The US Food and Drug Administration (FDA) has now approved the supplemental Biologics License Application (Comirnaty 2023-2024 Formulation) from US pharma major Pfizer (NYSE: PFE) and partner BioNTech (Nasdaq: BNTX).
The authorization is for individuals 12 years and older and emergency use authorization has been granted for individuals six months through 11 years of age for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.
This season’s vaccine is indicated as a single dose for most individuals five years of age and older. Children under the age of five may be eligible to receive additional doses of this season’s vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.
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