Pfizer, BioNTech Get FDA Approval for Omicron KP.2 COVID Vaccine

In a recent announcement, Pfizer Inc. and BioNTech SE have confirmed the U.S. Food and Drug Administration (FDA) approval of their updated COVID-19 vaccine, adapted to combat the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage. This updated vaccine, aimed at providing enhanced protection for the upcoming 2024-2025 fall and winter seasons, is recommended for everyone aged six months and older.

The FDA's approval includes a supplemental Biologics License Application for individuals aged 12 and older, under the brand name COMIRNATY® (COVID-19 Vaccine, mRNA). Additionally, the vaccine has been granted emergency use authorization for children aged six months to 11 years. The new formulation is generally intended as a single-dose vaccine for most individuals aged five and older. However, certain immunocompromised individuals and young children who have not completed a previous three-dose series may be eligible for additional doses.

This latest adaptation, which targets the KP.2 strain, comes in response to FDA guidance suggesting that KP.2 should be the preferred strain for the 2024-2025 U.S. COVID-19 vaccine campaign, if feasible. Staying current with vaccinations is particularly important as COVID-19 cases are on the rise again. The updated vaccine will soon be available in various healthcare facilities across the country, including pharmacies, hospitals, and clinics.

The FDA’s decision is backed by extensive clinical, non-clinical, and real-world data that reinforce the safety and efficacy of Pfizer and BioNTech's COVID-19 vaccines. The application included data showing that the KP.2-adapted vaccine elicits a significantly improved immune response against current Omicron sublineages, including KP.2, KP.3, and LB.1, compared to the previous Omicron XBB.1.5-adapted vaccine.

Pfizer and BioNTech’s COVID-19 vaccines are built on BioNTech’s proprietary mRNA technology. BioNTech holds the Marketing Authorization for COMIRNATY® and its adapted versions in the U.S., the European Union, the U.K., and other regions. The company also holds emergency use authorizations or equivalents in collaboration with Pfizer in the U.S. and other countries.

Pfizer is committed to leveraging science and global resources to develop therapies that improve and extend human life. The company prioritizes high standards of quality, safety, and value in its healthcare products, which include innovative medicines and vaccines. Globally, Pfizer collaborates with healthcare providers, governments, and local communities to enhance access to reliable and affordable healthcare. For 175 years, the company has dedicated itself to making a meaningful difference for those who rely on its products.

BioNTech, a leader in next-generation immunotherapy, is pioneering new treatments for cancer and other serious diseases. The company employs a range of computational discovery and therapeutic platforms to rapidly develop novel biopharmaceuticals. Its extensive portfolio includes mRNA-based therapies, chimeric antigen receptor (CAR) T cells, protein-based therapeutics, and small molecules. BioNTech’s expertise in mRNA vaccine development and manufacturing has facilitated the creation of multiple vaccine candidates for various infectious diseases, supported by numerous global and specialized pharmaceutical collaborations.

In summary, Pfizer and BioNTech’s newly approved KP.2-adapted COVID-19 vaccine represents a significant step forward in the ongoing battle against COVID-19, promising enhanced protection for the upcoming seasons and broader access to vaccination across the United States.