针对新冠病毒奥密克戎变异株的新疫苗开启上市步伐。4月26日,国药集团中国生物奥密克戎变异株新冠病毒灭活疫苗获国家药监局临床批件。新疫苗什么时候能上市?


图片来源:新华社

Clinical trials for China's vaccine against Omicron variants are expected to conclude in three to four months, according to the vaccine developer on Wednesday.

4月27日,国药集团中国生物称,针对新冠病毒奥密克戎变异株的疫苗临床研究工作预计需要3—4个月左右的时间来完成。

 

在即将开展的临床试验研究(clinical research)中,研究团队将高度关注疫苗是否能够激发人体产生针对奥密克戎的特异性的中和抗体。

 

Pre-clinical research showed the vaccine has good neutralizing activity against Omicron variants. said Zhang Yuntao, chief scientist and vice president of vaccine developer China National Biotec Group (CNBG), affiliated with Sinopharm, during an online press conference.

国药集团中国生物首席科学家、副总裁张云涛说,当前的研究结果显示,针对新冠病毒奥密克戎变异株的疫苗中,针对奥密克戎的中和抗体获得了很大幅度的提升。

 

Animal experiments have also shown that the vaccine offers some protection against Omicron infections, he said, noting that the protective effect of the vaccine needs to be observed further in clinical trials.

他说,动物试验也表明,该疫苗对奥密克戎具有一定的保护效果。他同时指出,该疫苗的防护作用需要在临床试验中进一步观察。

 

The vaccine was approved for clinical trials by the National Medical Products Administration on Tuesday.

4月26日,国药集团中国生物奥密克戎变异株新冠病毒灭活疫苗获国家药监局临床批件。

 

During the clinical trials, a randomized, double-blind and cohort study method will be adopted among people aged 18 and above who have already received two or three doses of COVID-19 vaccines to evaluate the safety and immunogenicity of the inactivated vaccine.

中国生物将采用随机、双盲、队列研究的形式,在已完成2或3剂新冠疫苗接种的18岁及以上人群中进行序贯免疫临床研究,评价奥密克戎变异株新冠病毒灭活疫苗的安全性和免疫原性。

 

With the successful development of the vaccine against Omicron variants, CNBG will coordinate its main production capacity and equipment to manufacture the new vaccine, said Yang Huichuan, chief scientist and vice president of CNBG.

中国生物首席科学家杨汇川表示,随着奥密克戎变异株疫苗的研发成功,主要产能设施将匹配到新毒株疫苗的生产上。

 

【相关词汇】

奥密克戎变异株 Omicron variants

双盲研究 double-blind study

疫苗 vaccine

 

参考来源:新华社、国际在线

编辑:Kirsten

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