Pfizer and BioNTech asked U.S. health authorities on Monday for authorization of their anticovid vaccine specifically targeting the omicron variant for children ages 5 to 11, the two groups announced in a press release.
The emergency authorization request to the FDA, the US drug agency, is for a booster dose of 10 micrograms.
In the event of a positive response from the FDA, the Centers for Disease Control and Prevention (CDC), the main federal health agency in the country, will have to issue their recommendations before the first injections are administered to children.
A similar authorization request will be sent in the coming days to the European Medicines Agency (EMA), specifies the press release.
The new generation of anticovid vaccine, called bivalent, targets both the original strain of the coronavirus and the BA.4 and BA.5 lineages of the omicron variant, which currently account for more than 90% of infections in the United States.
While children have been less affected by Covid-19 than adults, several hundred children ages 5 to 18 have died in the United States since the start of the pandemic, according to CDC figures.
In late August, the FDA licensed the omicron-targeted versions of the Pfizer-BioNTech and Moderna vaccines, and the CDC then recommended them, paving the way for a new vaccination campaign.
But only people over 12 years of age, for the Pfizer-BioNTech vaccine, and 18 years of age for the Moderna vaccine, are currently authorized to receive this specific booster dose.