Meeting Agenda

8:30 am

Welcome and overview of the agenda and the day’s proceedings
Committee Introductions

Claire V. Broome, Committee Chair
 
 Audio for Introduction
 

8:45 am

Panel 1: Identifying vaccine safety concerns  

 Moderator: Grace Lee, IOM Committee Member

 Topics of discussion may include:

• Assessing safety in pre-licensure clinical trials (Phase 1-3)
• Safety objectives pre-licensure vs. post licensure
• Gaps in the detection of safety signals and how to address them 
• The Vaccine Adverse Events Reporting System
• Active surveillance capabilities of the Vaccine Safety Datalink 

Participants:
Robert Ball, FDA
Louis Z. Cooper, Columbia University
Adrian Dana, Merck
Vicky Debold, NVIC
Susan Ellenberg, University of Pennsylvania 
Florence Houn, Celgene
Neal Halsey, Johns Hopkins University
Phillip Krause, FDA
Lanie Friedman Ross, University of Chicago
Thomas M. Vernon, Sanofi-pasteur
Melinda Wharton, CDC/ISO

Questions and Comments from the audience 
 
Audio for Panel 1 
 

10:30 am

Break

10:45 am

Panel 2: Studying vaccine safety

Moderator: Art Reingold, IOM Committee Member

 Topics for discussion may include:

• What triggers switching from surveillance to evaluation of a safety signal
• Evaluating safety signals, assessing potential causality of an observed adverse event
• Approaches and methodological, ethical, and practical advantages and challenges
• Assessing the relationship between immunization and diagnostic categories (e.g., demyelinating diseases, rheumatologic diseases)
• Vaccine Safety Datalink and Clinical Immunization Safety Assessment Network challenges and opportunities
• Enhancing timeliness of conducting and completing studies (e.g., tools like rapid cycle analysis)
• Gaps in vaccine safety science

Participants:
Robert Ball, FDA
Sean Hennessy, University of Pennsylvania
John Iskander, CDC/ISO
Samuel L. Katz, Duke University
Tracy Lieu, Harvard University
Andy Pavia, University of Utah, NVAC Vaccine Safety WG
Lanie Friedman Ross, University of Chicago
Kenneth J. Rothman, RTI International
Patricia Saddier, Merck
Brian Strom, University of Pennsylvania
Melinda Wharton, CDC/ISO

Questions and Comments from the audience

Audio for Panel 2 
 

12:30 pm

Lunch

1:30 pm

1:45

Update from the National Vaccine Advisory Committee Safety Working Group
 
Andy Pavia, NVAC working group chair

PowerPoint Presentation 
Audio
 

Panel 3: Basic science (in vivo, in vitro, and human clinical models)

Moderator: Claire V. Broom, IOM Committee Chair

Topics for discussion may include:

• Current research on host risk factors, gaps
• Genetic contributions to immune response
• Adequacy of animal models for studying vaccine responses
• Exploring the role of adjuvants in adverse reactions to vaccines
• Gaps in understanding of immune system (immune response to vaccines, the immature immune system, etc.)

Participants:
George Curlin, NIAID/NIH
Kathy Edwards, Vanderbilt University
Charles Hackett, NIAID/NIH
Neal Halsey, Johns Hopkins University
Ruth Karron, Johns Hopkins University
Phillip Krause, FDA

Questions and Comments from the audience
 
Audio for Panel 3 
 

3:15 pm

Break
 

3:30 pm

Panel 4: Policy issues related to vaccine safety and compensation for vaccine injuries

Moderator: Sara Rosenbaum, IOM Committee Member

Topics for discussion may include:

• Vaccine safety as conceived in the 1986 act that established the vaccine injury compensation program
• Implications of recent decisions of the U.S. Court of Federal Claims 

Participants:
Louis Z. Cooper, Columbia University
Barbara Loe Fisher, NVIC
Anthony Robbins, Tufts University
Jeff Sconyers, Seattle Children’s Hospital, outgoing chair ACCV
Tim Westmoreland, Georgetown University

 Questions and Comments from the audience

 Audio for Panel 4

The link for the webcast was taken down in error 30 minutes early, if you would like to listen to only that portion, please click here.

5:15 pm

Closing Comments

5:30 pm

Adjourn
 

Confirmed Discussants

Robert Ball
Chief, Vaccine Safety Branch
Division of Epidemiology
Food and Drug Administration

George Curlin
Medical Officer
Office of the Director
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
National Institutes of Health

Louis Z. Cooper
Professor Emeritus, Pediatrics
College of Physicians and Surgeons
Columbia University

Adrian Dana
Senior Director
Clinical Risk Management and Safety Surveillance
Merck Research Labs

Vicky Debold
Director of Patient Safety
National Vaccine Information Center

Kathryn Edwards
Sarah Sell Professor of Pediatrics
Director, Division of Pediatric Clinical Research
Vanderbilt University School of Medicine

Susan Ellenberg
Professor of Biostatistics
Associate Dean for Clinical Research
University of Pennsylvania School of Medicine

Barbara Loe Fisher
President and Co-Founder
National Vaccine Information Center

Charles Hackett
Deputy Director
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
National Institutes of Health

Neal Halsey
Professor
Department of International Health,
Disease Prevention & Control
Department of Pediatrics
Johns Hopkins University

Sean Hennessy
Senior Scholar, Epidemiology
Center for Clinical Epidemiology and Biostatistics
Assistant Professor of Epidemiology, University of Pennsylvania SOM
Assistant Professor of Pharmacology, Department of Pharmacology
Director of Ambulatory Drug Use and Effects, University of Pennsylvania Medical Center

Florence Houn 
Vice President, Regulatory Affairs
Celgene Corporation

John Iskander
Associate Director for Immunization Safety
Centers for Disease Control and Prevention

Ruth Karron
Director, Center for Immunization Research 
Director, Johns Hopkins Vaccine Initiative
Johns Hopkins University

Samuel L. Katz
Wilburt C. Davison Professor Emeritus of Pediatrics
Duke University

Phillip Krause
Laboratory Chief
Lead Research Investigator
Center for Biologics Evaluation and Research
Food and Drug Administration

Tracy Lieu
Professor
Director of Faculty Development
Director, Center for Child Health Care Studies
Department of Ambulatory Care and Prevention
Harvard Pilgrim Health Care and Harvard Medical School

Andy Pavia
Professor, Division of Infectious Diseases
University of Utah School of Medicine 
Chair, Vaccine Safety Working Group, National Vaccine Advisory Committee

Anthony Robbins
Professor
Department of Public Health and Family Medicine
Tufts University

Lanie Friedman Ross
Carolyn and Matthew Bucksbaum Professor of Clinical Ethics
Professor, Departments of Pediatrics, Medicine, and Surgery
Associate Director, MacLean Center for Clinical Medical Ethics
University of Chicago

Kenneth J. Rothman
Distinguished Fellow in epidemiology
Vice President, Epidemiology Research
RTI International
 

Patricia Saddier
Senior Director, Epidemiology Department
Merck Research Laboratories

Jeff Sconyers
Senior VP & General Counsel
Seattle Children's Hospital
Chair, Advisory Commission on Childhood Vaccines (ACCV)

Brian Strom
George S. Pepper Professor of Public Health and Preventive Medicine
Departments of Biostatistics and Epidemiology
University of Pennsylvania

Thomas M. Vernon
Consultant with Sanofi-pasteur
Former VP, Merck Vaccine Division
Former Executive Director, Colorado Department of Health

Tim Westmoreland
Visiting Professor of Law
Georgetown University

Melinda Wharton
Deputy Director
National Center for Immunizations and Respiratory Diseases
Centers for Disease Control and Prevention

 Some federal agencies contributed to the development of the draft strategic National Vaccine Plan