Pfizer and BioNTech SE have announced that the US Food and Drug Administration (FDA) has approved the companies’ supplemental Biologics License Application (sBLA) for their updated 2026–2027 COVID-19 vaccine formula targeting the XFG variant.

The updated vaccine, marketed as Comirnaty XFG (COVID-19 Vaccine, mRNA), is approved for adults aged 65 years and older, as well as individuals aged five through 64 years who have at least one underlying condition that places them at high risk of severe outcomes from COVID-19.

The FDA’s decision is supported by the cumulative evidence previously submitted by Pfizer and BioNTech, including clinical, non-clinical and real-world data demonstrating the safety and effectiveness of Comirnaty. The submission also included manufacturing and quality data, along with non-clinical findings supporting the immune response generated by the XFG-adapted vaccine.

According to the companies, the updated vaccine generated strong immune responses against currently circulating SARS-CoV-2 variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1, as well as other contemporary lineages.

The selection of XFG follows FDA guidance identifying the variant as the preferred composition for COVID-19 vaccines intended for use in the United States beginning in fall 2026.

Following the approval, Pfizer and BioNTech said shipments of the 2026–27 vaccine have begun immediately. The updated Comirnaty formula is expected to become available at pharmacies, hospitals and clinics across the US in the coming days.

Comirnaty has now surpassed five billion doses distributed globally, according to Pfizer and BioNTech. The companies said the vaccine continues to have a favourable safety and efficacy profile, supported by extensive real-world evidence as well as clinical, non-clinical, pharmacovigilance and manufacturing data.

The Pfizer-BioNTech COVID-19 vaccine is based on BioNTech’s proprietary mRNA technology and was developed jointly by the two companies. BioNTech serves as the Marketing Authorisation Holder for the vaccine and its adapted versions in the US, European Union, United Kingdom and several other markets, while also holding emergency-use authorisations or equivalent approvals in other countries.

The updated Comirnaty vaccine is intended to protect against coronavirus disease 2019 (COVID-19) in the populations covered by the FDA approval, particularly older adults and younger individuals with underlying conditions associated with a higher risk of severe disease.

The latest approval marks another seasonal update to the Pfizer-BioNTech COVID-19 vaccine as manufacturers adapt vaccine composition to address the evolution of circulating SARS-CoV-2 variants.