Pfizer and BioNTech submit data to U.S. FDA for COVID-19 vaccine in younger children

Pfizer Inc. and BioNTech SE submitted initial trial data for their COVID-19 vaccine in children aged 5 to 11 to U.S. regulators on Tuesday and said they would make a formal request for emergency use authorization in the coming weeks.

Coronavirus infections have soared in children and hit their highest point in early September, according to data from the American Academy of Pediatrics.

The vaccine, which is already authorized in teens aged 12 to 15 and fully approved for ages 16 and up in the U.S., 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 authorized in kids aged 12-15 roughly a month after the companies filed for authorization. If the same timeline is followed for this application, kids could start receiving their shots as soon as late October.

A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide.

While kids 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.

In a statement, Pfizer Canada said it is preparing to make a submission to Health Canada on the potential authorization of a COVID-19 vaccine for use in children aged five to 11. However, the company didn't provide any timelines on when exactly that would happen.