我国首个单针接种新冠疫苗获批上市
中国日报网 2021-03-01 11:15
2月25日,由中国工程院院士、军事科学院军事医学研究院研究员陈薇领衔的团队研发的我国重组新冠病毒疫苗(腺病毒载体新冠疫苗),获国家药品监督管理局附条件批准(conditional market approval)上市注册申请。
The vaccine, called Ad5-nCoV, has an efficacy rate of 65.7 percent at preventing symptomatic cases and is 90.9 percent effective in preventing severe disease with a single injection, according to interim analysis of late-stage human trials released in February.
今年2月发布的三期人体试验中期结果显示,这款名为Ad5-nCoV的疫苗单针接种后,对抗轻症的有效性为65.7%,对重症的有效性为90.9%。
【知识点】
疫情发生以来,国务院联防联控机制科研攻关组专门设立疫苗研发专班,按照灭活疫苗(inactivated vaccines)、重组蛋白疫苗(recombinant protein vaccines)、腺病毒载体疫苗(adenovirus vector vaccines)、减毒流感病毒载体活疫苗(vaccines using attenuated influenza virus as vectors)、核酸疫苗(nucleic acid vaccines)5条技术路线共布局12项研发任务。
中国疫苗行业协会会长封多佳介绍,重组新冠腺病毒载体疫苗和我们熟知的新冠灭活疫苗在原理、制备方法等方面都不相同,但最终的免疫效果是一样的。腺病毒载体疫苗(adenovirus vector vaccines)本质上是核酸疫苗的一种,就是将病毒的核酸片段装到经过安全处理的腺病毒(genetically modified adenovirus)身上,再注射到人体内,这样可以最大限度地发挥病毒核酸的抗原活性,激发身体的免疫作用(induce an immune response)。灭活疫苗(inactivated vaccines)则是将病毒杀死,消除致病性,保留免疫性,同样是为了激发身体的免疫作用。
Targeting people aged above 18, the vaccine can be transported and stored at a temperature ranging from 2 to 8 degrees Celsius.
该疫苗接种对象为18岁以上人群,可在2至8摄氏度间运输和存储。
腺病毒载体疫苗单针保护期至少6个月
陈薇院士接受央视采访时表示:
Data shows a single dose should provide protection for six months, and there is no need to take an additional shot during the six-month period.
数据显示,单针接种产生的保护期为6个月,6个月内无需再接种。
We also created booster shots for inoculation after six months, and with a single booster, we can increase the immune response by 10 to 20 times. Based on available data, we estimate two shots can provide protection for two years.
我们也做了6个月以后的加强针,再打一针,免疫反应可以有10倍、20倍的增高。根据数据,我们推测在两针之后,达到两年的免疫持久性。
年产能可达5亿剂
陈薇院士表示:
China is capable of producing 500 million doses of the vaccine annually, which can cover 500 million people.
我国年产能可达到5亿剂,相当于是5亿人的接种。
宁愿备而不用,不能用而不备
In regards to the vaccine's efficacy against mutated strains of SARS-CoV-2, the virus responsible for COVID-19, Chen said they are keeping a close eye on the situation and have begun developing vaccines for these new variants. "We may not need these vaccines, but we cannot be caught unprepared."
至于该疫苗对变异毒株的有效性,陈薇表示,他们团队在密切关注相关情况,且早已启动针对变异株的疫苗研发,这个疫苗不一定用得上,但宁愿备而不用,不能用而不备。
【相关词汇】
药品和疫苗研发 drug and vaccine development
随机试验 random trial
双盲试验 double-blind trial
安慰剂对照试验 placebo-controlled trial
免疫系统 immune system
毒性试验 toxicology test
有效性和安全性研究 safety and efficacy research
参考来源:央视新闻、新华网、中国日报
(中国日报网英语点津 Helen)