The efficacy or benefit-risk ratio of the vaccine is not questioned. However, after publishing the results of a large study conducted by the Epi-Phare structure, the High Health Authority of France (HAS) advises against the use of the Moderna vaccine for those under the age of thirty, In an opinion released on Monday.
So, it implemented Epi-Phare, which links the Health Insurance (Cnam) and the Medicines Agency (ANSM) Great study On people aged 12 to 50 hospitalized in France with myocarditis or pericarditis between May 15 and August 31, that is 919 cases of myocarditis and 917 cases of pericarditis. Myocarditis and pericarditis are infections of the heart. The first affects the myocardium, the main heart muscle, and the second affects the pericardium, the membrane surrounding the heart.
Increased risk of heart disease
As indicated by the pharmacovigilance reports, the results of the French study confirm that Pfizer and especially Moderna vaccines increase the risk of developing these diseases that occur within seven days after vaccination, and more often in men under 30 years old. “The association with the risk of developing myocarditis is particularly evident in young people under the age of 30, particularly after the second dose of Moderna vaccine, leading to an increase in cases to about 132 per million doses in this population,” the study details. If women are less anxious, “this risk also increases in young women under 30 years of age after the second dose of both vaccines,” Epi-Phare warns.
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Given these findings, the World Health Assembly “recommends, for the population under 30 years of age and when available, the use of the Pfizer vaccine as either a primary or a booster vaccination.”
A l’inverse, elle recommande que le vaccin moderna, “dont l’efficacité vaccinale semble légèrement meilleure, puisse être utilisé en primovaccination et pour l’administration d’uneets dose de rappel en demi-dose chez de les les 30 plus years”. On October 15, the Supreme Health Authority recommended the use of the Pfizer/BioNtech vaccine exclusively for booster doses.
Suspicions of an increased risk of developing one of these diseases are not new. Nordic countries such as Sweden, Norway and Finland stopped this vaccine against Covid-19 in men under the age of 30 in October. As early as June, US health authorities indicated a “possible” link between vaccines from Pfizer and Moderna and rare cases of inflammation in the heart in teenagers and young adults.
“The Moderna vaccine is likely to be a little overdose compared to Pfizer,” L’Express Professor Mathieu Molimard, chief of clinical pharmacology at Purdue University Hospital, analyzed in mid-October. This dose allows to obtain a slightly more effective result, if we look at the results “under the microscope” and in a very accurate way (on the order of 2 or 3 points of more protection), compared to the Pfizer vaccine. But the corollary to that is that if you take a little more dose, you also risk seeing more side effects, and that’s probably what we’re seeing here.”
Given that France feeds more Pfizer than Moderna, “the number of cases of myocarditis or pericarditis that we have is still very low,” the scientist confirmed last month.
The benefits and risks are still in favor of the vaccine
In all cases, the benefit-risk ratio remains in favor of the vaccine. Especially since, according to Matthew Mollemare, if there is little risk of increased myocarditis with this vaccine, “this is benign myocarditis.” “When we balance the efficacy of vaccines against severe forms of Covid-19 (estimated around 90%) and the current but rare risks of developing myocarditis and pericarditis, with positive development, the benefit-risk ratio of vaccines is not questioned,” added Mahmoud Zureik, Director of Epi Structure -Phare Monday.
The American Society for Vaccination, for its part, reiterates the necessity of vaccination as widely as possible: “The epidemic currently indicates a resumption of which its development is difficult to predict, but the winter period, which begins in conjunction with the expected decrease in the effectiveness of vaccines in people vaccinated before the summer, reminds us once again of the importance of getting better Possible vaccination coverage for the entire population and especially for people most vulnerable to infection with a severe form of Covid-19.” It also considers it necessary to “maintain a high level of protection by administering a booster dose in the most vulnerable and most vulnerable populations”.
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The Health Defense Council is scheduled to convene on Tuesday morning in Paris. And in the evening, President Emmanuel Macron will address the French again to discuss the health crisis in particular.