Vaccination of children aged 5 to 11: are the data “too weak” to rule out the risk of myocarditis?

With the opening of vaccination to children over 5, all eyes are on the United States. A real human-sized laboratory for France, the country has authorized vaccination against Covid-19 for the youngest since November 3. But according to some Internet users, the American data on the subject does not make it possible to rule out the risk of myocarditis for this public. “The number of participants in the current clinical development program is too small to detect the risks of myocarditis associated with vaccination”, regretted a user on December 12. What is it really?

To support his argument, this user posted a screenshot of a document from the Food and Drug Administration (FDA). These are the conclusions published last October 26 by this administration responsible in particular for the marketing of drugs. In his “general conclusions on risks and benefits” vaccination with Pfizer for this age group, the FDA noted that “no case of myocarditis or pericarditis was observed during the vaccination period and three months after the second dose”. However, she specifies that she observed that the number of participants in this observational study was “too weak to detect any risk of myocarditis associated with vaccination”.

That said, these are not the latest data available. This document, used during a meeting at the end of October, only covered 2,250 participants, including 1,518 vaccinated children aged 5 to 12 years. However, since then, nearly 5 million children have been immunized in the country. Other data have therefore come to definitively rule out this risk. This is the US Centers for Disease Control and Prevention (CDC) analysis of reports recorded by VAERS, the national pharmacovigilance program.

Published on December 13, 2021, it concerns a much larger cohort, of 7 million doses. And out of all of these vaccinated people, only eight reports of myocarditis were confirmed, with a clinical outcome. “light”. What push the CDC to write that “adolescents aged 12 to 17 have a higher risk of myocarditis than children aged 5 to 11 ”.

A posture confirmed by the director of the centers, Rochelle Walensky. In an interview with ABC News, the latter undoubtedly asserted that “Real-life surveillance shows vaccines are safe for young children”. And to confirm that “CDC has not identified any problems related to myocarditis.”

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