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New Three-Shot Vaccine 81.76% Effective Against Serious Covid
Published on: 2021-08-31
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A Chinese Covid-19 vaccine that is already being used in the country’s domestic vaccination campaign has been found to be nearly 82 per cent effective in a late stage clinical trial, the company said in an exchange filing on Friday.
 

A preliminary analysis of trial data also indicated the vaccine, developed by a unit of Chongqing Zhifei Biological Products, was able to hold up against the highly transmissible Delta variant, with almost 78 per cent efficacy.
 

The filing, which did not include detailed or peer-reviewed data, is the company’s first announcement of data from its large-scale trial. It could be a step toward full market approval for the three-dose vaccine, known as ZF2001, which received the green light for emergency use in China in March and is also being used in Uzbekistan.
 

The latest results come from an analysis of a phase three clinical trial that included 28,500 adults, split evenly between vaccines and placebos.
 

The trial took place in Uzbekistan, Pakistan, Indonesia, Ecuador and in China’s Hunan province, according to the Shenzhen-listed company’s filing.
 

The data, based on 221 Covid-19 cases among that group, found the vaccine was 81.76 per cent efficacious against Covid-19 of any degree of severity and had a 100 per cent efficacy rate against severe and fatal cases among participants.
 

The trial is expected to include robust data on efficacy in the elderly. Some 7,000 over-60s were slated to participate in the international study, according to the clinical trial registration, though no age breakdown for efficacy was yet reported.
 

3针国产重组新冠疫苗保护率披露:总体81.76%,德尔塔77.54%

重庆智飞生物8月27日发布官方公告称,根据自2020年年底起在湖南省、乌兹别克斯坦、印度尼西亚、巴基斯坦和厄瓜多尔开展的Ⅲ期临床试验关键数据及结论,由其子公司安徽智飞龙科马与中科院微生物研究所合作、采用重组蛋白技术研发的重组新型冠状病毒疫苗(CHO细胞)对新冠肺炎的总体保护率为81.76%,对新冠肺炎重症及以上病例、死亡病例的保护率均为100%。对德尔塔变异株的保护率为77.54%。
 

重庆智飞生物在公告中表示,近日接到全资子公司安徽智飞龙科马的上报,获悉重组新型冠状病毒疫苗(CHO细胞)获得了Ⅲ期临床试验的关键性数据。
 

公告称,重组新型冠状病毒疫苗(CHO细胞)自2020年12月12日起,陆续在我国湖南省、乌兹别克斯坦、印度尼西亚、巴基斯坦和厄瓜多尔开展国际多中心Ⅲ期临床试验,计划入组18周岁以上普通人群共计29000人,按照0、1、2月的免疫程序共接种3剂疫苗。
 

截至本次数据分析日,实际共入组28500人,其中疫苗组14251例、安慰剂组14249例。共监测到全程接种后的主要终点病例数221例,得出重组新型冠状病毒疫苗对任何严重程度的COVID-19(新冠肺炎)的保护效力为81.76%,达到WHO(世卫组织)要求的新冠疫苗有效性标准。其中对COVID-19重症及以上病例、死亡病例的保护效力均为100%。
 

公告称,目前已完成大部分主要终点病例的基因分型,初步分析结果显示,重组新型冠状病毒疫苗对新冠病毒Alpha(阿尔法)变异株的保护效力为92.93%,对Delta(德尔塔)变异株的保护效力为77.54%。

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