Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccines to target the LP.8.1 variant for the 2025-2026 season. The ETF stated that “targeting LP.8.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”

辉瑞公司（Pfizer， NYSE： PFE， “Pfizer”）和BioNTech SE （Nasdaq： BNTX， “BioNTech”）今天宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）已建议两家公司适应LP.8.1的单价COVID-19疫苗（COMIRNATY®LP.8.1） 用于主动免疫，以预防 6 个月及以上个体由 SARS-CoV-2 引起的 COVID-19。此次调整基于 EMA 紧急工作组 （ETF） 的建议，即更新 COVID-19 疫苗以针对 2025-2026 季节的 LP.8.1 变体。该 ETF 表示，“随着 SARS-CoV-2 的不断发展，针对 LP.8.1 将有助于保持疫苗的有效性。

The CHMP’s recommendation will be reviewed by the European Commission (EC), which is expected to make its final decision soon. Pfizer and BioNTech have already initiated manufacturing of the LP.8.1-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season, when the demand for COVID-19 vaccination is expected to increase. The updated vaccine will be available to ship to applicable EU member states immediately following the EC decision.

CHMP 的建议将由欧盟委员会 （EC） 审查，预计该委员会将很快做出最终决定。辉瑞和 BioNTech 已经开始生产面临风险的 LP.8.1 单价 COVID-19 疫苗，以确保在即将到来的秋冬季节之前做好供应准备，届时对 COVID-19 疫苗接种的需求预计将增加。更新后的疫苗将在欧共体做出决定后立即运送到适用的欧盟成员国。

The CHMP’s recommendation is based on the cumulative body of evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical, and real-world data supporting the safety and efficacy of Pfizer and BioNTech COVID-19 vaccines. This application included non-clinical and manufacturing data showing that the LP.8.1-adapted monovalent COVID-19 vaccine generates overall improved immune responses against multiple circulating SARS-CoV-2 lineages, including XFG, NB.1.8.1, LF.7, and other currently circulating contemporary sublineages, compared to the companies’ JN.1 and KP.2-adapted monovalent COVID-19 vaccines.

CHMP 的建议基于辉瑞和 BioNTech 之前提交的累积证据，其中包括支持辉瑞和 BioNTech COVID-19 疫苗安全性和有效性的临床、非临床和真实世界数据。该申请包括非临床和生产数据，表明与公司的 JN.1 和 KP.2 适应单价 COVID-19 疫苗相比，适应 LP.8.1 的单价 COVID-19 疫苗对多个流行的 SARS-CoV-2 谱系（包括 XFG、NB.1.8.1、LF.7 和其他当前流行的当代亚谱系）产生了整体改善的免疫反应。

The companies have also submitted data for the updated COVID-19 vaccine to regulatory authorities around the world. The companies are continuing to monitor the evolving epidemiology of COVID-19 in preparation to meet global public health needs.

这些公司还向世界各地的监管机构提交了更新后的 COVID-19 疫苗的数据。两家公司正在继续监测 COVID-19 不断变化的流行病学，为满足全球公共卫生需求做准备。

The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY® and its adapted vaccines in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

辉瑞和 BioNTech 的 COVID-19 疫苗基于 BioNTech 专有的 mRNA 技术，由两家公司开发。BioNTech 是 COMIRNATY® 及其改良疫苗在美国、欧盟、英国和其他国家的上市许可持有人，也是美国（与辉瑞联合）和其他国家的紧急使用授权或同等药物的持有人。