Pfizer/BioNTech and Moderna have each respectively received US Food and Drug Administration (FDA) approval for their supplemental biologics license applications for their LP.8.1-adapted COVID vaccines. The companies reported the approvals late last month (August 27, 2025).  

Earlier this year (May 2025), FDA advised the manufacturers of approved COVID-19 vaccines that to more closely match currently circulating SARS-CoV-2 viruses, the COVID-19 vaccines for use in the United States beginning in the fall of 2025 should be monovalent JN.1-lineage-based COVID-19 vaccines (2025-2026 formula), preferentially using the LP.8.1 strain.   

Pfizer/BioNTech received approval for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine 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. 

FDA also approved the 2025-2026 formulas for Moderna’s Spikevax and mNEXSPIKE, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. Moderna received FDA approval for the 2025-2026 formulas for its updated COVID-19 vaccine, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. mNEXSPIKE, Moderna’s new COVID-19 vaccine, is approved for individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older.  

Moderna’s updated COVID-19 vaccines targeting LP.8.1 has also been granted approval by regulatory authorities in Canada, Europe, Japan, Switzerland and other countries. Additional regulatory applications are under review globally in preparation for the coming season. 

Source: Pfizer/BioNTech & Moderna