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.

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. The PRAC has recommended updating the product information accordingly.

Myocarditis and pericarditis can develop within just a few days after vaccination, and have primarily occurred within 14 days. They have more often been observed after the second vaccination.
The French and Nordic studies provide estimates of the number of extra cases of myocarditis in younger males following the second dose, compared to unexposed persons of the same age and gender.

Myocarditis and pericarditis are inflammatory conditions of the heart that present a range of symptoms, often including breathlessness, a forceful heartbeat that may be irregular (palpitations), and chest pain. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general.