NEW YORK– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for their updated COVID-19 vaccine, COMIRNATY® LP.8.1 (COVID-19 Vaccine, mRNA). The approval covers adults 65 and older, as well as individuals ages 5 through 64 who have at least one underlying condition that increases their risk of severe illness from COVID-19.
The 2025–2026 vaccine formulation targets the SARS-CoV-2 LP.8.1 sublineage, in line with FDA guidance to more closely match circulating strains. Shipping of the adapted vaccine will begin immediately to ensure rapid availability across U.S. pharmacies, hospitals, and clinics.
The FDA’s decision was supported by extensive safety and efficacy data from the Pfizer-BioNTech COVID-19 vaccine program, including clinical trial evidence for children ages 5 through 11, as well as preclinical studies showing that the LP.8.1-adapted vaccine produced stronger immune responses against multiple circulating sublineages—including XFG and NB.1.8.1—compared to previous formulations.
The LP.8.1 sublineage was selected following FDA guidance recommending a monovalent JN.1-lineage-based vaccine beginning in fall 2025.
To date, more than 5 billion doses of the Pfizer-BioNTech COVID-19 vaccine have been distributed worldwide. The vaccines, based on BioNTech’s proprietary mRNA technology, continue to demonstrate a favorable safety and efficacy profile supported by large-scale real-world evidence as well as clinical, non-clinical, pharmacovigilance, and manufacturing data.
BioNTech is the Marketing Authorization Holder for COMIRNATY® and its adapted vaccines in the United States, the European Union, the United Kingdom, and other major markets.
