Pfizer Inc and BioNTech have asked U.S. regulators to approve emergency use of their COVID-19 vaccine for children aged five to 11, Pfizer said in a tweet on Thursday.
The U.S. Food and Drug Administration has set a date of Oct. 26 for its panel of outside advisers to meet and discuss the application, making it possible for kids to begin receiving the vaccines shortly afterwards.
A rapid authorization of the vaccine in young kids could help mitigate a potential surge of cases this fall, with schools already open nationwide.
The vaccine could be ready for roll out as early as November pending approval from federal regulatory health agencies, White House COVID-19 response coordinator Jeffrey Zients said on Thursday.
Pfizer has submitted its initial trial data to Health Canada, and plans to make a formal submission by mid-October, a spokesperson previously told Global News.
Health Canada said in a tweet Thursday that it’s aware of the FDA submission, adding its team will review the data as soon as it is received.
Children currently make up about 27 per cent of all U.S. coronavirus cases and an increasing percentage of hospitalizations, according to the American Academy of Pediatrics. That reflects the high contagiousness of the Delta variant among unvaccinated people.
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.
The vaccine is already authorized in teens aged 12-to-15 and fully approved for ages 16 and up, and 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 two drugmakers are also testing the vaccine in children ages 2-to-5 years and children ages 6 months-to-2 years, with data expected in the fourth quarter.
(Reporting by Susan Heavey in Washington, Manas Mishra and Manojna Maddipatla in Bengaluru; Editing by Timothy Heritage and Saumyadeb Chakrabarty)
— With files from Global News.
Comments