INSTITUTE OF MEDICINE

National Academy of Sciences
VACCINE SAFETY RESEARCH AND REPORTS  

During the past two decades, the Institute of Medicine (IOM), National Academy of Sciences, has assembled committees to examine vaccine research, policy and safety issues.  The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to “enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public.” The IOM acts under the Academy’s 1863 congressional charter responsibility to be an adviser to the federal government and also initiate the identification of issues of medical care, research and education.

Congress Asks IOM To Look At Vaccine Safety: The National Vaccine Information Center, (NVIC) founded by parents of vaccine injured children in 1982, supported a provision in the 1986 National Childhood Vaccine Injury Act in which Congress asked the IOM to assemble independent physician committees to review the medical literature for scientific evidence for a causal relationship between childhood vaccines and immune and neurological dysfunction. NVIC assisted the IOM committees in the early 1990’s by providing information about vaccine reactions. Four landmark reports were published by IOM in 1991 and 1994, including Adverse Effects of Pertussis and Rubella Vaccines; Adverse Events Associated with Childhood Vaccines; DPT Vaccine and Chronic Nervous System Dysfunction:  A New Analysis; and Research Strategies for Assessing Adverse Events Associated with Vaccines.

These IOM vaccine study committees and their reports were supported by funds coordinated through the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

IOM Creates Vaccine Safety Forum: In 1995, the IOM established a Vaccine Safety Forum to examine critical issues relevant to the safety of vaccines used in the U.S. and to discuss methods for improving the safety of vaccines and vaccination programs. NVIC co-founder and president, Barbara Loe Fisher, was appointed to the forum, which included individuals representing parent groups, vaccine manufacturers, physicians, academic researchers and representatives from federal agencies. The IOM Vaccine Safety Forum held five public workshops on vaccine safety and published three reports: Options for Poliomyelitis Vaccination in the United States; Summaries of Two Workshops (“Detecting and Responding to Adverse Events Following Vaccination” and “Research to Identify Risks for Adverse Events Following Vaccination: Biological Mechanisms and Possible Means of Prevention”); and Risk Communication and Vaccination.

The IOM Vaccine Safety Forum was supported by funds coordinated through the National Vaccine Program Office of the Public Health Service and by contributions from Connaught Laboratories and from Merck Research Laboratories.

To Obtain Copies of past IOM Reports on Vaccine Safety Issues: To order copies of any of the IOM reports, call 1-800-624-6242 or visit the on-line bookstore at http://www.iom.edu/IOM/IOMHome.nsf/Pages/iom+vaccine+studies

New IOM Immunization Safety Review Committee Appointed: In 2000, the Centers for Disease Control (CDC) and the National Institutes of Health (NIH) asked the Institute of Medicine (IOM), National Academy of Sciences, to assemble a physician committee to review hypotheses about existing and emerging vaccine safety concerns. The committee will assess evidence of causality; the biologic plausibility of the adverse event hypothesis; the likelihood of competing hypotheses; and the societal perspective, including level of public concern. Based on the assessment of these factors, the committee will recommend appropriate action for the federal government to take to address identified vaccine safety issues. http://www.iom.edu/IOM/IOMHome.nsf/Pages/immunization+safety+review

The IOM Immunization Safety Review Committee is chaired by Marie McCormick, M.D., Sc.D., Professor and Chair of the Department of Maternal and Child Health, Harvard School of Public Health. Other committee members include: Ronald Bayer, Ph.D., Professor, Division of Sociomedical Sciences, School of Public Health, Columbia University; Alfred Berg, M.D., M.P.H., Professor and Chair, Department of Family Medicine, University of Washington School of Medicine; Rosemary Casey, M.D., Associate Professor of Pediatrics, Jefferson Medical College; Joshua Cohen, Ph.D., Senior Research Associate, Harvard Center for Risk Analysis; Vernice Davis-Anthony, M.P.H., R.N., Senior Vice President of Corporate Affairs and Community Health, St. John Health System in Detroit; Betsy Foxman, Ph.D., Professor of Epidemiology, School of Public Health, University of Michigan; Constantine Gatsonis, Ph.D., Professor of Medical Science and Applied Math and Director, Center for Statistical Sciences, Brown University; Steven Goodman, M.D., M.H.S., Ph.D., Associate Professor of Oncology, Pediatrics, Epidemiology and Biostatistics, John Hopkins Schools of Medicine and Public Health; Ellen (abby) Horak, R.N., M.S N., Chief of Local Health Services, Office of Local and Rural Health, Kansas Department of Health and Environment; Michael Kaback, M.D., Professor of Pediatrics and Reproductive Medicine, University of California – San Diego; Gerald Medoff, M.D., Professor of Medicine and Microbiology and Immunology, Washington University School of Medicine; Rebecca Parkin, Ph.D., M.P.H., Associate Research Professor, Department of Occupational and Environmental Health, School of Public Health and Health Services, George Washington University Medical Center; Bennett Shaywitz. M.D., Professor of Pediatrics and Neurology and Co-Director, Yale Center for the Study of Learning and Attention, Yale University School of Medicine; and Christopher Wilson, M.D., Professor and Chair, Department of Immunology, University of Washington.

First Meeting of New IOM Committee: The first meeting of the IOM Immunization Safety Review Committee was held January 11-12, 2001 at the National Academy of Sciences, Washington, D.C. On January 11, an open public meeting was held to gather information to help the committee conduct its deliberations. Subjects discussed were perspectives on vaccine safety from federal agency, congressional, physician and consumer perspectives; current vaccine safety data sources; causality assessments of past IOM vaccine safety studies; methodological considerations in evaluating the evidence; decision making under uncertainty; risk assessment and management under uncertainty; decision analysis and applications to immunization policy; risk perception and risk communication; research in public perceptions of vaccine safety; and framework for considering issues and recommendations.

Presenters included Martin Meyers, M.D., Director, National Vaccine Program Office, Department of Health and Human Services (DHHS); Walter Orenstein, M.D., Director, National Immunization Program; CDC; Carole Heilman, Ph.D., Director, Division of Microbiology and Infectious Diseases, National Institute for Allergies and Infectious Diseases (NIAID); the Honorable Henry Waxman (D-CA); the Honorable Dave Weldon, M.D. (R-FL); S. Elizabeth Clay, U.S. House Committee on Government Reform; Louis Cooper, M.D., Vice President, American Academy of Pediatrics; Barbara Loe Fisher, president and co-founder, National Vaccine Information Center; Robert Chen, M.D., Chief, Vaccine Safety and Development Activity, National Immunization Program; CDC; Richard B. Johnson, Professor of Pediatrics, University of Colorado; David Tollerud, M.D., M.P.H., Professor, Public Health, Medicine and Community and Preventive Medicine, MCP Hahnemann University; Robert Lawrence, M.D., Professor of Health Policy, Johns Hopkins University School of Hygiene and Public Health; Michael Stoto, Ph.D., Professor and Chair, Epidemiology and Biostatistics, George Washington University; Richard Rheingans, Ph.D., Research Assistant Professor, Rollins School of Public Health, Emory University; Baruch Fischhoff, Ph.D., Professor of Social and Decision Sciences and Engineering and Public Policy, Carnegie Mellon University; Beth Hibbs, R.N., M.P.H., Vaccine Safety and Development Activity, National Immunization Program, CDC; Amy Fine, M.P.H., BSN, Health Policy and Program Consultant, Washington, D.C.

It is expected that a transcript of the January 11 meeting eventually will be posted on the IOM website.

MMR Vaccine and Autism: First Topic for IOM Committee -  The first vaccine safety issue the new IOM Immunization Safety Review Committee will examine is the hypothesis that there is a causal relationship between MMR or measles vaccine and autism. The Committee will meet March 8-10, 2001 in Washington, D.C. with an open public meeting on March 8. Andrew Wakefield, M.D., has been invited to make a presentation, along with other physicians and health officials. http://www.iom.edu/IOM/IOMHome.nsf/Pages/immunization+safety+review

NVIC To Provide Information to Institute Of Medicine Committee:  Since 1982, NVIC has operated a Vaccine Reaction Registry and has received thousands of reports of vaccine-related neuroimmune dysfunction, including MMR vaccine-related autism. NVIC has been asked to facilitate the providing of vaccine reaction information concerning MMR or measles vaccine-associated autism for consideration by the new IOM Committee.

NVIC Collecting More MMR Vaccine Reaction Reports - As NVIC prepares to collate past and present case history information of vaccine-associated autism in the US and provide non-identifying information to IOM, every case report documenting vaccine-associated brain and immune system dysfunction is critically important and should be included in NVIC’s National Vaccine Reaction Registry.

IF YOUR CHILD EXPERIENCED REGRESSION FOLLOWING VACCINATION AND MMR OR MEASLES VACCINE WAS RELATED TO YOUR CHILD’S DEVELOPMENT OF AUTISM, PLEASE CLICK HERE https://www.nvic.org/reaction.htm AND IMMEDIATELY MAKE A REPORT.  No personally identifying information will be provided to IOM or anyone else without your permission. This has always been NVIC’s policy regarding information on vaccine-related adverse events reported to NVIC.

In describing what happened to your child following vaccination, please be sure to include:

(1)   if your child experienced previous reactions to other vaccines and/or deterioration in health BEFORE the MMR or measles vaccination associated with the development of autism;

(2)   if your child was sick with an infection of any kind at the time of vaccination;

(3)   if there is a personal or family history of autoimmunity or neurological disorders such as thyroid disease, rheumatoid arthritis, diabetes, colitis, multiple sclerosis, epilepsy, etc.

NVIC’s Vaccine Reaction Registry database on vaccine reactions has served for two decades as an independent vaccine adverse event reporting mechanism along with the government’s Vaccine Adverse Events Reporting System (VAERS). The database is generating information which will contribute to a better understanding of the relationship between vaccination and neuroimmune dysfunction, including autism.