Pfizer and BioNTech requested Food and Drug Administration emergency authorization of their COVID-19 vaccine for children ages 5 to 11, the companies announced Thursday.
Pfizer took to Twitter to share the news, writing: “With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19.”
UPDATE: We and @BioNTech_Group officially submitted our request to @US_FDA for Emergency Use Authorization (EUA) of our #COVID19 vaccine in children 5 to <12. pic.twitter.com/72Z2HXlkOx
— Pfizer Inc. (@pfizer) October 7, 2021
The news comes just over a week after Pfizer-BioNTech submitted clinical trial data from a COVID-19 vaccine study among kids ages 5-11 to the FDA. Trial data included recent findings among 2,268 participants ages 5-11, which suggested a smaller dose shot was safe, well tolerated and resulted in neutralizing antibody responses.
The companies previously announced that trial results on younger age groups, like children ages 6 months to under 5 years, are expected by the fourth quarter.
This is a developing story, please check back for updates.