The Moderna laboratory said on Sunday that US health authorities are delaying approval of its COVID-19 vaccine for adolescents, in order to give itself time to better assess the risks of myocarditis.
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On Friday evening, the US drug agency FDA “informed Moderna that it needed more time to assess recent international analysts of the risk of myocarditis after vaccination,” Moderna said in a statement.
This review on the recommendation of the Moderna vaccine for 12 to 17 year olds could last until January 2022, specifies the laboratory.
An increased risk of myocardial inflammation has been described for COVID-19 vaccines, including Moderna, especially in young men and after the second dose.
According to the Centers for Disease Prevention and Control (CDC) in the United States, these myocarditis following vaccination with mRNA vaccines are “rare and generally benign,” Moderna says.
The rival vaccine Pfizer-BioNtech has just been authorized in the United States to be injected, in lower doses, in children aged 5 to 11 years.
Moderna had already announced that he was waiting, before also requesting the green light from the FDA for this age group, for the drug agency to decide on its vaccine for adolescents under 18 years old.