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WASHINGTON — Pfizer and BioNTech have asked U.S. regulators to approve emergency use of their COVID-19 vaccine for children aged 5 to 11, Pfizer said in a tweet on Thursday.
The application to the U.S. 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 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.
UPDATE: We and @BioNTech_Group officially submitted our request to @US_FDA for Emergency Use Authorization (EUA) of our #COVID19 vaccine in children 5 to <12. pic.twitter.com/72Z2HXlkOx
— Pfizer Inc. (@pfizer) October 7, 2021
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.
