EMA Publishes Vaccine Safety Update on Comirnaty

The European Medicines Agency (EMA) has issued the first safety update on a COVID-19 vaccine—Comirnaty (Pfizer/BioNTech vaccine)—according to a Jan. 29, 2020 press release.

Reflecting data collected and assessed since the regulatory authorization of Comirnaty, the safety update concludes that the safety of the vaccine as seen in vaccination campaigns is consistent with the known safety profile, with no new side effects identified. Data from EudraVigilance along with data from other sources, such as the company’s monthly safety report, have been included in the update.

Additionally, the update includes the assessment by EMA’s safety committee (PRAC) on the number of deaths reported after vaccination with Comirnaty. According to its assessment, PRAC found that the data did not show a link between the vaccination and cases of death, and the number of cases did not raise a safety concern.

EMA reported in the release that the safety and effectiveness of Comirnaty will be continually monitored as it is used across Europe and globally through its pharmacovigilance system.

Source: EMA