Workshop on Research Strategies for Assessing Adverse Events Associatedwith Vaccines

Institute of Medicine

National Academy of Sciences

Washington, D.C.

December 7, 1993

WORKSHOP PARTICIPANTS

Committee Members

Richard B. Johnston, Jr. (Chair), Medical Director, March of DimesBirth Defects Foundation, and Adjunct Professor of Pediatrics, YaleUniversity School of Medicine

E. Russell Alexander, Chief of Epidemiology, Seattle-King CountyHealth Department

Richard T. Johnson, Professor of Microbiology and Neuroscience, Chairmanof the Department of Neurology, Johns Hopkins University School ofMedicine

Michael S. Kramer, Professor, Departments of Pediatrics and of Epidemiologyand Biostatistics, McGill University Faculty of Medicine

Institute of Medicine Staff

Kathleen Stratton, Study Director

Cynthia Howe, Program Officer

Michael Stoto, Director, Division of Health Promotion and DiseasePrevention

Christopher Howson, Deputy Director, Division of International Health

Dorothy Majewski, Project Assistant

Invited Guests

Bascom Anthony, Director, Division of Bacterial Products, Centerfor Biologics Evaluation and Research, U.S. Food and Drug Administration



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 22
Research Strategies for Assessing Adverse Events Associated withVaccines:: A Workshop Summary Workshop on Research Strategies for Assessing Adverse Events Associatedwith Vaccines Institute of Medicine National Academy of Sciences Washington, D.C. December 7, 1993 WORKSHOP PARTICIPANTS Committee Members Richard B. Johnston, Jr. (Chair), Medical Director, March of DimesBirth Defects Foundation, and Adjunct Professor of Pediatrics, YaleUniversity School of Medicine E. Russell Alexander, Chief of Epidemiology, Seattle-King CountyHealth Department Richard T. Johnson, Professor of Microbiology and Neuroscience, Chairmanof the Department of Neurology, Johns Hopkins University School ofMedicine Michael S. Kramer, Professor, Departments of Pediatrics and of Epidemiologyand Biostatistics, McGill University Faculty of Medicine Institute of Medicine Staff Kathleen Stratton, Study Director Cynthia Howe, Program Officer Michael Stoto, Director, Division of Health Promotion and DiseasePrevention Christopher Howson, Deputy Director, Division of International Health Dorothy Majewski, Project Assistant Invited Guests Bascom Anthony, Director, Division of Bacterial Products, Centerfor Biologics Evaluation and Research, U.S. Food and Drug Administration

OCR for page 22
Research Strategies for Assessing Adverse Events Associated withVaccines:: A Workshop Summary Robert Chen, Chief of Vaccine Safety, National Immunization Program,Centers for Disease Control and Prevention Mary Lou Clements, Professor and Director, Center for ImmunizationResearch, Johns Hopkins University Elias Durry, Medical Epidemiologist, National Immunization Program,Centers for Disease Control and Prevention Kathryn Edwards, Professor, Department of Pediatrics, VanderbiltUniversity Susan Ellenberg, Director, Biostatistics and Epidemiology, Centerfor Biologics Evaluation and Research, U.S. Food and Drug Administration Gerald Fenichel, Professor of Neurology and Pediatrics, Chairmanof the Department of Neurology, Vanderbilt University Reinhard Fescharek, Drug Surveillance, Behringwerke AG James Froeschle, Director of Clinical Research, Connaught Laboratories,Inc. John Glasser, Epidemiologist, Vaccine Safety Activity, National ImmunizationProgram, Centers for Disease Control and Prevention Karen Goldenthal, Acting Director, Division of Vaccines and RelatedProducts Applications, Center for Biologics Evaluation and Research,U.S. Food and Drug Administration Steven Gordon, Ogden BioServices Corporation Marie Griffin, Associate Professor, Department of Preventive Medicine,Vanderbilt University Medical Center Penina Haber, Public Health Analyst, National Immunization Program,Centers for Disease Control and Prevention Jill Hackell, Director, Clinical Research and Medical Affairs, BiologicalsClinical Research, Lederle Laboratories Neal Halsey, Professor, Department of International Health, JohnsHopkins University School of Hygiene and Public Health Carolyn Hardegree, Director, Vaccines Research and Review, Centerfor Biologics Evaluation and Research, U.S. Food and Drug Administration William Jordan, Science Advisor, National Vaccine Program Office Richard Kapit, Medical Officer, Biostatistics and Epidemiology, Centerfor Biologics Evaluation and Research, U.S. Food and Drug Administration David Karzon, Professor of Pediatrics and Microbiology and Immunology,Vanderbilt University Roland Levandowski, Acting Director, Division of Viral Products,Center for Biologics Evaluation and Research, Food and Drug Administration Elizabeth Loupi, Drug Safety Monitor, Pharmacovigilance Department,Pasteur Mérieux Connaught Company Marie Mann, Medical Officer, National Vaccine Injury CompensationProgram Edgar Marcuse, Director, Ambulatory Care Services, Children's Hospital and Medical Center, Seattle Sandy Mintz, Director, Parents Concerned about the Safety of Vaccines J. Anthony Morris, Chairman, The Bell of Atri, Inc.

OCR for page 22
Research Strategies for Assessing Adverse Events Associated withVaccines:: A Workshop Summary David Nalin, Director, Clinical Research, Merck Research Laboratories Regina Rabinovich, Assistant Director and National Vaccine ProgramLiaison, National Institute of Allergy and Infectious Diseases Suresh Rastogi, Deputy Director, Biostatistics and Epidemiology,U.S. Food and Drug Administration Steve Rosenthal, EIS Officer, National Immunization Program, Centersfor Disease Control and Prevention David Salisbury, Principal Medical Officer for Childhood Immunization,Department of Health, London Kristine Severyn, Director, Ohio Parents for Vaccine Safety Dirk Teuwen, Director, Medical Affairs, SmithKline Beecham Biologicals Joel Ward, Director, Center for Vaccine Research, University of California,Los Angeles Robert Weibel, Medical Officer, National Vaccine Injury CompensationProgram Robert Wise, Epidemiologist, Biostatistics and Epidemiology, Centerfor Biologics Evaluation and Research, U.S. Food and Drug Administration