SUMMIT, N.J., March 6, 2024 /PRNewswire/ -- CSL Seqirus, a global leader in the protection of public health, confirmed it is fully prepared to deliver its influenza vaccine portfolio for the 2024/25 U.S. season, based on the trivalent strains recommended this week by the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC).

新泽西州萨米特（SUMMIT，N.J.），2024年3月6日/PRNewswire/-CSL-Seqirus，一家保护公众健康的全球领导者，证实其已做好充分准备，将根据美国食品和药物管理局（FDA）疫苗和相关生物产品咨询委员会（VRBPAC）本周推荐的三价菌株，为2024/25美国季节提供流感疫苗组合。

During the meeting, the committee confirmed the viral strain selection of influenza vaccines for the Northern Hemisphere 2024/25 season, which aligns with the February 2024 World Health Organization (WHO) annual recommendations and is unchanged from the Southern Hemisphere 2024 season.1.

在会议期间，委员会确认了北半球2024/25季节流感疫苗的病毒株选择，这与2024年2月世界卫生组织（WHO）的年度建议一致，与南半球2024季节没有变化。

'CSL Seqirus applauds the VRBPAC's commitment to providing a clear, evidence-backed recommendation to the FDA so that the composition of seasonal influenza vaccines for the upcoming season will be formulated to match projected circulating strains, based on the WHO's ongoing surveillance,' said Gregg Sylvester, Chief Health Officer and Head of Medical Affairs, CSL Seqirus. 'In addition to implementing this change, we are committed to working with our partners in public health to reverse the alarming decline in immunization rates and vaccine confidence that we have seen over the past two flu seasons.'.

CSL-Sevirus首席卫生官兼医疗事务负责人格雷格·西尔维斯特（GreggSylvester）说：“CSL-Sevirus赞扬VRBPAC承诺向FDA提供明确的、有证据支持的建议，以便根据世卫组织的持续监测，为即将到来的季节制定季节性流感疫苗的组成，以匹配预计的流行毒株。”。“除了实施这一变化外，我们还致力于与公共卫生合作伙伴合作，扭转过去两个流感季节免疫率和疫苗信心惊人下降的局面。”。

The VRBPAC's recommendation follows the October 2023 VRBPAC meeting, where the committee strongly supported the WHO's recommendation to expeditiously remove the B/Yamagata influenza virus strain from quadrivalent influenza vaccines and transition to trivalent influenza vaccines for the 2024/25 season.2 The recommendation was grounded in data from the WHO's global influenza response and surveillance system, which detected a decline in B/Yamagata circulation before the onset of the COVID-19 pandemic and no further circulation of B/Yamagata lineage viruses since March of 2020.3.

VRBPAC的建议是在2023年10月VRBPAC会议之后提出的，委员会强烈支持世卫组织的建议，即迅速从四价流感疫苗中去除B/山形流感病毒株，并在2024/25季节过渡到三价流感疫苗。2该建议基于世卫组织全球流感应对和监测系统的数据，在新型冠状病毒肺炎大流行之前检测到B/山形循环下降，自2020年3月以来，B/山形谱系病毒没有进一步循环。

The strain selection for the 2024/25 influenza season reflects the removal of B/Yamagata and it will not be included in the vaccines manufactured and delivered by CSL Seqirus. CSL Seqirus worked closely with the FDA during 2023 to align on a path forward and is fully prepared to transition its complete portfolio of seasonal influenza vaccines in the U.S.

2024/25流感季节的菌株选择反映了B/Yamagata的去除，它将不包括在CSL-Sevirus生产和交付的疫苗中。CSL-Seqirus在2023年期间与FDA密切合作，以调整前进的道路，并充分准备在美国过渡其完整的季节性流感疫苗组合。

market from quadrivalent to trivalent formulations for the 2024/25 influenza season. CSL Seqirus completed its transition plan for the 2024/2025 season by December 2023 and regulatory and manufacturing teams are on track to convert the full U.S. portfolio. As a result of this effort, CSL Seqirus received FDA approval on March 4, 2024 for all of its U.S.

2024/25流感季节从四价到三价配方的市场。CSL Sequirus在2023年12月之前完成了2024/2025赛季的过渡计划，监管和制造团队正在按计划转换整个美国投资组合。作为这项努力的结果，CSL-Seqirus于2024年3月4日获得了FDA对其所有美国公司的批准。

trivalent influenza vaccines. .

三价流感疫苗。。

'This strain consistency across hemispheres will support both speed and efficiency, as CSL Seqirus has experience manufacturing these recommended strains,' said Dave Ross, Vice President, North America Commercial Operations, CSL Seqirus.

CSL-Sevirus北美商业运营副总裁戴夫·罗斯（DaveRoss）说：“由于CSL-Sevirus拥有制造这些推荐菌株的经验，因此跨半球的菌株一致性将支持速度和效率。”。

Across the world, CSL Seqirus is collaborating with regulatory bodies and public health authorities on an appropriate transition timeline for each country that aims to ensure a smooth transition, increase vaccine confidence and improve immunization rates.

在世界各地，CSL-Seqirus正在与监管机构和公共卫生部门合作，为每个国家制定适当的过渡时间表，旨在确保平稳过渡，提高疫苗信心和提高免疫率。

The undetectable circulation of B/Yamagata is a testament to the critical role of widely implemented influenza immunization programs, amongst other contributing factors such as the inherent characteristics and epidemiology of the B/Yamagata virus and the unique environment created by the COVID-19 pandemic.3.

B/Yamagata的不可检测的传播证明了广泛实施的流感免疫计划的关键作用，以及其他促成因素，如B/Yamagata病毒的固有特征和流行病学以及COVID-19大流行产生的独特环境。

About VRBPACThe VRBPAC is the FDA's advisory committee of experts in the fields of immunology, molecular biology, rDNA, virology bacteriology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry.4 VRBPAC reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the FDA has regulatory responsibility.4.

关于VRBPACThe VRBPAC是FDA免疫学、分子生物学、rDNA、病毒学细菌学、流行病学或生物统计学、疫苗政策、疫苗安全科学、联邦免疫活动、疫苗开发（包括转化和临床评估计划）、过敏、预防医学、传染病、儿科、，微生物学和生物化学。4 VRBPAC审查和评估有关用于预防，治疗或诊断人类疾病的疫苗和相关生物产品的安全性，有效性和适当使用的数据，以及FDA有监管责任的任何其他产品。

About Seasonal InfluenzaInfluenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.5 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.

关于季节性流感流感是一种常见的传染性季节性呼吸系统疾病，可能会在某些人中引起严重疾病和危及生命的并发症。5流感可导致临床症状，从轻度至中度呼吸系统疾病到严重并发症，住院治疗，在某些情况下甚至死亡。

Because transmission of influenza viruses to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease can be easily transmitted to others.5 Preliminary estimates from the Centers for Disease Control and Prevention (CDC) report that during the 2023/24 influenza season, there have been an estimated 290,000-610,000 influenza-related hospitalizations in the U.S.6 The CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.7 Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.7 The CDC recommends that for most people who need only 1 dose of flu vaccine, vaccination should ideally happen in September or October.7.

由于流感病毒可能在症状出现前一天和患病后5至7天内传播给他人，因此该疾病很容易传播给他人。5疾病控制和预防中心（CDC）的初步估计报告称，在2023/24流感季节，据估计，美国有290000-610000例与流感相关的住院治疗。6疾病预防控制中心建议6个月及以上没有任何禁忌症的人每年接种疫苗。7由于接种疫苗后大约需要两周才能在体内产生抗体，从而有助于预防流感病毒感染，建议人们在流感开始在社区传播之前接种疫苗。7疾病预防控制中心建议，对于大多数只需要1剂流感疫苗的人，最好在9月或10月接种疫苗。

About CSL SeqirusCSL Seqirus is part of CSL (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K.

关于CSL-sequirus CSL-sequirus是CSL的一部分（ASX:CSL）。作为世界上最大的流感疫苗供应商之一，CSL-Seqirus是全球预防流感的主要贡献者，也是大流行防范的跨洲合作伙伴。英国在美国拥有最先进的生产设施。

and Australia, and leading R&D capabilities, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world..

和澳大利亚，以及领先的研发能力，CSL-Seqirus利用鸡蛋，细胞和佐剂技术在世界20多个国家提供广泛的分化流感疫苗组合。。

For more information about CSL Seqirus, visit CSL.com/CSLSeqirus.

有关CSL-Seqirus的更多信息，请访问CSL.com/CSLSeqirus。

About CSLCSL (ASX: CSL) (USOTC: CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies.

关于CSLCSL（ASX:CSL）（USOTC:CSLLY）是一家全球生物技术公司，拥有动态的救生药物组合，包括治疗血友病和免疫缺陷的药物，预防流感的疫苗以及缺铁和肾脏病的疗法。自1916年成立以来，我们一直致力于使用最新技术拯救生命。

Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

如今，CSL（包括我们的三大业务：CSL Behring、CSL Sequirus和CSL Vifor）为100多个国家的患者提供救生产品，拥有32000名员工。我们独特的商业实力、研发重点和卓越运营相结合，使我们能够识别、开发和提供创新，使我们的患者能够过上最充实的生活。

For inspiring stories about the promise of biotechnology, visit CSL.com/Vita and follow us on Twitter.com/CSL..

有关生物技术前景的鼓舞人心的故事，请访问CSL.com/Vita，并在Twitter.com/CSL上关注我们。。

For more information about CSL, visit www.CSL.com.

有关CSL的更多信息，请访问www.CSL.com。

Intended Audience This press release is issued from CSL Seqirus in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved CSL Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of CSL Seqirus products..

目标受众本新闻稿由美国新泽西州Summit的CSL Sequirus发布，旨在提供有关我们全球业务的信息。请注意，与已批准的CSL-Seqirus产品的批准状态和标签相关的信息可能因国家而异。请咨询当地监管机构关于CSL-Seqirus产品的批准状态。。

Forward-Looking Statements This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements.

前瞻性声明本新闻稿可能包含前瞻性声明，包括有关未来结果，绩效或成就的声明。这些声明涉及已知和未知的风险、不确定性和其他因素，这些因素可能导致我们的实际结果、业绩或成就与前瞻性声明中明示或暗示的任何未来结果、业绩或成就存在重大差异。

These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. .

这些声明反映了我们目前对未来事件的看法，并且基于假设，并且存在风险和不确定性。鉴于这些不确定性，您不应过度依赖这些前瞻性声明。。

USA-CRP-24-0011

USA-CRP-24-0011

MEDIA CONTACTTiffany Cody+1 (908) 370-1863Tiffany.Cody@Seqirus.com

媒体联系人Tiffany Cody+1（908）370-1863Tiffany.Cody@Seqirus.com

REFERENCES

参考文献

1 Food and Drug Administration (FDA). Center for Biologics Evaluation and Research. 184th Vaccines and Related Biological Products Advisory Committee. March 2024. Retrieved from: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-march-5-2024-meeting-announcement.

1食品和药物管理局（FDA）。生物制剂评估与研究中心。第184届疫苗和相关生物制品咨询委员会。2024年3月。检索自：https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-march-5-2024-meeting-announcement.

Accessed March 2024. 2 FDA. Center for Biologics Evaluation and Research. 183rd Vaccines and Related Biological Products Advisory Committee. Challenges and Opportunities for Vaccine Strain Composition with the Reduced Public Health Threat from Influenza B/Yamagata Lineage Viruses. Slide 7. October 2023.

2024年3月访问。2 FDA。生物制剂评估与研究中心。第183届疫苗和相关生物制品咨询委员会。疫苗株组成的挑战和机遇，减少了B型流感/山形谱系病毒对公众健康的威胁。幻灯片7。2023年10月。

Retrieved from: https://www.fda.gov/media/172762/download. Accessed March 2024.3 Koutsakos, M., Wheatley, A. K., Laurie, K., Kent, S. J., & Rockman, S. (2021). Influenza lineage extinction during the COVID-19 pandemic? Nature Reviews Microbiology, 19(12), 741-742. https://doi.org/10.1038/s41579-021-00642-4.4 FDA.

检索自：https://www.fda.gov/media/172762/download.2024年3月访问。3 Koutsakos，M.，Wheatley，A.K.，Laurie，K.，Kent，S.J.，和Rockman，S。（2021）。新型冠状病毒大流行期间流感谱系灭绝？《自然评论微生物学》，19（12），741-742。https://doi.org/10.1038/s41579-021-00642-4.4FDA。

Center for Biologics Evaluation and Research. Vaccines and Related Biological Products Advisory Committee. (2019). Retrieved from: https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-products-advisory-committee. Accessed March 2024.5 Centers for Disease Control and Prevention (CDC).

生物制剂评估与研究中心。疫苗和相关生物制品咨询委员会。（2019年）。检索自：https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-products-advisory-committee.2024年3月访问。疾病控制和预防中心（CDC）。

(2022). Key Facts About Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed March 2024.6 CDC. (2024). 2023-2024 U.S. Flu Season: Preliminary In-Season Burden Estimates. Retrieved from: https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm. Accessed March 2024.7 CDC.

（2022年）。关于流感（Flu）的关键事实。检索自：https://www.cdc.gov/flu/about/keyfacts.htm.2024.6年3月访问CDC。（2024年）。2023-2024年美国流感季节：初步的季节负担估计。检索自：https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm.2024年3月访问。7 CDC。

(2024). Who Needs a Flu Vaccine. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed March 2024..

（2024年）。世卫组织需要流感疫苗。检索自：https://www.cdc.gov/flu/prevent/vaccinations.htm.2024年3月访问。。

SOURCE CSL Seqirus

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