The Moderna laboratory said on Sunday that US health authorities were delaying the approval of its COVID-19 vaccine for adolescents, in order to give itself time to better assess the risks of myocarditis.
• Read also: U.S. committee recommends Pfizer’s COVID-19 vaccine for ages 5-11
• Read also: After Pfizer, Moderna announces positive results for its vaccine in young children
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.
- Listen to the interview of Dr. Olivier Drouin, pediatrician in Ste-Justine and clinician researcher at the school of public health, specialist in behavioral sciences at the microphone of Sophie Durocher on QUB radio:
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 for injection in a lower dose, in the United States, 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.
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