Inflammation of the heart muscle and inflammation of the pericardium are included in the package leaflet of the corona vaccines from Pfizer/BioNTech and Moderna as possible side effects, the European Medicines Agency (EMA) announced on Friday. In very rare cases, the conditions can follow vaccination with one of the two vaccines. In addition, the EMA advises against the Janssen vaccine for people with capillary leak syndrome, a very rare disease.
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The EMA’s safety committee (PRAC) communicated about this on Friday. Symptoms of the inflammation of the heart muscle or the pericardium may include shortness of breath, a strong and possibly irregular heartbeat (palpitations) and chest pain. On the webpage about the side effects of the vaccines, the Belgian medicines agency FAMHP writes that further research is needed to determine whether there is a causal relationship with the vaccines.
The EMA conducted an in-depth investigation of 145 cases of myocarditis, inflammation of the heart muscle, after vaccination with Pfizer and 19 cases after vaccination with Moderna, all in the European Economic Area. In addition, there were also 138 cases of pericarditis (inflammation of the pericardium) after Pfizer and 19 after Moderna. And that out of a total of 177 million Pfizer doses and 20 million Moderna doses.
The cases mainly occurred within 14 days of vaccination, most often after the second dose and mostly in younger males. There have been five deaths in the European Economic Area (EEA) of people who were already ill or of old age.
In addition, the EMA therefore also recommends not to give the Janssen vaccine to people who suffer from the very rare capillary leak syndrome. At the beginning of June, the European agency had already reached the same conclusion for the AstraZeneca vaccine. Capillary leak syndrome is a very rare and serious condition in which fluid leaks from small blood vessels (capillaries), leading to swelling, especially in the arms and legs, low blood pressure, thickening of the blood and low blood levels of albumin (a protein in the blood ).
The agency’s services investigated three cases of the syndrome that occurred within two days of receiving the Janssen vaccine. Two of them died shortly afterwards. More than 18 million doses of the Janssen vaccine have already been administered worldwide.
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