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CSL Seqirus is the only manufacturer to offer a differentiated influenza vaccine for all eligible people aged six months and older in the United States.
CSL-Seqirus是唯一一家为美国所有6个月及以上符合条件的人群提供分化型流感疫苗的制造商。
Centers for Disease Control and Prevention (CDC) trend findings indicate a significant decline in influenza vaccination rates, which poses a serious risk to public health infrastructure and underscores the importance of receiving an annual influenza vaccination.1,2
According to the CDC, it is recommended that all eligible people aged six months and older receive their annual influenza vaccine, especially people at an increased risk of severe influenza-related complications, such as older adults, pregnant people, and children under five years old.2,3
根据疾病预防控制中心的说法,建议所有6个月及以上的合格人群每年接种流感疫苗,特别是与严重流感相关并发症风险增加的人群,如老年人、孕妇和5岁以下儿童。2,3
SUMMIT, N.J., July 9, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), today announced that it has commenced shipping its differentiated portfolio of influenza vaccines. This year, the company's influenza vaccines are being produced as trivalent influenza vaccine (TIV) formulations, in compliance with the U.S.
新泽西州SUMMIT,2024年7月9日/PRNewswire/-CSL-Sevirus,CSL(ASX:CSL)的一家企业,今天宣布,它已经开始推出其差异化的流感疫苗组合。今年,该公司的流感疫苗正在生产三价流感疫苗(TIV)配方,符合美国。
Food and Drug Administration's (FDA) directive to remove the B/Yamagata strain.4.
美国食品和药物管理局(FDA)指令删除B/Yamagata菌株。
'We are proud to support healthcare providers in their efforts to vaccinate their patients and communities to help turn around concerning declines in seasonal influenza vaccination rates,' said Stefan Merlo, Vice President of Commercial Operations, North America, CSL Seqirus. 'We are a committed partner in public health and are doing our part to educate, inform, and meet the evolving needs of the public, ensure customers are prepared for the upcoming flu season, and help reverse this downward trend to restore vaccination rates.'.
CSL Sequirus北美商业运营副总裁斯特凡·梅洛(StefanMerlo)说:“我们很自豪地支持医疗保健提供者为患者和社区接种疫苗,以帮助扭转季节性流感疫苗接种率下降的局面。”我们是公共卫生领域的坚定合作伙伴,正在尽自己的力量教育、告知和满足公众不断变化的需求,确保客户为即将到来的流感季节做好准备,并帮助扭转这种下降趋势,恢复疫苗接种率。”。
This season, the 2024/25 influenza vaccine portfolio for CSL Seqirus, the only manufacturer to offer a differentiated influenza vaccine option approved for use in people aged six months and older, includes:
本季,针对CSL-Seqirus的2024/25流感疫苗组合是唯一一家提供经批准用于6个月及以上人群的差异化流感疫苗选择的制造商,包括:
FLUCELVAX® (Influenza Vaccine), the first and only cell-based influenza vaccine indicated for use in people six months and older.5
FLUCELVAX®(流感疫苗),这是第一种也是唯一一种适用于6个月及以上人群的基于细胞的流感疫苗。5
FLUAD® (Influenza Vaccine, Adjuvanted), the first and only adjuvanted seasonal influenza vaccine for adults 65 and older, which is preferentially recommended by the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) over standard-dose influenza vaccines.6,7.
FLUAD®(流感疫苗,佐剂),是第一种也是唯一一种针对65岁及以上成年人的佐剂季节性流感疫苗,由疾病控制和预防中心(CDC)免疫实践咨询委员会(ACIP)优先推荐,而不是标准剂量的流感疫苗[6,7]。
FLUAD contains an MF59® adjuvant that is designed to strengthen, broaden, and lengthen the immune response when added to an influenza vaccine.6,8,9
FLUAD含有MF59®佐剂,当添加到流感疫苗中时,该佐剂旨在增强,扩大和延长免疫反应。6,8,9
AFLURIA® (Influenza Vaccine), an egg-based, influenza vaccine approved for use in eligible people six months of age and older.10
AFLURIA®(流感疫苗),一种基于鸡蛋的流感疫苗,被批准用于六个月及以上的合格人群
The impact of declining vaccination rates poses a serious risk to public health infrastructure, with preliminary estimates from the CDC reporting an increase in influenza-related hospitalizations and deaths last season, in comparison to seasons prior, as well as an overburdened healthcare system.11,12 Across all age cohorts, vaccination rates experienced double-digit percentage declines over the past three flu seasons according to internal calculations based on influenza tracking data.13 This includes a notable 22% drop among children aged 6 months to 18 years and a 14% decrease in adults over 65, a group that typically maintains stable immunization rates.13 .
疫苗接种率下降的影响对公共卫生基础设施构成了严重风险,疾病预防控制中心的初步估计显示,与前几个季节相比,上个季节流感相关住院和死亡人数有所增加,医疗保健系统负担过重[11,12]。根据流感追踪数据的内部计算,在过去三个流感季节,疫苗接种率都出现了两位数的下降[13]。其中包括6个月至18岁儿童显着下降22%,65岁以上成年人下降14%,这一群体通常保持稳定的免疫率。
Additionally, the public health burden of influenza outpaces other respiratory illness.11,14,15 During the 2023/24 flu season, influenza accounted for nearly half of hospitalizations attributed to infectious diseases including influenza, COVID and respiratory syncytial virus (RSV) combined and over half of total deaths.11,14,15 This data underscores the importance of the CDC's recommendation that all eligible people aged six months and older receive an annual influenza vaccination as an essential measure to help prevent influenza and its complications.2 This is especially important for those at an increased risk of severe influenza-related complications, such as older adults, pregnant people, and children under five years old.3.
此外,流感的公共卫生负担超过了其他呼吸道疾病[11,14,15]。在2023/24流感季节,流感占包括流感,新型冠状病毒和呼吸道合胞病毒(RSV)在内的传染病住院人数的近一半,占总死亡人数的一半以上[11,14,15]。这一数据强调了疾病预防控制中心建议所有6个月及以上符合条件的人每年接种流感疫苗的重要性,这是帮助预防流感及其并发症的重要措施[2]。这对于那些严重流感相关并发症风险增加的人,如老年人,孕妇和5岁以下儿童尤为重要。
'Influenza continues to pose a significant threat, as evidenced by recent flu seasons,' said Dr. Gregg Sylvester, Chief Health Officer, CSL Seqirus. 'As we begin distributing influenza vaccines to healthcare providers throughout the U.S., it is imperative that we work to maintain high vaccination rates this season to help reduce the burden of influenza-related illnesses and the risk of severe outcomes.'.
CSL Seqirus首席卫生官格雷格·西尔维斯特(GreggSylvester)博士说,流感继续构成重大威胁,最近的流感季节就证明了这一点随着我们开始向美国各地的医疗保健提供者分发流感疫苗,我们必须努力保持本季的高接种率,以帮助减轻流感相关疾病的负担和严重后果的风险。”。
For additional information on our influenza vaccines for the upcoming flu season as well as resources about vaccination campaigns and CDC guidance, visit flu360.com.
有关即将到来的流感季节流感疫苗的更多信息,以及有关疫苗接种活动和CDC指导的资源,请访问flu360.com。
About Seasonal InfluenzaInfluenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.16 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.16 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.16 Preliminary estimates from the Centers for Disease Control and Prevention (CDC) report that during the 2023/24 influenza season, there were an estimated 390,000-810,000 influenza-related hospitalizations in the U.S.11 The CDC recommends annual vaccination for people aged six months and older, who do not have any contraindications.2 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.2 The CDC recommends that for most people who need only 1 dose of flu vaccine, vaccination should ideally happen in September or October.2.
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,可能会在某些人身上引起严重疾病和危及生命的并发症。16流感可导致临床症状,从轻度到中度的呼吸系统疾病到严重的并发症,住院治疗,在某些情况下甚至死亡。16由于流感病毒可能在症状出现前一天传播给其他人,并且在患病后5至7天内传播,因此该疾病很容易传播给其他人。16疾病控制和预防中心(CDC)的初步估计,在2023/24流感季节,美国估计有390000-810000例与流感相关的住院治疗。11 CDC建议每年为6个月大的人接种疫苗。年龄较大,没有任何禁忌症。2由于接种疫苗后大约需要两周才能在体内产生抗体,从而有助于防止流感病毒感染,建议人们在流感开始在社区传播之前接种疫苗。2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 a global leader in the protection of public health and one of the largest influenza vaccine providers in the world, CSL Seqirus is committed to preventing infectious diseases, like influenza and COVID-19, and is a transcontinental partner in pandemic preparedness.
关于CSL-sequirus CSL-sequirus是CSL的一部分(ASX:CSL)。作为保护公共卫生的全球领导者和世界上最大的流感疫苗供应商之一,CSL-Sevirus致力于预防流感和新型冠状病毒等传染病,并且是大流行防备的跨洲合作伙伴。
With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, CSL Seqirus offers a broad portfolio of innovative, differentiated vaccines in more than 20 countries around the world..
凭借在美国、英国和澳大利亚拥有最先进的生产设施,以及领先的研发能力,CSL-Sevirus在全球20多个国家提供了广泛的创新、差异化疫苗组合。。
For more information about CSL Seqirus, visit www.CSL.com.
有关CSL-Seqirus的更多信息,请访问www.CSL.com。
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 CSLBehring.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CSLBehring.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 AudienceThis 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..
。请注意,与批准的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 StatementsThis 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-24-0016
美国-CRP-24-0016
MEDIA CONTACTTiffany Cody+1 (908) 370-1863Tiffany.Cody@Seqirus.com
媒体联系人Tiffany Cody+1(908)370-1863Tiffany.Cody@Seqirus.com
FLUAD® (Influenza Vaccine, Adjuvanted), FLUCELVAX® (Influenza Vaccine), and AFLURIA® (Influenza Vaccine)
FLUAD®(流感疫苗,佐剂),FLUCELVAX®(流感疫苗)和AFLURIA®(流感疫苗)
IMPORTANT SAFETY INFORMATION
重要安全信息
What are FLUAD® (Influenza Vaccine, Adjuvanted), FLUCELVAX® (Influenza Vaccine), and AFLURIA® (Influenza Vaccine)?FLUAD is a vaccine that helps protect people aged 65 years and older from the flu.
什么是FLUAD®(流感疫苗,佐剂),FLUCELVAX®(流感疫苗)和AFLURIA®(流感疫苗)?FLUAD是一种有助于保护65岁及以上人群免受流感感染的疫苗。
FLUCELVAX and AFLURIA are vaccines that helps protect people aged 6 months and older from the flu.
FLUCELVAX和AFLURIA是帮助保护6个月及以上人群免受流感感染的疫苗。
Vaccination with any of these may not protect all people who receive the vaccine.
接种任何这些疫苗都可能无法保护所有接种疫苗的人。
Who should not receive FLUAD, FLUCELVAX, or AFLURIA?You should not receive FLUAD nor AFLURIA if you have a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine.
谁不应该接受FLUAD,FLUCELVAX或AFLURIA?如果您对疫苗的任何成分(包括蛋蛋白)或以前的流感疫苗有严重的过敏反应(例如过敏反应)史,则不应接受FLUAD或AFLURIA。
You should not receive FLUCELVAX if you have a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine.
如果您对疫苗的任何成分有严重过敏反应(例如过敏反应)史,则不应服用FLUCELVAX。
Before receiving FLUAD, FLUCELVAX, or AFLURIA, tell your healthcare provider about all medical conditions, including if you:
在接受FLUAD、FLUCELVAX或AFLURIA之前,请告知您的医疗保健提供者所有医疗状况,包括您是否:
have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks after getting a flu vaccine. The decision to give any flu vaccine should be made by your healthcare provider, based on careful consideration of the potential benefits and risks
接种流感疫苗后六周内曾患过格林-巴利综合征(严重肌肉无力)。您的医疗保健提供者应在仔细考虑潜在益处和风险的基础上,决定是否接种流感疫苗
have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine
你的免疫系统有问题,或者正在服用某些抑制免疫系统的药物,因为这些药物可能会降低你对疫苗的免疫反应
have ever fainted when receiving a vaccine
曾在接种疫苗时晕倒
What are the most common side effects of FLUAD, FLUCELVAX, and AFLURIA?
FLUAD、FLUCELVAX和AFLURIA最常见的副作用是什么?
pain, tenderness, redness, itching, bruising, and/or swelling where the vaccine was given
注射疫苗的地方有疼痛、压痛、发红、瘙痒、瘀伤和/或肿胀
headache
头痛
extreme tiredness
极度疲劳
muscle aches
肌肉酸痛
feeling unwell (malaise)
感觉不适(不适)
Additional side effects seen in children include:
儿童的其他副作用包括:
raised hardened area where the vaccine was given
接种疫苗的凸起硬化区域
changes in eating habits/loss of appetite
饮食习惯改变/食欲不振
sleepiness
嗜睡
irritability
易怒
diarrhea
腹泻
These are not all the possible side effects of FLUAD, FLUCELVAX, and AFLURIA. You can ask your healthcare provider for more information and for advice about any side effects that concern you.
。
What do I do if I have side effects?Report any severe or unusual side effects to your healthcare provider.
如果我有副作用该怎么办?向您的医疗保健提供者报告任何严重或异常的副作用。
To report SUSPECTED ADVERSE REACTIONS, contact CSL Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
要报告疑似不良反应,请联系CSL-Seqirus(电话:1-855-358-8966)或VAERS(电话:1-800-822-7967)或www.VAERS.hhs.gov。
Before receiving any of these vaccines, please see the full US Prescribing Information for FLUAD, FLUCELVAX, or AFLURIA. You can ask your healthcare provider or pharmacist for information about FLUAD, FLUCELVAX, or AFLURIA that is written for healthcare professionals.
在接受任何这些疫苗之前,请参阅美国有关FLUAD,FLUCELVAX或AFLURIA的完整处方信息。您可以向您的医疗保健提供者或药剂师咨询为医疗保健专业人员编写的有关FLUAD,FLUCELVAX或AFLURIA的信息。
REFERENCES
参考文献
1 Centers for Disease Control and Prevention (CDC). Flu Vaccination Coverage Update. Retrieved from: https://www.cdc.gov/flu/spotlights/2023-2024/vaccination-coverage-update.htm. Accessed June 2024.2 CDC. Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm.
1疾病控制和预防中心(CDC)。流感疫苗接种覆盖率更新。检索自:https://www.cdc.gov/flu/spotlights/2023-2024/vaccination-coverage-update.htm.。谁需要流感疫苗以及何时需要。检索自:https://www.cdc.gov/flu/prevent/vaccinations.htm.
Accessed June 2024.3 CDC. People at Higher Risk of Flu Complications. https://www.cdc.gov/flu/highrisk/index.htm. Accessed June 2024.4 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.
2024.3年6月访问CDC。流感并发症风险较高的人群。https://www.cdc.gov/flu/highrisk/index.htm.2024年6月访问。4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。。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 June 2024.5 FLUCLEVAX. Package Insert. CSL Seqirus Inc.6 FLUAD. Package Insert. CSL Seqirus Inc.7 Grohskopf LA, Blanton LH, Ferdinands JM, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023–24 Influenza Season.
2024.5年6月访问FLUCLEVAX。包装插页。CSL Seqirus Inc.6 FLUAD。。CSL Seqirus Inc.7 Grohskopf LA,Blanton LH,Ferdinands JM等。用疫苗预防和控制季节性流感:免疫实践咨询委员会的建议-美国,2023-24流感季节。
MMWR Recomm Rep 2023;72(No. RR-2):1–25. DOI: http://dx.doi.org/10.15585/mmwr.rr7202a1.8 Frey SE, Aplasca-De Los Reyes MR, Reynales H, et al. (2014). Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014;32:5027-5034.9 O'Hagan DT, Ott GS, Nest GV, Rappuoli R, Giudice GD.
MMWR建议代表2023;72(编号RR-2):1-25。内政部:http://dx.doi.org/10.15585/mmwr.rr7202a1.8Frey SE,Aplasca De Los Reyes MR,Reynales H等人(2014)。MF59®佐剂与非佐剂季节性流感疫苗在老年受试者中的安全性和免疫原性比较。疫苗。2014年;32:5027-5034.9奥哈根DT,奥特GS,Nest GV,拉普奥利R,Giudice GD。
(2013). The history of MF59® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines: 2013;12(1): 13-3.10 AFLURIA. Package Insert. CSL Seqirus Inc.11 CDC. 2023-2024 Preliminary In-Season Burden Estimate. Retrieved from: https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm.
(2013年)。MF59®佐剂的历史:从灰烬中崛起的凤凰。专家Rev疫苗:2013;12(1):13-3.10 AFLURIA。包装说明书。CSL Seqirus Inc.11疾病预防控制中心。2023-2024年初步季节负担估算。检索自:https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm.
Accessed June 2024.12.
2024.12年6月访问。
SOURCE CSL Seqirus