Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application with the FDA for emergency use authorization (EUA) for a 10-µg booster dose of their BNT162b2 COVID-19 vaccine in children aged 5 to 11.
The companies included data in the application from a Phase 2/3 study that tested a booster dose in children between 5 and 11, roughly six months after completion of a primary series.
The Pfizer-BioNTech vaccine remains one of the most popular COVID-19 vaccines globally.
FDA authorized an EUA for a primary series of the BNT162b2 vaccine for children 5 to 11 in October 2021.
Pfizer and BioNTech also intend to seek authorization from the European Medicines Agency (EMA) and other regulatory agencies for a booster dose soon.
In the U.S., the CDC recently estimated that roughly three-quarters of children had detectable antibodies to SARS-CoV-2, thanks in part to the rapid spread of the omicron variant.
More than half of U.S. adults have likely contracted COVID-19 at least once, CDC estimated in a recent study.