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Proposed Pharmacovigilance Plan for H5N1 Influenza Virus Vaccine


... 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

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

  • 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

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

Pharmacovigilance (PV) Planning
  • PV activities have to be designed considering the
  • 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
  • 5. Possible disruption of pharmacovigilance
  • Need for an on-going safety signal detection and
  • Feasibility and effectiveness of the proposed
    actions/ measures need to be tested prior to the

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

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

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

Spontaneous ReportingAdverse Events of Special
  • 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

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)

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
  • PSURs prepared on an ad-hoc basis upon request
    from Health Authority
  • An aggregated PSUR will be submitted when the
    pandemic is declared finished

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

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

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

  • Streamlining and prioritization are essential for
    early detection and communication of potential
  • 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
  • Sanofi pasteur is committed to global pandemic

  • 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.