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Activity Number:
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385
- SPEED: Statistical Methods and Applications in Medical Research, Risk Analysis, and Marketing Part 1
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Type:
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Contributed
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Date/Time:
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Wednesday, August 10, 2022 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #323487
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Title:
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Near Real-Time Surveillance of COVID-19 Vaccine Safety in the U.S. Food and Drug Administration Biologics Effectiveness and Safety (BEST) Initiative Data Network
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Author(s):
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Mao Hu* and Patricia Lloyd and Cindy Ke Zhou and An-Chi Lo and Yoganand Chillarige and John Hornberger and Jeffrey Kelman and Anne Marie Kline and Cheryl N McMahill-Walraven and Kandace L. Amend and John D Seeger and Daniel Beachler and Alex Secora and Christian Reich and Azadeh Shoaibi and Hui Lee Wong and Steven Anderson
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Companies:
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Acumen LLC and US Food and Drug Administration and US Food and Drug Administration and Acumen LLC and Acumen LLC and Acumen LLC and Centers for Medicare & Medicaid Services and Aetna and Aetna and Optum Epidemiology and Optum Epidemiology and HealthCore, Inc. and IQVIA and IQVIA and US Food and Drug Administration and US Food and Drug Administration and US Food and Drug Administration
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Keywords:
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COVID-19 vaccines;
distributed data network;
near real-time surveillance;
sequential tests;
vaccine safety
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Abstract:
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Objective: To describe signal detection methods and results for COVID-19 vaccine safety surveillance in the FDA Biologics Effectiveness and Safety (BEST) Initiative network. Methods: We conducted sequential monitoring in three commercial (12–64 years) and Medicare (65+ years) claims databases since Dec 11, 2020 in the US. The Poisson Maximized Sequential Probability Ratio Test was used to identify increased risk of outcomes versus expected rates following COVID-19 vaccination. Expected rates were estimated from a historical cohort and adjusted for observation delay. Results: With data available in Jan 2022, four outcomes signaled following BNT162b2 vaccination in adults aged 65+ years (34 million doses): pulmonary embolism, acute myocardial infarction, disseminated intravascular coagulation, and immune thrombocytopenia. Myocarditis and/or pericarditis signaled following BNT162b2 vaccination in individuals aged 12–64 years (31 million doses). Signals were triaged for further investigation. Conclusions: We used sequential monitoring to monitor safety outcomes following COVID-19 vaccination. Inferential studies are ongoing to verify signals identified in near real-time surveillance.
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Authors who are presenting talks have a * after their name.
