US pharmaceutical company Pfizer has filed a request before the US Food and Drug Administration (FDA) this week for an emergency clearance to vaccinate children aged 5 to 11 with a 10-microgram booster dose against the SARS-CoV-2 Omicron variant.
In the event of a positive response, the Centers for Disease Control and Prevention (CDC), the country's lead federal health agency, will be required to issue its recommendations before the first injections are administered.
A similar request is to be sent in the coming days to the European Medicines Agency (EMA).
The new generation of anticovid vaccine, called bivalent, targets both the original coronavirus strain 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 aged 5 to 18 years have died in the United States since the start of the pandemic, according to CDC figures.
In late August, the FDA cleared the Pfizer-BioNTech and Moderna versions of the vaccines aimed at Omicron, and the CDC later recommended them, paving the way for a new vaccination campaign. But only people 12 years and older for the Pfizer-BioNTech vaccine and 18 years and older for the Moderna vaccine are currently authorized to receive this specific booster dose.
The modified vaccines made by Pfizer and its rival Moderna offer Americans the opportunity to get the most up-to-date protection in another critical period of the pandemic. They are combination or bivalent shots: half the original vaccine and half the protection against the omicron BA.4 and BA.5 versions that now cause nearly all COVID-19 infections, it was reported.