Messenger RNA vaccines against Covid-19 increase the risk of myocarditis and pericarditis, but this is infrequent and does not call into question the benefit of vaccination, a large French study said on Monday.

Led by the Epi-Phare structure, which brings together the Health Insurance (Cnam) and the Medicines Agency (ANSM), this case-control study focused on people aged 12 to 50 years hospitalized in France for myocarditis or pericarditis between May 15 and August 31, or 919 cases of myocarditis and 917 cases of pericarditis.

Myocarditis and pericarditis are inflammations of the heart.

The first affects the myocardium, the main heart muscle, and the second the pericardium, the membrane that surrounds the heart.

As had been shown by pharmacovigilance reports, the results of the French study confirm that Pfizer and especially Moderna vaccines increase the risk of these diseases occurring within 7 days after vaccination.

No deaths reported among people hospitalized

Each case was compared to 10 "controls", who have the same age, sex and department of residence, but did not have myocarditis. The risks of hospitalization for myocarditis or pericarditis were thus compared between vaccinated and unvaccinated in otherwise similar situations. These risks appear to be more marked, even if low, in men under 30, especially after the second dose of Moderna. Vaccination with the latter would thus be the cause of 132 additional cases of myocarditis per million doses administered.

In women under 30, the excess myocarditis attributable to the second dose of Moderna is estimated to be in the order of 37 per million doses.

As for the risk of pericarditis, it also appears to be more marked after the Moderna vaccine in those under 30 years of age, in particular after the second dose which would be the cause of an excess of cases of around 18 per million doses in young men.

No deaths have been reported among people hospitalized for these conditions while following vaccination.

"Existing but infrequent risks"

"When we weigh the effectiveness of vaccines against severe forms of Covid-19 (estimated at around 90%) and these existing but infrequent risks, and with favorable development, the benefit-risk ratio of vaccines does not is not called into question ”, assures AFP Mahmoud Zureik, director of the structure Epi-Phare.

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