Announcements from health regulatory bodies such as the Swedish Medical Products Agency or other relevant authorities

Study Finds Batch-Dependent Safety Signal in BNT162b2 Vaccine Using Swedish Data, SAE Rate 1 in 800

Aug 19, 2024, 12:32 PM

A recent study has replicated findings from Danish data using Swedish data, indicating a batch-dependent safety signal for the BNT162b2 vaccine, developed by Pfizer and BioNTech. The study suggests that early commercial batches may have differed from those used later, resulting in more severe adverse events (SAE) in earlier batches, with an SAE rate of 1 in 800. The replication of these findings calls for further investigation into the causes of these differences. Reporting of adverse events, particularly by healthcare professionals, was notably low in Sweden.