德国CureVac新冠疫苗三期临床试验有效性仅为47%,病毒变异疫苗开发挑战增加

2021-06-17 JACKZHAO MedSci原创

6月16日,德国生物技术公司CureVac研发的mRNA新冠疫苗三期临床试验结果出炉,

6月16日,德国生物技术公司CureVac研发的mRNA新冠疫苗 2b/3 期研究的第二次中期分析结果,数据显示疫苗对重症新冠患者的有效性仅为47%,不符合预先设定的统计成功标准。

由 Curevac 与拜耳联合进行的 HERALD 研究在拉丁美洲和欧洲的十个国家招募了大约 40000 名参与者。第二次中期分析包括 134 例,发生在第二次接种后至少两周。为了在试验中识别导致新冠肺炎的感染毒株,CureVac公司拒绝透露有多少人接种了疫苗或安慰剂,迄今已对 424 例新冠肺炎病例进行了病毒变体测序,其中 124 例符合判定标准并被纳入目前的疗效分析。结果证实,只有一个病例可归因于原始 SARS-CoV-2 病毒。超过一半的案例 (57%) 是由关注的变体引起的。其余大部分病例是由其他特征较少的变异引起的,如 Lambda 或 C.37,首先在秘鲁 (21%) 和 B.1.621,首先在哥伦比亚 (7%) 中发现。在这种情况下,中期结果表明对年轻参与者的疗效,但不能得出对 60 岁以上年龄组的疗效的结论。

然而,首席技术官姆勒泽克周三在接受采访时说,这些结果表明,该疫苗对老年人的效果不如年轻人。尽管这只是初步结果,但该试验结果将使CureVac疫苗的未来受到质疑。

CureVac的可用数据与欧洲药品管理局(EMA)进行了交流。数据安全监测委员会 (DSMB) 确认了 CVnCoV 的良好安全性。该研究将继续进行最终分析,并将针对最合适的监管途径评估全部数据。

“虽然我们希望获得更强有力的中期结果,但我们认识到,在这种前所未有的广泛多样性变异中展示高效是具有挑战性的。 CureVac 首席执行官 Franz-Werner Haas 博士说:“随着我们继续对至少 80 个额外病例进行最终分析,疫苗的整体功效可能会发生变化。” “此外,随着新病毒变种不断出现,变种丰富的环境凸显了开发下一代疫苗的重要性。”

CureVac 仍然致力于新冠疫苗的开发。除了 CVnCoV,该公司还与葛兰素史克第二代 新冠候选疫苗合作开发。这些候选疫苗基于新的 mRNA 技术框架,包括多价疫苗形式的潜在变体以及用于在一种疫苗中潜在保护多种传染病的联合疫苗。来自第一个候选疫苗 CV2CoV 的临床前数据最近已被《自然通讯》接受发表。 CureVac 和 GSK 预计将在 2021 年第三季度将第二代候选疫苗推进临床试验,目标是在 2022 年推出该疫苗,但需获得监管部门的批准。

CureVac公司首席执行官哈斯说,尽管如此,CureVac公司仍将完成其试验并计划获得批准。哈斯说:“疫苗有巨大的需求,我认为我们仍然可以做出贡献。”作为 CureVac 唯一的主要供应交易,欧盟在 11 月获得了多达 4.05 亿剂疫苗,其中 1.8 亿剂是可选的。 随后与德国签署了另外 2000 万剂的谅解备忘录。

CureVac称,更多细节将在研究的最终报告中出现,其中将包括 200 多个新冠肺炎病例,可能会在两到三周内发布。就像 Moderna和辉瑞-BioNtech联合研发的疫苗一样,CureVac 的疫苗也基于 mRNA技术,利用人体自身的细胞作为疫苗工厂。 直到去年才得到证实,这项技术现在已经跃居全球抗击新冠病毒的前沿。

CureVac是一家位于德国杜秉根(Tuebingen)的新创公司,与德国另一家生技公司BioNTech同样专精信使核糖核酸(mRNA)技术,后者与美国辉瑞药厂(Pfizer)合作研发的疫苗去年底获英国、美国和欧盟批准,成为全世界最早获得西方国家批准的新冠疫苗。CureVac的疫苗同样被科学家寄与厚望,与英国葛兰素史克药厂(GlaxoSmithKline)、德国化学及制药巨擘拜耳集团(Bayer)和瓦克化学(Wacker Chemie)签约合作生产,预计今年产量可达3亿剂,明年提高到10亿剂。

此外,CureVac还与美国电动车先驱特斯拉(Tesla)旗下的德国生产设备制造商葛罗曼(Grohmann)合作研发疫苗列印机,有机会对制药界带来革命。

据报道,CureVac疫苗可能在发展中国家起到推动作用,因为该疫苗不像其他疫苗需要低温冷藏。截至周三收盘,该公司股价在今年以来上涨了 17% 之后,在盘后交易中下跌了 50% 以上。

CureVac 声明称,还将在 2021 年 6 月 17 日星期四下午 2 点举办网络广播和电话会议。 CET / 美国东部时间上午 8:00。可通过 CureVac 网站的投资者关系部分访问实时电话会议拨入详细信息和网络广播链接,网址为:

https://www.curevac.com/en/newsroom/events/

 

 

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    2021-10-25 徐岩
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    2021-06-17 公卫新人

    新冠肺炎,疫情何时才能消失

    0

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