Workshop Agenda

INSTITUTE OF MEDICINE VACCINE SAFETY FORUM

Workshop on Detecting and Responding to Adverse Events Following Vaccination

November 6, 1995

Washington, D.C.

I. Introduction to Adverse Events: The Questions

8:30–8:45 a.m.

Gerald Fenichel (Workshop Chair)

Vanderbilt University School of Medicine

II. Detecting Adverse Events

8:45–9:45

Surveillance for Vaccine Adverse Events

Rohert Chen, Centers for Disease Control and Prevention

9:45–10:00

Description of Data in the Vaccine Adverse Event Reporting System (VAERS)

Miles Braun, Food and Drug Administration

10:00–10:15

BREAK

III. Responding to Adverse Events

10:15–10:45

Epidemiologic Methods and the Study of Adverse Events

Samy Suissa, McGill University

10:45–11:15

Epidemiologic Methods Applied to Vaccine Adverse Events

Marie Griffin, Vanderbilt University Medical Center



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OCR for page 23
Vaccine Safety Forum: Summaries of Two Workshops Workshop Agenda INSTITUTE OF MEDICINE VACCINE SAFETY FORUM Workshop on Detecting and Responding to Adverse Events Following Vaccination November 6, 1995 Washington, D.C. I. Introduction to Adverse Events: The Questions 8:30–8:45 a.m. Gerald Fenichel (Workshop Chair) Vanderbilt University School of Medicine II. Detecting Adverse Events 8:45–9:45 Surveillance for Vaccine Adverse Events Rohert Chen, Centers for Disease Control and Prevention 9:45–10:00 Description of Data in the Vaccine Adverse Event Reporting System (VAERS) Miles Braun, Food and Drug Administration 10:00–10:15 BREAK III. Responding to Adverse Events 10:15–10:45 Epidemiologic Methods and the Study of Adverse Events Samy Suissa, McGill University 10:45–11:15 Epidemiologic Methods Applied to Vaccine Adverse Events Marie Griffin, Vanderbilt University Medical Center

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Vaccine Safety Forum: Summaries of Two Workshops 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 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 12:15–1:15 LUNCH IV. Examples of Methodologies Applied to Research on Vaccine Adverse Events 1:15–1:30 Vaccine Lot Surveillance Susan Ellenberg, Food and Drug Administration 1:30–1:45 Reviewing Case Reports Frederick Varricchio, Food and Drug Administration 1:45–2:00 Analysis of Seizure Reports in LLDBs Robert Davis, Group Health Cooperative, Seattle 2:00–2:15 Studying Immune-mediated Disorders John Martin, University of Southern California School of Medicine 2:15–2:30 BREAK V. Panel Discussions 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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Vaccine Safety Forum: Summaries of Two Workshops   Information Center; Luc Hessel, Pasteur Mérieux Connaught; Gina Terracciano, Centers for Disease Control and Prevention; Frederick Varricchio, Food and Drug Administration 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 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 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

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Vaccine Safety Forum: Summaries of Two Workshops 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

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Vaccine Safety Forum: Summaries of Two Workshops 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

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Vaccine Safety Forum: Summaries of Two Workshops This page in the original is blank.