CAMBRIDGE, MA / ACCESS Newswire / June 12, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved

剑桥，马萨诸塞州 / ACCESS 新闻专线 / 2025年6月12日 / Moderna, Inc.（纳斯达克股票代码：MRNA）今天宣布，美国食品和药物管理局（FDA）已批准

mRESVIA

mRESVIA

(mRNA-1345), the Company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease. This approval expands the previous indication of mRESVIA, which was approved in May 2024 for adults aged 60 years and older..

（mRNA-1345），即公司研发的呼吸道合胞病毒（RSV）疫苗，用于预防18至59岁因感染RSV而有较高患病风险的个体发生的下呼吸道疾病（LRTD）。此次批准扩大了mRESVIA之前的适用范围，该疫苗曾在2024年5月获批用于60岁及以上成年人。

'RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV,' said Stéphane Bancel, Chief Executive Officer of Moderna. 'We appreciate the FDA's review and thank all the participants in our clinical trial as well as the Moderna team for their dedication to protecting people against RSV.'.

“RSV对患有某些慢性疾病的成年人构成严重的健康风险，而今天的批准标志着我们在保护更多人群免受RSV严重疾病影响方面迈出了重要一步，”Moderna首席执行官Stéphane Bancel表示。“我们感谢FDA的审评，并向参与我们临床试验的所有参与者以及Moderna团队表达诚挚谢意，感谢他们致力于保护人们免受RSV的侵害。”

While the risk of RSV is well recognized in infants and older adult populations, adults aged 18-59 years with chronic conditions are also vulnerable.

虽然婴儿和老年人群中RSV的风险已得到广泛认识，但18-59岁患有慢性疾病的成年人也同样易感。

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Over one-third of adults aged 18-59 years have at least one underlying condition that puts them at increased risk of severe RSV disease,

超过三分之一的18-59岁成年人至少有一种基础疾病，使他们面临更高的严重RSV疾病风险，

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with disease burden and hospitalization rates in this population being comparable, or even exceeding, that observed in older adults.

疾病负担和住院率在这一群体中相当，甚至超过了老年人群的观察结果。

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This approval was supported by results from Moderna's Phase 3 study (NCT06067230), which evaluated the safety and immunogenicity of mRESVIA in adults aged 18-59 with underlying health conditions. The immune responses against both RSV-A and RSV-B met prespecified non-inferiority immunobridging criteria when compared to those observed in adults aged 60 years and older in the pivotal Phase 3, placebo-controlled safety and efficacy study.

该批准得到了Moderna的III期研究（NCT06067230）结果的支持，该研究评估了mRESVIA在18-59岁有基础健康状况的成年人中的安全性和免疫原性。针对RSV-A和RSV-B的免疫反应在与关键的III期安慰剂对照安全性和有效性研究中观察到的60岁及以上成年人的免疫反应对比时，均达到了预先设定的非劣效性免疫桥接标准。

Comparable levels of neutralizing antibodies were observed across both the 18-49 and 50-59 age subgroups, supporting the vaccine's consistent immunogenicity profile in this at-risk, younger adult population. These findings were presented at the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) meeting in April 2025 and have been published in .

在18-49岁和50-59岁年龄亚组中观察到相似水平的中和抗体，这支持了该疫苗在这一高风险的较年轻成人人群中具有一致的免疫原性特征。这些研究结果在2025年4月美国疾病控制与预防中心（CDC）免疫实践咨询委员会（ACIP）会议上公布，并已发表在 。

Clinical Infectious Diseases

临床感染病学

.

。

The vaccine was generally well-tolerated, and the most commonly reported solicited adverse reactions were injection site pain, fatigue, headache, myalgia and arthralgia.

疫苗通常耐受性良好，最常见的不良反应为注射部位疼痛、疲劳、头痛、肌肉疼痛和关节痛。

Moderna intends to have mRESVIA available for both younger adults at increased risk (ages 18-59) and older adults (ages 60+) in the U.S. for the 2025-2026 respiratory virus season.

Moderna计划在2025-2026年呼吸道病毒季节之前，使mRESVIA在美国对较高风险的年轻成人（18-59岁）和老年成人（60岁及以上）均可使用。

About mRESVIA® (Respiratory Syncytial Virus Vaccine)

关于mRESVIA®（呼吸道合胞病毒疫苗）

mRESVIA® is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes.

mRESVIA® 是一种 RSV 疫苗，包含编码稳定化融合前 F 糖蛋白的 mRNA 序列。F 糖蛋白表达于病毒表面，在感染过程中通过帮助病毒进入宿主细胞起关键作用。F 蛋白的融合前构象是强效中和抗体的重要靶点，并且在 RSV-A 和 RSV-B 亚型中高度保守。

The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccines..

该疫苗使用与莫德纳新冠疫苗相同的脂质纳米颗粒 (LNPs)。

About Moderna

关于莫德纳

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines..

Moderna 是 mRNA 医学领域的开创者之一。通过推进 mRNA 技术的发展，Moderna 正在重新定义药物的制造方式，并改变我们为所有人治疗和预防疾病的方法。公司在科学、技术和健康的交汇点上耕耘了十多年，以前所未有的速度和效率开发药物，其中包括最早且最有效的 COVID-19 疫苗之一。

Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines.

Moderna的mRNA平台促进了针对传染病、免疫肿瘤学、罕见病和自身免疫性疾病的治疗药物和疫苗的开发。凭借独特的企业文化以及由Moderna价值观和理念驱动的全球团队，Moderna致力于通过mRNA药物为人类健康未来带来负责任的改变，并努力为人们带来尽可能大的影响。

For more information about Moderna, please visit .

欲了解有关Moderna的更多信息，请访问。

modernatx.com

moderna.com

and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

请在X（原推特）、脸书、照片墙、优兔和领英上与我们联系。

mRESVIA® is a registered trademark of Moderna.

mRESVIA® 是 Moderna 的注册商标。

INDICATION

适应症

mRESVIA is a vaccine to protect you against lower respiratory tract disease caused by Respiratory Syncytial Virus (RSV).

mRESVIA 是一种疫苗，用于保护您免受由呼吸道合胞病毒 (RSV) 引起的下呼吸道疾病。

mRESVIA is for people 60 years of age and older and also for people 18 through 59 years of age who are at increased risk for RSV (people with medical conditions such as diabetes or with diseases affecting the lungs and heart). Vaccination with mRESVIA may not protect all people who receive the vaccine..

mRESVIA 适用于 60 岁及以上的人群，以及 18 至 59 岁之间感染 RSV 风险增加的人群（如患有糖尿病或影响肺部和心脏疾病的患者）。接种 mRESVIA 疫苗可能无法保护所有接种者。

mRESVIA does not contain RSV. mRESVIA cannot give you lower respiratory tract disease caused by RSV.

mRESVIA 不含 RSV。mRESVIA 不能导致由 RSV 引起的下呼吸道疾病。

IMPORTANT SAFETY INFORMATION

重要安全信息

Who should not get mRESVIA?

谁不应该使用mRESVIA？

You should not get mRESVIA if you had a severe allergic reaction to any ingredient in mRESVIA.

如果您对mRESVIA中的任何成分有过严重过敏反应，则不应使用mRESVIA。

What should you tell your healthcare provider?

你应该告诉你的医疗保健提供者什么？

Tell your healthcare provider about all of your medical conditions, including if you:

告诉您的医疗保健提供者您的所有健康状况，包括如果您：

Have any allergies

有任何过敏吗

Had a severe allergic reaction after receiving a previous dose of any other vaccine

接种过其他疫苗后出现严重过敏反应

Have a fever

发烧

Have a bleeding disorder or are on a blood thinner

有出血性疾病或正在服用血液稀释剂

Are immunocompromised or are on a medicine that affects your immune system

免疫系统受损或正在服用影响免疫系统的药物

Have received any other RSV vaccine

已接种过其他RSV疫苗

Have ever fainted in association with an injection

曾经在注射时晕倒过

How is mRESVIA given?

如何给药mRESVIA？

mRESVIA is given as an injection into the muscle.

mRESVIA 通过肌肉注射给药。

What are the risks of mRESVIA?

mRESVIA的风险有哪些？

There is a very small chance that mRESVIA could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of mRESVIA. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine.

mRESVIA引起严重过敏反应的几率非常小。严重过敏反应通常会在接种mRESVIA后的几分钟到一小时内发生。因此，您的医疗保健提供者可能会要求您在接种疫苗的地方短暂停留一段时间。

Signs of a severe allergic reaction may include:.

严重过敏反应的迹象可能包括：。

Trouble breathing

呼吸困难

Swelling of your face and throat

脸部和喉咙肿胀

A fast heartbeat

心跳加速

A rash all over your body

全身皮疹

Dizziness and weakness

头晕和虚弱

Side effects that have been reported in clinical trials with mRESVIA include:

在mRESVIA的临床试验中报告的副作用包括：

Injection-site reactions: pain, underarm swelling or tenderness in the same arm of the injection, swelling (hardness), and redness

注射部位反应：疼痛、同侧腋下肿胀或压痛、肿胀（硬化）和发红

Fatigue, headache, muscle pain, joint pain, chills, nausea or vomiting, fever and hives

疲劳、头痛、肌肉疼痛、关节疼痛、发冷、恶心或呕吐、发烧和荨麻疹

These may not be all of the possible side effects of mRESVIA. Ask your healthcare provider about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or

这些可能并非 mRESVIA 的全部可能副作用。如有任何令您担忧的副作用，请咨询您的医疗保健提供者。您可以致电 1-800-822-7967 或向疫苗不良事件报告系统 (VAERS) 报告副作用。

https://vaers.hhs.gov

https://vaers.hhs.gov

.

。

Please click

请单击

for mRESVIA Full Prescribing Information.

有关mRESVIA的完整处方信息，请参阅。

Moderna Forward-Looking Statements

莫德纳前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the efficacy, safety and tolerability of mRESVIA; the disease burden associated with RSV, particularly in adults with certain risk factors; and the availability of mRESVIA for the 2025-2026 season.

本新闻稿包含1995年《私人证券诉讼改革法案》（经修订）所指的前瞻性声明，包括关于以下内容的声明：mRESVIA的有效性、安全性和耐受性；与RSV相关的疾病负担，尤其是在具有某些风险因素的成人中；以及mRESVIA在2025-2026季节的可用性。

The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements.

本新闻稿中的前瞻性陈述既不是承诺也不是保证，您不应过度依赖这些前瞻性陈述，因为它们涉及已知和未知的风险、不确定性以及其他因素，其中许多因素超出Moderna的控制范围，并可能导致实际结果与这些前瞻性陈述中明示或暗示的结果存在重大差异。

These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading 'Risk Factors' in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov.

这些风险、不确定性和其他因素包括但不限于Moderna截至2024年12月31日财政年度的Form 10-K年度报告中标题为“风险因素”下描述的风险和不确定性，以及Moderna随后向美国证券交易委员会提交的文件中所包含的内容，这些文件可在美国证券交易委员会网站www.sec.gov上查阅。

Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release..

除非法律要求，Moderna否认任何更新或修改本新闻稿中包含的前瞻性陈述的意图或责任，即使出现新信息、未来发展或其他情况。这些前瞻性陈述基于Moderna的当前预期，仅截至本新闻稿发布之日。

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Prasad N, Walker TA, Waite B, et al. Respiratory syncytial virus-associated hospitalizations among adults with chronic medical conditions. Clin Infect Dis 2021; 73(1): e158-e63.

Prasad N、Walker TA、Waite B 等。患有慢性疾病的成人因呼吸道合胞病毒相关的住院情况。《临床感染病》2021年；73（1）：e158-e63。

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Wilker E, Jiang M, Francis B, et al. Burden of chronic medical conditions that are risk factors for severe RSV among adults aged 18-59 years in the United States. Poster presented at: ESCMID; April 2025; Vienna, Austria.

威尔克尔 E、江 M、弗朗西斯 B 等。美国 18-59 岁成人中作为严重 RSV 风险因素的慢性疾病负担。海报展示于：ESCMID；2025 年 4 月；奥地利维也纳。

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Weycker D, Averin A, Houde L, et al. Rates of Lower Respiratory Tract Illness in US Adults by Age and Comorbidity Profile. Infect Dis Ther 2024; 13(1): 207-20.

Weycker D, Averin A, Houde L, 等。美国成年人按年龄和合并症特征划分的下呼吸道疾病发病率。《感染病治疗》2024；13(1): 207-20。

SOURCE

源代码

:

：

Moderna, Inc.

莫德纳公司

mRESVIA (respiratory syncytial virus vaccine, mRNA) FDA Approval History

mRESVIA（呼吸道合胞病毒疫苗，mRNA）FDA批准历史

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