Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO®, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age. This expands the previous authorization for individuals aged 60 and older, and ABRYSVO now offers in the EU the broadest RSV vaccine indication, which includes:

辉瑞公司 (NYSE: PFE) 今天宣布，欧盟委员会 (EC) 已发布决定，修改该公司双价呼吸道合胞病毒 (RSV) 融合前 F (RSVpreF) 疫苗 ABRYSVO® 的上市许可，将适应症扩大到包括预防 18 至 59 岁人群中由 RSV 引起的下呼吸道疾病 (LRTD)。这扩大了之前针对 60 岁及以上人群的授权，ABRYSVO 现在在欧盟提供最广泛的 RSV 疫苗适应症，包括：

Active immunization of individuals 18 years of age and older for the prevention of LRTD caused by RSV Passive protection against lower respiratory tract disease (LRTD) caused by RSV in infants from birth through 6 months of age following maternal immunization during pregnancy

对 18 岁及以上的个人进行主动免疫，以预防呼吸道合胞病毒引起的 LRTD 孕期母亲接种疫苗后，可为出生至 6 个月大的婴儿提供针对呼吸道合胞病毒引起的下呼吸道疾病 (LRTD) 的被动保护

We are thrilled that ABRYSVO is now approved in the EU to help prevent RSV in adults aged 18 and older, which causes approximately 158,000 adult hospital admissions annually from RSV disease, a common respiratory virus with symptoms that can be severe or even life-threatening,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. “With an indication that also includes pregnant individuals between weeks 24 and 36 gestation to help protect infants from birth up to 6 months of age, ABRYSVO’s expanded authorization for adults aged 18 to 59 in the EU signifies another step for public health by offering the potential to substantially reduce the burden of RSV in future seasons.”

辉瑞公司首席国际商务官兼执行副总裁 Alexandre de Germay 表示：“我们很高兴 ABRYSVO 现已在欧盟获得批准，用于帮助预防 18 岁及以上成年人的呼吸道合胞病毒感染，该病毒每年导致约 158,000 名成人因呼吸道合胞病毒感染而入院，呼吸道合胞病毒感染是一种常见的呼吸道病毒，症状可能很严重，甚至危及生命。”“ABRYSVO 的适应症还包括妊娠 24 至 36 周的孕妇，以帮助保护从出生到 6 个月大的婴儿，ABRYSVO 在欧盟被扩大到 18 至 59 岁的成年人，这标志着公共卫生又迈出了一步，因为它有可能在未来几个季节大幅减轻呼吸道合胞病毒的负担。”

The amended marketing authorization follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states plus Iceland, Liechtenstein, and Norway. The approval is based on results from the pivotal phase 3 clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), which investigated the safety, tolerability, and immunogenicity of ABRYSVO in adults 18 through 59 years of age at risk of RSV-associated LRTD due to certain chronic medical conditions. It was also supported by the thousands of persons vaccinated in clinical trials involving ABRYSVO in this age group.1,2,3,4 The results of MONeT and other studies have been published in peer-reviewed journals.

修订后的营销授权是根据人用药品委员会 (CHMP)最近提出的积极意见而发布的。该授权在所有 27 个欧盟成员国及冰岛、列支敦士登和挪威有效。此次批准基于关键性 3 期临床试验 ( NCT05842967 ) MONeT （针对重症高风险成人的RSV I M免疫研究）的结果，该试验研究了 ABRYSVO 对 18 至 59 岁因某些慢性疾病而面临 RSV 相关 LRTD 风险的成人的安全性、耐受性和免疫原性。该年龄段的 ABRYSVO 临床试验中，数千名接种疫苗的人也支持这一决定。1,2,3,4 MONeT和其他研究的结果已发表在同行评议期刊上。

ABOUT RSV

关于RSV

Respiratory Syncytial Virus (RSV) is a contagious virus and a common cause of respiratory illness worldwide.

呼吸道合胞病毒 (RSV) 是一种传染性病毒，也是全球范围内导致呼吸道疾病的一种常见原因。

The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.

这种病毒可以影响感染者的肺部和呼吸道，可能导致严重疾病甚至死亡。

There are two major subgroups of RSV: RSV-A and RSV-B.

RSV有两个主要亚群：RSV-A和RSV-B。

Both subgroups cause disease and can co-circulate or alternate predominance from season to season. In total, RSV causes approximately 158,000 hospital admissions annually among adults aged 18 and older across the EU, with an estimated 13,000 hospitalizations in those aged 18 to 64 years.

两个亚组均会导致疾病，并且可以在不同季节共同流行或交替占据主导地位。总体而言，RSV每年在欧盟18岁及以上的成年人中导致约158,000例住院，其中估计有13,000例住院发生在18至64岁的人群中。

ABOUT ABRYSVO

关于ABRYSVO

ABRYSVO is an unadjuvanted, bivalent vaccine that was designed to provide protection against RSV-LRTD, regardless of the virus subgroup. In the prefusion state, the RSV fusion protein (F) is a major target of neutralizing antibodies, serving as the basis of Pfizer’s RSV vaccine. Variations in the F protein sequence among RSV-A and RSV-B subgroups are clustered in a key antigenic site, a target for potent neutralizing antibodies..

ABRYSVO是一种未添加佐剂的二价疫苗，旨在提供针对呼吸道合胞病毒（RSV）引起的下呼吸道疾病的保护，无论病毒亚型如何。在融合前状态，呼吸道合胞病毒的融合蛋白（F）是中和抗体的主要靶点，也是辉瑞呼吸道合胞病毒疫苗的基础。RSV-A和RSV-B亚组之间F蛋白序列的变异集中在一个关键抗原位点，这是强效中和抗体的靶标。

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。我们致力于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恐惧的疾病。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，支持并扩大世界各地获得可靠且负担得起的医疗保健的机会。

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，我们一直努力为所有依赖我们的人带来改变。我们经常在网站上发布可能对投资者重要的信息。