- The updated mRNA vaccine targets the XFG variant and is approved for adults 65 and older, plus people ages 5 through 64 with an underlying condition that raises the risk of severe COVID-19.
- Pfizer and BioNTech said the vaccine will be available in U.S. pharmacies, hospitals and clinics in the coming days.
- The FDA approval relies on previously submitted clinical, non-clinical and real-world evidence, along with data showing strong immune responses against XFG and other circulating lineages.
Quotes
“Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ 2026-2027 COVID-19 vaccine formula targeting the XFG variant (COMIRNATY® XFG; 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.”
“This season’s Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and will be available in pharmacies, hospitals, and clinics across the U.S. in the coming days.”