9 July 2021 - EMA’s safety committee (PRAC) has concluded that myocarditis and pericarditis can occur in very rare cases following vaccination with the COVID-19 vaccines Comirnaty and Spikevax (previously COVID-19 vaccine Moderna).
The Committee is therefore recommending listing myocarditis and pericarditis as new side effects in the product information for these vaccines, together with a warning to raise awareness among healthcare professionals and people taking these vaccines.