European drug authorities have concluded that the heart diseases pericarditis (myocarditis) and myocarditis (myocarditis) should be mentioned as rare side effects in the product information of the mRNA vaccines Comirnaty and Spikevax (Pfizer / BioNTech and Moderna).
It writes the Norwegian Medicines Agency in one press release.
It has been discussed before that heart disease has been one possible side effect after vaccination. The Safety Committee for Medicinal Products (PRAC) has now concluded that vaccines can lead to these heart diseases.
A final decision will be made by the EU Commission.
These are the heart diseases
Pericarditt is inflammation of the pericardium. The condition is not uncommon. The most common cause is a viral infection. It is estimated that pericarditis is the cause of about 5% of all referrals to the emergency department due to chest pain. Pericarditis occurs more frequently in men than in women. Pericarditis has a good prognosis and often requires no treatment, or only treatment with painkillers or anti-inflammatory drugs.
Myokarditt is inflammation of the heart muscle itself and can occur with, for example, viral infections, or with the use of certain drugs. Most cases are mild and often do not require treatment beyond painkillers or anti-inflammatory drugs. In rare cases, myocarditis can have a severe course with impaired heart function and heart failure.
Source: The Norwegian Medicines Agency
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Should consult a doctor
The PRAC has concluded after evaluating available data from a number of countries on the prevalence of these two diseases.
The European Medicines Agency (EMA) emphasizes that the benefits of taking the vaccines outweigh the risks of getting these heart diseases.
– Anyone who gets chest pain, shortness of breath or rapid or irregular heartbeat should see a doctor regardless of whether they have been vaccinated or not, says medical director Steinar Madsen in the Norwegian Medicines Agency in the press release.
75 cases in Norway
A total of 75 cases of these two heart diseases have been reported after vaccination.
As of 6 July, 61 cases of pericarditis (pericarditis) have been reported after vaccination in Norway. 47 of the cases come after vaccination with the Pfizer vaccine, 10 after Moderna vaccination.
In addition, 14 cases of myocarditis (myocarditis) have been reported, 10 of them after Pfizer vaccination.
The vast majority of patients had recovered or were improving when the adverse reaction report was sent.
Five deaths have been reported in the EU / EEA in connection with these diseases. Those who died were elderly or had other underlying illness.
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