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 |
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 |
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
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
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
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.