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The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, in line with FDA guidance to more closely match circulating strains1
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Shipping of the LP.8.1-adapted vaccine will begin immediately to ensure robust supply and rapid access of this season’s vaccine in pharmacies, hospitals, and clinics across the country
August 27, 2025 -NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.2
The FDA approval is based on the cumulative body of evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine, including clinical trial data supporting the approval for children 5 through 11 years of age. The application also included data from pre-clinical models showing that the LP.8.1-adapted monovalent COVID-19 vaccine generates improved immune responses against multiple circulating SARS-CoV-2 sublineages, including XFG, NB.1.8.1, and other contemporary sublineages, compared to the companies’ JN.1- and KP.2-adapted monovalent COVID-19 vaccines.3
The LP.8.1 sublineage selection is based on guidance from the FDA, which stated that LP.8.1 is the preferred sublineage of a monovalent JN.1-lineage-based COVID-19 vaccine for use in the U.S. beginning in fall 2025.1 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. in the coming days.
To date, 5 billion doses have been distributed globally of the Pfizer-BioNTech COVID-19 vaccine, which continues to demonstrate a favorable safety and efficacy profile supported by extensive real-world evidence as well as by clinical, non-clinical, pharmacovigilance, and manufacturing data.3 The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY® and its adapted vaccines in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in other countries.
1 FDA. COVID-19 Vaccines (2025-2026 Formula) for Use in the United States Beginning in Fall 2025. Available at: https://www.fda.gov/vaccines-blood-biologics/industry-biologics/covid-19-vaccines-2025-2026-formula-use-united-states-beginning-fall-2025. Updated: May 22, 2025. Accessed: August 21, 2025.
2 CDC. Underlying Conditions and the Higher Risk for Severe COVID-19. Available at: https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.html. Updated: February 6, 2025. Accessed: August 21, 2025.
3 Vaccines and Related Biological Products Advisory Committee. Meeting Presentation- 2025-2026 COVID-19 Vaccine Formula: Pfizer/BioNTech Supportive Data. Available at: https://www.fda.gov/media/186597/download. Presented: May 22, 2025. Accessed: August 21, 2025.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us.
About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Bristol Myers Squibb, Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron.