The U.S. Food and Drug Administration 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 Pfizer Inc. (PFE) and BioNTech SE's (BNTX) Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, the companies said in a statement on Monday.
This season'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's vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.
Pfizer and BioNTech noted that they have been manufacturing the 2023-2024 COVID-19 vaccine at risk to ensure supply readiness ahead of the fall and winter season, when demand for COVID-19 vaccination is expected to increase in line with the seasonality period also seen with other respiratory viruses.
The companies said that the COVID-19 vaccine will be available in pharmacies, hospitals, and clinics across the U.S. following a recommendation by the Centers for Disease Control and Prevention.
In the European Union, the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY Omicron XBB.1.5) has also received marketing authorization by the European Commission for individuals 6 months of age and older on August 31, 2023.
Pfizer and BioNTech have submitted data for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine to other regulatory authorities around the world.
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