Reference:
BioNTech Manufacturing GmbH. (2022). COVID-19 mRNA vaccine (nucleoside modified) Reporting Period Periodic Safety Update Report (PSUR) 3: 19 December 2021 through 18 June 2022.
Summary:
The third Periodic Safety Update Report (PSUR) for the COVID-19 mRNA vaccine (BNT162b2), also known as COMIRNATY®, covers data from 19 December 2021 to 18 June 2022. It outlines the vaccine’s mechanism, which involves delivering modified mRNA to elicit immune responses against SARS-CoV-2. The report highlights the cumulative exposure, with over 3.5 billion doses shipped globally and approximately 2.69 billion doses administered. No marketing authorisations were withdrawn during the reporting period, and although reports of adverse events, such as Guillain-Barré syndrome, emerged, they did not significantly alter the risk-benefit profile of the vaccine. Additionally, it discusses ongoing monitoring for safety signals, including myocarditis and pericarditis, and updates to the reference safety information. Overall, the benefit-risk assessment remains favourable, supporting the continued use of the vaccine in various populations.