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6月16日,由国药集团中国生物武汉生物制品研究所研制的全球首款新冠病毒灭活疫苗Ⅰ/Ⅱ期临床试验盲态审核暨阶段性揭盲会,在北京、河南两地同步举行。

China National Biotech Group Co Ltd announced on Tuesday the phase-1 and phase-2 clinical trials of its inactivated vaccine had demonstrated good performance in safety and effectiveness on vaccinated volunteers. No subjects showed serious adverse reactions, the company said.

国药中国生物6月16日宣布,其新冠病毒灭活疫苗Ⅰ/Ⅱ期临床试验在接种的志愿者身上表现出良好的安全性和有效性,受试者无一例严重不良反应。

国药中国生物介绍,此次新冠灭活疫苗临床试验为随机(random trial)、双盲(double-blind trial)、安慰剂对照(placebo-controlled trial)的Ⅰ/Ⅱ期临床研究。

The company said a total of 1,120 volunteers were vaccinated during the phase-1 and phase-2 clinical trials, all of whom produced high-titer antibodies.

国药中国生物介绍,Ⅰ/Ⅱ期临床研究受试者共1120人,疫苗组接种者均产生高滴度抗体。

In the 18-to-59-year-old age group, those who got two doses of vaccine based on the 0-and-28-day procedure demonstrated 100 percent antibody positive conversion rate, while those who got two doses based on the 0-and-14-day procedure and 0-and-21-day procedure showed a 97.6 percent antibody positive conversion rate.

在18—59岁健康受试者中,按照0/28天程序接种两剂后,受试者中和抗体阳转率达100%。按照0/14天和0/21天程序接种后的受试者中和抗体阳转率为97.6%。

专家表示,

The results were the world's first clinical data on safety and effectiveness collected after two doses of vaccination, offering scientific and measurable support for epidemic prevention and control and emergency use.

这也是全球首个接种两剂疫苗后收集到的临床安全性及有效性数据,为疫情防控和紧急使用提供了科学、可评价的数据。

国药中国生物同时透露,正积极推进Ⅲ期临床研究的海外合作。

It has received cooperation overtures from companies and institutions overseas. Once the inactivated vaccine completes the three trials, it is expected to hit the market by the end of this year or the beginning of next year.

该公司已经收到了海外几家公司和机构的合作意向。灭活疫苗完成三期试验之后,有望于今年年底或明年初面市。

国务院新闻办公室6月7日发布的《抗击新冠肺炎疫情的中国行动》白皮书指出,

To date, four inactivated vaccines and one adenovirus vaccine have been approved for clinical trials. While scientists in China and abroad have kept up with mutual developments, China leads the world in the development of certain types of vaccines.

目前,已有4种灭活疫苗和1种腺病毒载体疫苗获批开展临床试验,总体研发进度与国外持平,部分技术路线进展处于国际领先。

【相关词汇】

临床试验

clinical trial

临床前研究

preclinical research

动物试验

animal test

毒性试验

toxicology test

有效性和安全性研究

safety and efficacy research

免疫系统

immune system

疫苗临床试验和上市使用

clinical trial and application of vaccines

文章来源:Chinadaily

photo by marcelo-leal on unsplash

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