Pfizer announced on Monday that its Phase 2/3 trial proved its COVID-19 vaccine was safe and effective in kids ages 5 to 11.
“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,” Pfizer CEO Albert Bourla said.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine,” Bourla added. “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’s trial involved 2,268 children ages 5 and 11 and gave two doses of the vaccine administered three weeks apart.
“The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” Pfizer said in a press release Monday.
