NEW YORK, NY and MAINZ, Germany – August 27, 2026

Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has approved their 2026–2027 XFG-adapted COVID-19 vaccine, COMIRNATY® XFG, marking an important seasonal vaccine update aimed at improving alignment with currently circulating SARS-CoV-2 variants. The approval supports use of the updated mRNA vaccine in adults aged 65 years and older, as well as individuals 5 through 64 years of age who have at least one underlying condition associated with a high risk of severe COVID-19 outcomes. The companies said shipments will begin immediately, with doses expected to become available through pharmacies, hospitals and clinics across the United States in the coming days. The FDA’s selection of XFG as the preferred vaccine composition for fall 2026 reflects the agency’s guidance to more closely match contemporary circulating variants, positioning the updated formulation as a key component of the upcoming COVID-19 vaccination season.

XFG-Adapted Vaccine Targets Current Variants

The updated COMIRNATY XFG formulation was developed to address the evolving SARS-CoV-2 landscape and was selected in accordance with FDA guidance for the 2026–2027 season. Pfizer and BioNTech said the regulatory submission included a cumulative evidence package comprising clinical, non-clinical and real-world data, together with manufacturing and quality information. Data supporting the updated formulation showed strong immune responses against XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1, among other contemporary SARS-CoV-2 lineages. The companies highlighted the ability to rapidly update the vaccine formula as the virus continues to evolve, with the latest formulation designed to provide a closer antigenic match to variants expected to circulate during the coming respiratory-virus season. The approval therefore represents a continued effort to maintain an adaptable mRNA vaccine platform capable of responding to changes in the COVID-19 virus.

Immediate Distribution Supports Seasonal Access

With the FDA decision now in place, Pfizer and BioNTech have initiated shipping of the updated vaccine to support rapid seasonal availability in the United States. The companies said the vaccine will be distributed through multiple healthcare channels, including pharmacies, hospitals and clinics, helping providers prepare for the 2026–2027 vaccination season. COMIRNATY has already established a substantial global manufacturing and distribution footprint, with more than five billion doses distributed worldwide to date. The latest approval extends that established vaccine infrastructure to the XFG-adapted formulation. For Pfizer and BioNTech, continued regulatory authorization of updated COVID-19 vaccines also demonstrates the practical role of their established mRNA technology and manufacturing capabilities in responding to an evolving infectious-disease threat.

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Safety Profile Remains Central to Vaccine Use

The FDA approval is supported by the broader safety and effectiveness evidence accumulated for COMIRNATY, alongside data generated specifically for the updated formulation. The companies continue to identify severe allergic reactions, myocarditis and pericarditis among important potential risks associated with mRNA COVID-19 vaccination. Myocarditis and pericarditis have been observed most commonly in males aged 12 through 24 years following mRNA vaccination. Other reported adverse effects include injection-site pain, fatigue, headache, muscle pain, chills, joint pain, fever, nausea and swollen lymph nodes. Pfizer and BioNTech also note that individuals with weakened immune systems may have a reduced immune response and that vaccination may not protect every recipient. The latest regulatory milestone keeps COVID-19 vaccine updating, variant surveillance and mRNA manufacturing at the center of the companies’ ongoing response to SARS-CoV-2 evolution.

Source: Pfizer ,press relese