On Sept. 11, 2023, Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (COMIRNATY 2023-2024 Formulation) for individuals 12 years and older, and granted emergency use authorization for individuals 6 months through 11 years of age for the companiesﾒ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.

This seasonﾒs vaccine is indicated as a single dose for most individuals 5 years of age and older. Children under the age of 5 may be eligible to receive additional doses of this seasonﾒs vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.