阿斯利康疫苗接种12周有效性仍达76%,将推出新一代疫苗

2021-02-06 Oranghy MedSci原创

单剂接种有效率76%。

截至英国当地时间2月5日凌晨3点,英国新冠总确诊人数为3,892,459例,单日新增确诊人数为20,634人,单日新增死亡人数为915人。相较于之前病毒传播迹象有所减缓。

图片数据来源:: CDC · WHO · ECDC

英国卫生部长马特汉考克表示,阿斯利康疫苗已经开始慢慢发挥作用并减缓病毒传播,而疫苗是摆脱疫情大流行的出路。不过,首相约翰逊警告称,现在谈论解除封锁仍为时过早,英国政府不会同意在3月8前重新开放英格兰地区的学校。

去年12月30日,阿斯利康疫苗被英国监管机构MHRA批准紧急使用,其疗程为两剂标准剂量,间隔时间为4至12周。计划在英国的推广将包括对高危人群立即接种第一剂疫苗,并在12周后交付第二剂疫苗。

尽管该疫苗在对抗新冠病毒英国变种时显示有效,但随着巴西变种和南非变种的出现,研发团队对疫苗是否对其他变种同样有效表示担心。疫苗的研发团队表示,已经开始“第二代”疫苗的研发工作,将针对新冠病毒变种对现有疫苗进行改良,希望能够在秋季前完成研发,并得到英国药品和保健品管理局(MHRA)的批准。

图片xinouzhou

近日,牛津大学在《柳叶刀》(Lancet)网站上发布未经同行评审的一项与阿斯利康共同研发的新冠疫苗研究结果显示,其新冠疫苗在接种一剂后可能对遏制病毒传播产生“明显效果”,单次注射后三个月内对症状性感染有效率为76%,如果推迟第二次注射,疗效会提高,支持英国的疫苗推广政策。此前,英国决定通过延长初次注射和加强注射之间的时间,尽快为尽可能多的人接种疫苗,达到群体免疫效果,以应对COVID-19大流行。

图片SOURCE: bit.ly/3apMSyt Preprints with The Lancet, online February 1, 2021.

图片单剂有效率

图片疫苗对原发症状COVID-19的疗效,按第一次和第二次给药间隔时间,A)SD/SD或LD/SD给药后,B)SD/SD给药后,C)LDSD给药后的疗效

从英国、巴西和南非的试验中收集到的疫苗的结果来看,在18岁至55岁的17000参与者中,间隔较长的第二剂疫苗可提高免疫反应,在第一剂接种后12周或以上,第二剂疫苗的有效率为82.4%,而在第一剂疫苗接种后6周以下进行第二剂接种的则为54.9%,56岁及以上的人群服药间隔时间最长的是6-8周,因此该人群中没有12周服药间隔的疗效数据

此外,牛津大学还表示,数据表明该疫苗减少了感染的传播,在试验的英国组中,接种疫苗的人的阳性拭子减少了67%。

疫苗试验的首席研究员安德鲁-波拉德指出,数据显示,12周的剂量间隔是 "推出疫苗的最佳方法,人们在单剂疫苗后22天就能得到保护。阿斯利康公司的研究主管表示,两次注射之间的8-12周似乎是疗效的重点,与美国制药商辉瑞公司形成鲜明对比,辉瑞疫苗没有经过这样的间隔试验。

但一些独立研究人员表示,由于这一试验的局限性,很难从这些结果中得出一个全面结论。新的研究并没有解决对缺乏数据的高龄人群,英国政府在其疫苗推广中给予最高优先权的疗效担忧。 

图片observer

据法新社报道,欧盟药品管理局(EMA)表示,尽管缺乏充分数据了解牛津疫苗对高龄人群的有效性,然而,鉴于在该年龄群体试验中看到的免疫反应,预期还是具有防护力,因此比照英国的做法,认可疫苗可用于年长者。

尽管EMA建议成年的各年龄层都能接种疫苗,但有一些欧盟国家不建议高龄人群体接种。德国已宣布不建议65岁以上老年人接种。意大利药品管理局(AIFA)上月30日批准疫苗能接种于所有成年人,但建议55岁以上群体接种其他品种。

而瑞士药品监督管理局直接给该疫苗亮红灯,在2月3日发布的声明中表示,需要了解更多有关于其安全性、功效和品质的信息,因此需要药厂方面提供更多的数据,如果药厂愿意提供这些数据,以供瑞士国家机构评估,评估合格后将在最短的时间内,发布紧急使用授权。

值得一提的是,数月前,泰国一私立医院集团曾向泰国药监局提交了中国科兴新冠疫苗的进口注册审批申请,但此后提交申请的英国牛津疫苗已获得申请,中国科兴新冠疫苗依然没有得到审批。泰国药监局解释称,不管是中国科兴疫苗还是英国牛津疫苗,我们首要在乎的是其疫苗安全性和有效性,这并非是简单的商业行为,先到先得。科兴新冠疫苗在巴西接种后的效果并没有预期的那么高,导致我们对如何取舍的舆论压力非常大。

 图片observer

据了解,阿斯利康将继续履行其对广泛和公平获得疫苗的承诺。到目前为止,已经与流行病防范创新联盟(CEPI)、疫苗联盟Gavi、印度血清研究所(SII)和包容性疫苗联盟(IVA)等达成了提供超过20亿剂疫苗的承诺。

共同社2月5日消息,英国制药巨头阿斯利康5日表示,已向日本厚生劳动省提交新冠疫苗批准申请,并供应1.2亿剂,当中9,000万剂将在国内生产。报道称,阿斯利康是继美国辉瑞后第二家申请日本国内疫苗批准的公司。

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    2021-02-06 用户被禁用

    期待新的结果!

    0

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    2021-02-06 13c30453m58暂无昵称

    学习了

    0

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    2021-02-06 ms4000001286954603

    学习了

    0

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    2021-02-06 yangchou

    疫苗对新冠的有效预防有待研究。

    0