National Academies Press: OpenBook
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×

The Childhood

IMMUNIZATION SCHEDULE

and Safety

img

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

Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×

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 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 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 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). 2013. The childhood immunization schedule and safety: Stakeholder concerns, scientific evidence, and future studies. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×

Knowing is not enough; we must apply.
Willing is not enough; we must do.

—Goethe

image

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

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 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. Charles M. Vest 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. Harvey V. Fineberg 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. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×

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.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×

This page is blank

Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×

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

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×

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.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×

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 organizations 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 immunization 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 submissions 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 committee 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 report, 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

Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×

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.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×

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) identify 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 effects 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 committee 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 concerns about the entire childhood immunization schedule, with the goal to improve communication with health care professionals, and between health care professionals and the public regarding safety;
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
  • standardize definitions of key elements of the schedule, and relevant health outcomes;
  • establish research priorities on the basis of epidemiological evidence, biological plausibility, and feasibility; and
  • continue to fund and support the Vaccine Safety Datalink project to study the safety of the recommended immunization schedule.
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×

This page is blank

Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R1
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R2
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R3
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R4
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R5
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R6
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R7
Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R8
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R9
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R10
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R11
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R12
Page xiii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R13
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R14
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R15
Suggested Citation:"Front Matter." Institute of Medicine. 2013. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press. doi: 10.17226/13563.
×
Page R16
Next: Summary »
The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies Get This Book
×
Buy Paperback | $47.00 Buy Ebook | $37.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

Vaccines are among the most safe and effective public health interventions to prevent serious disease and death. Because of the success of vaccines, most Americans today have no firsthand experience with such devastating illnesses as polio or diphtheria. Health care providers who vaccinate young children follow a schedule prepared by the U.S. Advisory Committee on Immunization Practices. Under the current schedule, children younger than six may receive as many as 24 immunizations by their second birthday. New vaccines undergo rigorous testing prior to receiving FDA approval; however, like all medicines and medical interventions, vaccines carry some risk.

Driven largely by concerns about potential side effects, there has been a shift in some parents' attitudes toward the child immunization schedule. The Childhood Immunization Schedule and Safety identifies research approaches, methodologies, and study designs that could address questions about the safety of the current schedule.

This report is the most comprehensive examination of the immunization schedule to date. The IOM authoring committee uncovered no evidence of major safety concerns associated with adherence to the childhood immunization schedule. Should signals arise that there may be need for investigation, however, the report offers a framework for conducting safety research using existing or new data collection systems.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!