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
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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.
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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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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
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.
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
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.
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
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.
Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule
2 DETERMINATION OF THE IMMUNIZATION SCHEDULE
Immunization at the Population Level
Vaccine Development and Approval Specifics
Past and Present Immunization Schedules
3 EXISTING DATA SOURCES AND SYSTEMS
Immunization Safety Surveillance
Databases Examining Adverse Events After Immunization for Vaccine-Preventable Diseases
Immunization Data Systems in Other Countries
4 STAKEHOLDER CONCERNS RELATED TO THE SAFETY OF THE IMMUNIZATION SCHEDULE
Identification of Stakeholders
Parental Concerns in the Scientific Literature
Public Concerns Presented to the Committee
5 REVIEW OF SCIENTIFIC FINDINGS
6 METHODOLOGICAL APPROACHES TO STUDYING HEALTH OUTCOMES ASSOCIATED WITH THE CURRENT IMMUNIZATION SCHEDULE: OPTIONS, FEASIBILITY, ETHICAL ISSUES, AND PRIORITIES
Considerations to Determine Need for Initiation of New Studies
Potential Research Questions of Interest
General Research Approaches to Address Primary Research Questions of Interest
Methods to Monitor Community Immunity and Measure Population-Level Impacts of Studies of the Immunization Schedule
7 CONCLUSIONS AND RECOMMENDATIONS
Committee Response to Its Statement of Task
A 2012 Advisory Committee on Immunization Practices’ Recommended Immunization Schedule for Children
D Study Designs for the Safety Evaluation of Different Childhood Immunization Schedules, Martin Kulldorff
E Agendas of Public Meetings Held by the Committee
F Biographical Sketches of Committee Members
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;
- 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.