Pfizer, BioNTech's XFG-Adapted COVID-19 Vaccine Wins FDA Approval for At-Risk Adults
核心洞察
The U.S. FDA approved COMIRNATY XFG (搜索), Pfizer and BioNTech's 2026-2027 COVID-19 (搜索) vaccine formulation targeting the XFG variant, for at-risk adults.
The vaccine is authorized for adults aged 65 and older, plus individuals aged 5 through 64 with at least one high-risk underlying condition.
Non-clinical and manufacturing data showed 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.
Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has approved COMIRNATY XFG (搜索), their 2026-2027 COVID-19 (搜索) vaccine formulation targeting the XFG variant. The approval covers adults aged 65 years and older, as well as individuals aged 5 through 64 years with at least one underlying condition that places them at high risk for severe outcomes from COVID-19.
The approval is based on clinical, non-clinical and real-world data previously submitted by Pfizer and BioNTech supporting the safety and effectiveness of COMIRNATY. Manufacturing and quality data, along with non-clinical data, showed that the XFG-adapted COVID-19 (搜索) vaccine generated immune responses against circulating SARS-CoV-2 variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1 and other contemporary lineages.
Variant Selection and Regulatory Basis
Pfizer and BioNTech stated that the selection of the XFG variant was based on FDA guidance recommending it as the preferred composition of COVID-19 (搜索) vaccines for use in the U.S. beginning in fall 2026. The companies' COVID-19 vaccines are based on BioNTech's proprietary mRNA technology and were jointly developed by Pfizer and BioNTech.
Distribution and Supply Readiness
According to the companies, shipments of the vaccine will begin immediately, with doses expected to be available at pharmacies, hospitals and clinics across the U.S. in the coming days. More than five billion doses of COMIRNATY have been distributed globally to date, according to Pfizer and BioNTech.
Broader Regulatory Progress
The U.S. approval follows parallel regulatory activity in Europe. The European Commission previously granted marketing authorisation for the XFG-adapted COVID-19 (搜索) vaccine for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. That authorisation is valid in all 27 European Union Member States, as well as Iceland, Liechtenstein and Norway, and followed a recommendation from the Committee for Medicinal Products for Human Use (CHMP) in July 2026.
The European adaptation was based on a recommendation from the Emergency Task Force (ETF) of the European Medicines Agency (EMA) to update COVID-19 (搜索) vaccines to target the XFG variant. Pfizer and BioNTech have also submitted data for the updated COVID-19 vaccine to other regulatory authorities, and have already initiated manufacturing of the monovalent XFG-adapted COVID-19 vaccine at risk to ensure supply readiness in expectation of the respiratory disease season, when demand for COVID-19 vaccination is expected to increase.