Research Strategies for Assessing Adverse Events Associated with Vaccines:

A Workshop Summary

Committee to Study New Research on Vaccines

Kathleen R. Stratton, Cynthia J. Howe, and Richard B. Johnston, Jr., Editors

Division of Health Promotion and Disease Prevention

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C. 1994



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Research Strategies for Assessing Adverse Events Associated withVaccines:: A Workshop Summary Research Strategies for Assessing Adverse Events Associated with Vaccines: A Workshop Summary Committee to Study New Research on Vaccines Kathleen R. Stratton, Cynthia J. Howe, and Richard B. Johnston, Jr., Editors Division of Health Promotion and Disease Prevention INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1994

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Research Strategies for Assessing Adverse Events Associated withVaccines:: A Workshop Summary National Academy Press 2101 Constitution Avenue, N.W.,Washington, D.C. 20418 NOTICE: The project that is the subject of this report was approvedby the Governing Board of the National Research Council, whose membersare 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 chosenfor their special competences and with regard for appropriate balance. This report has been reviewed by a group other than the authors accordingto procedures approved by a Report Review Committee consisting ofmembers of the National Academy of Sciences, the National Academyof Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academyof Sciences to enlist distinguished members of the appropriate professionsin the examination of policy matters pertaining to the health ofthe public. In this the Institute acts under the Academy's 1863 congressionalcharter responsibility to be an adviser to the federal governmentand, upon its own initiative, to identify issues of medical care,research, and education. Dr. Kenneth I. Shine is president of theInstitute of Medicine. The project was supported by funds coordinated through the NationalInstitute of Allergy and Infectious Diseases of the National Institutesof Health (contract no. NO1-AI-15130). Additional copies of this report are available in limited quantitiesfrom: Division of Health Promotion and Disease Prevention Institute of Medicine 2101 Constitution Avenue, N.W. Washington, DC 20418 Copyright 1994 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Research Strategies for Assessing Adverse Events Associated with Vaccines:: A Workshop Summary COMMITTEE TO STUDY NEW RESEARCH ON VACCINES RICHARD B. JOHNSTON, JR. (Chair), Medical Director, The March of Dimes Birth Defects Foundation, White Plains, New York; Adjunct Professor of Pediatrics, Yale University School of Medicine, New Haven, Connecticut E. RUSSELL ALEXANDER, Professor of Epidemiology, School of Public Health and Community Medicine, University of Washington; Chief of Epidemiology, Seattle-King County Health Department, Seattle, Washington RICHARD T. JOHNSON, * Professor and Director, Department of Neurology, The Johns Hopkins University School of Medicine, Baltimore, Maryland MICHAEL S. KRAMER, Professor, Departments of Pediatrics and of Epidemiology and Biostatistics, McGill University Faculty of Medicine, Montreal, Quebec, Canada BENNETT A. SHAYWITZ, Professor of Pediatrics, Neurology, and Child Study Center, Yale University School of Medicine, New Haven, Connecticut PAUL D. STOLLEY, * Professor and Chairman, Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland Project Staff Kathleen R. Stratton, Project Director Cynthia J. Howe, Program Officer Dorothy R. Majewski, Project Assistant Michael A. Stoto, Director, Division of Health Promotion and Disease Prevention Michael K. Hayes, Contract Editor * Member, Institute of Medicine

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Research Strategies for Assessing Adverse Events Associated withVaccines:: A Workshop Summary This page in the original is blank.