These risks would be particularly high after the second dose with the Moderna vaccine, which led the High Health Authority to advise against it for people under 30.
- The director of the Epi-Phare structure explained that the risk-benefit ratio of vaccines is not called into question.
- Vaccination would thus be the cause of 132 additional cases of myocarditis per million doses administered.
- For pericarditis, there would be an excess of about 18 cases per million doses in young men.
The study of vaccines in real life continues to provide information on their side effects. This Monday, November 8, the Epi-phare survey, a scientific interest group in epidemiology created by Health Insurance (Cnam) and the National Medicines Safety Agency (ANSM), confirmed the existence of risks of myocarditis and pericarditis after the injection of vaccines to messenger RNA. This risk would be even higher after the second dose of Moderna.
A risk within seven days of the second injection
The study focused on people aged 12 to 50 hospitalized in France for myocarditis or pericarditis between May 15 and August 31, i.e. 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 envelops the heart.
This confirmed that mRNA vaccines, in this case Pfizer and especially Moderna, increase the risk of occurrence of these diseases within 7 days of vaccination. A risk confirmed after each case was compared to 10 “controls” of the same age, same sex and same department of residence. The risks of occurrence of hospitalization for myocarditis or pericarditis were thus compared between vaccinated and unvaccinated in otherwise similar situations.
The risk-benefit ratio is not called into question
The risk appears to be greatest in men under the age of 30 after the second injection of Moderna. Vaccination would thus be the cause of 132 cases – including 37 in women – of additional myocarditis per million doses administered. For pericarditis, there would be an excess of about 18 cases per million doses in young men. “When we balance the effectiveness of vaccines against severe forms of Covid-19 (estimated at around 90%) against these existing but infrequent risks, and with favorable evolution, the benefit-risk ratio of vaccines is not not questioned”, concluded Mahmoud Zureik, director of the Epi-Phare structure.
These conclusions, however, led the High Authority for Health (HAS) to advise against injection of the Moderna vaccine for those under 30 years of age. Only the Pfizer product is now recommended for young people. A suspension confirmed on Tuesday by the Ministry of Health.
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