Pfizer says COVID-19 vaccine is safe and effective for children ages 5 to 11
Data has shown that the Pfizer and BioNTech COVID-19 vaccine is safe and effective for children ages 5 to 11, the companies announced Monday morning.
We’re told there were a total of 2,268 participants in the ages 5 to 11 trial, which used a lesser dose than the amount given to people ages 12 and older, for the “safety, tolerability and immunogenicity” of younger children.
In a news release, the company said that “in participants 5 to 11 years of age, the vaccine was safe, well-tolerated, and showed robust neutralizing antibody responses”.
Pfizer and BioNTech plan to share their date with the U.S. Food and Drug Administration, European Medicines Agency, and other regulators soon, and plan to submit a request for emergency use authorization in the U.S.
The FDA has already approved the Pfizer vaccine for people ages 16 and older, and is currently authorized for emergency use in children ages 12 to 15.
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, according to the companies.
Pfizer has also received emergency use authorization from the FDA to give a third dose of the vaccine to those 12 years and older who have certain kinds of immunocompromise.