The Safety Committee of the European Medicines Agency (EMA) has updated information on side effects from Pfizer/BioNTech and Moderna COVID-19 vaccines.
The regulator’s report says that Comirnaty (Pfizer/Biotech) and Spikevax (Moderna) drugs can lead to myocarditis and pericarditis in extremely rare cases.
In the European Union, after using 177 million doses of Pfizer’s vaccine, 145 cases of myocarditis and 138 cases of pericarditis were detected. Among about two million people vaccinated with Moderna, 19 cases of both heart diseases were detected.
At the end of June, the US pharmaceutical regulator, the FDA, announced the expansion of the accompanying documentation of Pfizer and Moderna vaccines: it added warnings about a rare side effect in the form of myocarditis or pericarditis. In the United States, as of the end of June, three hundred million doses of these drugs were used. As a result, about 1,200 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, Mariangela Simao, assistant Director-General of the World Health Organization, said that WHO is studying data on cases of inflammation of the heart muscle after vaccination against coronavirus with a Pfizer drug. Simao added that the WHO will release all the information as soon as scientific data becomes available.