FDA approval & authorization for Omicron KP.2-adapted COVID-19 Vaccine – BioNTech SE + Pfizer

Pfizer Inc. and BioNTech SE announced that the FDA has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY (COVID-19 Vaccine, mRNA), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies’ Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine.

This season’s vaccine is for use as a single dose for most individuals 5 years of age and older. Individuals 5 years of age and older with certain kinds of immunocompromise previously vaccinated with Pfizer and BioNTech COVID-19 vaccines or children under the age of 5 who have not already completed a three-dose series with previous formulas of a COVID-19 vaccine may be eligible to receive additional doses.