FDA Approves Pfizer-BioNTech XFG-Adapted COVID-19 Vaccine for 2026-27 Season

The US Food and Drug Administration has approved Pfizer and BioNTech’s supplemental Biologics License Application for their 2026-2027 XFG-adapted COVID-19 vaccine formula, COMIRNATY XFG, for adults aged 65 years and older and individuals aged 5 through 64 years with at least 1 underlying condition that puts them at high risk for severe COVID-19 outcomes.

The updated vaccine formula targets the XFG variant, in alignment with FDA guidance for the 2026-2027 COVID-19 vaccine composition. Pfizer and BioNTech stated that shipping would begin immediately, with the vaccine expected to become available in pharmacies, hospitals, and clinics across the US in the coming days.

What data supported FDA approval?

According to the companies, the FDA approval was based on the cumulative body of evidence previously submitted for COMIRNATY, including clinical, nonclinical, and real-world data supporting safety and effectiveness. The submission also included manufacturing, quality, and nonclinical data showing that the XFG-adapted vaccine generated strong immune responses against currently circulating SARS-CoV-2 variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1, and other contemporary lineages.

The companies noted that more than 5 billion doses of COMIRNATY have been distributed globally to date, with the vaccine continuing to demonstrate a favorable safety and efficacy profile supported by real-world evidence, clinical and nonclinical data, pharmacovigilance, and manufacturing data.

Who is eligible for COMIRNATY XFG?

COMIRNATY is indicated to protect against coronavirus disease 2019. For the 2026-2027 formula, the approved population includes adults aged 65 years and older, as well as individuals aged 5 through 64 years with at least 1 underlying condition associated with high risk for severe outcomes from COVID-19.

For primary care clinicians, the updated indication reinforces the need to identify patients who meet age- or risk-based eligibility criteria and to counsel those patients on timing, expected availability, and safety considerations for the seasonal COVID-19 vaccine.

What safety information should clinicians know?

COMIRNATY should not be administered to individuals who had a severe allergic reaction after a previous dose of COMIRNATY, any Pfizer-BioNTech COVID-19 vaccine, or any ingredient in those vaccines. Severe allergic reactions can occur after vaccination, and vaccination providers may ask patients to remain under observation after receiving a dose.

Myocarditis and pericarditis have occurred in some people who received mRNA COVID-19 vaccines, including COMIRNATY and Pfizer-BioNTech COVID-19 vaccines. These events have occurred most commonly in males aged 12 through 24 years, and symptoms generally began within 1 week after vaccination. Patients should seek medical attention for chest pain, shortness of breath, palpitations, fainting, unusual and persistent fatigue, persistent vomiting, abdominal pain, or unusual and persistent cool, pale skin after vaccination.

The safety information also notes that people with weakened immune systems may have a reduced immune response to COMIRNATY and that vaccination may not protect all recipients. Additional reported adverse effects include nonsevere allergic reactions; injection-site pain, swelling, redness, and arm pain; and systemic symptoms such as tiredness, headache, muscle pain, chills, joint pain, fever, nausea, malaise, lymphadenopathy, decreased appetite, diarrhea, vomiting, and dizziness. Febrile seizures have been reported in children aged 5 through 11 years.

Reference

1. Pfizer Inc; BioNTech SE. Pfizer and BioNTech receive U.S. FDA approval for XFG-adapted COVID-19 vaccine. Published August 27, 2026.