FDA Approves Pfizer & BioNTech’s Updated COVID-19 Vaccine for High-Risk Groups

Pfizer Inc. and BioNTech SE announced on Wednesday that the U.S. Food and Drug Administration (FDA) has approved their supplemental Biologics License Application for a new monovalent COVID-19 vaccine, COMIRNATY LP.8.1, targeting adults aged 65 and older and individuals aged 5 to 64 with underlying conditions that increase their risk of severe COVID-19 outcomes.

The approval covers the LP.8.1-adapted vaccine, designed to address evolving SARS-CoV-2 sublineages. The FDA’s decision follows a review of clinical trial data, including studies in children aged 5 to 11, and preclinical data demonstrating the vaccine’s enhanced immune response against multiple circulating variants, such as XFG and NB.1.8.1, compared with the companies’ earlier JN.1- and KP.2-adapted vaccines. The FDA had previously identified LP.8.1 as the preferred sublineage for monovalent vaccines for the 2025 fall season.

The companies said shipments of the updated vaccine will begin immediately, with availability expected in U.S. pharmacies, hospitals, and clinics within days. The vaccine leverages BioNTech’s mRNA technology, which has underpinned the distribution of 5 billion doses of the Pfizer-BioNTech COVID-19 vaccine globally. Extensive real-world evidence, alongside clinical and pharmacovigilance data, continues to support the vaccine’s safety and efficacy.

BioNTech serves as the Marketing Authorization Holder for COMIRNATY in the U.S., European Union, U.K., and other markets, with emergency use authorizations in additional regions. The approval bolsters the companies’ efforts to adapt their vaccine platform to address shifting viral dynamics, a critical factor as public health officials prepare for the fall and winter respiratory season.