GSK plc (LSE/NYSE: GSK) today announced that the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended for use a single-vial, fully liquid presentation of Menveo (Meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial groups A, C, W, and Y..

葛兰素史克股份有限公司（伦敦证交所/纽约证交所：葛兰素史克）今天宣布，欧洲药品管理局（EMA）人类使用药品委员会（CHMP）建议使用单瓶全液体呈现Menveo（脑膜炎球菌a、C、W-135和Y组结合疫苗，MenACWY疫苗），以帮助预防由细菌a、C、W和Y组引起的侵袭性脑膜炎球菌病（IMD）。。

If approved, this single-vial presentation will be licenced for active immunisation of children from 2 years of age, adolescents and adults, offering healthcare providers an option that does not require reconstitution before its use.

如果获得批准，这种单瓶展示将被许可用于2岁以下儿童，青少年和成人的主动免疫，为医疗保健提供者提供一种在使用前不需要重建的选择。

Philip Dormitzer, GSK Head of Global Vaccines Research & Development, said: “As a global leader in meningococcal vaccines, we are committed to finding innovative solutions that simplify immunisation against bacterial meningitis, support vaccine uptake and help protect as many people as possible from this devastating disease.

葛兰素史克全球疫苗研发负责人菲利普·多米策（PhilipDormitzer）表示：“作为脑膜炎球菌疫苗的全球领导者，我们致力于寻找创新的解决方案，简化针对细菌性脑膜炎的免疫接种，支持疫苗接种，并帮助尽可能多的人免受这种毁灭性疾病的侵害。

We will continue our efforts to help prevent this disease in at-risk populations in the European Union.”.

我们将继续努力，帮助欧盟高危人群预防这种疾病。”。

GSK’s submission to the EMA is based on two positive Phase IIb trials (2017-003692-61; 2017-003456-23).2,3 The primary and secondary outcomes of these trials, supported by post-hoc pooled analyses, show that the fully liquid formulation of this vaccine has comparable immunogenicity, tolerability and a comparable safety profile to the existing lyophilized/liquid formulation.

GSK提交给EMA的是基于两项阳性IIb期试验（2017-003692-61；2017-003456-23）。2,3这些试验的主要和次要结果，由事后汇总分析支持，表明这种疫苗的全液体制剂具有与现有冻干/液体制剂相当的免疫原性，耐受性和安全性。

Today’s positive opinion marks one of the final steps prior to the potential extension of the marketing authorisation by the European Commission (EC). The EC’s final decision is expected by November 2024..

今天的积极意见标志着欧盟委员会（EC）可能延长上市许可之前的最后一步。预计欧盟委员会将于2024年11月做出最终决定。。

IMD is an unpredictable but serious illness that can cause life-threatening complications.4 Despite treatment, among those who contract IMD one in six will die, sometimes in as little as 24 hours.4 One in five survivors may suffer long-term consequences such as brain damage, amputations, hearing loss and nervous system problems.4 Although anyone can get IMD, babies, young children and those who are in their late teens and early adulthood are amongst the groups at higher risk.4.

IMD是一种不可预测但严重的疾病，可能会导致危及生命的并发症。4尽管接受了治疗，但患有IMD的人中有六分之一会死亡，有时会在24小时内死亡。4五分之一的幸存者可能会遭受长期后果，如脑损伤，截肢，听力下降和神经系统问题。4尽管任何人都可能患有IMD，但婴儿，幼儿以及十几岁和成年早期的人都是风险较高的人群。4。

The original presentation of Menveo that requires reconstitution and which was approved by the EMA in 2010 is unaffected by this recommendation.5

Menveo的原始演示文稿需要重建，并于2010年获得EMA的批准，不受此建议的影响。5

About Menveo

关于门韦

GSK’s MenACWY vaccine has received regulatory approval in over 60 countries, with more than 82 million doses distributed worldwide since 2010.6,7 Over 6 million doses have been distributed to European countries since 2017.1 It offers evidence of immunogenicity with a well-characterised safety profile.8,9 In the European Union (EU), this vaccine has received regulatory approval for active immunisation to prevent IMD caused by Neisseria meningitidis serogroups A, C, Y, and W in children from 2 years of age, adolescents and adults.10 EMA Prescribing Information for Menveo can be accessed at: https://www.ema.europa.eu/en/medicines/human/EPAR/menveo.

葛兰素史克（GSK）的MenACWY疫苗已在60多个国家获得监管部门的批准，自2010年以来，全球已分发8200多万剂。6,7自2017年以来，已向欧洲国家分发了600多万剂。1它提供了具有良好特征的免疫原性证据。8,9在欧盟（EU），该疫苗已获得监管部门的主动免疫批准，以预防2岁以下儿童，青少年和成人中由脑膜炎奈瑟菌血清群a，C，Y和W引起的IMD。10 EMA为Menveo开处方的信息可访问：https://www.ema.europa.eu/en/medicines/human/EPAR/menveo.

About GSK

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.

葛兰素史克是一家全球性的生物制药公司，旨在联合科学、技术和人才共同战胜疾病。更多信息请访问gsk.com。