FDA approves Pfizer-BioNTech LP.8.1-adapted monovalent COVID-19 vaccine for high-risk groups
The vaccine is approved for adults aged 65 years and older and individuals aged 5 to 64 years with underlying conditions
Pfizer and BioNTech SE announced that 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). The approval covers use in adults aged 65 years and older, as well as in individuals aged 5 through 64 years with at least one underlying condition that places them at high risk for severe outcomes from COVID-19.
According to the companies, the FDA approval is based on the cumulative body of evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine. This includes clinical trial data supporting approval for children 5 through 11 years of age. The application also contained data from pre-clinical models showing that the LP.8.1-adapted monovalent COVID-19 vaccine generated improved immune responses against circulating SARS-CoV-2 sublineages, including XFG, NB.1.8.1, and other contemporary sublineages, compared to the JN.1- and KP.2-adapted monovalent COVID-19 vaccines.
The companies stated that the LP.8.1 sublineage selection is based on FDA guidance, which identified LP.8.1 as the preferred sublineage of a monovalent JN.1-lineage-based COVID-19 vaccine for use in the United States beginning in fall 2025. Pfizer and BioNTech confirmed that this season’s COVID-19 vaccine will begin shipping immediately and will be available in pharmacies, hospitals, and clinics across the U.S. in the coming days.
Pfizer and BioNTech reported that to date, 5 billion doses of their COVID-19 vaccine have been distributed globally. The vaccine continues to demonstrate a favourable safety and efficacy profile supported by extensive real-world evidence as well as clinical, non-clinical, pharmacovigilance, and manufacturing data.
The COVID-19 vaccines developed by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology. The vaccines were co-developed by the two companies. 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 is the holder of emergency use authorisations or equivalents in additional countries.