Options for Poliomyelitis Vaccination in the United States

Workshop Summary

Vaccine Safety Forum

Division of Health Promotion and Disease Prevention

INSTITUTE OF MEDICINE

Cynthia J. Howe and Richard B. Johnston, Editors

NATIONAL ACADEMY PRESS
Washington, D.C.
1996



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Options for Poliomyelitis Vaccination in the United States: Workshop Summary Options for Poliomyelitis Vaccination in the United States Workshop Summary Vaccine Safety Forum Division of Health Promotion and Disease Prevention INSTITUTE OF MEDICINE Cynthia J. Howe and Richard B. Johnston, Editors NATIONAL ACADEMY PRESS Washington, D.C. 1996

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Options for Poliomyelitis Vaccination in the United States: Workshop Summary National Academy Press 2101 Constitution Avenue, N.W. Washington, DC 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). Printing of the document was made possible by a contribution from Merck Research Laboratories. This Summary is available in limited quantities from the Institute of Medicine, FO-3030, 2101 Constitution Avenue, N.W., Washington, DC 20418. For more information about the Institute of Medicine, visit the IOM home page at http://www.nas.edu. Copyright 1996 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Options for Poliomyelitis Vaccination in the United States: Workshop Summary 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 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, American Cyanamid Company, Lederle-Praxis Biologicals Division, 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 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

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Options for Poliomyelitis Vaccination in the United States: Workshop Summary 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 Thomas P. Stagnaro, President and CEO, Univax Biologics, Inc., Rockville, Maryland 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, Associate Director, Division of Health Promotion and Disease Prevention Michael A. Stoto, Director, Division of Health Promotion and Disease Prevention Dorothy Majewski, Project Assistant Donna Thompson, Administrative Assistant

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Options for Poliomyelitis Vaccination in the United States: Workshop Summary Preface The workshop described in this summary represents the first major activity of the Institute of Medicine's (IOM) Vaccine Safety Forum. The forum was established early 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. Membership in the forum includes 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 academicians with expertise in vaccine-related issues. The Vaccine Safety Forum is a follow-up to and continuation of discussions begun during vaccine safety-related activities undertaken by IOM 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 purpose of a forum is to foster dialogue and discussion across sectors and institutions. Forum activities at the IOM 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 the IOM, forums cannot provide advice or

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Options for Poliomyelitis Vaccination in the United States: Workshop Summary 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 participants.