Phase 2 clinical trials of COVID-19 vaccines to complete in July
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On May 15th, during the press briefing on epidemic prevention and control work, a question was raised that the public would like to know more about the progress of vaccine research and development.
5月15日下午,国务院新闻办公室举行新闻发布会,介绍新冠肺炎疫情常态化防控工作,会上有提问称,现在随着疫情防控的常态化,公众比较关注疫苗研发的进展,请问能否介绍目前疫苗研发的有关情况?
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Zeng Yixin, deputy director of National Health Commission, answered the question in details, but here are the main highlights from his answer.
国家卫生委员会副主任曾益新详细回答了这个问题,但以下是主要要点。
Currently, there is one adenovirus vector vaccine and four inactivated vaccines which have been approved by the State Food and Drug Administration. They have all been cleared to carry out phase I and phase II combined clinical trials. This is also through the revision of the emergency approval of the drug administration, i.e. approving the enterprises to carry out phase I and phase II clinical trials simultaneously.
目前,我们已经有一项重组腺病毒载体疫苗和四项灭活疫苗,相继获得了国家药监局的批准,开展一期和二期合并的临床试验,这也是药监局应急审批的创新,批准企业一期试验和二期试验同步进行。
So far, 2575 volunteers have been administered vaccines through various projects. Among them, 539 volunteers have taken vaccine for the first phase of clinical trials. Preliminary data of the body's safety and protective antibody production for some of them have already been obtained. For the second phase of clinical trials, 2036 volunteers have been inoculated and currently, researchers are assessing the safety and effectiveness of the vaccine.
截止到目前,各个项目中总共已经接种了2575名志愿者。其中一期的临床试验已累计完成了539名志愿者的接种,有的已经获得了初步的安全性和保护性抗体产生的数据,这是一期的临床试验;二期临床试验已经累计完成了2036名志愿者的接种,正在开展全过程接种和安全性、有效性评价。
Up until now, no major adverse reactions from the trials had been reported. According to the plan, if all goes well, the projects will complete the second phase of clinical trials in July this year.
在这些项目的临床试验过程中我们目前没有收到有重大不良反应的报告,按照计划,如果一切顺利的话,上面的这些项目在今年的7月份陆续完成二期临床试验
Apart from those mentioned above, there are others that have made rapid progress and have begun to submit applications for pharmaceutical research, preclinical research and clinical trial scheme to the drug audit center of the State Food and drug administration. It is expected that in June, there will be more projects that will be approved by the State Food and Drug Administration to enter the clinical trial stage. At present, this is the overall situation of vaccine development.
除了刚刚讲的腺病毒载体之外,还有的进展较快已经开始向国家药监局药审中心滚动递交药学研究、临床前研究、临床试验方案等申报资料,预计6月份开始还会有项目能够获得国家药监局的批准,进入临床试验阶段。目前来看,我们的疫苗方面总体的状况就是这样的。
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