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Theme: What would an ideal post licensure vaccine safety system be?
This meeting addressed the evolution of the assessment of vaccine safety, the current approaches to post-marketing safety evaluation, and opportunities for making advances and developing innovative approaches. Presenters represented FDA, CDC, HRSA, NIH, NVPO, the vaccine industry, the international public health community and their regulatory agencies, the clinical community, academic medicine, HMOs and group health organizations, parental groups, vaccine advocacy groups.
The objective of the workshop was to enhance approaches to the evaluation of vaccine safety once a vaccine has been licensed and is in use through a discussion of methodologies, opportunities and limitations. The meeting included discussion of current methods, study designs, including meta-analyses, case-control, prospective and cohort studies; new approaches and novel designs; techniques used by international regulatory agencies and other countries; hypotheses that each study design in use can and cannot address; and data sources relevant to each hypothesis or design.
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Tuesday, April 10, 2007 |
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8:30 am
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Speaker and Attendee Check-In
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Session I: Moderator: Bruce Gellin (Director, NVPO) |
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9:00 am
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Opening Remarks
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Bruce Gellin
Director, NVPO
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9:10 am
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Government keynote
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Jesse Goodman (PPT) (5.13MB)
Director of CBER
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9:30 am
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Meeting keynote
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Harvey Fineberg
President, Institute of Medicine
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10:00 am
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"How we got here?"
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Robert Ball (PPT) (395KB)
(FDA)
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10:20 am
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- Break �
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10:50 am
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FDA role
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Miles Braun (PPT) (1.38MB)
(FDA)
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11:10 am
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The Epidemiology of Safety
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Melinda Wharton (PPT) (189KB)
(CDC)
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11:30 pm
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Current CDC Activities
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John Iskander (PPT) (1.03MB)
(CDC)
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11:50 pm
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A Case Study: Post-Marketing Screening Studies of Influenza Vaccine
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Jason Glanz (PPT) (118KB)
Kaiser Permanente
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12:00 pm
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- Lunch -
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Session II: Moderator: John Iskander (Acting Director, ISO/CDC)
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1:00 pm
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Genomics and Adverse Events
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Robert Davis (PPT) (59KB)
Kaiser Permanente
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1:10 pm
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NIH role
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Charles Hackett (PPT) (1.91MB)
(NIH)
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Vaccine safety and the genotype of vaccines: mechanism of adverse events in smallpox vaccination.
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Christopher Wilson (PPT) (117KB)
(NIH)
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1:30 pm
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New developments and capabilities: DOMESTICALLY
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Richard Platt (PPT) (201KB)
(Harvard Pilgrim Health Care)
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2:00 pm
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- Break �
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2:30 pm
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Roundtable #1
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Moderator: John Iskander (PPT) (70KB)
(CDC)
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Introduction: Cutting edge safety systems
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Mads Melbye (PPT) (3.11MB)
Staten Serum Institute (Denmark)
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Discussion
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Richard Platt (Harvard Pilgrim Health Care)
Alexander Walker (i3 Drug Safety)
Adwoa Bentsi-Enchill (PPT) (411KB)
(WHO)
Steven Black
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Public Comments
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5:00 pm
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Summary of the day
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Marie Griffin (Rapporteur)
Vanderbilt University
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5:20 pm
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- Adjourn -
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Wednesday, April 11, 2007 |
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8:30 am
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Speaker Check-In
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Session III: Moderator: Miles Braun (FDA) |
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9:00 am
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New developments and capabilities: GLOBALLY
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Barbara Law (PPT) (1.73MB)
(Public Health Agency of Canada)
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9:20 am
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European Regulatory Authority (EMEA) experience
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Xavier Kurz (PPT) (12.8MB)
(EMEA)
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9:40 am
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United Kingdom Country Experience:GPRD
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John Parkinson (PPT) (1.59MB)
Medicines & Healthcare Products Regulatory Agency
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10:00 am
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Sequential Methodology in Case Series Analysis
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Nacima Hocine (PPT) (133KB) (Open University, London)
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10:20 am
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- Break -
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10:50 am
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Australian Country Experience
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Glenda Lawrence (PPT) (3.09MB)
National Centre for Immunisation Research & Surveillance
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11:10 am
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New Zealand Experience with Meningococcal Vaccine Post-Marketing Surveillance
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Stewart Reid (PPT) (514KB)
University of Auckland (NZ)
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11:30 am
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Military Experiences Monitoring Safety
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Renata Engler (PPT) (2.39MB)
(DoD)
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11:50 am
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The CMS database and its future potential
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Jeffery Kelman (CMS)
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12:10 am
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Vaccines and Drugs: Different paradigms?
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Bruce Psaty (PPT) (75KB)
(University of Washington)
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12:30 am
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- Lunch -
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Session IV: Moderator: Karen Midthun (FDA) |
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1:30 pm
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A Consumer Voice
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Peter Lurie (PPT) (71KB)
(Public Citizen)
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1:50 pm
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How industry can improve the system
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Joseph Heyse (PPT) (146KB)
(Merck)
Michael Decker (PPT) (2.06MB)
(sanofi pasteur)
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DISCUSSION & PUBLIC COMMENTS
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2:45 pm
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Roundtable #2
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Moderator: Karen Midthun (NIH)
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Introduction: Applicability of drug safety initiatives and recommendations to vaccines?
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Alistair Wood (PPT) (62KB)
(Vanderbilt University)
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Discussion
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Richard Platt (Harvard Pilgrim Health Care)
Paul Stolley (University of Maryland)
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3:45 pm
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- Break -
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4:00 pm
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Public Comment & Open Discussion
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4:30 pm
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Rapporteur�s Meeting Summary
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Marie Griffin
Vanderbilt University
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5:00 pm
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- Adjourn �
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