WASHINGTON, D.C. (ABC) – Data shows the Pfizer and BioNTech COVID-19 vaccine is safe and effective for children ages 5 to 11, the companies announced Monday morning.
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.
“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.