The Safety Committee of the European Medicines Agency (EMA) has updated information on the side effects of the Pfizer / BioNTech and Moderna COVID-19 vaccines.
The regulator’s report says that the drugs Comirnaty (Pfizer / BioNTech) and Spikevax (Moderna) in extremely rare cases can lead to myocarditis and pericarditis.
In the European Union, after using 177 million doses of Pfizer vaccine, 145 cases of myocarditis, pericarditis – 138 were detected. Among about two million people vaccinated with Moderna, 19 cases of both heart diseases were identified.
At the end of June, the US pharmaceutical regulator, the FDA, announced the expansion of the accompanying documentation for the Pfizer and Moderna vaccines: they added warnings about the rare side effect of myocarditis or pericarditis. Three hundred million doses of these drugs have been used in the United States at the end of June. As a result, about 1200 cases of such diseases were registered. About 300 people under the age of thirty were admitted to the hospital, but almost all of them were discharged immediately after the examination.
Myocarditis is an inflammatory disease of the heart muscle of the myocardium, pericarditis is an inflammatory lesion of the serous membrane of the heart.
In mid-June, World Health Organization Assistant Director-General Marianjela Simao announced that WHO is studying data on cases of heart muscle inflammation following Pfizer’s coronavirus vaccination. Simao added that WHO will release all information as soon as scientific evidence becomes available.