Pfizer Inc and BioNTech have asked US regulators to approve emergency use of their COVID-19 vaccine for children aged five to 11, Pfizer said in a tweet on Thursday.
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The US 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.
Children currently make up about 27% of all US 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.
Pfizer Inc's new vaccine for children aged five to 11 could be ready as early as November pending approval from federal regulatory health agencies, White House COVID-19 response coordinator Jeffrey Zients said on Thursday.
Once the authorization is complete, Zients said: "We are ready. We have the supply. We're working with states to set up convenient locations for parents and kids to get vaccinated including pediatricians' offices and community sites."
Asked if he thought vaccines could begin before the US Thanksgiving Day holiday at the end of November, Zients said, "Up to the FDA and CDC scientific processes, but yes it could."
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