Batch dependent safety

Batch-dependent safety of the BNT162b2 mRNA COVID-19 vaccine (2023). Reports of Batch-Dependent Suspected Adverse Events of the BNT162b2 mRNA COVID-19 Vaccine: Comparison of Results from Denmark and Sweden 2023, Nationwide study from Denmark Identified a batch-dependent safety signal for the BNT162b2 mRNA COVID-19 vaccine 2024, Suspected adverse events (SAEs) Denmark and Sweden SAEs reported to national authorities Results Significant batch-dependent heterogeneity was found, in the number of SAEs per 1000 doses for both countries, with batches associated with high SAE rates detected in the early phase of the vaccination campaign, and positive correlations observed between the two countries for the severity of SAEs from vaccine batches that they shared. Conclusions The batch-dependent safety signal observed in Denmark and now confirmed in Sweden suggests that early commercial batches of BNT162b2 may have differed from those used later on, and these preliminary and hypothesis-generating results warrant further study.