Pfizer and BioNTech have announced that the US 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) for use in adults ages 65 years and older — as well as in individuals aged 5–64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
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 aged 5–11.
The application also included data from preclinical 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 with the companies’ JN.1- and KP.2-adapted monovalent COVID-19 vaccines.
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 US beginning in autumn 2025.
This season’s Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and be available in pharmacies, hospitals and clinics across the US in the coming days.
To date, five billion doses of the Pfizer-BioNTech COVID-19 vaccine have been distributed globally, which continues to demonstrate a favourable safety and efficacy profile supported by extensive real-world evidence as well as by clinical, non-clinical, pharmacovigilance and manufacturing data.
BioNTech is the Marketing Authorisation 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 authorisations or equivalents in other countries.