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Proposed Pharmacovigilance Plan for H5N1 Influenza Virus Vaccine

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... database dedicated to flu pandemic vaccines could be used and ... Should be tested with seasonal flu vaccines. 12. Monitoring for Vaccine Effectiveness ... – PowerPoint PPT presentation

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Title: Proposed Pharmacovigilance Plan for H5N1 Influenza Virus Vaccine


1
Proposed Pharmacovigilance Plan for H5N1
Influenza Virus Vaccine
  • Patrick Caubel, MD, PhD
  • Head of Pharmacovigilance North America
  • February 27, 2007

2
Background
  • Planning for the prospect of pandemic influenza
    is one of the most effective steps to mitigate
    the impacts of such an event
  • Vaccination remains a critical defense against
    pandemic influenza
  • Vaccine safety monitoring is necessary
  • Part of a comprehensive public health
    surveillance program

3
Pharmacovigilance Plan Objectives
  • Detect, evaluate and minimize risks due to the
    pandemic influenza vaccine
  • Contributes to the benefit-risk evaluation in a
    pandemic situation
  • Agree beforehand on
  • Objectives for postmarketing safety surveillance
  • Collaborative plan with key stakeholders
  • Put in place an adequate system tailored to a
    pandemic situation to allow adequate responses

4
Pharmacovigilance (PV) Planning
  • PV activities have to be designed considering the
    following
  • 1. Limited clinical data available
  • 2. High volume of safety data anticipated within
    a short time frame
  • 3. Increased public anxiety with AEs (adverse
    events) reported, regardless of causality
  • 4. Limited personnel in industry and regulatory
    agencies
  • 5. Possible disruption of pharmacovigilance
    systems
  • Need for an on-going safety signal detection and
    evaluation
  • Feasibility and effectiveness of the proposed
    actions/ measures need to be tested prior to the
    pandemic

5
Pre-pandemic Standard PV Practices
  • Applicable in pre-pandemic period
  • Spontaneous reporting
  • Aggregate reports at defined time intervals
  • Signal detection and analysis
  • Safety surveillance studies (possible cohort
    study in first responders)
  • Passive collection of vaccine failure reports
  • Objective Develop a better understanding of
    vaccine safety profile that could impact pandemic
    safety monitoring

6
Pandemic Proposed PV Practices
  • Applicable in pandemic situation
  • Spontaneous reporting with a focus on special AEs
  • Simplified aggregate reports
  • Real time signal detection and analysis
  • Safety surveillance studies (in early recipients
    after pandemic is declared)
  • Passive collection of vaccine failure reports
  • Objective Allocation of available resources on
    tasks critical for understanding the evolving
    benefit-risk profile in a pandemic situation

7
Spontaneous ReportingData Collection
  • Spontaneous reporting will remain the basis for
    safety evaluation
  • One common simplified and targeted collection
    form could be used by all parties when the
    vaccination process begins
  • Healthcare professionals and patients should be
    encouraged to report primarily serious adverse
    events, life-threatening events, adverse events
    of special interest (AESI), and deaths

8
Spontaneous ReportingAdverse Events of Special
Interest
  • All parties must consider a list of adverse
    events of special interest (AESI) for which a
    common case definition will be used in order to
    ensure harmonized safety assessment
  • EMEA has proposed a list of AESI for pandemic
    vaccine surveillance

9
Spontaneous Reporting Safety Database
  • Rapid and open communication and information
    sharing between sanofi pasteur, other vaccine
    manufacturers and Authorities/Public Health
    Services (FDA, CDC, state and local authorities)
    is essential
  • Electronic communication should be established
    prior to the pandemic period
  • One single safety database dedicated to flu
    pandemic vaccines could be used and shared by all
    parties (VAERS database)

10
Aggregate Reports
  • Periodic Safety Update Reports (PSURs) are
    prepared at defined time intervals however,
    during the pandemic period due to limited
    resources, preparation and submission of PSURs
    may not be feasible
  • Options
  • Simplified PSURs
  • Focusing on serious adverse events, deaths,
    life-threatening events, and AESI can be
    prepared.
  • PSURs prepared on an ad-hoc basis upon request
    from Health Authority
  • An aggregated PSUR will be submitted when the
    pandemic is declared finished

11
Signal Detection and Analysis
  • Crude inspection of single cases or line-listings
    not adequate
  • Quantitative and automated data-mining methods
    should be considered (e.g. proportional reporting
    ratios, Bayesian methods)
  • Modification of standard methods may be required
    (stratifications, use of appropriate comparator)
  • May detect increase in incidence of AESI and
    support detection of unexpected AEs
  • Should be tested with seasonal flu vaccines

12
Monitoring for Vaccine Effectiveness
  • There is no vaccine that is 100 effective
  • Vaccine failure evaluation done through
    pharmacovigilance monitoring should not be used
    to assess vaccine effectiveness

13
Safety Surveillance Studies
  • Safety profile will remain unknown in numerous
    populations prior to vaccination campaign
  • Consideration should be given to initiating
    cohort studies either prior to the pandemic
    (first responders, critical workers) or after the
    pandemic is declared (early recipients)
  • Case-control studies using large population-based
    databases (e.g. Vaccine Safety Data Link) may be
    useful for rare serious AEs
  • Should be coordinated by national and
    international public health agencies

14
Summary
  • Streamlining and prioritization are essential for
    early detection and communication of potential
    risks
  • Pharmacovigilance plan and information-sharing
    system could be tested and harmonized during the
    forthcoming and subsequent flu seasons
  • Proposed pharmacovigilance actions are part of an
    evolving plan to be refined with key
    stakeholders, together with roles and
    responsibilities
  • Sanofi pasteur is committed to global pandemic
    preparedness

15
Conclusion
  • Safety of our vaccines are of paramount
    importance for sanofi pasteur.
  • Sanofi pasteur is prepared to work with the
    Government on efficient methods of collecting
    safety and effectiveness data.
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