Pfizer-BioNTech XFG COVID-19 Vaccine Wins FDA Approval

Pfizer and BioNTech have received U.S. Food and Drug Administration (FDA) approval for COMIRNATY XFG, their updated 2026-2027 COVID-19 vaccine targeting the XFG SARS-CoV-2 variant. The supplemental Biologics License Application (sBLA) covers adults aged 65 years and older and individuals aged 5 through 64 years with at least one underlying condition that puts them at high risk for severe COVID-19.

The companies will begin shipping the updated vaccine immediately, with doses expected to reach pharmacies, hospitals and clinics across the U.S. in the coming days.

Moderna also received FDA approval on August 27 for XFG-containing 2026-2027 formulations of its two COVID-19 vaccines, Spikevax and mNEXSPIKE, placing both mRNA vaccine developers on the U.S. market with updated vaccines targeting the same JN.1-lineage XFG variant.

XFG Selected for the 2026-2027 Vaccine Formula

The updated formulation follows FDA guidance recommending a monovalent JN.1-lineage XFG vaccine for the 2026-2027 season to more closely match currently circulating SARS-CoV-2 viruses. FDA’s recommendation followed an assessment of variant circulation, vaccine effectiveness, antigenic characteristics and available human and animal immunogenicity data.

Pfizer and BioNTech reported that the XFG-adapted vaccine generated strong immune responses against XFG and other contemporary SARS-CoV-2 lineages, including XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1. These lineage names reflect the variants reported in the companies’ supporting data and are presented here as company-reported findings.

Regulatory Decision Builds on Established COMIRNATY Evidence

The FDA approval relied on the cumulative evidence previously submitted for COMIRNATY, including clinical, non-clinical and real-world data supporting the vaccine’s safety and effectiveness. The submission also included manufacturing and quality information, together with non-clinical data supporting the immune response generated by the XFG-adapted formulation.

The seasonal update does not represent development of an entirely new COVID-19 vaccine. Instead, it reflects the established FDA approach for updating vaccine composition as SARS-CoV-2 evolves. For the 2026-2027 formula, FDA considered human immunogenicity data, antigenic characterization, animal studies, current vaccine effectiveness and circulating variants when selecting XFG.

As a result, the XFG antigen update did not require a new phase 3 clinical efficacy trial solely because the vaccine composition changed. The regulatory evidence instead combined the established clinical and real-world evidence for COMIRNATY with immunogenicity and non-clinical data supporting the updated formulation.

Large-Scale Manufacturing and Distribution

COMIRNATY has now surpassed five billion doses distributed globally, giving the Pfizer-BioNTech vaccine a substantial body of clinical, real-world, pharmacovigilance and manufacturing experience.

The vaccine uses BioNTech’s proprietary mRNA technology. BioNTech serves as the Marketing Authorization Holder for the Pfizer-BioNTech COVID-19 vaccine and its adapted formulations in the U.S., European Union, United Kingdom and other markets.

Path Forward

The immediate priority is distribution of COMIRNATY XFG ahead of the 2026-2027 respiratory virus season. Pfizer and BioNTech said the vaccine will become available through pharmacies, hospitals and clinics across the U.S. within days.

The approval also establishes the XFG formulation as the companies updated U.S. COVID-19 vaccine for the coming season. FDA will continue monitoring vaccine safety and effectiveness alongside the evolution of SARS-CoV-2, leaving the composition of future seasonal vaccines subject to changes in circulating variants and the emerging evidence base.

Reference

Pfizer and BioNTech Receive U.S. FDA Approval for XFG-adapted COVID-19 Vaccine | Pfizer

Pfizer and BioNTech Receive U.S. FDA Approval for XFG-adapted COVID-19 Vaccine