Pfizer and BioNTech have secured U.S. Food and Drug Administration approval for their updated 2026-2027 COVID-19 vaccine, designed to target the XFG variant as the virus continues to evolve.
The companies said that the FDA approved their supplemental Biologics License Application for COMIRNATY XFG, clearing the vaccine for adults 65 and older and people ages 5 through 64 who have at least one underlying condition that puts them at high risk of severe COVID-19.
Shipments are beginning immediately, with Pfizer and BioNTech saying the updated vaccine will reach pharmacies, hospitals and clinics across the United States in the coming days.
The new formulation follows FDA guidance calling for an XFG-based vaccine composition for the fall 2026 season, bringing the vaccine more closely in line with contemporary circulating SARS-CoV-2 variants.
Pfizer and BioNTech said the approval was supported by a body of previously submitted clinical, non-clinical and real-world evidence on COMIRNATY, along with manufacturing and quality data. The companies said the XFG-adapted vaccine generated strong immune responses against XFG and other currently circulating lineages.
The companies said more than five billion doses of COMIRNATY have been distributed globally to date, with extensive clinical and real-world evidence supporting its safety and effectiveness profile.
Who can receive the vaccine? Under the FDA-approved indication, COMIRNATY is intended for: Adults 65 years and older. People ages 5 through 64 with at least one underlying condition that places them at high risk of severe COVID-19.
The vaccine is not appropriate for people who have experienced a severe allergic reaction after a previous dose of COMIRNATY, another Pfizer-BioNTech COVID-19 vaccine, or an ingredient in those vaccines.
Pfizer also warns of a remote risk of severe allergic reactions following vaccination. Myocarditis and pericarditis have also occurred in some people following mRNA COVID-19 vaccination, with cases occurring most commonly among males ages 12 through 24.
Pfizer says people should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or a fast-beating, fluttering or pounding heart following vaccination.
Other reported side effects include injection-site pain, swelling and redness, as well as fatigue, headache, muscle and joint pain, chills, fever, nausea and swollen lymph nodes.
The companies noted that people with weakened immune systems may have a reduced immune response and that vaccination may not protect everyone who receives it.
The updated vaccine is based on BioNTech's proprietary mRNA technology and was developed jointly by Pfizer and BioNTech.
