The FDA is expected to take several weeks to look over and analyze data that was collected by the companies and included over 2,000 children.
"These data have been shared with the FDA for the Agency’s initial review. A formal submission to request Emergency Use Authorization (EUA) of the companies’ COVID-19 vaccine in children 5 to <12 years of age is expected to follow in the coming weeks. Submissions to the European Medicines Agency (EMA) and other regulatory authorities are also planned," Pfizer said.
Pfizer is the only fully approved FDA vaccine, which is also authorized for emergency use in children aged 12 to 15.
Earlier on Sept. 23, CDC endorsed Pfizer’s COVID-19 booster shots for individuals Aged 65+ and vulnerable population.
On Sept. 27, U.S. President Biden received Pfizer’s booster shot.
"I know it doesn't look like it, but I am over 65," President Biden, said while receiving the booster shot. "Way over. And that's why I'm getting the booster shot today."