This story was updated Sept. 28, 2021. 

Sept. 27, 2021 -- Pfizer-BioNTech plans to ask for authorization of its COVID-19 vaccine for kids under 12 soon, which could make the shot available to ages 5-11 this fall and on Tuesday submitted data from clinical trials to the FDA. 

"These results are the first from a pivotal trial of any COVID-19 vaccine in this age group," Pfizer CEO Albert Bourla, PhD, said on Twitter. "Our formal submission to request emergency use authorization will follow in the coming weeks."

Sunday on ABC News's This Week, Bourla said the data would be coming soon. 

“And then it is up to the FDA to be able to review the data and come to their conclusions and approve it or not,” he said. “If they approve it, we will be ready with our manufacturing to provide this new formulation of the vaccine.”

Once Pfizer sends clinical trial data to the FDA, independent committees for the FDA and CDC will review it. If the paperwork is submitted this week, the committees will likely review the information in October, according to CNN.

Nearly 26% of all COVID-19 cases nationwide are being reported in children, according to the latest data from the American Academy of Pediatrics, though children under age 18 make up 22% of the U.S. population.

More than 225,000 cases were reported during the past week, marking the third highest number of child cases in a week since the pandemic began. In addition, about 266 children were hospitalized with COVID-19 each day last week, CNN reported.

“After declining in early summer, child cases have increased exponentially, with over 925,000 cases in the past 4 weeks,” the AAP said.

Scott Gottlieb, MD, a former FDA commissioner, said he encourages parents to vaccinate their children when they’re eligible for the shot.

“This is a dangerous pathogen,” Gottlieb, a member of the Pfizer board of directors, told CNN on Sunday. “I wouldn’t be so cavalier about this virus. We know that this virus has long-term consequences in a lot of people who contract it, including children.”

Also on Sunday, Bourla said the U.S. should distribute first doses and booster shots of the COVID-19 vaccine at the same time.

“It’s not, ‘Shall we give boosters or give primary doses to other people?’” he said. “I think the answer should be, ‘Let’s give both boosters and doses for other people.’”

Out of the 2 billion doses that Pfizer has produced so far, 500 million have gone to middle- or low-income countries, he said. During the rest of the year, the company will produce another 1 billion doses, and 500 million of that will go to other countries.

“And 1 billion of these doses will have gone to low- and middle-income countries,” he said. “That will not change because of the approval or not of boosters.”

WebMD Health News Brief

Sources

ABC News: “‘This Week’ Transcript 9-26-21: Speaker Nancy Pelosi, Albert Bourla & Brian Murphy.”

CNN: “In a matter of days, Pfizer CEO says they’ll be ready to ask for approval of a Covid-19 vaccine for kids.”

American Academy of Pediatrics: “Children and COVID-19: State-Level Data Report.”

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