Pfizer Inc and BioNTech have asked US regulators to approve emergency use of their Covid-19 vaccine for children aged five to 11, Pfizer said in a tweet on Thursday.
The application to the US Food and Drug Administration comes as Covid-19 infections have soared in children, hitting their highest point in the pandemic in early September, according to data from the American Academy of Pediatrics.
The FDA has set a date of Oct 26 for outside advisers to meet and discuss the Pfizer application, making it possible for kids to begin receiving the vaccines shortly afterwards.
A rapid authorisation could help mitigate a potential surge of cases this fall, with schools already open nationwide.
The vaccine, which is already authorised in 12 to 15-year-olds and fully approved for ages 16 and up, has been shown to induce a strong immune response in the target age group in a 2,268 participant clinical trial, the companies said on Sept 20.
The Pfizer-BioNTech vaccine was authorised in kids aged 12-15 roughly a month after the companies filed for authorisation.
While children are less susceptible to severe Covid-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness.