(CMR) Pfizer Inc and BioNTech have asked the U.S. Food and Drug Administration to authorize emergency use of their COVID-19 vaccine for children ages 5 to 11. The FDA set a date of October 26 for its panel of outside advisers to meet and discuss the application.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer said Thursday.
The vaccine has been authorized for emergency use in teens ages 12 to 15 and is fully approved by the FDA for people ages 16 and up.
A rapid authorization of the Pfizer/BioNTech vaccine in young kids could help mitigate a potential surge of cases in the coming weeks and months, with schools open nationwide and colder weather driving activities indoors, Reuters reported.
If given regulatory authorization, the two-dose Pfizer/BioNTech vaccine would become the first COVID-19 shot made available to children 5 to 11 in the United States.
Pfizer/BioNTech said the vaccine had been shown to induce a robust immune response in 5 to 11-year-olds in a 2,268-participant clinical trial.
The vaccine is also being tested in children ages 2 to 5 years old and children ages six months to 2 years.