Pfizer and BioNTech’s XFG-adapted COVID-19 vaccine has been approved by the US FDA, with the companies announcing the approval of the supplemental Biologics License Application (sBLA) for their 2026-2027 COVID-19 vaccine formula.
The formula targets the XFG variant and is suitable for adults aged 65 years and older, as well as in those aged from 5 to 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 evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical and real-world data supporting the safety and effectiveness of COMIRNATY, as well as manufacturing/quality and non-clinical data showing that the XFG-adapted COVID-19 vaccine generated strong immune responses against currently circulating SARS-CoV-2 variants.
The selection of the XFG variant is based on guidance from the FDA as the preferred composition of COVID-19 vaccines for use in the US beginning in autumn 2026. The vaccine will be available in pharmacies, hospitals and clinics across the US.
To date, more than five billion doses of COMIRNATY have been distributed globally and it continues to demonstrate a favourable safety and efficacy profile.