Workshop Agenda

INSTITUTE OF MEDICINE VACCINE SAFETY FORUM

Workshop on Research to Identify Risks for Adverse Events Following Vaccination: Mechanisms and Possible Means of Prevention

April 1, 1996

Washington, D.C.

8:25 a.m.

Introduction

Russell Alexander, Seattle-King County Health Department; Workshop Chair

8:30

Challenges for Vaccine Safety Research: Creating a Comprehensive System

James Hanson, NICHD

8:45

Immune Response to Vaccine Antigens

Ira Berkower, FDA

9:15

Anaphylaxis

Lynelle Phillips, CDC

9:35

Personal and Family History of Convulsions

Robert Chen, CDC

9:55

Using LLDBs to Identify Children at Risk

Robert Davis, University of Washington

10:15

Adverse Effects of Immunization of the Premature Infant

Genevieve Losonsky, University of Maryland

10:35

BREAK



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Vaccine Safety Forum: Summaries of Two Workshops Workshop Agenda INSTITUTE OF MEDICINE VACCINE SAFETY FORUM Workshop on Research to Identify Risks for Adverse Events Following Vaccination: Mechanisms and Possible Means of Prevention April 1, 1996 Washington, D.C. 8:25 a.m. Introduction Russell Alexander, Seattle-King County Health Department; Workshop Chair 8:30 Challenges for Vaccine Safety Research: Creating a Comprehensive System James Hanson, NICHD 8:45 Immune Response to Vaccine Antigens Ira Berkower, FDA 9:15 Anaphylaxis Lynelle Phillips, CDC 9:35 Personal and Family History of Convulsions Robert Chen, CDC 9:55 Using LLDBs to Identify Children at Risk Robert Davis, University of Washington 10:15 Adverse Effects of Immunization of the Premature Infant Genevieve Losonsky, University of Maryland 10:35 BREAK

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Vaccine Safety Forum: Summaries of Two Workshops 10:50 High-Titer Measles Vaccines: Gender, Mortality, and Immunologic Profile Elizabeth Holt, Johns Hopkins University Maria Elena Leon, Johns Hopkins University Brian Ward, McGill University 11:40 Discussion 12:15 p.m. LUNCH 1:15 Rubella and Arthritis Hira Nakhasi, FDA 1:35 Genetic Risk Factors for Environmentally Associated Autoimmune Diseases Frederick Miller, FDA 1:55 Jumping Genes, Genetics, and Molecular Memory Howard Urnovitz, Calypte Biomedical Corporation 2:15 Research Needs, Perspective from Parents Barbara Loe Fisher, National Vaccine Information Center 2:35 Methodologic Considerations in Studying People Receiving Multiple Antigens Philip Pittman, USAMRIID 3:05 BREAK 3:20 Autoimmune Demyelinating Diseases Henry McFarland, NINDS 3:40 Hepatitis B Vaccine and Autoimmune Demyelinating Diseases Burton Waisbren, Waisbren Clinic 4:00 Learning Disorders and Vaccines Marcel Kinsbourne 4:20 Discussion 5:00 ADJOURN

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Vaccine Safety Forum: Summaries of Two Workshops PARTICIPANTS E. Russell Alexander, Chief of Epidemiology, Seattle-King County Health Department, Seattle, Washington Norman Baylor, Associate Director for Regulatory Policy, Food and Drug Administration, Rockville, Maryland Judy Beeler, Medical Officer, Food and Drug Administration, Rockville, Maryland Ira Berkower, Chief, Laboratory of Immunoregulation, Food and Drug Administration, Rockville, Maryland Ann Bostrom, Assistant Professor, School of Public Policy, Georgia Institute of Technology, Atlanta, Georgia M. Miles Braun, Medical Officer, Food and Drug Administration, Rockville, Maryland Gregg Burgess, Vaccine Educator, Vaccine Information Center, Vienna, Virginia K. Lynn Cates, Associate Professor of Pediatrics, Case Western Reserve University, School of Medicine, Rainbow Babies and Childrens Hospital, Cleveland, Ohio Mary Ann Chaffee, Legislative Assistant, U.S. Senate, Washington, D.C. Karen Chaitkin, Technical Information Specialist, Food and Drug Administration, Rockville, Maryland Robert T. Chen, Chief, Vaccine Safety and Development Activity, Centers for Disease Control and Prevention, Atlanta, Georgia Linda D. Cowan, Professor, Department of Biostatistics and Epidemiology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma Dack Dalrymple, Senior Vice President, Bailey & Robinson David M. Davis, Technical Information Specialist, Food and Drug Administration, Rockville, Maryland Robert Davis, Assistant Professor, Department of Pediatrics and Department of Epidemiology, University of Washington, Seattle, Washington Jose Luis DiFabio, Pan American Health Organization, Washington, D.C. Jerome Donlon, Director, Office of Establishment Licensing and Product Surveillance, Food and Drug Administration/CBER, Rockville, Maryland Susan S. Ellenberg, Director, Division of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland Elaine C. Esber, Associate Director for Medical and International Affairs, Food and Drug Administration, Rockville, Maryland

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Vaccine Safety Forum: Summaries of Two Workshops Geoffrey Evans, Chief Medical Officer, Division of Vaccine Injury Compensation, Rockville, Maryland Gerald M. Fenichel, Professor of Neurology and Pediatrics, Chairman Department of Neurology, Vanderbilt University School of Medicine, Nashville, Tennessee Amy Fine, Senior Policy Analyst, Association of Maternal and Child Health Programs, Washington, D.C. Barbara Loe Fisher, President, National Vaccine Information Center, Vienna, Virginia Jill A. Foster, Children's Hospital of Philadelphia, Pennsylvania John Furesz, Former Director, Bureau of Biologics, Department of National Health, Health Canada, Ontario Joan Fusco, Director of Business Development, North American Vaccine, Inc., Beltsville, Maryland Maryann R. Gallagher, Consumer Safety Officer, Advertising and Promotional Labeling Staff, Food and Drug Administration, Rockville, Maryland Elizabeth Goss, Associate, Fox, Bennett & Turner, Washington, D.C. Marjorie A. Grant, Beaver Dam, Wisconsin Jill G. Hackell, Senior Director, Clinical Research and Medical Affairs, Lederle-Praxis Biologicals Division, Pearl River, New York James Hanson, Special Assistant to the Director, Center for Research for Mothers and Children, National Institute of Child Health and Human Development, Bethesda, Maryland M. Carolyn Hardegree, Director, Office of Vaccines Research and Review, Food and Drug Administration, Rockville, Maryland Elizabeth Holt, Assistant Professor, Department of International Health, School of Hygiene and Public Health, Johns Hopkins University, Baltimore, Maryland Akira Homma, Pan American Health Organization, Washington, D.C. Cynthia Howe, Project Director, Institute of Medicine, Washington, D.C. Richard B. Johnston, Medical Director, March of Dimes Birth Defects Foundation, White Plains, New York Marcel Kinsbourne, Research Professor, Center for Cognitive Studies, Tufts University, Winchester, Massachusetts Michael S. Kramer, Professor, Department of Pediatrics, and of Epidemiology and Biostatistics, McGill University, Montreal, Quebec, Canada Robert C. Kohberger, Wyeth-Lederle Vaccines, Pearl River, New York Carol Krueger, VAERS Project Officer, Food and Drug Administration, Rockville, Maryland Dale N. Lawrence, Chief, Medical Office for Vaccine Science, Division of AIDS, NIAID, Bethesda, Maryland

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Vaccine Safety Forum: Summaries of Two Workshops Maria Elena Leon, Research Associate, Department of International Health, School of Hygiene and Public Health, Johns Hopkins University, Baltimore, Maryland Genevieve Losonsky, Chief, Applied Immunology Laboratory, Center for Vaccine Development, University of Maryland, Baltimore, Maryland Henry McFarland, Chief, Neuroimmunology Branch, National Institute of Neurological Diseases and Stroke, Bethesda, Maryland Dorothy Majewski, Project Assistant, Institute of Medicine, Washington, D.C. Marie Mann, Vaccine Injury Compensation Program, Health Resources Services Administration, Rockville, Maryland Vincent Matanoski, Trial Attorney, Department of Justice, Washington, D.C. Martha Mattheis, Chief Clinical and Regulatory Affairs Branch, NIAID, Rockville, Maryland Paul M. Mendelman, Merck Research Laboratories, Mountain View, California John H. Menkes, Professor Emeritus, UCLA, Beverly Hills, California Frederick Miller, Medical Officer and Senior Investigator, Food and Drug Administration, Bethesda, Maryland J. Anthony Morris, Chairman, Governing Board, The Bell of Atri, Inc., College Park, Maryland Hira Nakhasi, Chief, Laboratory of Molecular Pharmacology, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland Manette Niu, Medical Officer, Food and Drug Administration, Rockville, Maryland M. Louis Offen, Physician/Attorney, Johns Hopkins Medical Center, Bethesda, Maryland Deborah Outlaw, Attorney Margie Patlak, Science Writer, Washington, D.C. Lynelle Phillips, Nurse Consultant, Vaccine Safety and Development Activity, Centers for Disee Control and Prevention, Atlanta, Georgia Philip Pittman, Chief, Special Immunizations Branch, USA Medical Research Institute of Infectious Diseases, Ft. Detrick, Maryland Robert Pless, Head, Vaccine-Associated Adverse Events Surveillance Section, Division of Immunization, Health Canada, Ontario Robert H. Parrott, Director Emeritus, Professor, Children's Hospital National Medical Center, Washington, D.C. Peter A. Patriarca, Associate Director, Division of Viral Products, Food and Drug Administration, Bethesda, Maryland Regina Rabinovich, Chief, Clinical Studies Section and Assistant Director, Division of Microbiology and Infectious Diseases, NIAID, National Institutes of Health, Rockville, Maryland

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Vaccine Safety Forum: Summaries of Two Workshops Suresh C. Rastogi, Deputy Director, Food and Drug Administration, Rockville, Maryland Marion E. Ray, Attorney, Hunt, Lees, Farrel and Kessler, Charleston, West Virginia Mary Jane Reynolds, Project Coordinator, Center for Immunization Research, Johns Hopkins University, Baltimore, Maryland Marcel E. Salive, Chief, Epidemiology Branch, Food and Drug Administration, Rockville, Maryland Barbara Savarese, Medical Officer, Division of AIDS, NIH, Bethesda, Maryland Helen Miller Scott, Microbiologist, USAMRIID, Fort Detrick, Maryland Robert G. Sharrar, Director, Report Evaluation and Safety Surveillance, Worldwide Product Safety and Epidemiology, Merck Research Laboratories, West Point, Pennsylvania Judith Shindman, Medical Director, Medical Affairs, Connaught Laboratories Ltd., Ontario Howard R. Six, Vice President, Research and Development, Connaught Laboratories Inc., Swiftwater, Pennsylvania William M. Stevens, Public Health Advisor, Food and Drug Administration, Rockville, Maryland Paul D. Stolley, Professor and Chairman, Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland Kathleen Stratton, Study Director, and Deputy Director, Division of Health Promotion and Disease Prevention, Institute of Medicine, Washington, D.C. David L. Terzian, Attorney, Torts Branch, Civil Division, U.S. Department of Justice, Washington, D.C., and Edmund C. Tramont, Professor and Director, University of Maryland Biotechnology Center, Baltimore, Maryland Dennis W. Trent, Director, Division of Viral Products, Food and Drug Administration, Rockville, Maryland Frederick Varricchio, Medical Officer, Food and Drug Administration, Rockville, Maryland Howard Urnovitz, Chief Scientific Officer, Calypte Biomedical Corporation, Berkeley, California Burton Waisbren, Internist, Waisbren Clinic, Milwaukee, Wisconsin Brian Ward, Assistant Professor, Faculty of Medicine, McGill University, Montreal, Quebec Robert E. Weibel, Senior Medical Officer, Vaccine Injury Compensation Program, Rockville, Maryland Dena Wichansky, Program Assistant, Immunization Education and Action Center, Healthy Mothers Healthy Babies Coalition, Washington, D.C.

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Vaccine Safety Forum: Summaries of Two Workshops Kathi Williams, Director, National Vaccine Information Program, Vienna, Virginia Robert P. Wise, Medical Epidemiologist, FDA, Rockville, Maryland