Vaccine Safety Forum

Summaries of Two Workshops

Vaccine Safety Forum

Board on Health Promotion and Disease Prevention

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.
1997



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Vaccine Safety Forum: Summaries of Two Workshops Vaccine Safety Forum Summaries of Two Workshops Vaccine Safety Forum Board on Health Promotion and Disease Prevention INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1997

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Vaccine Safety Forum: Summaries of Two Workshops NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, D.C. 20418 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 forum responsible for the report were chosen for their special competences and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. 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. In this, the Institute acts under the Academy’s 1863 congressional charter responsibility to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The project was supported by funds coordinated through the National Vaccine Program Office of the Public Health Service (Contract No. 282-94-0031) and by contributions from Connaught Laboratories, Inc., and from Merck Research Laboratories. International Standard Book No. 0-309-05791-4 This summary is available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, D.C. 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP’s on-line bookstore at http://www.nap.edu. For more information about the Division of Health Promotion and Disease Prevention, visit our homepage at http://www2.nas.edu/iom/hpdp. Copyright 1997 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 religious 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 Staatlichemuseen in Berlin.

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Vaccine Safety Forum: Summaries of Two Workshops VACCINE SAFETY FORUM Richard B. Johnston, Jr.* (Chair), Adjunct Professor of Pediatrics, Yale University School of Medicine, and Medical Director, March of Dimes Birth Defects Foundation, White Plains, New York E. Russell Alexander, Chief of Epidemiology, Seattle-King County Health Department, Seattle, Washington Robert F. Breiman, Director, National Vaccine Program Office, Centers for Disease Control and Prevention, Atlanta, Georgia Robert T. Chen, Chief, Vaccine Safety and Development Activity, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia Linda D. Cowan, Professor, Department of Biostatistics and Epidemiology, College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma Jerome Donlon, Director, Office of Establishment Licensing and Product Surveillance, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland Geoffrey Evans, Chief Medical Officer, Division of Vaccine Injury Compensation, Health Resources and Services Administration, Rockville, Maryland Gerald M. Fenichel, Professor of Neurology and Pediatrics, and Chair, Department of Neurology, Vanderbilt University School of Medicine, Nashville, Tennessee Amy Fine, Maternal and Child Health Policy Analyst, Washington, D.C. Barbara Loe Fisher, President, National Vaccine Information Center, Vienna, Virginia Marjorie A. Grant,** Determined Parents to Stop Hurting Our Tots, Beaver Dam, Wisconsin Jill G. Hackell, Senior Director, Clinical Research and Medical Affairs, Wyeth-Lederle Vaccines and Pediatrics, Wyeth-Lederle Laboratories, Pearl River, New York M. Carolyn Hardegree, Director, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland Michael S. Kramer, Professor, Departments of Pediatrics and of Epidemiology and Biostatistics, McGill University, Montreal, Quebec, Canada *    Institute of Medicine member. **   Marjorie Grant has not agreed to the publication of the summary entitled Detecting and Responding to Adverse Events Following Vaccination as written.

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Vaccine Safety Forum: Summaries of Two Workshops John H. Menkes, Professor Emeritus, Neurology, University of California, Los Angeles, California Regina Rabinovich, Chief, Clinical Studies Section, and Assistant Director, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland Marion E. Ray, Attorney, Hunt, Lees, Farrel & Kessler, Charleston, West Virginia Robert G. Sharrar, Director, Report Evaluation and Safety Surveillance, Merck Research Laboratories, West Point, Pennsylvania Howard R. Six, Vice President, Research and Development, Connaught Laboratories, Inc., Swiftwater, Pennsylvania Paul D. Stolley,* Professor and Chairman, Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland Staff Cynthia J. Howe, Project Director Kathleen R. Stratton, Interim Director, Division of Health Promotion and Disease Prevention Michael A. Stoto, Senior Staff Officer Dorothy Majewski, Senior Project Assistant Jennifer K. Holliday, Senior Project Assistant Donna Thompson, Administrative Assistant Margie Patlak, Science Writer

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Vaccine Safety Forum: Summaries of Two Workshops Preface The Institute of Medicine's (IOM's) Vaccine Safety Forum was established in 1995 to examine critical issues relevant to the safety of vaccines used in the United States and to discuss methods for improving the safety of vaccines and vaccination programs. Government agencies, vaccine manufacturers, health professionals, and vaccine consumers share a responsibility for vaccine safety. Members of the forum thus include individuals representing parent or consumer groups with an interest in immunization, individuals representing vaccine manufacturers, physicians, representatives from federal agencies responsible for regulating vaccines and implementing vaccine policies, and academic researchers with expertise in vaccine-related issues. The Vaccine Safety Forum's activities are a continuation of discussions undertaken by other IOM committees over the past 7 years. Previous IOM work on the subject resulted in the volumes Adverse Effects of Pertussis and Rubella Vaccines (1991), Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality (1994a), DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis (1994b), and Research Strategies for Assessing Adverse Events Associated with Vaccines: A Workshop Summary (1994c). The first workshop of the Vaccine Safety Forum resulted in the publication Options for Poliomyelitis Vaccination in the United States: Workshop Summary (1996). On November 6, 1995, the Vaccine Safety Forum convened a workshop on detecting and responding to adverse events following vaccination. Workshop speakers and participants discussed the difficulties in detecting adverse events, current adverse events detection and response methods and procedures, suggestions for improving the means of detecting and responding to adverse events following vaccination, and future areas of research. On April 1, 1996, the

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Vaccine Safety Forum: Summaries of Two Workshops Vaccine Safety Forum convened a workshop entitled Research to Identify Risks for Adverse Events Following Vaccination: Mechanisms and Possible Means of Prevention. The workshop discussed the various immunologic and genetic factors that might influence individuals' responses to vaccines, current research aimed at assessing what populations are at increased risk for experiencing adverse events from vaccines, and some research avenues that could be pursued in this regard. A number of known and hypothetical vaccine adverse effects were discussed at the workshop; their mention in this document does not imply that Forum members of the IOM regard them as scientifically established risks. This document represents a summary of both workshop. The purpose of a forum at IOM is to foster dialogue and discussion across sectors and institutions. Forum activities offer a mechanism for convening individuals from a variety of government, academic, industry, and citizen groups in connection with a particular theme. Such activities provide a structured opportunity for regular and open communication among representatives of these groups. The objective, however, is to illuminate issues, not to resolve them. Unlike study committees of IOM, forums cannot provide advice or recommendations to any government agency or other organization. Similarly, workshop summaries or other products resulting from forum activities are precluded from reaching conclusions or recommendations but, instead, are intended to reflect the variety of opinions expressed by the participants. The discussion is intended to be speculative and thought-provoking, not definitive. The comments in this report represent the views of the workshop participants, as indicated in footnotes for each section and generically in the text. The identification of a speaker as a "vaccine manufacturer's representative" or a "CDC representative" is not intended to suggest that any particular organization holds the same views.

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Vaccine Safety Forum: Summaries of Two Workshops Contents Detecting and Responding to Adverse Events Following Vaccination         EXECUTIVE SUMMARY   1     INTRODUCTION   2     DIFFICULTIES IN DETECTING ADVERSE EVENTS FOLLOWING VACCINATION   3     CURRENT ADVERSE EVENT DETECTION AND RESPONSE PROCEDURES   5     Vaccine Adverse Event Reporting System   5     Large Linked Databases   6     Surveillance by Vaccine Manufacturers   7     Food and Drug Administration   8     IMPROVING DETECTION OF AND RESPONSE TO ADVERSE EVENTS   9     Increasing Reporting to VAERS   9     Improving the Quality of Information in VAERS   11     Improving Vaccine Lot Information   13     Improving the Usefulness of LLDB Data   15

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Vaccine Safety Forum: Summaries of Two Workshops     Clinical Trials   15     Comparison Studies   17     ADDITIONAL AREAS FOR RESEARCH   18     REFERENCES   21     WORKSHOP AGENDA   23 Research to Identify Risks for Adverse Events Following Vaccination: Biological Mechanisms and Possible Means of Prevention         EXECUTIVE SUMMARY   29     INTRODUCTION   30     IMMUNE RESPONSE TO VACCINE ANTIGENS   31     Premature Infants   33     GENETIC FACTORS AFFECTING DEVELOPMENT OF AUTOIMMUNITY   35     RESEARCH ON IDENTIFYING POPULATIONS AT RISK FOR ADVERSE EVENTS   37     Arthritis and Rubella Vaccine   37     Anaphylaxis and Measles, Mumps and Rubella Vaccine   38     Convulsions and DPT   39     High-Titer Measles Vaccine   40     Multiple Sclerosis or Guillain-Barré Syndrome and Vaccines   42     Multiple-Antigen Vaccination and Adverse Immune Responses   43     RESEARCH OPPORTUNITIES   44     REFERENCES   51     WORKSHOP AGENDA   57