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.
Myocarditis and pericarditis are inflammatory conditions of the heart. Symptoms can vary but often include breathlessness, a forceful heartbeat that may be irregular (palpitations), and chest pain.
In reaching its conclusion, the Committee took into consideration all currently available evidence.
This included an in-depth review of 145 cases of myocarditis in the European Economic Area (EEA) among people who received Comirnaty and 19 cases among people who received Spikevax. PRAC also reviewed reports of 138 cases of pericarditis following the use of Comirnaty and 19 cases following the use of Spikevax. As of 31 May 2021, around 177 million doses of Comirnaty and 20 million doses of Spikevax had been given in the EEA.
In addition the PRAC also looked into cases received worldwide.
The Committee concluded that the cases primarily occurred within 14 days after vaccination, more often after the second dose and in younger adult men. In five cases that occurred in the EEA, people died. They were either of advanced age or had concomitant diseases. Available data suggest that the course of myocarditis and pericarditis following vaccination is similar to the typical course of these conditions, usually improving with rest or treatment.
Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. They should tell people receiving these vaccines to seek immediate medical attention if symptoms indicative of myocarditis or pericarditis occur. These include breathlessness, a forceful heartbeat that may be irregular and chest pain.
Healthcare professionals should consult applicable guidance and/or consult specialists (e.g. cardiologists) to diagnose and treat these conditions.
At this point in time, no causal relationship with myocarditis or pericarditis could be established with two other COVID-19 vaccines authorised in the EEA, COVID-19 Vaccine Janssen and Vaxzevria, and the Committee has requested additional data from the companies marketing these vaccines.
EMA confirms that the benefits of all authorised COVID-19 vaccines continue to outweigh their risks, given the risk of COVID-19 illness and related complications and as scientific evidence shows that they reduce deaths and hospitalisations due to COVID-19.
As for all vaccines, EMA will continue to monitor the vaccines’ safety and effectiveness and provide the public with the latest information, particularly as more adolescents and young adults are vaccinated and more second doses are given. The agency will take necessary action if any new safety issues are identified.