Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced positive topline results from an ongoing Phase 3 clinical trial cohort evaluating the safety, tolerability, and immunogenicity of a 30-µg dose of the LP.8.1-adapted monovalent COMIRNATY

辉瑞公司（纽约证券交易所代码：PFE，“辉瑞”）和BioNTech SE（纳斯达克：BNTX，"BioNTech"）今天宣布了正在进行的第三阶段临床试验队列的积极顶线结果，该试验评估了30微克剂量的LP.8.1适应性单价COMIRNATY的安全性、耐受性和免疫原性。

(COVID-19 Vaccine, mRNA) 2025-2026 Formula in adults aged 65 and older and in adults aged 18 through 64 with at least one underlying risk condition for severe COVID-19. The preliminary data show a robust increase in neutralizing antibodies targeting the LP.8.1 sublineage of SARS-CoV-2 following vaccination.

（COVID-19疫苗，mRNA）2025-2026年配方适用于65岁及以上成年人，以及18至64岁具有至少一种严重COVID-19潜在风险条件的成年人。初步数据显示，接种疫苗后针对SARS-CoV-2 LP.8.1亚谱系的中和抗体显著增加。

These clinical findings reinforce pre-clinical data that supported the recent U.S. Food and Drug Administration (FDA) approval of the LP.8.1-adapted COVID-19 vaccine, which demonstrated.

这些临床研究结果加强了支持最近美国食品药品监督管理局（FDA）批准的LP.8.1适应性COVID-19疫苗的临床前数据，该疫苗已证明。

improved immune responses against multiple circulating SARS-CoV-2 sublineages.

针对多种流行中的SARS-CoV-2亚谱系的免疫反应有所改善。

A total of 100 participants were enrolled in the open-label Phase 3 trial cohort, 50 adults aged 65 and older and 50 adults aged 18-64

共有100名参与者参加了开放标签的3期试验队列，其中50名为65岁及以上的成年人，50名为18-64岁的成年人。

with at least one underlying risk condition for severe COVID-19. Prior to receiving the LP.8.1-adapted COVID-19 vaccine 2025-2026 Formula, all participants had received the KP.2-adapted COVID-19 vaccine at least six months prior to enrollment and had not received any other COVID-19 vaccine or had COVID-19 disease since the KP.2 vaccination through enrollment in the study.

至少有一种可能导致严重新冠肺炎的潜在风险条件。在接种LP.8.1适应性新冠肺炎疫苗2025-2026配方之前，所有参与者均在入组前至少六个月接种过KP.2适应性新冠肺炎疫苗，并且自KP.2疫苗接种后至参与研究期间，未接种任何其他新冠疫苗或感染新冠肺炎。

Data from evaluable participants showed that the LP.8.1-adapted COVID-19 vaccine elicited a robust immune response against the LP.8.1 sublineage. In both age groups, 14 days following vaccination, LP.8.1-neutralizing antibody titers exceeded pre-vaccination levels, on average, by at least 4-fold. The safety profile of the vaccine was consistent with previous studies, with no new safety concerns identified..

可评估参与者的数据表明，LP.8.1适应性新冠疫苗针对LP.8.1亚谱系引发了强烈的免疫反应。在两个年龄组中，接种疫苗14天后，LP.8.1中和抗体滴度平均比接种前水平高出至少4倍。该疫苗的安全性与之前的研究一致，未发现新的安全性问题。

The favorable neutralizing antibody responses and consistent safety profile of the LP.8.1-adapted vaccine for individuals with higher risk and who had been previously exposed to SARS-CoV-2 provide early information for prescribers for this year’s vaccination period. This study was conducted to provide additional information about immunological effects of the vaccine and is not intended to replace the post marketing commitments requested by the FDA..

LP.8.1适应性疫苗在高风险人群及先前曾接触过SARS-CoV-2的个体中显示出良好的中和抗体反应和一致的安全性，为今年的疫苗接种期提供了早期信息。本研究旨在提供关于该疫苗免疫学效果的更多信息，并不打算取代FDA要求的上市后承诺。

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. COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies.

迄今为止，辉瑞-BioNTech的新冠疫苗已在全球分发了50亿剂，该疫苗持续展现出良好的安全性和有效性，得到了广泛的现实世界证据以及临床、非临床、药物警戒和生产数据的支持。辉瑞和BioNTech的新冠疫苗基于BioNTech专有的mRNA技术，并由两家公司共同开发。

BioNTech is the Marketing Authorization Holder for COMIRNATY.

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.

并在美国、欧盟、英国和其他国家获得紧急使用授权或许可。

U.S. INDICATION AND IMPORTANT SAFETY INFORMATION

美国适应症和重要安全信息

INDICATION

适应症

COMIRNATY (COVID-19 VACCINE, mRNA) is a vaccine to protect against coronavirus disease 2019 (COVID-19).

COMIRNATY（新冠疫苗，mRNA）是一种用于预防2019冠状病毒病（COVID-19）的疫苗。

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，为人们带来能够延长生命并显著改善生活的疗法。我们努力在医疗保健产品的发现、开发和生产过程中，为质量、安全性和价值设定标准，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畏惧的疾病。作为全球首屈一指的创新型生物制药公司之一，我们与医疗保健提供者、政府和当地社区合作，支持并扩大全球范围内可靠、负担得起的医疗保健服务的可及性。

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依赖的所有人带来改变。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，致力于开发用于癌症和其他严重疾病的新颖研究性疗法。BioNTech利用多种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.

其多样化的肿瘤学候选产品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）以及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，同时还有其多样化的肿瘤学管线。BioNTech已经与多家全球性和专业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。