Pfizer Inc. and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY

辉瑞和BioNTech(Nasdaq: BNTX, “BioNTech”) 今天宣布，美国食品和药物管理局 (FDA) 已批准该公司针对 LP.8.1 改良的单价 COVID-19 疫苗 (COMIRNATY) 的补充生物制品许可申请 (sBLA)。

LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

LP.8.1；mRNA新冠疫苗，用于65岁及以上的成年人，以及5至64岁且至少有一种基础疾病、使其面临新冠重症高风险的个体。

The FDA approval is based on the cumulative body of evidence supporting the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine, including clinical trial data supporting the approval for children 5 through 11 years of age. The application also included data from pre-clinical models showing that the LP.8.1-adapted monovalent COVID-19 vaccine generates improved immune responses against multiple circulating SARS-CoV-2 sublineages, including XFG, NB.1.8.1, and other contemporary sublineages, compared to the companies’ JN.1- and KP.2-adapted monovalent COVID-19 vaccines..

FDA 的批准是基于支持辉瑞-BioNTech COVID-19 疫苗安全性和有效性的累积证据，包括支持 5 至 11 岁儿童批准的临床试验数据。申请还包含了临床前模型的数据，显示与公司针对 JN.1 和 KP.2 的单价 COVID-19 疫苗相比，LP.8.1 适应型单价 COVID-19 疫苗能够产生对多种流行中的 SARS-CoV-2 亚系（包括 XFG、NB.1.8.1 及其他当代亚系）更强的免疫反应。

The LP.8.1 sublineage selection is based on guidance from the FDA, which stated that LP.8.1 is the preferred sublineage of a monovalent JN.1-lineage-based COVID-19 vaccine for use in the U.S. beginning in fall 2025.

LP.8.1亚系的选择是基于FDA的指导，该指导指出，从2025年秋季开始，LP.8.1是美国使用的单价JN.1系新冠疫苗的首选亚系。

This season’s Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and be available in pharmacies, hospitals, and clinics across the U.S. in the coming days.

本季的辉瑞和BioNTech新冠疫苗将立即开始发货，并将在未来几天内在美国各地的药店、医院和诊所供应。

To date, 5 billion doses have been distributed globally of the Pfizer-BioNTech COVID-19 vaccine, which continues to demonstrate a favorable safety and efficacy profile supported by extensive real-world evidence as well as by clinical, non-clinical, pharmacovigilance, and manufacturing data.

迄今为止，辉瑞-BioNTech COVID-19 疫苗已在全球分发 50 亿剂，并通过广泛的实际证据以及临床、非临床、药物警戒和生产数据，持续表现出良好的安全性和有效性。

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

辉瑞和BioNTech的COVID-19疫苗基于BioNTech的专有mRNA技术，并由两家公司共同开发。BioNTech是COMIRNATY的上市许可持有人。

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 other countries.

并且其改良疫苗在美国、欧盟、英国和其他国家获得紧急使用授权或许可。

About Pfizer: Breakthroughs That Change Patients’ Lives

关于辉瑞：改变患者生活的突破性进展

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

在辉瑞，我们运用科学和全球资源为人们带来延长和显著改善他们生活的疗法。我们努力在医疗保健产品的发现、开发和生产中树立质量、安全和价值的标准，包括创新药物和疫苗。

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.

每天，辉瑞的同事们在发达市场和新兴市场开展工作，推动健康、预防、治疗和攻克当今最令人恐惧的疾病。作为全球首屈一指的创新生物制药公司之一，我们与医疗保健提供者、政府和当地社区合作，支持并扩大全球获得可靠且负担得起的医疗保健的机会，这与我们的责任一致。

For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at .

175 年来，我们一直努力为我们所服务的所有人带来改变。我们经常在我们的网站上发布可能对投资者重要的信息。

About BioNTech

关于BioNTech

Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals.

生物制药新技术公司（BioNTech）是一家全球下一代免疫治疗公司，率先开发用于癌症和其他严重疾病的新研究性疗法。BioNTech利用广泛计算发现和治疗模式，旨在快速开发新型生物制药。

Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies.

其多样化的肿瘤学产品候选组合旨在应对癌症的整个连续过程，包括mRNA癌症免疫疗法、下一代免疫调节剂和靶向疗法，如抗体药物偶联物（ADC）和创新的嵌合抗原受体（CAR）T细胞疗法。

Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Bristol Myers Squibb, Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron..

基于其在mRNA开发方面的深厚专业知识和内部生产能力，BioNTech及其合作伙伴正在研究和开发多种针对一系列传染病的mRNA疫苗候选产品，同时推进其多样化的肿瘤学管线。BioNTech已经与多家全球性和专业性制药合作伙伴建立了广泛的合作关系，其中包括百时美施贵宝、Duality Biologics、复星医药、罗氏集团成员基因泰克、Genevant、Genmab、MediLink、OncoC4、辉瑞和再生元。