Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November – 2 December 2021

PRAC update on risk of myocarditis and pericarditis with mRNA vaccines

EMA’s safety committee (PRAC) has assessed recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax (previously COVID-19 Vaccine Moderna). This review included two large European epidemiological studies. One study was conducted using data from the French national health system (Epi-phare) and the other one was based on Nordic registry data.

Overall, the outcome of the review confirms the risk of myocarditis and pericarditis, which is already reflected in the product information for these two vaccines, and provides further details on these two conditions.

Based on the reviewed data, the PRAC has determined that the risk for both of these conditions is overall “very rare”, meaning that up to one in 10,000 vaccinated people may be affected. Additionally, the data show that the increased risk of myocarditis after vaccination is highest in younger males…