Pfizer/BioNTech Comirnaty® Studies

Pfizer/BioNTech Comirnaty® Studies

The Pfizer-BioNTech Post-Authorization Safety Studies (PASS) began in 2021 and 2022 with the aim of studying the safety of the Pfizer/BioNTech Comirnaty® vaccine, and to identify incidence rates and potential predictors. Separate studies for focusing on the analysis of myocarditis and pericarditis outcomes for the Pfizer vaccine also began at the request of the PRAC.

Registration and Protocols
EUPAS108847. Arana A et al. Post-Authorisation Safety Study of Comirnaty Original/Omicron BA.1 and Comirnaty Original/Omicron BA.4-5 in Europe. 22 January 2024.
EUPAS41623. Arana A et al. Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine. 18 October 2023.
EUPAS47708. Arana A et al. Post-Authorisation Active Surveillance Study of Myocarditis and Pericarditis Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine. 13 May 2022.