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6-K: Gsk's Fully Liquid Menveo Meningococcal Vaccine Approved by European Commission

6-K: Gsk's Fully Liquid Menveo Meningococcal Vaccine Approved by European Commission

6-K：葛蘭素史克全液體Menveo腦膜炎球菌疫苗獲歐盟委員會批准
美股SEC公告 ·  2024/11/27 19:13

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GSK announced that the European Commission has approved a new single-vial, fully liquid presentation of Menveo vaccine for protection against invasive meningococcal disease (IMD). The vaccine is licensed for active immunization of individuals from age 2 and above, offering healthcare providers a simplified administration process that eliminates the need for reconstitution.The approval was supported by two positive Phase IIb trials demonstrating comparable immunogenicity, tolerability, and safety profile to the existing lyophilised/liquid formulation. The vaccine targets bacterial serogroups A, C, W and Y, addressing a serious illness that can cause life-threatening complications with up to one in six mortality rate among infected individuals.Since its initial approval in 2010, Menveo has been distributed globally with over 82 million doses worldwide, including 6 million doses in European countries since 2017. The original presentation requiring reconstitution remains unaffected by this new authorization.
GSK announced that the European Commission has approved a new single-vial, fully liquid presentation of Menveo vaccine for protection against invasive meningococcal disease (IMD). The vaccine is licensed for active immunization of individuals from age 2 and above, offering healthcare providers a simplified administration process that eliminates the need for reconstitution.The approval was supported by two positive Phase IIb trials demonstrating comparable immunogenicity, tolerability, and safety profile to the existing lyophilised/liquid formulation. The vaccine targets bacterial serogroups A, C, W and Y, addressing a serious illness that can cause life-threatening complications with up to one in six mortality rate among infected individuals.Since its initial approval in 2010, Menveo has been distributed globally with over 82 million doses worldwide, including 6 million doses in European countries since 2017. The original presentation requiring reconstitution remains unaffected by this new authorization.
GSk宣佈，歐洲委員會已批准一種新的單瓶完全液態的Menveo生物-疫苗，用於預防侵襲性腦膜炎球菌病（IMD）。該生物-疫苗獲得許可用於2歲及以上人群的主動免疫，爲醫療提供者提供了一種簡化的管理流程，消除了重組的需要。該批准得到了兩項積極的IIb期試驗的支持，這些試驗表明其免疫原性、耐受性和安全性與現有的凍幹/液態製劑相當。該生物-疫苗針對A、C、W和Y型細菌血清群，解決了可能導致致命併發症的嚴重疾病，感染者的死亡率可達六分之一。自2010年首次獲得批准以來，Menveo在全球已分發超過8200萬劑，其中自2017年以來在歐洲國家分發了600萬劑。要求重組的原始製劑未受這一新授權的影響。
GSk宣佈，歐洲委員會已批准一種新的單瓶完全液態的Menveo生物-疫苗，用於預防侵襲性腦膜炎球菌病（IMD）。該生物-疫苗獲得許可用於2歲及以上人群的主動免疫，爲醫療提供者提供了一種簡化的管理流程，消除了重組的需要。該批准得到了兩項積極的IIb期試驗的支持，這些試驗表明其免疫原性、耐受性和安全性與現有的凍幹/液態製劑相當。該生物-疫苗針對A、C、W和Y型細菌血清群，解決了可能導致致命併發症的嚴重疾病，感染者的死亡率可達六分之一。自2010年首次獲得批准以來，Menveo在全球已分發超過8200萬劑，其中自2017年以來在歐洲國家分發了600萬劑。要求重組的原始製劑未受這一新授權的影響。
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