FDA批准辉瑞新版新冠疫苗：针对XFG变异株 65岁以上及高风险人群适用 已开始发货
纽约——辉瑞（Pfizer）与 BioNTech 宣布，美国食品药品监督管理局（FDA）已批准其2026–2027季新冠疫苗 Comirnaty XFG 的补充生物制品许可申请，该配方针对 XFG 变异株。
此次批准适用于65岁及以上人群，以及5至64岁、至少有一项基础疾病、属于重症高风险的人群。两家公司表示，FDA 的决定基于 Comirnaty 既有的临床、非临床与真实世界证据，以及新配方针对当前流行变异株（包括 XFG、XFG.1.1、NB.1.8.1 等）产生强劲免疫应答的制造与非临床数据；XFG 也是 FDA 指引中2026年秋季美国疫苗的首选毒株。
更新版疫苗已经开始发货，预计未来几天内在全美药房、医院与诊所陆续供应。Comirnaty 迄今在全球累计分发已逾50亿剂。（GSM 据辉瑞与 BioNTech 公开信息报道）
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)
发布：GSM·美国（发布链接）
图片来源：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.
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