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System Overview for Seasonal Influenza Vaccine Safety Monitoring 2010-2011

System Overview for Seasonal Influenza Vaccine Safety Monitoring 2010-2011. Daniel Salmon, PhD, MPH Director of Vaccine Safety National Vaccine Program Office. Vaccine Adverse Event Reporting System (CDC/FDA).

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System Overview for Seasonal Influenza Vaccine Safety Monitoring 2010-2011

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  1. System Overview for Seasonal Influenza Vaccine Safety Monitoring 2010-2011 Daniel Salmon, PhD, MPH Director of Vaccine Safety National Vaccine Program Office

  2. Vaccine Adverse Event Reporting System (CDC/FDA) • Purpose: to detect signals of unanticipated events that may deserve further follow-up • US population, self-reported, from many sources including healthcare providers and the public • Focus on identifying deviations from prior seasonal (and H1N1) influenza monitoring • Three analysis methods: • Automated – certain events reported daily • Clinical review – medical officers review daily reports, serious cases classified by body system • Data mining –assesses for patterns of disproportionate reporting

  3. Real-Time Immunization Monitoring System (CDC/Johns Hopkins) • Automated real-time/web-based active surveillance • 11,700 persons, primarily from healthcare facilities • Can target subpopulations • Vaccinees either • Give permission to be contacted for follow-up at time of immunization (active capture) • Voluntarily log in to on line surveys (passive capture) • Online questionnaires at baseline, 10 days and 42 days • Analyzed in real time using rule-based algorithms • Focus is on patient related symptoms with active follow-up of adverse events associated with health care visits • Only information on vaccinees; lacks comparison group (so while active surveillance still primarily for signal generation)

  4. Rapid Cycle Analysis • Developed by VSD to monitor pre-specified outcomes in near real-time • Near real time: Compares rates of outcomes in pre-specified time windows among vaccinees to comparison group (rates of same event during same post-vaccination time window among persons receiving flu vaccine in previous years) • End of season: self controlled case series • Potential adverse events are based on data from pre-licensure vaccine studies, early VAERS analyses, and concerns published in scientific articles

  5. Guillain-Barré Syndrome Demyelinating disease Disorders of the peripheral nervous system and neuropathies Seizures (epilepsy, convulsions) Encephalitis, myelitis, encephalomyelitis Bell’s Palsy Other cranial nerve disorders (Facial/Trigeminal nerve disorders) Ataxia (other cerebellar ataxia, ataxia) Anaphylaxis Angioneurotic edema, Allergic Reaction, Urticaria Myocarditis and pericarditis (LAIV only) Hemorrhagic stroke Ischemic stroke (excludes transient ischemic attack) Wheezing (LAIV only) Asthma, wheezing, respiratory distress/insufficiency, other diseases of trachea/bronchi Multiple definitions with and without bronchiolitis TP/ITP Pre-specified Outcomes

  6. Steps in Rapid Cycle Analysis Signal Evaluation Check the data Examine descriptive statistics Check computer code and complete equivalent non sequential analysis Look for patterns in time from exposure to outcome Adjust for additional cofounders Use other comparison groups Conduct chart review Compare results for similar outcomes Compare results with other existing data Collect more data and/or conduct new study Ten signals appeared over three years of surveillance: one was reported to external stakeholders, ultimately leading to a change in national vaccination policy (MMRV and febrile seizures); nine were found to be spurious after rigorous internal investigation Yih WK, Kulldorff M, Fireman BH, et al. Active surveillance for adverse events: the experience of the Vaccine Safety Datalink Project. In Press. Pediatrics. 2011;127(3 suppl):

  7. Vaccine Safety Datalink (CDC) • Active surveillance, near real-time • ~9 million people in 10 linked MCOs • Can study subpopulations • Can add adverse events if signals arise from other source • Rapidly conduct chart review if needed

  8. Influenza Awareness System (IHS) • Moderate size population from 21 sites • ~350,000 people from all life phases of the American Indian and Alaska Native community • Unified system, chart-review capable • Predominantly focused on Bell’s Palsy, ITP, and febrile seizures

  9. Medicare Data • FDA-CMS collaborative project • Very large database • ~14 million vaccinations this year • Predominantly ages 65 years and older • May be underrepresented in some other databases • Capability to monitor rare adverse events • Focus on GBS

  10. Dept. of Veterans Affairs Large study population ~5 million persons Captures elderly patients and patients with multiple co-morbidities Chart-review capable Predominantly focused on Bell’s Palsy, GBS, anaphylaxis, and TP/ITP

  11. System Overview for Seasonal Influenza Vaccine Safety Monitoring 2010-2011 Daniel Salmon, PhD, MPH Director of Vaccine Safety National Vaccine Program Office

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