2月24日,康希诺生物发布公告,2月21日已正式向国家药监局提交重组新型冠状病毒疫苗(5型腺病毒载体)附条件上市申请,并获得受理。此款疫苗商品名为“克威莎?”,是由康希诺生物与军事科学院军事医学研究院生物工程研究所陈薇院士团队共同开发。
目前国内已有两款疫苗获批附条件上市,分别是来自国药集团中国生物和科兴,均为灭活疫苗。如果康希诺生物最终顺利获批,将成为国内获得附条件上市的第三款疫苗,也是国内获批的首款腺病毒载体新冠疫苗。
康希诺生物在公告中称,此款疫苗的Ⅲ期临床试验期中分析数据结果显示,单针接种疫苗28天后,疫苗对所有症状的总体保护效力为65.28%;在单针接种疫苗14天后,疫苗对所有症状总体保护效力为68.83%。疫苗对重症的保护效力分别为,单针接种疫苗28天后为90.07%;单针接种疫苗14天后为95.47%。
对此,业内人士解读,康希诺生物在公告中的数据显示了保护效力数据结果,达到世界卫生组织相关技术标准及国家药品监督管理局印发的《新型冠状病毒预防用疫苗临床评价指导原则(试行)》中相关标准要求。
Ⅲ期临床试验的保护效力数据证明,腺病毒载体新冠疫苗除可产生高效的体液免疫外,还可刺激机体产生细胞免疫反应,疫苗接种后,体液免疫和细胞免疫迅速发挥作用,14天即可保护机体免受SARS-CoV-2感染。
“克威莎是国内研发进展处于前列的几款新冠候选疫苗中,唯一采用单针免疫程序的新冠疫苗。”康希诺生物研发中心高级总监李军强介绍。
之所以能实现单针接种方案,是因为此次疫苗的研发,依托了康希诺生物拥有自主知识产权的腺病毒载体技术平台,采用基因工程方法,以复制缺陷型人5型腺病毒为载体,表达新型冠状病毒S蛋白,没有生物安全的风险。同时安全性好,无疫苗相关严重不良反应。
“单剂接种可以快速实现免疫保护,缩短接种周期,这种单剂接种方案将在更短的时间内实现群体免疫。”李军强介绍,由于该款疫苗使用腺病毒载体技术路线,与相同技术路线开发的重组埃博拉病毒病疫苗一样,可于2°C至8°C之间稳定保存,更易于正常运输及存储,疫苗可及性更高。
来源:央视新闻科技日报
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柬埔寨的國人什麼時候可以打疫苗?
等两年应该轮到国人打了。
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柬埔寨的國人什麼時候可以打疫苗?
本地人打完了,外國人有得打就不錯,你还想先打疫苗做夢。
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