Monitoring of adverse events following 2024–2025 BNT162b2 KP.2 COVID-19 vaccination in the United States

Large real-world data studies are needed to understand the safety profile of the 2024-2025 adapted COVID-19 vaccines. This study monitors the occurrence of 20 adverse events of special interest (AESIs) following 2024-2025 BNT162b2 KP.2 COVID-19 vaccination. Individuals age ≥ 6 months vaccinated between 08/22/2024 and 03/10/2025 were identified within the Optum pre-adjudicated database. A self-controlled risk interval design was used to compare the incidence of 20 AESIs during a risk period following vaccination to a subsequent control period among 894,852,024-2025 BNT162b2 COVID-19-vaccinated individuals (median age: 46.9 years). While point estimates were higher in the risk period compared to the control period for non-febrile convulsions/seizures (relative incidence: 1.29; 95% CI: 0.92-1.81) and herpes zoster (relative incidence: 1.05; 95% CI: 0.59-1.85), the magnitude was not significant. No safety signals were identified following 2024-2025 BNT162b2 COVID-19 vaccination among commercially insured individuals in the United States, though the study was underpowered for rare outcomes.