US biopharmaceutical company Pfizer Inc (NYSE:PFE) and German biotechnology company BioNTech SE (NASDAQ:BNTX) announced on Thursday that the US Food and Drug Administration (FDA) has approved their 2026-2027 COVID-19 vaccine formula targeting the XFG variant (COMIRNATY XFG).

The vaccine is authorised for adults aged 65 and older and for people aged 5-64 with at least one underlying condition that increases their risk of severe outcomes from COVID-19. This approval is supported by previously submitted clinical, non-clinical and real-world data, along with manufacturing and quality data.

The companies said the XFG-adapted vaccine generated strong immune responses against circulating SARS-CoV-2 variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1. The XFG formulation follows FDA guidance for the preferred US COVID-19 vaccine composition beginning in autumn 2026.

Shipments will begin immediately, with the vaccine expected to become available at pharmacies, hospitals and clinics across the United States in the coming days. More than five billion doses of COMIRNATY have been distributed globally to date.