FDA Approves Pfizer's Updated COVID-19 Vaccine Targeting XFG Variant for 2026-27 Season
NEW YORK — Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental biologics license application for Comirnaty XFG, their 2026-2027 season COVID-19 vaccine formulated against the XFG variant.
The approval covers adults 65 and older, as well as individuals ages 5 through 64 who have at least one underlying condition that puts them at high risk for severe COVID-19 outcomes. The companies said the FDA decision rests on Comirnaty's existing body of clinical, nonclinical and real-world evidence, along with manufacturing and nonclinical data showing the XFG-adapted formula generates strong immune responses against currently circulating variants including XFG, XFG.1.1 and NB.1.8.1; XFG is also the strain identified in FDA guidance as the preferred composition for the United States beginning in fall 2026.
Shipments of the updated vaccine have begun, with availability expected at pharmacies, hospitals and clinics nationwide in the coming days. More than 5 billion doses of Comirnaty have been distributed globally to date. (GSM, from Pfizer and BioNTech public information)
Published by GSM · USA (original Chinese edition)
Photo: 图：辉瑞-BioNTech 新冠疫苗药瓶（资料图）。图片来源：Wikimedia Commons，公共领域。Photo: A vial of the Pfizer-BioNTech COVID-19 vaccine (file photo). Source: Wikimedia Commons, public domain.
