FX.co ★ Pfizer, BioNTech Obtain FDA Approval & Authorization For Omicron KP.2-adapted COVID-19 Vaccine

Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application for individuals aged 12 and older for COMIRNATY (COVID-19 Vaccine, mRNA). Additionally, an emergency use authorization has been granted for individuals aged 6 months to 11 years for the companies' Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine.

This season's vaccine is intended for use as a single dose for most individuals aged 5 and older. Individuals aged 5 and older with certain types of immunocompromised conditions who have previously been vaccinated with Pfizer and BioNTech COVID-19 vaccines, or children under 5 who have not yet completed a three-dose series with previous COVID-19 vaccine formulas, may be eligible to receive additional doses, according to the companies.

The companies indicated that this season's COVID-19 vaccine will begin shipping immediately and will be available in pharmacies, hospitals, and clinics across the U.S. in the coming days.

BioNTech holds the Marketing Authorization for COMIRNATY and its adapted vaccines (COMIRNATY (COVID-19 Vaccine, mRNA); COMIRNATY Original/Omicron BA.1; COMIRNATY Original/Omicron BA.4-5; COMIRNATY Omicron XBB.1.5; COMIRNATY JN.1; and COMIRNATY KP.2) in the United States, the European Union, the United Kingdom, and other countries. BioNTech, jointly with Pfizer, also holds emergency use authorizations or their equivalents in the United States and other countries.