FDA Approves Pfizer and BioNTech’s Omicron KP.2-adapted COVID-19 Vaccine
Pfizer and BioNTech have announced that the U.S. Food and Drug Administration (FDA) has approved their supplemental Biologics License Application for the COMIRNATY® (COVID-19 Vaccine, mRNA) for individuals aged 12 and older. Additionally, the FDA has granted emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine for children aged 6 months to 11 years. Both approvals pertain to the companies’ new Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine, designed for use as a single dose for most individuals aged 5 and up.
For individuals 5 years and older with certain immunocompromising conditions, and for children under 5 who have not completed a three-dose series with previous COVID-19 vaccines, additional doses may be recommended. The KP.2 adaptation aligns with the FDA’s guidance indicating that KP.2 is the preferred strain of the JN.1 lineage for the 2024-2025 fall and winter seasons in the U.S.
The newly approved Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and will be available in pharmacies, hospitals, and clinics across the United States in the coming days.
The FDA’s approval is based on extensive clinical, non-clinical, and real-world evidence demonstrating the safety and efficacy of Pfizer and BioNTech’s COVID-19 vaccines. The application also included manufacturing and non-clinical data indicating that the KP.2-adapted vaccine produces a significantly enhanced immune response against currently circulating Omicron JN.1 sublineages, including KP.2, KP.3, and LB.1, compared to the companies’ previously adapted Omicron XBB.1.5 COVID-19 vaccine.
Pfizer and BioNTech’s COVID-19 vaccines utilize BioNTech’s proprietary mRNA technology and have been jointly developed by both companies. BioNTech holds the Marketing Authorization for COMIRNATY® and its adapted vaccines in the United States, the European Union, the United Kingdom, and other countries. Additionally, BioNTech, in collaboration with Pfizer, is the holder of emergency use authorizations or equivalents in these regions.
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