European PRAC safety information relating to very rare cases of myocarditis and pericarditis with mRNA COVID-19 vaccines

Following a review of very rare cases of myocarditis and pericarditis in people who received Comirnaty (Pfizer) and Spikevax (Moderna) vaccines, PRAC is advising healthcare professionals to be alert to the signs and symptoms and seek medical attention if required.

SPS commentary:

The conclusion was based on an in-depth review of 145 cases of myocarditis people who received Comirnaty and 19 cases among people who received Spikevax. PRAC also reviewed reports of 138 cases of pericarditis with Comirnaty and 19 cases with Spikevax. As of 31 May 2021, around 177 million doses of Comirnaty and 20 million doses of Spikevax had been given in the EEA.

The Committee is therefore recommending listing myocarditis and pericarditis as new adverse effects in the product information for these vaccines, together with a warning to raise awareness among healthcare professionals and people taking these vaccines.

European Medicines Agency