Pfizer and BioNTech’s supplemental Biologics License Application (sBLA) has been approved by the US Food and Drug Administration (FDA) for its LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY LP.8.1; COVID-19 Vaccine, mRNA) for use in adults aged 65 years and older, as well as in adults 64 years and younger and children from the age of five who have at least one underlying condition that makes them 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 between five and 11 years of age. The application also included data from pre-clinical 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 to the companies’ JN.1- and KP.2-adapted monovalent COVID-19 vaccines.
This season’s Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and be available in pharmacies, hospitals, and clinics across the US.
To date, five billion doses have been distributed globally of the Pfizer-BioNTech COVID-19 vaccine, 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.
The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY and its adapted vaccines in the United States, the European Union, the UK and other countries, and the holder of emergency use authorisations or equivalents in other countries.