Data shows the Pfizer and BioNTech COVID-19 vaccine is safe and effective for children ages 5 to 11, the companies announced Monday morning.
"We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the delta variant and the substantial threat it poses to children," Pfizer chairman and CEO Albert Bourla said in a statement. "Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. -- underscoring the public health need for vaccination."
There were 2,268 participants ages 5 to 11 in the trial, which, while it still followed a two-dose regimen, used a lesser dose than the amount given to people ages 12 and older, for the "safety, tolerability and immunogenicity" of younger children.
"In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralizing antibody responses," the companies said in a news release.
Pfizer and BioNTech plan to share their data with the U.S. Food and Drug Administration, the European Medicines Agency and other regulators soon and will submit a request for emergency use authorization in the United States.
The FDA approved the Pfizer vaccine, which is marketed as Comirnaty, for people ages 16 and older in August. It is currently authorized for emergency use in children ages 12 to 15.
"These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency," Bourla said.
Results from two other ongoing trials -- one of children ages 2 to 5 and one of children 6 months to 2 years old -- are expected as soon as later this year, the companies said.
Pfizer has also received emergency use authorization from the FDA to give a third dose of vaccine to those 12 years of age and older who have been determined to have certain kinds of immunocompromise.
However, a panel advising the federal government on vaccines recently rejected President Joe Biden's suggestion to roll out booster shots for all Americans, recommending that for now, a third dose should only be given to those 65 and older or those at high risk of severe COVID-19.