The US drug authority FDA suspects a link between Pfizer’s covid vaccine and the risk of an inflamed heart muscle or pericardium, especially in young men. She therefore expands the package leaflet with a warning.
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The US drug agency FDA on Friday added a warning about the risk of rare heart infections to the package leaflet of the corona vaccines from Pfizer and Moderna. It states that there are reports of side effects after the second dose of the vaccines. Specifically, this concerns an increased risk of inflammation of the heart muscle (myocarditis) and the pericardium (pericarditis).
‘Vaccinate everyone over the age of 12’
The warning comes after the US Centers for Disease Prevention (CDC) registered and confirmed 393 cases in people younger than 30 who had received a Pfizer or Moderna vaccine. That is more than predicted without vaccination. The number of cases is markedly higher in men, and in the week after the administration of the second dose.
The possible side effect is very rare. Preliminary data indicate an incidence of 12.6 in 1 million. The CDC is sticking to their recommendation to vaccinate everyone over the age of 12. The health service does encourage medical personnel to pay special attention to symptoms such as sudden chest pain, shortness of breath and palpitations after vaccination.
Previously in Israel
Israel previously reported a “more likely” link between vaccination in young men between the ages of 16 and 19 and inflammation of the heart or surrounding tissue. The frequency of the side effect in Israel in this age group is 5 to 25 times higher than the normal rate of myocardial inflammation among young men, according to the trade journal Science.
Unlike in Israel, few teenagers in the European Union have been vaccinated against Covid. The European figures on side effects therefore mainly concern the elderly, who are by nature less sensitive to inflammation of the heart tissue than young people.
Not enough data
The European Medicines Agency (EMA) is looking at 122 cases of myocarditis and 126 cases of pericarditis reported before the end of May. At that time, 160 million doses of the Pfizer vaccine had already been administered.
The agency continues to investigate the matter, but does not yet have enough data to determine whether there is a link to the vaccine. It also assesses the risk of damage from a corona infection in this age group as (much) greater than the risk of serious side effects and thus follows the recommendation of the CDC.
Pfizer is aware of the side effects reported, but did not see any association in its studies.
Myocarditis and pericarditis are naturally triggered by viral and bacterial infections. This happens to between 1 and 10 in 100,000 people every year. The inflammation often goes away on its own, if not treatment with anti-inflammatories helps in most cases. Very rarely, the ailment leads to admission to the intensive care unit or even death.
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