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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 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.
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VACCINE SAFETY FORUM
Richard B. Johnston, Jr.* (Chair), Adjunct Professor of Pediatrics,
Yale University School of Medicine, and
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,
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
John H. Menkes, Professor Emeritus, Neurology,
University of California, Los Angeles, California
Regina Rabinovich, Chief,
Clinical Studies Section, and
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
Anne Bostrom, Assistant Professor,
School of Public Policy, Georgia Institute of Technology, Atlanta, Georgia
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
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 5 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). The second and third workshops dealt with detecting and responding to adverse events following vaccination and research to identify risks for adverse events following vaccination, respectively. A summary of these two workshops is in press.
On May 13, 1996, the forum convened a workshop on risk communication and vaccination. Workshop speakers and participants discussed key concepts in risk communication, unique aspects of communicating risks about vaccines, and
current practices in vaccine risk communication. The focus was on the risk of adverse effects of vaccines, but the risks of the disease the vaccines protect against, and of vaccine failure, were also discussed. This document represents a summary of that workshop.
The workshop began with an overview of risk communication in general and communicating risks about vaccines more specifically. The overview was followed by presentations about issues of ethics, medical decisionmaking, and informed consent. Next a panel of "stakeholders," people with a professional or personal interest in communicating information about vaccine risk, spoke about their roles, expectations, and perceptions of the risk communication process. Members of this panel represented consumers, government, health care providers, vaccine manufacturers, media, and legal profession. The afternoon session began with individuals from government, industry, and consumer groups speaking about and giving examples of their current vaccine risk communication activities. A panel discussion among risk communication researchers followed. These individuals were intentionally chosen as having expertise in risk communication without necessarily having deep knowledge of the issues related to vaccines and vaccination. Their purpose was to react to what had been discussed previously in the workshop and to help participants fit vaccine risk communication into the context of risk communication theory and practice in general. The final panel of the day brought back the stakeholders from the morning session for a discussion of potential improvements in the way that vaccine risk communication is carried out. Open discussion among all participants was encouraged after each of the afternoon panels. An agenda and list of participants can be found at the end of the workshop summary.
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 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.