The US Food and Drug Administration approved Pfizer and BioNTech’s XFG-adapted COVID-19 vaccine (COMIRNATY) for adults aged 65 years and older and patients aged 5 through 64 years with at least 1 underlying condition that places them at high risk for severe COVID-19 outcomes, according to a press release from Pfizer and BioNTech.
The supplemental Biologics License Application approval was for the companies’ 2026 to 2027 COVID-19 vaccine formulation targeting the XFG variant. The selection of XFG was based on the US Food and Drug Administration guidance that identifies the variant as the preferred composition for COVID-19 vaccines used in the US beginning in fall 2026.
The approval was based on previously submitted clinical, nonclinical, and real-world data supporting the safety and effectiveness of COMIRNATY. Manufacturing, quality, and nonclinical data showed that the XFG-adapted vaccine generated immune responses against circulating SARS-CoV-2 variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17, and PQ.2.8.1, according to the companies.
Pfizer and BioNTech said shipping of the updated vaccine would begin immediately, with availability at pharmacies, hospitals, and clinics across the US expected in the coming days. The companies reported that more than 5 billion doses of COMIRNATY have been distributed globally.
COMIRNATY should not be administered to patients who had a severe allergic reaction following a previous dose of COMIRNATY or another Pfizer-BioNTech COVID-19 vaccine or to any component of these vaccines. The companies noted a remote chance of severe allergic reactions following vaccination.
Myocarditis and pericarditis have occurred following administration of messenger RNA COVID-19 vaccines, including COMIRNATY, most commonly among males aged 12 through 24 years. In most affected patients, symptoms began within 1 week following vaccination.
Reported adverse events include injection-site pain, swelling, and redness; fatigue; headache; myalgia; chills; arthralgia; fever; nausea; lymphadenopathy; decreased appetite; diarrhea; vomiting; and dizziness. Febrile seizures have also been reported in pediatric patients aged 5 through 11 years.
Patients who are immunocompromised may have a reduced immune response to COMIRNATY. Vaccination may not protect all recipients.
Source: BioNTech
