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Preparedness to Monitor Safety of the Pandemic (H1N1) 2009 Vaccines VRBPAC July 23, 2009. Presented by Hector S. Izurieta CBER/FDA. 1. Pandemic (H1N1) 2009 Vaccine Potential Issues. New strain, monovalent vaccine Potential for use of novel adjuvants Large numbers of vaccinees expected

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preparedness to monitor safety of the pandemic h1n1 2009 vaccines vrbpac july 23 2009

Preparedness to Monitor Safety of thePandemic (H1N1) 2009 VaccinesVRBPACJuly 23, 2009

Presented by

Hector S. Izurieta

CBER/FDA

1

pandemic h1n1 2009 vaccine potential issues
Pandemic (H1N1) 2009 Vaccine Potential Issues
  • New strain, monovalent vaccine
  • Potential for use of novel adjuvants
  • Large numbers of vaccinees expected
    • Most age and risk groups
    • Relatively rapid vaccine administration
  • Heightened public attention and expectation for robust safety surveillance
  • Expected increase in reporting of temporally-associated events regardless of causal association to vaccination (compared to seasonal vaccine)
adverse event monitoring
Adverse Event Monitoring
  • Improvements in passive surveillance (VAERS) for all events (data mining, timeliness of analysis)
  • Enhanced surveillance for pre-specified events identified by:
    • Pre-licensure safety data
    • Published literature
    • Post-licensure safety data with seasonal influenza vaccines
    • Accruing available international data on pandemic (H1N1) 2009 vaccines with and without adjuvants
  • Need for adaptable toolbox
strategy
Strategy
  • Enhanced/more timely pharmacovigilance tools for:
    • Signal detection
    • Signal strengthening and verification
    • Confirmation of possible association
  • Increased communication/collaboration among U.S. agencies, and also internationally
    • Methods
    • Sharing of preliminary safety surveillance results
    • Signal validation and confirmation of potential associations
vaccine safety data link cdc timely identification and rapid assessment
Vaccine Safety Data Link (CDC)Timely Identification and Rapid Assessment

Eight managed care organizations representing approximately 9 million US individuals

Sequential Analytical methods

Allows rapid assessment of pre-specified adverse events

Simultaneous analysis with appropriate comparison group

Requires accurate vaccination information linked to managed care database

Outcome linked with exposure

other cdc tools for signal strengthening and verification
Other CDC Tools for Signal Strengthening and Verification
  • Emerging Infections Program (EIP) for special studies
  • Collaboration with the American Academy of Neurology (AAN)
    • Guillain Barre Syndrome (GBS) reporting
  • Field investigations
  • Adverse event clinical assessments - CISA (Clinical Immunization Safety Assessment)
fda cms collaboration
Development of capability for electronic safety monitoring using Medicare data:

CMS-FDA pilot project, focused on pandemic preparedness, showed ability to use weekly Medicare data for potential vaccine safety monitoring

Example of CBER/CMS collaboration: Rapid analysis of rare adverse event (AE) after flu vaccine in 2006.*

Vaccinations

AE Cases Per Million

FDA-CMS Collaboration
dod fda cdc h1n1 research plan flow chart

Pre-specified AEs

Non-prespecified AEs

Tier-1 AEs

Tier-2 AEs

Tier-3 AEs

Retrospective cohorts to estimate background rates

Phase 1: Prior to vax

Bi/Weekly listings of cases and vaccine doses distributed

Enhanced surveillance through RCA

Data mining, other analyses

Phase 2: During vax

Positive signal (expert review)

Scan Statistics to confirm the signal

Positive signal

Positive signal

Self-controlled case series to verify the signal

Phase 3: Post-vax

Retrospective cohorts to estimate incidence rates of AEs during H1N1 vaccination season and to evaluate risk of AE following H1N1 vaccine

DOD-FDA-CDC H1N1 Research Plan Flow Chart
considerations regarding vaccine administration
Considerations Regarding Vaccine Administration
  • Distribution and administration of vaccines likely to vary by state, city and county
    • usefulness for safety surveillance will vary
  • Linkage of vaccination data (exposure) to outcome data (medically attended event) is essential to capacity and timeliness for detection/evaluation of safety signals
summary
Summary
  • Pandemic preparedness has:
    • Enhanced capacity for timely signal detection, verification and confirmation
    • Strengthened collaboration and communication among government agencies and internationally
  • There is variability in data quality and timeliness
  • Timely availability of conclusive post-utilization safety data remains a challenge given:
    • Expected rapid vaccination period
    • Questions regarding vaccine distribution and recording
    • Rarity of expected adverse events
acknowledgements
Robert Ball

Rickey Wilson

Robert Wise

Andrea Sutherland

Claudia Vellozzi

Michael McNeil

Douglas Pratt

Amy Groom

Cunningham Fran

Jeff Kelman

Patrick Garman

Dale Burwen

Wei Hua

Aysha Akhtar

Sukhminder Sandhu

Yandong Qiang

Laura Polakowski

Angela Eick

Acknowledgements