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GSK五合一脑膜炎球菌疫苗Penmenvy获得美国免疫实践咨询委员会积极推荐

GSK’s 5-in-1 meningococcal vaccine Penmenvy receives positive recommendation from US Advisory Committee on Immunization Practices

葛兰素史克 等信源发布 2025-04-16 04:44

可切换为仅中文


Vaccine doses will be ready for use in the US from Summer 2025

疫苗剂量将从2025年夏季开始在美国投入使用。

GSK plc (LSE/NYSE: GSK) today announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to recommend use of Penmenvy

GSK plc(LSE/NYSE:GSK)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)已投票建议使用Penmenvy

(Meningococcal Groups A, B, C, W, and Y Vaccine) as part of the adolescent meningococcal vaccination schedule. Recommendations made by the ACIP are reviewed and, if adopted, are published as official CDC recommendations.

(脑膜炎球菌A、B、C、W和Y群疫苗)作为青少年脑膜炎球菌疫苗接种计划的一部分。ACIP提出的建议会经过审查,如果被采纳,则会作为CDC的官方建议发布。

ACIP voted to recommend that persons over 10 years old receive a single dose of

ACIP投票建议10岁以上的人群接种单剂疫苗。

Penmenvy as an alternative to separate administration of meningococcal serogroups A, C, W and Y (MenACWY) and meningococcal serogroup B (MenB) vaccinations when both vaccines would be given on the same clinic visit, typically at age 16. This recommendation, if adopted, will allow for vaccination against serogroups A, B, C, W and Y in fewer doses, could simplify meningococcal vaccination delivery and could improve immunisation rates, helping protect more US adolescents against these five disease-causing serogroups for which the US CDC has previously issued recommendations..

Penmenvy作为一种替代方案,当在同一次诊所就诊时(通常在16岁时)需同时接种脑膜炎球菌血清群A、C、W和Y(MenACWY)以及脑膜炎球菌血清群B(MenB)疫苗,该建议如果被采纳,将允许以更少的剂量预防血清群A、B、C、W和Y感染,可简化脑膜炎球菌疫苗的接种流程,并可能提高免疫接种率,从而帮助更多美国青少年针对这五种致病血清群获得保护,美国疾控中心(CDC)此前已对这些血清群发布了相关建议。

GSK’s MenABCWY vaccine combines the antigenic components of the Company’s two well-established meningococcal vaccines—Bexsero

GSK的MenABCWY疫苗结合了该公司两种成熟的脑膜炎球菌疫苗的抗原成分——Bexsero

(Meningococcal Group B Vaccine) and

(脑膜炎球菌B群疫苗)和

Menveo

曼海欣

(Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM

(脑膜炎球菌 [A、C、Y 和 W-135 群] 寡糖白喉 CRM

Conjugate Vaccine). On 14 February 2025, the US Food and Drug Administration (FDA)

结合疫苗)。2025年2月14日,美国食品药品监督管理局(FDA)

approved

已批准

GSK’s MenABCWY vaccine for use in individuals aged 10 through 25 years.

GSK的MenABCWY疫苗,适用于10至25岁的人群。

Tony Wood, Chief Scientific Officer at GSK, said:

葛兰素史克首席科学官托尼·伍德表示:

“We welcome this positive recommendation that can help  strengthen disease prevention efforts in the US. Pentavalent vaccines can reduce the number of injections required to help protect against invasive meningococcal disease – especially disease caused by serogroup B. Their use could improve immunisation rates among adolescents and young adults in the US, who are at an age with increased risk.”.

“我们欢迎这一积极建议,这有助于加强美国的疾病预防工作。五价疫苗可以减少所需注射次数,帮助预防侵袭性脑膜炎球菌病,特别是由B群血清型引起的疾病。它们的使用可以提高美国青少年和年轻成年人的免疫接种率,这个年龄段的风险有所增加。”

Although MenB is the leading cause of invasive meningococcal disease (IMD) among this population, less than 13% of 17-year-olds received the recommended two-dose vaccination series; around 32% received at least one dose according to 2023 CDC survey data.

尽管MenB是该人群中侵袭性脑膜炎球菌病(IMD)的主要病因,但根据2023年CDC的调查数据,只有不到13%的17岁青少年接种了推荐的两剂疫苗系列;大约32%的人至少接种了一剂。

Three of every four MenB doses currently administered in the US are manufactured by GSK,

目前美国接种的每四剂MenB疫苗中有三剂是由GSK生产的,

positioning the company well to lead in the US market as MenB-containing vaccination schedules must be completed with the same manufacturer’s MenB vaccine.

使公司在美国市场占据有利位置,因为含MenB的疫苗接种计划必须使用同一制造商的MenB疫苗完成。

About IMD

关于IMD

IMD is an uncommon but serious illness that can lead to death for up to one in six of those who contract it in as little as 24 hours from onset, despite treatment.

IMD 是一种罕见但严重的疾病,即使进行治疗,每六名感染者中就可能有一人在出现症状后短短 24 小时内死亡。

IMD is easily misdiagnosed, with early symptoms often mistaken for the flu.

IMD很容易被误诊,其早期症状常被误认为是流感。

Approximately one in five survivors may experience long-term consequences such as brain damage, amputations, hearing loss, and nervous system problems.

大约五分之一的幸存者可能会经历脑损伤、截肢、听力丧失和神经系统问题等长期后遗症。

Although anyone can get IMD, adolescents and young adults between the ages of 16 and 23 years are one of the groups at highest risk due to common behaviours that help transmit the bacteria that cause IMD, such as living in close quarters like college dormitories, kissing and sharing drinks, utensils, or smoking devices..

虽然任何人都可能患上侵袭性脑膜炎球菌病 (IMD),但 16 至 23 岁的青少年和年轻人是风险最高的群体之一,原因是他们的某些常见行为有助于导致 IMD 的细菌传播,例如住在大学宿舍等近距离生活环境中、接吻、共用饮品、餐具或吸烟装置。

About Penmenvy

关于Penmenvy

GSK’s MenABCWY vaccine is an injectable suspension for intramuscular use. The vaccine is supplied as one vial of lyophilized MenACWY Component (powder) which is reconstituted at the time of use with the accompanying prefilled syringe of MenB Component (liquid). It is indicated in the US for active immunization to prevent invasive disease caused by .

GSK的MenABCWY疫苗是一种用于肌肉注射的悬浮液。该疫苗提供了一瓶冻干的MenACWY组分(粉末),在使用时用附带的预装MenB组分(液体)注射器进行复溶。它在美国适用于主动免疫,以预防由以下原因引起的侵袭性疾病:。

About Bexsero

关于Bexsero

GSK’s MenB vaccine has received regulatory approval in over 55 countries, including the US, and is used in 18 national immunisation programmes worldwide for the prevention of IMD caused by

GSK的MenB疫苗已获得包括美国在内的55多个国家的监管批准,并在全球18个国家免疫规划中使用,用于预防由以下原因引起的IMD:

Neisseria meningitidis

脑膜炎奈瑟菌

It is supported by clinical data supporting its effectiveness in helping to protect adolescents and young adults against diverse disease-causing strains of MenB, with a well-characterised safety profile. In the US, this vaccine has received regulatory approval for active immunisation to prevent invasive disease caused by .

它得到了临床数据的支持,证明其在帮助保护青少年和年轻成人免受多种致病性MenB菌株侵害方面的有效性,并具有明确的安全性特征。在美国,该疫苗已获得监管机构的批准,用于预防由MenB引起的侵袭性疾病的主动免疫。

About Menveo

关于 Menveo

GSK’s MenACWY vaccine has received regulatory approval in over 60 countries, including the US, with more than 80 million doses distributed worldwide since 2010.

GSK的MenACWY疫苗已在包括美国在内的60多个国家获得监管批准,自2010年以来,全球已分发超过8000万剂。

It offers evidence of immunogenicity with a well-characterised safety profile. In the US, this vaccine has received regulatory approval for active immunisation to prevent IMD caused by

它提供了具有明确安全性特征的免疫原性证据。在美国,该疫苗已获得监管部门的批准,用于预防由以下原因引起的侵袭性脑膜炎球菌病(IMD)的主动免疫:

Neisseria meningitidis

脑膜炎奈瑟菌

serogroups A, C, Y, and W in individuals from 2 months through 55 years of age. The US Prescribing Information is available

2个月至55岁个体中的血清群A、C、Y和W。美国处方信息可获取。

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,致力于整合科学、技术和人才,共同战胜疾病。欲了解更多信息,请访问gsk.com。