Pfizer, BioNTech confirm FDA approval for update COVID-19 vaccine

Pfizer (PFE) and BioNTech SE (BNTX) announced that the Food and Drug Administration has approved the supplemental Biologics License Application for individuals 12 years of age and older for Comirnaty 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 KP.2 adaptation is based on guidance from the FDA, which stated that KP.2 is the preferred strain of the JN.1 lineage for COVID-19 vaccines for use in the U.S. during the 2024-2025 fall and winter season, if feasible.1 Staying up to date on vaccinations in line with the Centers for Disease Control and Prevention recommendations remains important, particularly in light of COVID-19 cases on the rise again.2 This season’s Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and be available in pharmacies, hospitals, and clinics across the U.S. beginning in the coming days,” the companies stated.