Pfizer (NYSE: PFE) and BioNTech Seek FDA Nod For COVID Booster Shot For Children

On Monday, Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) announced that they have submitted an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) for a 10 -µg booster dose of its Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age.

The companies also stated that they intend to submit an application seeking an extension of marketing authorization for the Omicron BA.4/BA.5-adapted bivalent vaccine targeting children ages 5 through 11 years to the European Medicines Agency (EMA).