ACIP投票扩大了对辉瑞呼吸道合胞病毒疫苗ABRYSVO®的建议，纳入50至59岁患病风险增加的成年人-动脉网

ACIP Votes to Expand Recommendation for Pfizer’s RSV Vaccine ABRYSVO® to Include Adults Aged 50 to 59 at Increased Risk of Disease

辉瑞等信源发布 2025-04-16 05:02

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Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74

投票扩大了现有的建议范围，之前建议所有75岁及以上的成年人以及60至74岁的高风险成年人接种疫苗。

NEW YORK--(BUSINESS WIRE)--

纽约--（商业资讯）--

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD).

辉瑞公司（纽约证券交易所代码：PFE）今天宣布，美国疾病控制与预防中心（CDC）免疫实践咨询委员会（ACIP）投票决定扩大其对呼吸道合胞病毒（RSV）疫苗的使用建议，推荐给50至59岁患有RSV相关下呼吸道疾病（LRTD）风险增加的成年人群。

This includes ABRYSVO.

这包括ABRYSVO。

(Respiratory Syncytial Virus Vaccine), which in October 2024, the U.S. Food and Drug Administration approved for the prevention of RSV-associated LRTD in adults aged 18 to 59 at increased risk of severe disease.

（呼吸道合胞病毒疫苗），在2024年10月，美国食品和药物管理局批准用于预防18至59岁重症风险增加的成人与RSV相关的下呼吸道疾病。

According to the CDC, between 15,000 - 20,000 RSV-associated hospitalizations occur annually in U.S. adults aged 50 - 59 years.

根据CDC的数据，美国每年有15,000至20,000名50至59岁的成年人因RSV相关疾病住院。

The risk of hospitalization is highest among those adults with one or more underlying medical conditions such as obesity, cardiovascular disease, diabetes, chronic obstructive pulmonary disorder (COPD), asthma, and other chronic or immunocompromising conditions.

有一种或多种基础疾病（如肥胖、心血管疾病、糖尿病、慢性阻塞性肺病 (COPD)、哮喘及其他慢性或免疫功能受损相关疾病）的成年人住院风险最高。

With respect to ABRYSVO, ACIP stated:

关于ABRYSVO，ACIP表示：

ACIP recommends adults 50–59 years of age who are at increased risk of severe RSV disease receive a single dose of RSV vaccine.

ACIP 建议 50 至 59 岁有严重 RSV 疾病风险的成年人接种一剂 RSV 疫苗。

“With its vote to expand adult RSV vaccination recommendations, ACIP has taken an important step toward protecting individuals aged 50 to 59 who have underlying medical conditions that increase their risk for severe RSV illness,” said Alejandro Cane, Vice President, Vaccines and Antivirals U.S. Medical Lead, Pfizer.

“随着ACIP投票扩大成人RSV疫苗接种建议，该委员会已采取重要步骤，保护那些因潜在健康问题而面临严重RSV疾病风险的50至59岁人群，”辉瑞美国医学负责人、疫苗与抗病毒副总裁亚历杭德罗·凯恩表示。

“We are proud that ABRYSVO has the broadest indication among RSV vaccines, covering older adults, adults 18 and older at heightened risk of severe disease, and pregnant women to help protect infants.”.

“我们为ABRYSVO拥有最广泛的适用范围而感到自豪，它覆盖了老年人、18岁及以上重症高风险成年人，以及孕妇，以帮助保护婴儿。”

The updated ACIP recommendation, which lowers the recommended age for RSV vaccination from 60 to 50 for high-risk adults, is pending final approval by the director of the CDC and the Department of Health and Human Services.

更新后的ACIP建议将高危成年人接种RSV疫苗的推荐年龄从60岁降低到50岁，目前正在等待CDC主任和卫生与公众服务部的最终批准。

ABOUT RSV

关于RSV

Respiratory syncytial virus (RSV) is a contagious virus and a common cause of respiratory illness.

呼吸道合胞病毒 (RSV) 是一种传染性病毒，也是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，可能导致严重疾病或死亡。

3,4

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Chronic cardiovascular disease, chronic lung disease, moderate or severe immune compromise, diabetes with complications, and severe obesity are among the conditions that increase an individual’s risk for severe RSV.

慢性心血管疾病、慢性肺部疾病、中度或重度免疫功能受损、伴有并发症的糖尿病和重度肥胖症等状况均会增加个体感染严重RSV的风险。

There are two major subgroups of RSV: RSV-A and RSV-B. Both subgroups cause disease and can co-circulate or alternate predominance from season to season.

RSV有两个主要亚组：RSV-A和RSV-B。这两个亚组都会引起疾病，并且可以在不同季节共同传播或交替占据主导地位。

ABOUT ABRYSVO

关于ABRYSVO

Pfizer currently is the only company with an RSV vaccine to help protect adults aged 60 and older, and adults 18 and older at increased risk of lower respiratory tract disease caused by RSV (RSV-LRTD), as well as infants through maternal immunization. ABRYSVO is an unadjuvanted, bivalent vaccine that was designed to provide broad protection against RSV-LRTD, regardless of the virus subgroup.

目前，辉瑞是唯一一家拥有RSV疫苗的公司，该疫苗可帮助保护60岁及以上的成年人，以及18岁及以上因RSV（呼吸道合胞病毒）导致下呼吸道疾病风险增加的成年人，同时通过母体免疫保护婴儿。ABRYSVO是一种无佐剂、双价疫苗，旨在提供对RSV-LRTD（由不同病毒亚组引起的下呼吸道疾病）的广泛保护。

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..

在融合前状态，RSV融合蛋白（F）是中和抗体的主要靶点，也是辉瑞RSV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。

In May 2023, the FDA

2023年5月，FDA

approved

已批准

ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age or older. In June 2024, the Advisory Committee on Immunization Practices (ACIP) voted to update its

ABRYSVO用于预防60岁及以上人群因RSV引起的LRTD。2024年6月，免疫实践咨询委员会（ACIP）投票决定更新其

recommendation

推荐

for maternal immunization to help protect newborns from RSV seasonally where the vaccine should be administered from September through January in most of the continental United States.

为了进行母体免疫，以帮助保护新生儿免受季节性呼吸道合胞病毒（RSV）的侵害，在美国大陆的大部分地区，疫苗应在九月至一月期间接种。

Also in August 2023, Pfizer

同样在2023年8月，辉瑞

announced

宣布

that the European Commission granted marketing authorization for ABRYSVO for both older adults and maternal immunization to help protect infants, and in March 2025

欧盟委员会已授予ABRYSVO用于老年人和孕产妇免疫接种的上市许可，以帮助保护婴儿，并在2025年3月

announced

宣布

the amended marketing authorization to extend the indication to include a broader adult population. Additionally, ABRYSVO has received approvals for both indications in multiple countries worldwide.

修订后的上市许可，将适应症扩展至更广泛的成人人群。此外，ABRYSVO已在全球多个国家获得两项适应症的批准。

INDICATIONS FOR ABRYSVO

ABRYSVO的适应症

ABRYSVO

阿布瑞斯沃

is a vaccine indicated in the U.S. for:

在美国，疫苗的适应症为：

the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older

预防60岁及以上人群因呼吸道合胞病毒（RSV）引起的下呼吸道疾病（LRTD）

the prevention of LRTD caused by RSV in people 18 through 59 years of age who are at increased risk for LRTD caused by RSV

预防18至59岁因RSV导致LRTD风险增加的人群中由RSV引起的LRTD。

pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age

怀孕32至36周的个体，用于预防婴儿从出生到6个月大时由RSV引起的LRTD和严重LRTD

IMPORTANT SAFETY INFORMATION FOR ABRYSVO

ABRYSVO的重要安全信息

ABRYSVO should not be given to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any of its components

ABRYSVO 不应给予对其任何成分有严重过敏反应（例如，过敏性休克）病史的人。

An increased risk of Guillain-Barré syndrome (severe muscle weakness) was observed after vaccination with ABRYSVO

接种ABRYSVO后观察到吉兰-巴雷综合征（严重肌肉无力）的风险增加。

For pregnant individuals: to avoid the potential risk of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age

对于孕妇：为避免早产的潜在风险，ABRYSVO应在妊娠32至36周时接种。

Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury during fainting

接种注射疫苗（包括ABRYSVO）后可能会发生晕厥。应采取预防措施，避免晕倒时跌倒和受伤。

Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO

免疫系统减弱的成年人，包括那些正在接受抑制免疫系统药物治疗的人，对ABRYSVO的免疫反应可能会降低。

Vaccination with ABRYSVO may not protect all people

接种ABRYSVO疫苗可能无法保护所有人。

In adults 60 years of age and older, the most common side effects (≥10%) were fatigue, headache, pain at the injection site, and muscle pain

在 60 岁及以上的成年人中，最常见的副作用（≥10%）为疲劳、头痛、注射部位疼痛和肌肉疼痛。

In adults 18 through 59 years of age, the most common side effects (≥10%) were pain at the injection site, muscle pain, joint pain and nausea

在18至59岁的成年人中，最常见的副作用（≥10%）为注射部位疼痛、肌肉疼痛、关节疼痛和恶心。

In pregnant individuals, the most common side effects (≥10%) were pain at the injection site, headache, muscle pain, and nausea

在孕妇中，最常见的副作用（≥10%）为注射部位疼痛、头痛、肌肉疼痛和恶心。

In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% ABRYSVO versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo)

在ABRYSVO与安慰剂的临床试验中，接种疫苗的孕妇所产下的婴儿出现低出生体重（5.1% ABRYSVO 对比 4.4% 安慰剂）和黄疸（7.2% ABRYSVO 对比 6.7% 安慰剂）。

View the full ABRYSVO Prescribing Information

查看完整的ABRYSVO处方信息

。

About Pfizer: Breakthroughs That Change Patients’ Lives

关于辉瑞：改变患者生命的突破性进展

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、开发和生产过程中树立质量、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，辉瑞的员工在发达市场和新兴市场工作，以促进健康、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。

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。我们经常在我们的网站上发布可能对投资者重要的信息。

www.Pfizer.com

. In addition, to learn more, please visit us on

此外，欲了解更多，请访问我们

www.Pfizer.com

and follow us on X at

关注我们在X平台上的账号

@Pfizer

@辉瑞

and

和

@Pfizer News

辉瑞新闻

，

领英

，

YouTube

and like us on Facebook at

并在 Facebook 上关注我们

Facebook.com/Pfizer

Facebook.com/辉瑞

。

DISCLOSURE NOTICE:

披露通知：

The information contained in this release is as of April 16, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

本新闻稿中的信息截至2025年4月16日。辉瑞不对因新信息或未来事件或发展而更新本新闻稿中包含的前瞻性声明承担任何责任。

This release contains forward-looking information about ABRYSVO, including its potential benefits and a vote by ACIP to expand its recommendation to include adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

本发布包含关于ABRYSVO的前瞻性信息，包括其潜在益处以及ACIP投票扩大其建议范围，以涵盖50至59岁有较高风险与RSV相关的下呼吸道疾病成年人，其中涉及重大风险和不确定性，可能导致实际结果与这些声明所表达或暗示的结果存在重大差异。

Risks and uncertainties include, among other things, uncertainties regarding the commercial success of ABRYSVO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when biologic license applications may be filed in particular jurisdictions for ABRYSVO for any potential indications; whether and when any applications that may be pending or filed for ABRYSVO may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether ABRYSVO for any such indications will be commercially successful; intellectual property and other litigation; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or .

风险和不确定性包括（但不限于）：关于ABRYSVO商业成功的不确定性；研发过程中固有的不确定性，包括是否能够达到预期的临床终点、临床试验的启动和/或完成日期、监管提交日期、监管批准日期和/或上市日期，以及可能出现不利的新临床数据并对现有临床数据进行进一步分析的可能性；与中期数据相关的风险；临床试验数据可能受到监管机构不同解读和评估的风险；监管机构是否对我们的临床研究设计和结果感到满意；在特定司法管辖区，是否及何时能为ABRYSVO提交生物制品许可申请以覆盖任何潜在适应症；任何已提交或许可申请是否及何时会获得监管机构的批准，这将取决于众多因素，包括确定产品的收益是否大于其已知风险，以及对产品功效的评估，并且如果获得批准，ABRYSVO针对任何此类适应症是否会在商业上取得成功；知识产权和其他诉讼；监管当局对标签、生产工艺、安全性及其他的决定。

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S.

辉瑞公司截至2024年12月31日的财政年度的10-K表格年报以及其后的10-Q表格报告中，包含“风险因素”和“前瞻性信息及可能影响未来结果的因素”等部分，其中进一步描述了风险和不确定性；此外，其后续提交的8-K表格报告中也包含了相关信息，所有这些文件均已提交给美国证券交易委员会。

Securities and Exchange Commission and available at .

证券交易委员会，可从以下网址获取。

www.sec.gov

and

和

www.pfizer.com

。

____________________

U.S. Centers for Disease Control and Prevention. “Evidence to Recommendations Framework (EtR): RSV Vaccination in Adults Aged 50–59 years”

美国疾病控制与预防中心。《证据到建议框架（EtR）：50-59岁成人RSV疫苗接种》

https://www.cdc.gov/acip/downloads/slides-2025-04-15-16/06-Melgar-Surie-adult-rsv-508.pdf

Presented April 16, 2025. Accessed April 2025.

发布于2025年4月16日，访问于2025年4月。

World Health Organization. Respiratory Syncytial Virus (RSV) disease.

世界卫生组织。呼吸道合胞病毒（RSV）疾病。

https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/norms-and-standards/vaccine-standardization/respiratory-syncytial-virus-disease

. Accessed February 2025.

访问时间：2025年2月。

U.S. Centers for Disease Control and Prevention. How RSV Spreads.

美国疾病控制与预防中心。RSV的传播方式。

https://www.cdc.gov/rsv/causes/index.html

. Updated August 30, 2024. Accessed February 2025.

. 更新于2024年8月30日。访问于2025年2月。

U.S. Centers for Disease Control and Prevention. RSV in Older Adults.

美国疾病控制与预防中心。老年人中的RSV。

https://www.cdc.gov/rsv/older-adults/index.html

. Updated August 30, 2024. Accessed February 2025.

. 更新于2024年8月30日，访问于2025年2月。