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Sinovac vaccine is 50.7% effective against COVID with symptoms
Published on: 2021-04-14
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Detailed late-stage trial data for the Covid-19 vaccine developed by Sinovac Biotech Ltd. has been disclosed in a paper penned by Brazilian researchers, which may help allay concerns over Chinese-made shots exacerbated by a dearth of such public information.
 

The preprint paper, which has not yet been peer-reviewed, was released Sunday via online research platform SSRN. It said Sinovac’s inactivated virus vaccine, known as CoronaVac, is 50.7% effective at preventing symptomatic Covid-19 cases. Brazilian officials previously gave the figure of 50.4%.
 

The researchers found that the efficacy rate against cases “requiring assistance” and cases showing moderate-to-severe symptoms was 83.7% and 100% respectively.
 

A total of 12,396 volunteers participated in the phase 3 clinical trial, which was conducted across 16 sites in Brazil between last July and December, according to the paper. The volunteers were required to be health care professionals caring for Covid-19 patients.
 

A total of 67 severe adverse events were detected among 64 participants who received two CoronaVac doses, including two deaths. The study said that these events were “determined as unrelated to the vaccine.”
 

The release of the study marks the first time that a Chinese-made vaccine’s late-stage trial results have been published, as until now, only the results of early and mid-stage trials of Chinese vaccines have been published. These trials are not designed to examine whether vaccines actually prevent people getting sick from the disease, though headline efficacy figures have been announced by various officials and executives.
 

修正有效率至50.7%!巴西公布科兴新冠疫苗Ⅲ期临床结果

4月11日,巴西圣保罗州布坦坦研究所公布了中国科兴中维生物公司新冠疫苗克尔来福在巴西Ⅲ期临床试验的最终研究结果,将该疫苗对含不需就医的轻症病例在内的所有新冠病例的保护效力从今年1月初公布的50.38%修正为50.7%,对有明显症状且需就医的新冠病例的保护效力从1月的78%修正为83.7%。此外,重症有效率是100%。
 

这项研究由布坦坦研究所主导,目前已提交给医学杂志《柳叶刀》等待同行评审。根据该研究,在去年7月至12月期间,有12396名18至59岁的医护人员参与科兴疫苗的第三期研究,每位人员接种了最少一剂疫苗或安慰剂,其中9823人打了两针。在接种组4953人里,有85人确诊;而在对照组4870人里,有168人确诊。

该研究显示,当接种两剂疫苗的间隔时间较长时,克尔来福对含不需就医的轻症病例在内的所有新冠病例的保护效力可以进一步提升至62.3%。研究人员认为,接种两剂疫苗的最优间隔是28天。


研究还显示,克尔来福对于P.1和P.2这两种变异新冠病毒同样有效。P.1变异病毒最初发现于亚马孙州首府玛瑙斯市,是导致今年以来巴西疫情严重反弹的一个因素。P.2变异病毒主要在里约热内卢等地流行。


在副作用方面,六成人会针口痛,34%人有头痛,0.2%人有发烧。另外,在研究期间,64名参与者报告了67件严重异常事件,当中包括两宗死亡,但都被列为与疫苗无关,一人是对照组内,因心肺骤停而死;另一人是接种组,研究内只提到涉及过量药物。

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