Pfizer and BioNTech introduced Thursday that that they had submitted an emergency request to the U.S. Meals and Drug Administration for authorization of the businesses’ two-dose Covid-19 vaccine in kids ages 5 to 11.
“With new circumstances in kids within the U.S. persevering with to be at a excessive stage, this submission is a vital step in our ongoing effort towards #COVID19,” Pfizer tweeted. “We’re dedicated to working with the FDA with the last word purpose of serving to shield kids towards this severe public well being menace.”
An FDA advisory committee plans to satisfy to debate authorization on Oct. 26.
The businesses mentioned final month that the vaccine was protected in kids 5 to 11 and confirmed a “sturdy” antibody response based mostly on knowledge collected in a trial that included greater than 2,000 kids.
In the course of the trial, kids got two smaller doses than these given to people who find themselves 12 and older. Pfizer and BioNTech mentioned the photographs produced antibody responses and negative effects that had been akin to these seen in an identical research of individuals 16 to 25 who obtained the complete dose of the vaccine.
Pfizer first utilized for emergency use authorization for its vaccine for adults in November. The FDA in August granted full approval to the vaccine for individuals ages 16 and older, changing into the primary vaccine towards the coronavirus to move this closing regulatory hurdle.
The vaccine is at the moment given to 12- to 15-year-olds below the FDA’s emergency use authorization.
In line with knowledge by the Facilities for Illness Management and Prevention, greater than 186 million People have been totally vaccinated.
Pfizer’s photographs are one in all three which are getting used within the U.S, together with Moderna’s two-dose vaccine and Johnson & Johnson’s single-shot vaccine. Moderna and Johnson & Johnson are nonetheless within the analysis part of the photographs getting used for kids 5 to 11.
This can be a breaking story; test again for updates.