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

(RTTNews) - Pfizer Inc. (PFE) and BioNTech SE (BNTX) said that the U.S. Food and Drug Administration 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 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, the companies said.

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

BioNTech is the Marketing Authorization Holder 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; COMIRNATY KP.2) in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

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