Pfizer and BioNTech received FDA approval for their updated COVID-19 mRNA vaccine for the 2026–2027 season in the United States.
The new formulation, marketed as COMIRNATY XFG, is designed to target the XFG variant and other contemporary SARS-CoV-2 lineages. Its approved use includes adults aged 65 and older, as well as individuals aged 5 to 64 with at least one condition that increases the risk of developing severe COVID-19.
The authorization comes as the FDA updates vaccine compositions annually to align them with currently circulating variants.
Separately, Pfizer and BioNTech are maintaining a program to develop a combined influenza and COVID-19 vaccine, but that product is not listed among the FDA's confirmed approvals for this season.