauer, Steege Thomson Communications Gary L. Freed, University of Michigan Health System Sean Hennessy, University of Pennsylvania S. Claiborne Johnston, University of California, San Francisco Stanley Lemeshow, Ohio State University Tracy Lieu, Kaiser Permanente Northern California Kenneth McIntosh, Harvard University Arthur Reingold, University of California, Berkeley Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions vii

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viii REVIEWERS or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Bradford H. Gray, the Milbank Quarterly, the Urban Institute, and Donald M. Steinwachs, Johns Hopkins University. Appointed by the National Research Council and the Institute of Medicine, they were 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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Acknowledgments The committee thanks colleagues both within and outside the National Academies who provided expertise and time to inform the committee and enhanced the quality of the report. Numerous individuals and organiza- tions shared their knowledge and expertise with the committee during information-gathering sessions held on February 9, March 8, and May 29, 2012. These sessions were intended to assist the committee in collecting information on the safety and study of current and past vaccine schedules in the United States and abroad to inform the committee’s understanding and vision in completing its task. These individuals are listed in Appendix E. Of particular note, Martin Kulldorff provided a commissioned paper on study designs that could be considered to assess the safety of the im- munization schedule (see Appendix D). Both draft and revised versions of the paper were posted on the study’s website to receive public comments to inform the committee’s work. In total, the committee reviewed more than 900 public comments. The commissioned paper and public submis- sions were critical to ensuring fruitful discussions among the members of the committee. Committee members Alfred Berg and Elena Fuentes-Afflick graciously hosted committee meetings near their respective institutions. The commit- tee thanks the numerous staff members of the Institute of Medicine (IOM), the National Research Council, and the National Academies Press who contributed to the development, production, and dissemination of the re- port, including study staff Karen Helsing, Suzanne Landi, Chelsea Frakes, Rose Marie Martinez, and Hope Hare. In addition, the study received valuable contributions from Christine Stencel (Office of News and Public ix

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x ACKNOWLEDGMENTS Information), Daniel Bethea, Marton Cavani, Laura Harbold DeStefano, and Diedtra Henderson (IOM Office of Reports and Communication), and Doris Romero (IOM Office of Financial Administration). Clyde Behney, Katharine Bothner, and Sarah Ziegenhorn (IOM Deputy Executive Office) provided guidance on best practices throughout the study. Michael Hayes served as the editor for the report.

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Contents ABSTRACT xiv SUMMARY 1 1 INTRODUCTION 17 Study Background, 20 Committee on the Assessment of Studies of Health Outcomes  Related to the Recommended Childhood Immunization Schedule, 20 Committee Process, 21 Previous IOM Vaccine Studies, 22 Organization of the Report, 23 References, 23 2 DETERMINATION OF THE IMMUNIZATION SCHEDULE 25 Immune System Responses, 25 Immunization at the Population Level, 28 Immunization Policy, 30 Vaccine Development and Approval Specifics, 31 Past and Present Immunization Schedules, 34 References, 37 3 EXISTING DATA SOURCES AND SYSTEMS 39 Immunization Safety Surveillance, 39 Databases Used to Assess Coverage, 46 xi

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xii CONTENTS Databases Examining Adverse Events After Immunization for Vaccine-Preventable Diseases, 48 Immunization Data Systems in Other Countries, 50 References, 54 4  STAKEHOLDER CONCERNS RELATED TO THE SAFETY OF THE IMMUNIZATION SCHEDULE 59 Identification of Stakeholders, 60 Information Gathering, 61 Literature Search, 61 Parental Concerns in the Scientific Literature, 62 Public Concerns Presented to the Committee, 65 Patient-Provider Communication, 66 Conclusions, 68 References, 72 5 REVIEW OF SCIENTIFIC FINDINGS 75 Literature Search Methods, 76 Literature Summary, 78 Conclusions, 94 References, 95 6 METHODOLOGICAL APPROACHES TO STUDYING HEALTH OUTCOMES ASSOCIATED WITH THE CURRENT IMMUNIZATION SCHEDULE: OPTIONS, FEASIBILITY, ETHICAL ISSUES, AND PRIORITIES 99 Considerations to Determine Need for Initiation of New Studies, 100 Potential Research Questions of Interest, 103 General Research Approaches to Address Primary Research Questions of Interest, 105 Methods to Monitor Community Immunity and Measure  Population-Level Impacts of Studies of the Immunization Schedule, 119 Conclusions, 122 References, 123 7 CONCLUSIONS AND RECOMMENDATIONS 127 Committee Response to Its Statement of Task, 127 Concluding Observations, 135 References, 136

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CONTENTS xiii APPENDIXES A 2012 Advisory Committee on Immunization Practices’ Recommended Immunization Schedule for Children 137 B Glossary 145 C Acronyms 157 D Study Designs for the Safety Evaluation of Different Childhood Immunization Schedules, Martin Kulldorff 161 E Agendas of Public Meetings Held by the Committee 201 F Biographical Sketches of Committee Members 207 G Institute of Medicine Publications on Vaccines 217

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Abstract The charge to the Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule was to (1) review scientific findings and stakeholder concerns related to the safety of the recommended childhood immunization schedule and (2) iden- tify potential research approaches, methodologies, and study designs that could inform this question, considering strengths, weaknesses, as well as the ethical and financial feasibility of each approach. As reviewed by prior Institute of Medicine studies, a substantial literature exists on adverse ef- fects of individual vaccines, but few studies have focused on elements of or the recommended childhood immunization schedule as a whole. The lack of conclusive evidence linking adverse events to multiple immunizations or other “schedule” exposures suggests that the recommended schedule is safe. There are concerns from some stakeholders that merit exploration through research if epidemiological signals are detected and an indication of biological plausibility is available. However, the committee concludes that it is not ethical to implement any study requiring that some children receive fewer vaccines than recommended as part of the childhood immunization schedule because this would needlessly endanger children’s lives. The com- mittee concludes that data from existing surveillance systems, such as the Vaccine Safety Datalink, could be used and offer the best means for ongoing research efforts regarding the safety of the schedule. In recognition of this, future federal research approaches should • collect and assess evidence regarding public confidence in and con- cerns about the entire childhood immunization schedule, with the xiv

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ABSTRACT xv goal to improve communication with health care professionals, and between health care professionals and the public regarding safety; • standardize definitions of key elements of the schedule, and rel- evant health outcomes; • establish research priorities on the basis of epidemiological evi- dence, biological plausibility, and feasibility; and • continue to fund and support the Vaccine Safety Datalink project to study the safety of the recommended immunization schedule.

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