Pfizer submits data to FDA on COVID-19 vaccine for kids ages 5 to 11

Data on the Pfizer-BioNTech coronavirus vaccine's effectiveness in children ages 5 to 11 has been submitted to the US Food and Drug Administration, the companies said Tuesday. Though the companies must still formally submit an application for emergency use authorization, it's the latest step toward getting younger kids vaccinated against COIVD-19. 

Pfizer and BioNTech previously released the results of the trial, which included 2,268 children, two-thirds of whom were given a lesser dose than that given to people aged 12 and up. The group was given two doses of the Pfizer-BioNTech vaccine three weeks apart, and were compared with others who received a saltwater placebo.

"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population," Albert Bourla, Pfizer's chairman and CEO, said in a Sept. 20 release. 

The COVID-19 vaccines are highly effective in preventing hospitalization. As some states see record numbers of cases, unvaccinated people have accounted for nearly all the hospitalizations and deaths -- over 97% as of July. With kids returning to classrooms, COVID-19 cases in children have also been "exceptionally high," according to the American Academy of Pediatrics, which noted that Thursday marked the "fifth consecutive week with over 200,000 child cases added."

Pfizer said that in the coming weeks it plans to formally submit its COVID vaccine for an emergency use authorization in the US for children ages 5 to 11. The company also plans to make submissions to the European Medicines Agency and other regulatory authorities around the world.