Adverse Effects of Vaccines: Evidence and Causality

892 Pages·2012·6.24 MB·English

by  Committee to Review Adverse Effects of Vaccines

Adverse
Effects of
Vaccines
Evidence
and
Causality
Editors
Kathleen Stratton,
Andrew Ford,
Erin Rusch,
Ellen Wright Clayton
Adverse Effects of Vaccines: Evidence and Causality
Adverse
Effects of
Vaccines
Evidence and Causality
Committee to Review Adverse Effects of Vaccines
Board on Population Health and Public Health Practice
Kathleen Stratton, Andrew Ford, Erin Rusch, and Ellen Wright Clayton,
Editors
Copyright © National Academy of Sciences. All rights reserved.
Adverse Effects of Vaccines: Evidence and Causality
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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 No. HHSH230200446009I, Task Order 13 between the
National Academy of Sciences and the Health Resources and Services Administration of the
U.S. Department of Health and Human Services. The Centers for Disease Control and Preven-
tion and the National Vaccine Program Office also provided support through that contract.
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that provided support for this project.
Library of Congress Cataloging-in-Publication Data
Institute of Medicine (U.S.). Committee to Review Adverse Effects of Vaccines.
Adverse effects of vaccines : evidence and causality / Committee to Review Adverse Effects
of Vaccines, Board on Population Health and Public Health Practice ; Kathleen Stratton ...
[et al.], editors.
p. ; cm.
Includes bibliographical references and index.
ISBN 978-0-309-21435-3 (hardcover) — ISBN 978-0-309-21436-0 (PDF)
I. Stratton, Kathleen R. II. Title.
[DNLM: 1. Vaccines—adverse effects. 2. Bacterial Infections—prevention & control. 3.
Causality. 4. Virus Diseases—prevention & control. QW 805]

615.3’72—dc23
2012007052
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Copyright 2012 by the National Academy of Sciences. All rights reserved.
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Suggested citation: IOM (Institute of Medicine). 2012. Adverse effects of vaccines: Evidence
and causality. Washington, DC: The National Academies Press.
Copyright © National Academy of Sciences. All rights reserved.
Adverse Effects of Vaccines: Evidence and Causality
“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
—Goethe
Advising the Nation. Improving Health.
Copyright © National Academy of Sciences. All rights reserved.
Adverse Effects of Vaccines: Evidence and Causality
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Copyright © National Academy of Sciences. All rights reserved.
Adverse Effects of Vaccines: Evidence and Causality
COMMITTEE TO REVIEW ADVERSE EFFECTS OF VACCINES
Ellen Wright Clayton (Chair), Craig-Weaver Professor of Pediatrics;
Director, Center for Biomedical Ethics and Society; Professor of Law;
Vanderbilt University
Inmaculada B. Aban, Associate Professor, Department of Biostatistics,
University of Alabama, Birmingham
Douglas J. Barrett, Professor, Departments of Pediatrics, Molecular
Genetics & Microbiology, Pathology, Immunology, & Laboratory
Medicine, University of Florida College of Medicine
Martina Bebin, Associate Professor of Neurology and Pediatrics,
University of Alabama at Birmingham
Kirsten Bibbins-Domingo, Associate Professor and Attending Physician,
University of California, San Francisco
Graham A. Colditz,1 Associate Director for Prevention and Control,
Alvin J. Siteman Cancer Center, and Niess-Gain Professor in the
School of Medicine, Department of Surgery, Washington University
School of Medicine
Martha Constantine-Paton, Investigator, McGovern Institute for Brain
Research; Professor of Biology, Department of Biology, Department
of Brain and Cognitive Sciences, Massachusetts Institute of
Technology
Deborah J. del Junco, Senior Epidemiologist and Associate Professor of
Biostatistics, Epidemiology, and Research Design, University of Texas
Health Science Center at Houston
Betty A. Diamond, Head, Center for Autoimmune and Musculoskeletal
Disease, The Feinstein Institute for Medical Research, North Shore-
LIJ Health System
S. Claiborne Johnston, Associate Vice Chancellor of Research; Director,
Clinical and Translational Science, Institute Professor of Neurology
and Epidemiology; Director, Neurovascular Disease and Stroke
Center; University of California, San Francisco
Anthony L. Komaroff, Steven P. Simcox, Patrick A. Clifford, and James
H. Higby Professor of Medicine; Senior Physician, Brigham and
Women’s Hospital; Harvard Medical School
B. Paige Lawrence, Associate Professor of Environmental Medicine;
Associate Professor of Microbiology and Immunology, University of
Rochester School of Medicine and Dentistry
M. Louise Markert, Associate Professor of Pediatrics and Immunology,
Division of Pediatric Allergy and Immunology, Department of
Pediatrics, Duke University Medical Center
1 Committee member resigned August 2010.
v
Copyright © National Academy of Sciences. All rights reserved.
Adverse Effects of Vaccines: Evidence and Causality
Ruby H. N. Nguyen,2 Assistant Professor, Division of Epidemiology and
Community Health, University of Minnesota School of Public Health
Marc C. Patterson, Chair, Division of Child and Adolescent Neurology;
Professor of Neurology, Pediatrics, and Medical Genetics; Director,
Child Neurology Training Program, Mayo Clinic
Hugh A. Sampson, Professor of Pediatrics and Immunology; Dean for
Translational Biomedical Sciences; Director of the Jaffe Food Allergy
Institute, Mount Sinai School of Medicine
Pauline A. Thomas, Associate Professor, Department of Preventive
Medicine and Community Health, New Jersey Medical School; and
Associate Professor, School of Public Health, University of Medicine
and Dentistry of New Jersey
Leslie P. Weiner, Richard Angus Grant, Sr. Chair in Neurology; Professor
of Neurology and Molecular Microbiology and Immunology, Keck
School of Medicine, University of Southern California
Study Staff
Kathleen Stratton, Study Director
Andrew Ford, Program Officer
Erin Rusch, Research Associate
Trevonne Walford, Research Assistant (from August 2009)
William McLeod, Senior Research Librarian
Hope Hare, Administrative Assistant
Amy Pryzbocki, Financial Associate
Rose Marie Martinez, Director, Board on Population Health and Public
Health Practice
2 Committee member resigned March 2010.
vi
Copyright © National Academy of Sciences. All rights reserved.
Adverse Effects of Vaccines: Evidence and Causality
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:
Steven Black, Cincinnati Children’s Hospital
Patricia K. Crumrine, University of Pittsburgh School of Medicine
Anne A. Gershon, Columbia University College of Physicians &
Surgeons
Marie R. Griffin, Vanderbilt University Medical Center
Neal Halsey, Johns Hopkins Bloomberg School of Public Health
Diane Harper, University of Missouri-Kansas City School of Medicine
Gerald T. Nepom, University of Washington
Richard Platt, Harvard Medical School
Stanley A. Plotkin, University of Pennsylvania
Sam Shekar, Northrop Grumman
Donald Silberberg, University of Pennsylvania Medical Center
vii
Copyright © National Academy of Sciences. All rights reserved.
Adverse Effects of Vaccines: Evidence and Causality
viii REVIEWERS
John J. Treanor, University of Rochester School of Medicine and
Dentistry
Chris Wilson, The Bill & Melinda Gates 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 Charles C. J. Carpenter,
The Miriam Hospital, and Floyd E. Bloom, The Scripps Research Institute.
Appointed by the National Research Council and 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.
Copyright © National Academy of Sciences. All rights reserved.
Adverse Effects of Vaccines: Evidence and Causality
Preface
Vaccines are widely recognized as one of the greatest public health
successes of the last century, significantly reducing morbidity and mortality
from a variety of bacteria and viruses. Diseases that were once the cause of
many outbreaks, common causes of loss of health and life, are now rarely
seen, because they have been prevented by vaccines. However, vaccines can
in rare cases themselves cause illness. A rare potential for harm can loom
large when people no longer experience or fear the targeted disease. In this
regard, the public opinion of vaccines can be a victim of their success. The
Institute of Medicine (IOM) was charged by Congress when it enacted the
National Childhood Vaccine Injury Act in 1986 with reviewing the litera-
ture regarding the adverse events associated with vaccines covered by the
program, a charge which the IOM has addressed 11 times in the past 25
years. Following in this tradition, the task of this committee was to assess
dispassionately the scientific evidence about whether eight different vaccines
cause adverse events (AE), a total of 158 vaccine-AE pairs, the largest study
undertaken to date, and the first comprehensive review since 1994.
The committee had a herculean task, requiring long and thoughtful
discussions of our approach to analyzing the studies culled from more than
12,000 peer-reviewed articles in order to reach our conclusions, which are
spelled out in the chapters that follow. In the process, we learned some
lessons that may be of value for future efforts to evaluate vaccine safety.
One is that some issues simply cannot be resolved with currently available
epidemiologic data, excellent as some of the collections and studies are.
Particularly for rare events, we look to the day when electronic medical
records truly are universal and when society reaches a broad-based con-
ix
Copyright © National Academy of Sciences. All rights reserved.