北京科兴新冠灭活疫苗Ⅲ期临床研究数据公布

2021-02-05 JACKZHAO MedSci原创

近日,继国药集团新冠疫苗去年底获中国国家药监局批准附条件上市后,科兴公司宣布,其新冠疫苗附条件上市申请也已获中国国家药监局受理。

随后,科兴控股生物技术有限公司旗下子公司北京科兴中维生物技术有限公司(“科兴中维”)研制的新型冠状病毒灭活疫苗克尔来福®Ⅲ期临床研究数据完成初步统计分析,而正是基于这些结果,国家药监局受理附条件上市申请,现将其数据公布如下:

科兴中维于2020年7月21日起陆续选择在南美洲的巴西、智利,东南亚的印尼和中东的土耳其这四个处于不同地域、各具特点的国家开展Ⅲ期临床研究。这几项研究使用同一批疫苗(中剂量600 SU),按照相同的免疫程序(0,14程序),按药物临床试验质量管理规范(GCP)要求独立开展,总入组人数达2.5万人。

在巴西和土耳其两国开展的Ⅲ期临床研究分别评价了克尔来福®在高危人群(接诊COVID-19患者的医务人员)和普通人群中的保护效力,两国均采用多中心、随机、双盲、安慰剂平行对照设计,主要终点为接种2剂疫苗或安慰剂14天后新型冠状病毒所致疾病(COVID-19)的发病率。

截至2020年12月16日,巴西针对18岁及以上医务人员的研究共入组12,396名受试者,获得253例监测期有效病例。按照0,14天程序接种2剂疫苗14天后预防由新型冠状病毒所致疾病(COVID-19)的保护效力为50.65%,对需要就医的病例保护效力为83.70%,对住院、重症及死亡病例的保护效力为100.00%。

土耳其Ⅲ期临床试验目标人群为18~59岁处于高风险的医护人员(K-1)和处于正常风险的一般人群(K-2),截至2020年12月23日,K-1队列受试者入组918例,K-2队列入组受试者6453例,总计入组7371例,其中1322例受试者完成两剂接种并进入第二剂接种后14天观测期。基于29例病例的分析结果显示,按照0,14天程序接种2剂疫苗14天后预防COVID-19的保护效力为91.25%。

《柳叶刀传染疾病》(Infectious Diseases)3日在线发表克尔来福疫苗在Ⅰ/Ⅱ期临床研究中针对60岁及以上健康人群的试验结果。其中显示超400名60岁及以上的健康人士2020年于河北接种疫苗。当中有72人参与一期试验,接种两剂疫苗后,抗体产生比率为95.7%至100%;而参与二期试验的350人,抗体比率则有90.7%至99%。结果还显示,克尔来福疫苗对60岁及以上健康人群具有良好的安全性和免疫原性,与18-59岁健康人群的结果相当。

目前,克尔来福疫苗在国内是18-59岁群体,但部分海外国家已将这种疫苗扩大至老年人群体接种。

科兴疫苗早前已在巴西、印度尼西亚等国获得紧急使用许可。科兴中维董事长尹卫东日前表示,已陆续收到来自巴西、印度尼西亚、土耳其、智利等多个国家和地区的疫苗订单。

目前科兴的疫苗年生产能力已提升到10亿剂。国药此前表示年产能达10亿剂以上。另外,首批近200万剂科兴疫苗于上周运抵智利。

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    2021-02-05 公卫新人

    新冠肺炎,疫情何时才能消失

    0

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    2021-02-05 ms7000001964934849

    涨知识了

    0

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    2021-02-05 ms2000001051330459

    学习了,涨知识了!

    0

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