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Post-licensure Evaluation of Vaccine Safety:
Current Status and Future Directions
Scientific Committee
Co-chairpersons:
Steve Black, University of Cincinnati, Ohio, USA
Paul-Henri Lambert, University of Geneva, Switzerland
PROGRAMME
Day 1 - Wednesday, April 27, 2011
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07:30
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Registration
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08:30
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Welcome address and opening
Johannes Löwer, IABS, Germany and Paul-Henri Lambert, University of Geneva, Switzerland
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08:45
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Lecture: What is the current status of post-marketing surveillance in the US and in Europe?
- What techniques are available: data base, rapid cycle, passive reporting systems?
- What analytic techniques are available: cohort studies, case series, case control?
- What is working and what needs to be changed?
Jan Bonhoeffer, Brighton Collaboration : Slides Abstract
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09:15
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Discussion
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Session 1
What Have We Learned About How to Approach the Assessment of Vaccine Safety Analytically?
Chairpersons:
Nick Andrews, Health Protection Agency (HPA), UK
Steve Black, University of Cincinnati, USA
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09:30
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Vaccine safety signal detection and assessment.
Karen Broder, Centers for Disease Control and Prevention (CDC), USA : Slides Abstract
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09:50
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Epidemiological designs for vaccine safety assessment: methods and pitfalls.
Nick Andrews, Health Protection Agency, UK : Slides Abstract
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10:20
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Discussion
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10:35
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Break
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10:50
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Rapid & routine retection of vaccine safety signals
Robert Davis, Kaiser Permanente, Atlanta, USA : Abstract
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11:10
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Does size really matter in post-licensure vaccine safety monitoring?
Daniel Salmon, National Vaccine Program Office (NVPO), USA : Slides Abstract
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11:30
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Discussion
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11:45
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Panel Discussion 1:
What constitutes an optimal analytic approach to signal detection and evaluation?
How large should a study be, what outcomes should be looked at, what is the optimum mix of data link and other approaches?
What about rapid cycle methods?
What about stable infrastructure such as VSD? Can this example be applied generally?
How can post-marketing safety assessments be best structured to meet the needs of public health agencies, regulators, manufacturers?
What are the limits to what can or should be addressed in post-marketing studies?
Panelists: Nick Andrews (HPA, UK); Pier Luigi Lopalco (European Center for Disease Control and Prevention-ECDC, Sweden); Dan Salmon (NVPO, USA); Hector Izurieta (FDA, USA); Robert Chen (CDC, USA); Robert Davis (Kaiser Permanente, USA); Karen Broder (CDC, USA); Caitlin Dodd (Cincinnati Children's Hospital Medical Center, USA)
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Open discussion
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12:30
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Lunch
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13:45
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Panel Discussion 2:
What is the role of pharmaceutical-sponsored projects versus those sponsored or conducted by public health agencies?
Can these activities be coordinated for optimum efficiency?
Panelists: Tom Verstraeten (GSK Biologicals, Belgium); Neal Halsey (Johns Hopkins Bloomberg School of Public Health, USA); Miles Braun (Utrecht University, The Netherlands & University of Pennsylvania, USA); John Ferguson (Novartis Vaccines & Diagnostics); Dan Salmon (NVPO, USA), Miriam Sturkenboom (Erasmuc MC, the Netherlands)
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Open Discussion
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Session 2
Causality Assessment, Risk Perception and Risk Communication
Chairpersons
Neal Halsey, Johns Hopkins Bloomberg School of Public Health, USA
Adam Finn, Institute of Child Life & Health, UK
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14:15
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Causality assessment and vaccine safety
Neal Halsey, Johns Hopkins Bloomberg School of Public Health, USA : Slides Abstract
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14:35
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Experience with population-based approaches to causality assessment: VSD, VAESCO, GBRD, Global Data linkage studies. Possible new approaches: PGRx system
Lucien Abenhaim, LA-SER ltd & London School of Hygiene & Tropical Medicine, UK
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15:50
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Discussion – 15 min
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15:20
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Communication about vaccines: how to understand and overcome ignorance and superstition
Adam Finn, Institute of Child Life & Health, UK : Slides Abstract
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15:40
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Discussion
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15:45
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Break
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16:00
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What is the role of risk benefit analyses? How does one best frame risk-benefit from the manufacturer, public and academic perspective?
John Ferguson, Novartis Vaccines and Diagnostics, USA : Slides Abstract
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16:20
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Discussion
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16:30
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Panel Discussion 3:
How can causality be better assessed at the population level?
Is individual-level causality assessment feasible for population-based studies?
What are the roles of epidemiological studies of association and of individual-level causality assessment in post-marketing monitoring?
What are the benefits and limitations of each approach?
What information is needed in the post-marketing setting to assess causality?
How can this assessment best be performed?
How can the results of post-licensure evaluations best be communicated to regulators, practitioners and the public?
Panelists: Barbara Law (Public Health Agency of Canada); Tom Verstraeten (GSK Biologicals, Belgium); Patrick Zuber (WHO, Switzerland); Adam Finn, (Institute of Child Life & Health, UK); Karen Broder (CDC, USA); Robert Davis (Kaiser Permanente, Atlanta, USA)
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Open discussion
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17:15
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End of first day
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Day 2 - Thursday, April 28, 2011
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8:30
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Risk perception, risk management and safety assessment: what can governments do to increase confidence in their vaccine system?
Noni MacDonald, Dalhousie University, Canada : Slides Abstract
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09:00
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Discussion
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Session 3
Post-Marketing Safety Outside Industrialized Countries
Chairpersons
Steve Black, University of Cincinnati, USA
Patrick Zuber, WHO, Switzerland
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09:15
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The assessment of vaccine safety in low and middle income countries.
Patrick Zuber, WHO, Switzerland : Abstract
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09:35
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Vaccine safety and the widespread use of newer vaccines in the developing world – how to mitigate the risk of vaccine safety scares.
Barbara Law, Public Health Agency of Canada : Abstract
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09:55
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Discussion
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10:15
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Break
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10:40
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Applying epidemiologic infrastructure to the assessment of vaccine safety – the experience in Kenya.
Kayla Laserson, KEMRI/CDC Research and Public Health Collaboration, Kenya : Slides
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11:00
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International evaluation of GBS following pandemic influenza vaccine – an example of global collaboration.
Steve Black, University of Cincinnati, USA : Slides Abstract
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11:20
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Optimal safety assessment system for future vaccines against poverty-related diseases (e.g., HIV, malaria, TB) in developing countries.
Robert Chen, Centers for Disease Control and Prevention (CDC), Atlanta : Slides Abstract
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11:40
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Panel Discussion 4:
Next steps for safety assessment in developing and low income countries.
Panelists: Patrick Zuber (WHO, Switzerland); Steve Black (University of Cincinnati, USA); Kayla Laserson (KEMRI/CDC Research and Public Health Collaboration, Kenya); Hector Izurieta (FDA, USA); Barbara Law (Public Health Agency in Canada); Robert Chen (CDC, USA); Maria Luz Pombo (Pan American Health Organization, USA)
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Open discussion
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12:10
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Lunch
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Session 4
Safety at the Individual Level
Chairpersons
Robert Davis, Kaiser Permanente, Atlanta, USA;
Neal Halsey, Johns Hopkins Bloomberg School of Public Health, USA
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13:15
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Vaccine safety at the individual level – what have we learned?
Neal Halsey, John Hopkins Bloomberg School of Public Health, USA : Abstract
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13:35
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Genomics and vaccine safety: Is it possible to pre-identify populations or individuals at risk for adverse events? Example of myocarditis and vaccinia.
Robert Davis, Kaiser Permanente, Atlanta, USA
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13:55
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Panel Discussion 5:
Genomics – the road forward.
Panelists: Neal Halsey (Johns Hopkins Bloomberg School of Public Health, USA); Robert Davis (Kaiser Permanente, Atlanta, USA); Paul-Henri Lambert (University of Geneva, Switzerland)
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Open discussion
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14:40
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Break
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Session 5
Manufacturing Quality
Chairpersons
Tom Verstraeten, GSK Biologicals, Belgium
Corinne Pierfitte, Sanofi Pasteur, France
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15:00
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The role of safety monitoring to detect manufacturing quality issues.
Tom Verstraeten, GSK Biologicals, Belgium : Slides Abstract
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15:20
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Panel Discussion 6:
Experience with using safety monitoring to detect manufacturing quality issues in the developed and developing world.
Panelists: Tom Verstraeten (GSK Biologicals, Belgium); Corinne Pierfitte (Sanofi Pasteur, France); John Ferguson (Novartis Vaccines and Diagnostics); Xavier Kurz (EMA); William Egan (PharmaNet, USA); Hector Izurieta (FDA, USA)
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15:50
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Discussion
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16:10
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Closing Remarks
Steve Black, University of Cincinnati, USA
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16:45
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End of the Meeting
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To the members of IABS