BRIEF—Comirnaty clears EU pharmacovigilance hurdle

The European regulator has released a  safety update on BioNTech and Pfizer’s COVID-19 vaccine, Comirnaty, concluding that real-world data from vaccinations is consistent with the known safety profile of the vaccine, with no new side effects to report.

The agency has been collecting data since the product was launched, and intends to publish monthly safety updates for all authorised COVID-19 vaccines.

This safety update includes the assessment by EMA’s safety committee (PRAC) of deaths reported after vaccination with Comirnaty, including deaths in frail, elderly people.