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GSK获美国免疫实践咨询委员会建议Arexvy用于50-59岁患严重RSV风险较高的成年人

Arexvy recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices

葛兰素史克 等信源发布 2025-04-16 05:14

可切换为仅中文


GSK plc (LSE/NYSE: GSK) is pleased that the Advisory Committee on Immunization Practices (ACIP) voted in favour of recommending the use of RSV vaccines including GSK’s

GSK plc(LSE/NYSE:GSK)很高兴免疫实践咨询委员会(ACIP)投票支持推荐使用包括GSK的RSV疫苗在内的疫苗。

Arexvy

阿雷克斯维

(Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 50-59 who are at increased risk for severe RSV disease. This includes people with conditions like COPD, asthma, diabetes, heart disease and those in residential care

(呼吸道合胞病毒疫苗,佐剂)适用于50-59岁且患严重RSV疾病风险增加的成年人。这包括患有慢性阻塞性肺病、哮喘、糖尿病、心脏病等疾病的人,以及住在护理机构中的人。

. This expands on ACIP’s previous vote in June 2024 to recommend RSV vaccines for adults aged 60-74 who are at increased risk and all adults aged 75 and older.

这项建议扩展了ACIP在2024年6月的先前投票,即建议为60-74岁风险增加的成年人以及所有75岁及以上的成年人推荐RSV疫苗。

A systematic review of studies in the US shows that RSV is estimated to cause 42,000 hospitalisations

美国的一项系统性研究表明,RSV估计导致42,000例住院治疗

each year in adults aged 50-64 years old.

每年在50至64岁的成年人中。

Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk from severe consequences from an RSV infection compared to those without these conditions.

患有慢性阻塞性肺疾病(COPD)、哮喘、心力衰竭和糖尿病等基础疾病的成年人,与没有这些疾病的人相比,感染RSV后出现严重后果的风险更高。

RSV can exacerbate these conditions and lead to pneumonia, hospitalisation, or death.

RSV会加重这些病情,并导致肺炎、住院或死亡。

Tony Wood, Chief Scientific Officer, GSK

葛兰素史克首席科学官 Tony Wood

: “We are pleased with ACIP's recommendation to expand the benefits of RSV immunisation to more than 13 million adults aged 50-59 who are at increased risk for the severe consequences of this virus. RSV can have a significant impact for those with underlying medical conditions. We look forward to helping protect more people with RSV vaccination.”.

“我们对ACIP建议将RSV免疫接种的益处扩大到超过1300万名50至59岁、面临较高病毒严重后果风险的成年人感到高兴。对于有基础健康状况的人,RSV可能带来重大影响。我们期待通过RSV疫苗接种帮助保护更多人群。”

In making its recommendation, the ACIP considered positive results from a phase III trial [NCT05590403]

在提出建议时,ACIP 考虑了 III 期试验 [NCT05590403] 的积极结果。

evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions

评估GSK的RSV疫苗在50-59岁成年人中的免疫反应和安全性,包括那些因某些基础医疗条件而具有较高RSV-LRTD风险的人群。

compared to older adults aged 60 years and above where efficacy has been demonstrated after a single dose of GSK’s RSV vaccine.

与60岁及以上的老年人相比,GSK的RSV疫苗在单剂接种后已显示出效力。

The ACIP recommendations will be forwarded for review and approval. Once approved, the final recommendations will be published to advise healthcare providers on appropriate use of the vaccine and to inform insurance coverage.

ACIP 的建议将被提交审查和批准。一旦获得批准,最终的建议将会发布,以指导医疗保健提供者适当使用疫苗,并告知保险覆盖范围。

About GSK’s RSV Vaccine

关于GSK的RSV疫苗

Respiratory Syncytial Virus Vaccine, Adjuvanted, contains recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01

呼吸道合胞病毒疫苗(含佐剂)包含稳定在融合前构象的重组RSV糖蛋白F(RSVPreF3)。该抗原与GSK专有的AS01佐剂相结合。

adjuvant.

辅助的。

The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 61 countries, including Europe, Japan and US. In addition, it is approved in the US, EU/EEA countries and Japan for use in individuals aged 50-59 who are at increased risk for lower respiratory disease caused by RSV due to certain underlying medical conditions.

该疫苗已获准在61个国家(包括欧洲、日本和美国)用于预防60岁及以上人群的RSV-LRTD。此外,它在美国、欧盟/欧洲经济区国家和日本还被批准用于因某些基础医疗状况而导致RSV引起的下呼吸道疾病风险增加的50-59岁人群。

Regulatory reviews for this extended indication are ongoing in other countries..

其他国家正在进行这一扩展适应症的监管审查。

The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees.

该疫苗的使用应遵循官方建议。与任何疫苗一样,并非所有接种者都会产生保护性免疫反应。

The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus.

GSK专有的AS01佐剂系统包含从Antigenics Inc.(Agenus Inc.的全资子公司)授权的STIMULON QS-21佐剂。STIMULON是Agenus子公司SaponiQx Inc.的商标。

About RSV in adults

关于成人中的RSV

RSV is a common contagious virus affecting the lungs and breathing passages. Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age.

RSV是一种常见的传染性病毒,影响肺部和呼吸道。由于合并症、免疫功能受损或高龄,成年人患RSV疾病的风险可能会增加。

RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.

RSV可能加重包括慢性阻塞性肺病、哮喘和慢性心力衰竭在内的疾病,并可能导致肺炎、住院和死亡等严重后果。

Each year, RSV is estimated to cause approximately 177,000 hospitalisations in adults 65 years and older

每年,RSV估计会导致约177,000名65岁及以上的成年人住院。

and 42,000* in adults aged 50-64 years old in the US.

在美国,50-64岁的成年人中有42,000人。

About GSK

关于GSK

GSK is a global biopharma Company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com

GSK是一家全球生物制药公司,致力于联合科学、技术和人才,共同战胜疾病。欲了解更多信息,请访问gsk.com。