Moderna has filed an application for authorization of its vaccine against Covid-19 for children aged 6 to 11 with the European regulator, the American biotechnology company announced on Tuesday, November 9.
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The dosage of the two injections, administered four weeks apart, was adjusted to 50 micrograms, against 100 micrograms for the older age groups. "
We are pleased to announce the filing of this variant with the EMA
", the European Medicines Agency, said in a statement Stéphane Bancel, boss of Moderna. “
This marks our first request for use in this age group
,” he said.
Moderna's vaccine is currently authorized from the age of 12 by the EMA.
But several countries, including France on Monday, advised against the use of Moderna below a certain age (30 years in France), because of concerns about the risk of myocarditis.
This side effect has been detected especially in adolescents and young adults, especially males.
"A strong immune response"
At the end of October, Moderna announced positive results from its clinical trials for children aged 6 to 11, the vaccine having elicited "
a strong immune response
" with "
robust
"
antibody levels
detected. On Tuesday, the company delivered more details, saying that two weeks after the first dose, the vaccine was 100% effective against confirmed cases of Covid-19 causing two symptoms (such as fever, cough, loss of taste ...), or one of these symptoms and pneumonia. These efficacy results remain preliminary and will be monitored over time.
The EMA is also studying data from Pfizer, which has applied for authorization for its own vaccine in 5 to 11 year olds.
The review could be concluded in December, she said last week.
Pfizer's remedy has only recently been authorized for this age group in the United States, where Moderna's remedy is currently only authorized from the age of 18.
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The company announced at the end of October that it would not file its request for authorization for 6-11 year olds with the United States Medicines Agency (FDA) until the latter had finished its examination for 12-17 year olds.
However, the FDA has delayed the approval of Moderna's vaccine for 12-17 year olds in order to give itself time to better assess the risks of myocarditis.
This assessment could last until January 2022.