Following suit with the USA and Great Britain, the two mRNA vaccines are now also receiving new side effect warnings for myocarditis and pericarditis in the product information in the EU. The change is based on a recommendation by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). This recommendation is based on an in-depth review of 145 cases of myocarditis in the European Economic Area (EEA) in people who had received Comirnaty and 19 cases in people who had been vaccinated with Spikevax. The PRAC Safety Committee also reviewed reports of 138 cases of pericarditis after using Comirnaty and 19 cases after using Spikevax.
By 31 May, 2021, approximately 177 million doses of Comirnaty and 20 million doses of Spikevax had been administered in the EEA. The PRAC also examined cases received worldwide. According to the EMA, most of those affected developed the symptoms within 14 days of vaccination. Most often this occured after the second dose and in younger adult men. Five cases were fatal. The deceased were either of advanced age or had comorbidities. The available data suggest that the course of myocarditis and pericarditis after vaccination is similar to the typical course of these conditions and usually improves with rest or treatment. The EMA urges doctors to look out for the signs and symptoms of myocarditis and pericarditis in people who have received these vaccines. People who have received these vaccines should be advised to see a doctor immediately if they experience acute and persistent chest pain, palpitations, or shortness of breath after vaccination.