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One-shot recombinant COVID-19 vaccine
Published on: 2021-03-02
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The Chinese National Medical Products Administration granted conditional market approval to a recombinant novel coronavirus vaccine that requires only one shot.
 

Developed by a research team led by Chen Wei, an academician at the Chinese Academy of Engineering and a researcher at the Institute of Military Medicine under the Academy of Military Sciences, it is China's first approved COVID-19 vaccine that relies on adenovirus as the vector to deliver the coronavirus spike gene into the body.
 

Targeting people aged above 18, the vaccine can be transported and stored at a temperature ranging from 2 to 8 degrees Celsius.
 

The vaccine shows a 65.7-percent efficacy at preventing symptomatic cases and a 90.98-percent efficacy against severe disease in an interim analysis of its global phase-3 clinical trials, according to media reports. In the Pakistan subset, its efficacy at preventing symptomatic cases is 74.8 percent and 100 percent at preventing severe disease.
 

åªéœ€æ‰“一针ï¼ä¸­å›½é¦–个å•å‰‚新冠疫苗æ¥äº†


2月25日,国家è¯å“监ç£ç®¡ç†å±€å®˜ç½‘å‘布公告,附æ¡ä»¶æ‰¹å‡†åº·å¸Œè¯ºç”Ÿç‰©è‚¡ä»½å…¬å¸ã€å›½è¯ä¸­ç”Ÿæ­¦æ±‰å…¬å¸çš„新冠疫苗上市注册申请。
 

截至目å‰ï¼Œå›½å†…已有4款获批上市的新冠疫苗产å“,它们分别是国è¯é›†å›¢ä¸­å›½ç”Ÿç‰©åŒ—京生物制å“研究所有é™è´£ä»»å…¬å¸çš„新型冠状病毒ç­æ´»ç–«è‹—ã€åŒ—京科兴中维生物技术有é™å…¬å¸çš„新型冠状病毒ç­æ´»ç–«è‹—ã€å›½è¯é›†å›¢ä¸­å›½ç”Ÿç‰©æ­¦æ±‰ç”Ÿç‰©åˆ¶å“研究所有é™è´£ä»»å…¬å¸çš„新型冠状病毒ç­æ´»ç–«è‹—,以åŠåº·å¸Œè¯ºç”Ÿç‰©è‚¡ä»½å…¬å¸é‡ç»„新型冠状病毒疫苗(5型腺病毒载体)。
 

国内已有4款新冠疫苗获批上市,包括3款新冠ç­æ´»ç–«è‹—å’Œ1款腺病毒载体疫苗
 

在新添的两款疫苗中,国è¯ä¸­ç”Ÿæ­¦æ±‰å…¬å¸çš„新冠疫苗为ç­æ´»ç–«è‹—。2月24日,国è¯é›†å›¢ä¸­å›½ç”Ÿç‰©æ­¦æ±‰ç”Ÿç‰©åˆ¶å“研究所官网å‘布消æ¯ç§°ï¼Œåœ¨é˜¿è”酋等多个国家开展的Ⅲ期临床试验结果显示,该疫苗接ç§åŽå®‰å…¨æ€§è‰¯å¥½ï¼Œä¸¤é’ˆå…疫程åºæŽ¥ç§åŽï¼Œç–«è‹—接ç§è€…å‡äº§ç”Ÿé«˜æ»´åº¦æŠ—体,中和抗体阳转率为99.06%,疫苗针对由新冠病毒感染引起的疾病的ä¿æŠ¤æ•ˆåŠ›ä¸º72.51%。
 

康希诺生物股份公å¸çš„疫苗是首家获批的国产腺病毒载体新冠病毒疫苗。此款疫苗商å“å为“克å¨èŽŽâ€ï¼Œç”±åº·å¸Œè¯ºç”Ÿç‰©ä¸Žå†›äº‹ç§‘学院军事医学研究院生物工程研究所陈薇院士团队共åŒå¼€å‘。2020å¹´3月,康希诺新冠疫苗在武汉开展Ⅰ期临床试验,æˆä¸ºå…¨çƒé¦–个进入临床研究阶段的新冠候选疫苗。2021年春节期间,该疫苗先åŽèŽ·å¾—巴基斯å¦å’Œå¢¨è¥¿å“¥çš„紧急使用授æƒã€‚
 

康希诺生物在公告中称,此款疫苗的Ⅲ期临床试验期中分æžæ•°æ®ç»“果显示,å•é’ˆæŽ¥ç§ç–«è‹—28天åŽï¼Œç–«è‹—对所有症状的总体ä¿æŠ¤æ•ˆåŠ›ä¸º65.28%;在å•é’ˆæŽ¥ç§ç–«è‹—14天åŽï¼Œç–«è‹—对所有症状总体ä¿æŠ¤æ•ˆåŠ›ä¸º68.83%。疫苗对é‡ç—‡çš„ä¿æŠ¤æ•ˆåŠ›åˆ†åˆ«ä¸ºï¼Œå•é’ˆæŽ¥ç§ç–«è‹—28天åŽä¸º90.07%ï¼›å•é’ˆæŽ¥ç§ç–«è‹—14天åŽä¸º95.47%。
 

与附æ¡ä»¶ä¸Šå¸‚的三款新冠ç­æ´»ç–«è‹—ä¸åŒï¼Œè¿™æ¬¾ç–«è‹—采用的是腺病毒载体疫苗技术路线。
 

腺病毒载体疫苗属于新型疫苗中的载体疫苗,它是以改造åŽä¸å…·æœ‰è‡´ç—…性的腺病毒作为载体,将ä¿æŠ¤æ€§æŠ—原基因é‡ç»„到腺病毒基因组中,使用能表达ä¿æŠ¤æ€§æŠ—原基因的é‡ç»„腺病毒制æˆçš„疫苗。腺病毒载体疫苗注射入人体åŽï¼Œå…疫系统会识别出这个病毒抗原,激活机体å…ç–«å应获得å…疫力。

中国疫苗行业å会会长å°å¤šä½³è¡¨ç¤ºï¼Œé‡ç»„新冠腺病毒载体疫苗和我们熟知的新冠ç­æ´»ç–«è‹—在原ç†ã€åˆ¶å¤‡æ–¹æ³•ç­‰æ–¹é¢éƒ½ä¸ç›¸åŒï¼Œä½†æœ€ç»ˆçš„å…疫效果是一样的。

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