Early Detection of Safety Signal for COVID-19 Vaccine Safety Surveillance

Abstract

Early detection of adverse events is crucial in vaccine safety surveillance, especially for rare events often missed in pre-licensure clinical trials due to limited sample sizes. To address the challenge of vaccine safety monitoring and early signal detection, we conducted a comprehensive safety surveillance study utilizing Poisson and Binomial-based MaxSPRT methods. For Guillain-Barré Syndrome (GBS) and anaphylaxis, we employed the PMaxSPRT model due to their rarity, while for syncope and seizures; the Binomial-based MaxSPRT was applied. Using PMaxSPRT, no signal was detected for GBS, emphasizing the vaccine's safety in this regard. However, a signal for anaphylaxis was generated in the twelfth month, indicating a potential association. Employing the Binomial model, we found signals for both seizures and syncope.