Pfizer Inc. and BioNTech asked regulators in the United States to allow the use of its COVID-19 vaccine for children aged 5 to 11, Pfizer said in a tweet on Thursday. If regulators agree, shots could begin within a matter of weeks.
The application to the U.S. Food and Drug Administration (FDA) 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 afterward.
A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide.
The vaccine, which is already authorized 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 authorized in kids aged 12-15 roughly a month after the companies filed for authorization.
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.
