The American biotechnology company Moderna announced this Sunday (31) that authorities have delayed the authorization of its vaccine against covid-19 for teenagers, in order to gain more time to better assess the potential risk of myocarditis or cardiac inflammation.
The US Food and Drug Administration (FDA) “informed Moderna that the agency requires additional time to assess recent international analyzes of the risk of myocarditis after vaccination,” the company explained in a statement.
The evaluation to determine whether or not the Moderna vaccine should be recommended for 12 to 17-year-olds could last until January 2022, the company anticipated.
Myocarditis and an associated risk, pericarditis (inflammation around the heart), have previously been associated with Pfizer and Moderna anti-covid vaccines, particularly among adolescents and young men.
However, the risk is much higher after covid-19 infection, according to a study published in August by the US Centers for Disease Control and Prevention (CDC).
The CDC found that “myocarditis following vaccination with mRNA vaccines was unusual and generally mild,” said Moderna.
Another mRNA vaccine, that of Pfizer-BioNTech, received US clearance on Friday for children ages 5 to 11, at lower doses than for adults.
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