Pfizer, BioNTech announce FDA approval for sBLA for COVID-19 vaccine

Pfizer (PFE) and BioNTech SE (BNTX) announced the U.S. Food and Drug Administration has approved the supplemental Biologics License Application for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine, COMIRNATY LP.8.1; COVID-19 Vaccine, mRNA, for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years 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 5 through 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,” the companies stated.