– FDA approves Pfizer-BioNTech LP.8.1 vaccine for adults 65+ and high-risk 5-64 age group.
– Vaccine targets SARS-CoV-2 sublineages XFG, NB.1.8.1, improving immune response.
– 5 billion doses of Pfizer-BioNTech COVID-19 vaccine distributed globally.
The U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Pfizer and BioNTech’s LP.8.1-adapted monovalent COVID-19 vaccine, known as COMIRNATY LP.8.1. This approval is specifically for adults aged 65 years and older, as well as individuals aged 5 through 64 years with at least one underlying condition that increases their risk of severe COVID-19 outcomes.
The FDA’s decision is based on a comprehensive body of evidence demonstrating the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine. This includes clinical trial data supporting its use in children aged 5 through 11 years. Additionally, pre-clinical models indicated that the LP.8.1-adapted vaccine generates improved immune responses against circulating SARS-CoV-2 sublineages, such as XFG and NB.1.8.1, compared to previous versions like the JN.1- and KP.2-adapted vaccines.
The selection of the LP.8.1 sublineage follows FDA guidance, which identified it as the preferred sublineage for a monovalent JN.1-lineage-based COVID-19 vaccine in the U.S., starting in fall 2025. Pfizer and BioNTech have 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.
To date, Pfizer and BioNTech have distributed 5 billion doses of their COVID-19 vaccine globally. The vaccine continues to show a favorable 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, with BioNTech serving as the Marketing Authorisation Holder for COMIRNATY and its adapted vaccines in the United States, European Union, United Kingdom, and other countries.