Pfizer and BioNTech COVID-19 Vaccine Approved by FDA for Seniors and High-Risk Groups
The U.S. Food and Drug Administration (FDA) has approved an updated formulation of Pfizer and BioNTech's COMIRNATY COVID-19 vaccine, targeting the LP.8.1 sublineage, for individuals aged 65 and older and those aged 5-64 at increased risk.
NEW YORK & MAINZ, Germany – The U.S. Food and Drug Administration (FDA) has granted approval for an updated formulation of Pfizer and BioNTech's COMIRNATY COVID-19 vaccine. The supplemental Biologics License Application (sBLA) covers the use of the LP.8.1-adapted monovalent vaccine in adults aged 65 and older, as well as in individuals aged 5 through 64 years who have at least one underlying condition that places them at high risk for severe COVID-19.
The approval is based on a cumulative body of evidence, including clinical trial data. The application also incorporated preclinical model data, which indicated that the LP.8.1-adapted vaccine generates improved immune responses against multiple circulating SARS-CoV-2 sublineages compared to previous vaccine versions. The LP.8.1 sublineage was selected following FDA guidance for the 2025-2026 vaccination campaign in the U.S.
Pfizer and BioNTech stated that shipping of the adapted vaccine will commence immediately, aiming for rapid access in pharmacies, hospitals, and clinics across the country. To date, over 5 billion doses of the Pfizer-BioNTech COVID-19 vaccine have been distributed globally, with the companies maintaining that it continues to demonstrate a favorable safety and efficacy profile supported by extensive real-world evidence and clinical data.
The Pfizer-BioNTech COVID-19 vaccine is based on BioNTech's mRNA technology. BioNTech holds the Marketing Authorization for COMIRNATY and its adapted vaccines in the United States and other regions.