針對(duì)新冠病毒奧密克戎變異株的新疫苗開啟上市步伐。4月26日，國(guó)藥集團(tuán)中國(guó)生物奧密克戎變異株新冠病毒滅活疫苗獲國(guó)家藥監(jiān)局臨床批件。新疫苗什么時(shí)候能上市？

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，國(guó)藥集團(tuán)中國(guó)生物稱，針對(duì)新冠病毒奧密克戎變異株的疫苗臨床研究工作預(yù)計(jì)需要3—4個(gè)月左右的時(shí)間來(lái)完成。

在即將開展的臨床試驗(yàn)研究（clinical research）中，研究團(tuán)隊(duì)將高度關(guān)注疫苗是否能夠激發(fā)人體產(chǎn)生針對(duì)奧密克戎的特異性的中和抗體。

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.

國(guó)藥集團(tuán)中國(guó)生物首席科學(xué)家、副總裁張?jiān)茲f(shuō)，當(dāng)前的研究結(jié)果顯示，針對(duì)新冠病毒奧密克戎變異株的疫苗中，針對(duì)奧密克戎的中和抗體獲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.

他說(shuō)，動(dòng)物試驗(yàn)也表明，該疫苗對(duì)奧密克戎具有一定的保護(hù)效果。他同時(shí)指出，該疫苗的防護(hù)作用需要在臨床試驗(yàn)中進(jìn)一步觀察。

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

4月26日，國(guó)藥集團(tuán)中國(guó)生物奧密克戎變異株新冠病毒滅活疫苗獲國(guó)家藥監(jiān)局臨床批件。

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.

中國(guó)生物將采用隨機(jī)、雙盲、隊(duì)列研究的形式，在已完成2或3劑新冠疫苗接種的18歲及以上人群中進(jìn)行序貫免疫臨床研究，評(píng)價(jià)奧密克戎變異株新冠病毒滅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.

中國(guó)生物首席科學(xué)家楊匯川表示，隨著奧密克戎變異株疫苗的研發(fā)成功，主要產(chǎn)能設(shè)施將匹配到新毒株疫苗的生產(chǎn)上。

【相關(guān)詞匯】

奧密克戎變異株 Omicron variants

雙盲研究 double-blind study

疫苗 vaccine

參考來(lái)源：新華社、國(guó)際在線

編輯：Kirsten