GSK plc (LSE/NYSE: GSK) today announced that the European Commission (EC) has approved 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 serogroups A, C, W and Y..

葛兰素史克公司（LSE/NYSE：GSK）今天宣布，欧盟委员会（EC）已经批准了一种单瓶全液型Menveo（A、C、W-135和Y群脑膜炎球菌结合疫苗，MenACWY疫苗），以帮助预防由A、C、W和Y群细菌血清引起的侵袭性脑膜炎球菌病（IMD）。

This single-vial presentation is now 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.

现在，这种单瓶展示已被许可用于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了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 leader in meningococcal vaccines, GSK is dedicated to finding innovative solutions that simplify immunisation and support vaccine uptake. We remain committed to safeguarding individuals from bacterial meningitis, and we will persist in our efforts to prevent this devastating disease among at-risk populations in the European Union.”.

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领导者，葛兰素史克致力于寻找简化免疫接种和支持疫苗接种的创新解决方案。我们仍然致力于保护个人免受细菌性脑膜炎的侵害，我们将继续努力，在欧盟高危人群中预防这种毁灭性疾病。”。

GSK’s submission to the EC was based on two positive Phase IIb trials (2017-003692-61; 2017-003456-23).1,2 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 lyophilised/liquid formulation..

GSK提交给EC的是基于两项IIb期阳性试验（2017-003692-61；2017-003456-23）。1,2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。。

IMD is an unpredictable but serious illness that can cause life-threatening complications.3 Despite treatment, among those who contract IMD up to one in six will die, sometimes in as little as 24 hours.4,5 One in five survivors may suffer long-term consequences such as neurological damage6, 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.7.

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。3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。4,5五分之一的幸存者可能会遭受长期后果，如神经损伤6、截肢、听力丧失和神经系统问题。4虽然任何人都可能患有IMD，但婴儿、幼儿以及青少年和成年早期的人群都是风险较高的人群。7。

The original presentation of Menveo that requires reconstitution, and which was approved by the EMA in 2010, is unaffected by this marketing authorisation.8

Menveo最初的介绍需要重组，并于2010年获得EMA的批准，不受此上市授权的影响。8

About Menveo

关于Menveo

GSK’s MenACWY vaccine has received regulatory approval in over 60 countries.9 It offers evidence of immunogenicity with a well-characterised safety profile.10,11 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.12 EMA Prescribing Information for Menveo can be accessed at: https://www.ema.europa.eu/en/medicines/human/EPAR/menveo.12  More than 82 million doses of this vaccine have been distributed worldwide since 2010;13 over 6 million doses have been distributed to European countries since 2017.14.

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。9它提供了免疫原性的证据，具有良好的安全性。10,11在欧盟（EU），该疫苗已获得监管部门的批准，可用于主动免疫，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。12 EMA为Menveo开出的处方信息可在以下网址获得：https://www.ema.europa.eu/en/medicines/human/EPAR/menveo.12自2010年以来，该疫苗已在全球分发了8200多万剂；自2017年以来，已经向欧洲国家分发了超过600万剂。

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生物制药公司，旨在将科学、技术和人才团结起来，共同战胜疾病。更多信息请访问gsk.com。