NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO® (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

纽约-（商业新闻短讯）-辉瑞公司（纽约证券交易所：PFE）今天宣布，美国食品和药物管理局（FDA）已批准该公司的二价RSV prefusion F（RSVpreF）疫苗ABRYSVO®（呼吸道合胞病毒疫苗），用于预防18至59岁因RSV引起的LRTD风险增加的个体中由RSV引起的下呼吸道疾病（LRTD）。

ABRYSVO now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older. Additionally, it remains the only RSV immunization approved for pregnant individuals at 32 through 36 weeks of gestation to protect infants from birth up to 6 months of age..

ABRYSVO现在为成年人提供最广泛的RSV疫苗适应症，以前包括60岁及以上的成年人。此外，它仍然是唯一批准用于妊娠32至36周的孕妇的RSV免疫接种，以保护婴儿出生至6个月大。。

“RSV represents a significant threat to younger adults with certain chronic conditions. After decades of vaccine research by the scientific community and Pfizer, we now have the opportunity to help alleviate the burden of RSV in this high-risk adult population,” said Aamir Malik, Chief U.S. Commercial Officer and Executive Vice President, Pfizer.

辉瑞首席美国商务官兼执行副总裁阿米尔·马利克（AamirMalik）表示：“RSV对患有某些慢性病的年轻人构成了重大威胁。经过科学界和辉瑞公司数十年的疫苗研究，我们现在有机会帮助减轻这一高危成年人群的RSV负担。”。

“With this approval, we are proud that ABRYSVO is now the only RSV vaccine indicated for adults aged 18 to 49 at increased risk for the disease, expanding on its existing indications for older adults and pregnant women.”.

“有了这一批准，我们感到骄傲的是，ABRYSVO现在是唯一适用于18至49岁患病风险增加的成年人的RSV疫苗，扩大了其对老年人和孕妇的现有适应症。”。

The FDA’s decision is based on inferred efficacy1 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 at risk of RSV-associated disease due to certain chronic medical conditions.

FDA的决定是基于关键的3期临床试验（NCT05842967）MONeT（针对重症风险较高的成年人的RSV免疫研究）的推断效力1，该研究调查了ABRYSVO在成年人中的安全性，耐受性和免疫原性。由于某些慢性病，有患RSV相关疾病的风险。

The company intends to submit results from MONeT for publication in a peer-reviewed scientific journal and for presentation at an upcoming scientific conference..

该公司打算将莫奈的研究结果提交给同行评审的科学期刊，并在即将举行的科学会议上发表。。

Among U.S. adults 18 to 49 years of age, 9.5% have an underlying chronic condition, such as obesity, diabetes, chronic obstructive pulmonary disease (COPD), heart failure, chronic kidney disease, and asthma2 that puts them at increased risk of developing, and being hospitalized for, RSV-associated LRTD, and this rises to 24.3% among those 50 to 64 years of age.3,4.

在18至49岁的美国成年人中，有9.5%患有潜在的慢性病，如肥胖，糖尿病，慢性阻塞性肺病（COPD），心力衰竭，慢性肾病和哮喘2，这使他们患RSV相关LRTD的风险增加，住院治疗，在50至64岁的人群中，这一比例上升到24.3%[3,4]。

ABOUT RSV

关于RSV

Respiratory syncytial virus (RSV) is a contagious virus and a common cause of respiratory illness.5 The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.6,7 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.8 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..

这两个亚组都会引起疾病，并且可以在不同季节共同循环或交替优势。。

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.

辉瑞公司目前是唯一一家使用RSV疫苗的公司，该疫苗有助于保护60岁及以上的成年人，以及18岁及以上的成年人，这些成年人因RSV（RSV-LRTD）引起的下呼吸道疾病风险增加，以及通过母体免疫接种的婴儿。ABRYSVO是一种未经调整的二价疫苗，旨在提供针对RSV-LRTD的广泛保护，无论病毒亚组如何。

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..

在融合前状态下，RSV融合蛋白（F）是中和抗体的主要靶标，是辉瑞公司RSV疫苗的基础。RSV-A和RSV-B亚组之间F蛋白序列的变异聚集在关键抗原位点，这是有效中和抗体的靶标。。

In May 2023, the FDA approved 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 recommendation of RSV vaccines for use in adults aged ≥75 years and adults age 60-74 years who are increased risk for severe RSV disease.

2023年5月，FDA批准ABRYSVO用于预防60岁或以上人群中由RSV引起的LRTD。。

In August 2023, the FDA approved ABRYSVO for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to 6 months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. This was followed in September 2023 with ACIP’s recommendation 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..

2023年8月，FDA批准ABRYSVO通过在32至36周胎龄的孕妇中进行主动免疫，预防出生至6个月大的婴儿中由RSV引起的LRTD和严重LRTD。随后在2023年9月，ACIP建议孕妇免疫，以帮助保护新生儿免受RSV的季节性影响，该疫苗应于9月至1月在美国大陆大部分地区接种。。

Also in August 2023, Pfizer announced that the European Commission granted marketing authorization for ABRYSVO for both older adults and maternal immunization to help protect infants. Additionally, ABRYSVO has received approvals for both indications in multiple countries worldwide.

同样在2023年8月，辉瑞公司宣布，欧盟委员会批准ABRYSVO用于老年人和母亲免疫接种，以帮助保护婴儿。此外，ABRYSVO已在全球多个国家获得这两种适应症的批准。

INDICATIONS FOR ABRYSVO

ABRYSVO适应症

ABRYSVO® is a vaccine indicated in the US for:

ABRYSVO®是美国的一种疫苗，用于：

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

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

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

在18至59岁的人群中预防RSV引起的LRTD，这些人群的RSV引起的LRTD风险增加

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

妊娠32至36周的孕妇，用于预防出生至6个月大的婴儿中由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不应给予任何对其任何成分有严重过敏反应（例如过敏反应）史的人

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：为了避免早产的潜在风险，应在胎龄32至36周期间服用ABRYSVO

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

接种包括ABRYSVO在内的可注射疫苗后可能会晕倒。应采取预防措施，避免晕倒时摔倒和受伤

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，包括那些接受抑制免疫系统药物的成年人，对ABRYSVO的免疫反应可能会降低

Vaccination with ABRYSVO may not protect all people

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%）是疲劳、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%）是注射部位疼痛、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%）是注射部位疼痛、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)

在将ABRYSVO与安慰剂进行比较的临床试验中，孕妇所生的婴儿出生体重较轻，出生体重较轻，出生体重较轻，出生体重较轻，出生体重较轻，出生体重较轻，出生体重较轻，出生体重较轻，出生体重较轻，出生体重较轻，出生体重较轻，出生体重较轻，出生体重较轻，出生体重较轻，出生体重较轻，出生体重较轻，出生体重较轻，出生

View the full ABRYSVO Prescribing Information. If it is not currently available via this link, it will be visible as soon as possible as we work to finalize the document. Please check back for the full information shortly.

查看完整的ABRYSVO处方信息。如果目前无法通过此链接获得，则在我们完成文档定稿后，将尽快看到该文档。请稍后再查看完整信息。

About Pfizer: Breakthroughs That Change Patients’ Lives

关于辉瑞：改变患者生活的突破

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治疗方法，延长并显着改善他们的生活。。

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.

辉瑞公司的同事们每天都在发达市场和新兴市场开展工作，促进健康、预防、治疗和治愈，挑战我们这个时代最可怕的疾病。作为世界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，支持和扩大全球可靠、负担得起的医疗保健服务。

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 www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer..

175年来，我们一直致力于为所有依赖我们的人带来改变。我们经常在我们的网站www.Pfizer.com上发布对投资者可能很重要的信息。此外，要了解更多信息，请访问我们的网站www.Pfizer.com，并在X上关注我们@Pfizer和@Pfizer News，LinkedIn，YouTube，以及在Facebook上关注我们。。

DISCLOSURE NOTICE:

披露通知：

The information contained in this release is as of October 22, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

本版本中包含的信息截至2024年10月22日。辉瑞没有义务因新信息或未来事件或发展而更新本版本中包含的前瞻性声明。

This release contains forward-looking information about ABRYSVO, including its potential benefits and an approval in the U.S. for the prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

本新闻稿包含有关ABRYSVO的前瞻性信息，包括其潜在益处以及美国批准预防18至59岁因RSV引起的LRTD风险增加的个人因RSV引起的LRTD，这涉及重大风险和不确定性，可能导致实际结果与此类声明明示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 .

除其他外，风险和不确定性包括ABRYSVO商业成功的不确定性；研究和开发中固有的不确定性，包括满足预期临床终点的能力，我们临床试验的开始和/或完成日期，监管提交日期，监管批准日期和/或发布日期，以及不利的新临床数据的可能性和现有临床数据的进一步分析；与中期数据相关的风险；；监管机构是否会对我们临床研究的设计和结果感到满意；是否以及何时可以在特定司法管辖区为ABRYSVO提交任何潜在适应症的生物许可证申请；监管机构是否以及何时批准任何未决或提交给ABRYSVO的申请，这将取决于多种因素，包括确定产品的益处是否超过其已知风险，确定产品的功效，以及如果批准，ABRYSVO对任何此类适应症的应用是否会取得商业成功；知识产权和其他诉讼；监管机构的决定影响标签、制造过程和安全。

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, 2023, 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.

有关风险和不确定性的进一步说明，请参阅辉瑞公司截至2023年12月31日的10-K表年度报告，以及随后的10-Q表报告，包括标题为“风险因素”和“前瞻性信息和可能影响未来结果的因素”的部分，以及随后的8-K表报告，所有这些报告均已提交给美国。

Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com..

证券交易委员会（sec），网址为www.sec.gov和www.pfizer.com。。

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REFERENCES

参考文献

1 Fink D. Immunobridging to Evaluate Vaccines. https://cdn.who.int/media/docs/default-source/blue-print/doran-fink_4_immunobridging_vrconsultation_6.12.2021.pdf. Published June 2021, Accessed October 2024

1 Fink D.免疫桥接评估疫苗。https://cdn.who.int/media/docs/default-source/blue-print/doran-fink_4_immunobridging_vrconsultation_6.12.2021.pdf.2021年6月出版，2024年10月访问

2 U.S. Centers for Disease Control and Prevention. “Morbidity and Mortality Weekly Report.” August 15, 2024. https://www.cdc.gov/mmwr/volumes/73/wr/mm7332e1.htm

2美国疾病控制和预防中心。《发病率和死亡率周报》，2024年8月15日。https://www.cdc.gov/mmwr/volumes/73/wr/mm7332e1.htm

3 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: 207–220. doi: 10.1007/s40121-023-00904-z. Epub 2024 Jan 18. PMID: 38236516; PMCID: PMC10828164.

3 Weycker，D.，Averin，A.，Houde，L.等人。按年龄和合并症分布的美国成年人下呼吸道疾病发生率。感染疾病2024；13： 207–220。doi:10.1007/s40121-023-00904-z。Epub 2024年1月18日。PMID:38236516；PMCID:PMC10828164。

4 U.S. Centers for Disease Control and Prevention. “Epidemiology of Respiratory Syncytial Virus Hospitalizations in Adults — RSV-NET.” https://www.cdc.gov/acip/downloads/slides-2023-10-25-26/03-Patton-Adult-RSV-508.pdf. Presented October 25, 2023. Accessed October 2024.

4美国疾病控制和预防中心。“成人呼吸道合胞病毒住院流行病学-RSV-NET。”https://www.cdc.gov/acip/downloads/slides-2023-10-25-26/03-Patton-Adult-RSV-508.pdf.2023年10月25日提交。2024年10月访问。

5 World Health Organization. Respiratory Syncytial Virus (RSV) disease. https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/norms-and-standards/vaccine-standardization/respiratory-syncytial-virus-disease. Accessed October 2024.

5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.2024年10月访问。

6 U.S. Centers for Disease Control and Prevention. How RSV Spreads. https://www.cdc.gov/rsv/causes/index.html. Updated August 30, 2024. Accessed October 2024.

6美国疾病控制和预防中心。RSV如何传播。https://www.cdc.gov/rsv/causes/index.html.2024年8月30日更新。2024年10月访问。

7 U.S. Centers for Disease Control and Prevention. RSV in Older Adults. https://www.cdc.gov/rsv/older-adults/index.html. Updated August 30, 2024. Accessed October 2024.

7美国疾病控制和预防中心。老年人的RSV。https://www.cdc.gov/rsv/older-adults/index.html.2024年8月30日更新。2024年10月访问。

8 U.S. Centers for Disease Control and Prevention. Clinical Overview of RSV. https://www.cdc.gov/rsv/hcp/clinical-overview/index.html. Updated August 30, 2024. Accessed October 2024.

。RSV的临床概述。https://www.cdc.gov/rsv/hcp/clinical-overview/index.html.2024年8月30日更新。2024年10月访问。

Category: Vaccines

类别：疫苗