Vaccine Safety Forum: Summaries of Two Workshops (1997)
Chapter: WORKSHOP AGENDA
Workshop Agenda
INSTITUTE OF MEDICINE VACCINE SAFETY FORUM
Workshop on Detecting and Responding to Adverse Events Following Vaccination
November 6, 1995
Washington, D.C.
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I. Introduction to Adverse Events: The Questions |
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8:30–8:45 a.m. |
Gerald Fenichel (Workshop Chair) Vanderbilt University School of Medicine |
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II. Detecting Adverse Events |
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8:45–9:45 |
Surveillance for Vaccine Adverse Events Rohert Chen, Centers for Disease Control and Prevention |
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9:45–10:00 |
Description of Data in the Vaccine Adverse Event Reporting System (VAERS) Miles Braun, Food and Drug Administration |
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10:00–10:15 |
BREAK |
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III. Responding to Adverse Events |
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10:15–10:45 |
Epidemiologic Methods and the Study of Adverse Events Samy Suissa, McGill University |
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10:45–11:15 |
Epidemiologic Methods Applied to Vaccine Adverse Events Marie Griffin, Vanderbilt University Medical Center |
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11:15–11:45 |
Detection and Response Activities of Vaccine Manufacturers Luc Hessel, Pasteur Mérieux Connaught Robert Levine, Lederle-Praxis Biologicals Robert Sharrar, Merck Research Laboratories |
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11:45–12:15 p.m. |
Experiences of Consumers with Adverse Event Detection and Response Barbara Loe Fisher, National Vaccine Information Center Mark Geier, Medical/Legal Consultant Kathy Schaus, Little Rock, Arkansas Jack Sexton, Woodbridge, Virginia |
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12:15–1:15 |
LUNCH |
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IV. Examples of Methodologies Applied to Research on Vaccine Adverse Events |
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1:15–1:30 |
Vaccine Lot Surveillance Susan Ellenberg, Food and Drug Administration |
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1:30–1:45 |
Reviewing Case Reports Frederick Varricchio, Food and Drug Administration |
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1:45–2:00 |
Analysis of Seizure Reports in LLDBs Robert Davis, Group Health Cooperative, Seattle |
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2:00–2:15 |
Studying Immune-mediated Disorders John Martin, University of Southern California School of Medicine |
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2:15–2:30 |
BREAK |
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V. Panel Discussions |
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2:30–3:15 |
Panel 1—Reporting and Data Collection Moderator: Linda Cowan, University of Oklahoma Health Sciences Center Panelists: Barbara Loe Fisher, National Vaccine |
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Information Center; Luc Hessel, Pasteur Mérieux Connaught; Gina Terracciano, Centers for Disease Control and Prevention; Frederick Varricchio, Food and Drug Administration |
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3:15–4:00 |
Panel 2—Detection Methodologies Moderator: Paul Stolley, University of Maryland School of Medicine Panelists: Bart Classen, Classen Immunotherapies; Susan Ellenberg, Food and Drug Administration; Barbara Loe Fisher, National Vaccine Information Center; James Singleton, Centers for Disease Control and Prevention; Robert Wise, Food and Drug Administration |
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4:00–4:45 |
Panel 3—Response Methodologies Moderator: Paul Stolley, University of Maryland School of Medicine Panelists: Barbara Loe Fisher, National Vaccine Information Center ; John Glasser, Centers for Disease Control and Prevention; Marie Griffin, Vanderbilt; John Martin, University of Southern California |
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4:45–5:30 |
Panel 4—Summation Panel: Where do we stand? Moderator: Gerald Fenichel (Workshop Chair), Vanderbilt University School of Medicine Panelists: Robert Chen, Centers for Disease Control and Prevention; Susan Ellenberg, Food and Drug Administration; Barbara Loe Fisher, National Vaccine Information Center; Robert Kohberger, Lederle-Praxis Biologicals |
PARTICIPANTS
M. Miles Braun, Medical Officer, Division of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland
Robert T. Chen, Chief, Vaccine Safety and Development Activity, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia
J. Barthelow Classen, President and Chief Executive Officer, Classen Immunotherapies, Inc., Baltimore, Maryland
Linda D. Cowan, Professor, Department of Biostatistics and Epidemiology, College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma
Robert Davis, Assistant Professor, Department of Pediatrics, University of Washington Medical School; and Assistant Professor, Department of Epidemiology, University of Washington School of Public Health and Community Medicine, Seattle, Washington
Susan Ellenberg, Director, Division of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland
Gerald M. Fenichel, Professor of Neurology and Pediatrics, and Chair, Department of Neurology, Vanderbilt University School of Medicine, Nashville, Tennessee
Barbara Loe Fisher, President, National Vaccine Information Center, Vienna, Virginia
Mark Geier, Medical/Legal Consultant, Silver Spring, Maryland
John W. Glasser, Epidemiologist, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia
Marie R. Griffin, Professor, Department of Preventive Medicine, Vanderbilt University Medical Center, Nashville, Tennessee
Luc Hessel, Pasteur Mérieux: Connaught, Lyon, France
Robert C. Kohberger, Director, Statistics and Data Management, Wyeth-Lederle Vaccines and Pediatrics, Pearl River, New York
Robert Levine, Director, Worldwide Safety Surveillance, Lederle-Praxis Biologicals, Philadelphia, Pennsylvania
W. John Martin, Department of Pathology, University of Southern California School of Medicine, Los Angeles, California
Kathy Schaus, Little Rock, Arkansas
Jack Sexton, Woodbridge, Virginia
Robert G. Sharrar, Director, Report Evaluation and Safety Surveillance, Worldwide Product Safety and Epidemiology, Merck Research Laboratories, West Point, Pennsylvania
James Singleton, Statistician, Klemm Analysis Group, Centers for Disease Control and Prevention, Atlanta, Georgia
Paul D. Stolley, Professor and Chairman, Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland
Samy Suissa, Associate Professor, Pharmacoepidemiology Research Unit, McGill University, Montreal, Quebec
Gina Terracciano, Medical Officer, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia
Frederick Varricchio, Medical Officer, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland
Robert P. Wise, Medical Epidemiologist, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland
