Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for their COMIRNATY® COVID-19 vaccine for individuals aged 12 and older. The FDA has also granted emergency use authorization for the vaccine, adapted to the Omicron KP.2 strain, for children aged 6 months to 11 years. This updated vaccine is recommended as a single dose for most individuals aged 5 and older. Some individuals aged 5 and older with specific immunocompromises, who were previously vaccinated with Pfizer and BioNTech’s COVID-19 vaccines, or children under 5 who haven’t completed a three-dose series with prior vaccines, may be eligible for additional doses.
The Omicron KP.2-adapted vaccine is designed to target the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is approved for use in individuals 6 months and older. This adaptation follows FDA guidance, which identified KP.2 as the preferred strain for the U.S. 2024-2025 fall and winter season, where feasible.
Shipping of the new vaccine will begin immediately to ensure it is readily available in pharmacies, hospitals, and clinics across the U.S. This timely distribution is in response to rising COVID-19 cases and aligns with the Centers for Disease Control and Prevention (CDC) recommendations for staying current with vaccinations.
The FDA’s approval is based on extensive clinical, non-clinical, and real-world evidence demonstrating the safety and efficacy of the Pfizer and BioNTech COVID-19 vaccines. The data included in the application showed that the KP.2-adapted vaccine offers a significantly improved response against the currently circulating Omicron JN.1 sublineages, including KP.2, KP.3, and LB.1, compared to the previous Omicron XBB.1.5 adapted vaccine.
Developed using BioNTech’s proprietary mRNA technology, the Pfizer and BioNTech COVID-19 vaccines are marketed under the COMIRNATY® brand. BioNTech holds marketing authorization for these vaccines in the U.S., European Union, United Kingdom, and other countries, and shares emergency use authorizations with Pfizer where applicable.
