PRAC December 2021 – Assessment of recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax
December 9, 2021
During the December 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has assessed recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax.
Source: FAMHP
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.