我国已有三种新冠病毒疫苗进入二期临床试验,其中包括一种腺病毒疫苗和两种灭活疫苗,还需进行更多研究评估这三种疫苗的安全性和有效性。
Three COVID-19 vaccines - one adenovirus vector and two inactivated - have entered phase II clinical trials in China, and more research is needed to evaluate their safety and efficacy.
目前,我国两款新冠病毒灭活疫苗获得国家药品监督管理局许可启动一二期合并的临床试验,成为最先获得临床研究批件的采用“灭活”技术路线的新冠病毒疫苗。此前,军事科学院军事医学研究院腺病毒载体疫苗已获批开展临床试验。
通常而言,启动一期临床试验之前需完成动物实验,证实可将病毒蛋白送入免疫系统的关键部位,使免疫系统能识别病毒。该过程可通过使用灭活或减活的病毒、重组或提取病毒蛋白等方式实现。
临床试验分为一期、二期、三期,样本量不断扩大,疫苗的安全性和有效性需经过持续验证、依次“过关”。根据世界卫生组织之前发布的消息,这个时间通常需要一年以上。
【重要讲话】
疫苗对疫情防控至关重要,对安全性的要求也是第一位的。要加快推进已有的多种技术路线疫苗研发,同时密切跟踪国外研发进展。
Vaccine is vital to epidemic prevention and control, with its safety the top priority. We should speed up the vaccine research and development while closely tracking the progress of related research overseas.
——2020年3月2日,习近平在清华大学医学院主持召开座谈会并发表重要讲话
【相关词汇】
抗体药物
antibody medicines
应急科研攻关
contingency scientific research
新型检测试剂
new-type testing kits
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