Pfizer and BioNTech Receive FDA Approval and Authorization for Omicron KP.2 Modified COVID-19 Vaccine

• The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals aged 6 months and older
• The KP.2 modification is based on FDA guidance stating that KP.2 is the preferred strain for COVID-19 vaccines for the 2024-2025 U.S. fall and winter season, if feasible.
• Shipments will begin immediately to ensure robust supply and rapid access of this season’s vaccine to pharmacies, hospitals and clinics across the country

NEW YORK and MAINZ, GERMANY, August 22, 2024 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE BioNTech, Inc. (Nasdaq: BNTX, “BioNTech”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY (COVID-19 Vaccine, mRNA)) and granted emergency authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies’ Omicron KP.2-modified 2024-2025 Formula COVID-19 vaccine. This season’s vaccine is intended for use as a single dose for most individuals 5 years of age and older. Individuals 5 years of age and older with certain types of immunocompromise who have previously been vaccinated with Pfizer and BioNTech COVID-19 vaccines or children under 5 years of age who have not completed a three-dose series with previous formulations of a COVID-19 vaccine may be eligible to receive additional doses.

The KP.2 modification 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 fall and winter 2024-2025 vaccine seasons, if feasible.¹ It remains important to stay up-to-date on vaccinations in accordance with the recommendations of the Centers for Disease Control and Prevention (“CDC”), especially in light of the fact that COVID-19 cases are again on the rise.² This season’s Pfizer and BioNTech COVID-19 vaccine is shipping immediately and will be available in pharmacies, hospitals and clinics across the U.S. in the coming days.