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DNA新冠疫苗来了！印度已紧急授权使用

2021-08-22 网络 网络

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8月20日，印度政府在一份声明中表示，由总部在艾哈迈达巴德的Cadila Healthcare Ltd.开发的首个基于DNA的新冠疫苗于本周五获得紧急授权许可

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8月20日，印度政府在一份声明中表示，由总部在艾哈迈达巴德的Cadila Healthcare Ltd.开发的首个基于DNA的新冠疫苗于本周五获得紧急授权许可，在7月份的临床试验中，该疫苗对于预防有症状感染的有效率为67%。
 
声明中说，该疫苗是“世界上第一种也是印度本土开发的基于 DNA 技术的新冠疫苗，可用于人类，包括 12 岁及以上的儿童和成人。”它还计划寻求批准该疫苗的两剂方案，并每年生产1-1.2 亿剂。
 
与传统疫苗不同，Cadila的ZyCoV-D是质粒DNA疫苗，ZyCoV-D是一种无针疫苗，使用 PharmaJet® 无针涂药器给药，可确保无痛皮内注射疫苗。
 
它在体内引入编码抗原的 DNA 序列，DNA疫苗是将编码目的抗原蛋白基因序列的质粒经肌肉注射导入宿主细胞，通过转录系统表达抗原蛋白，诱导宿主产生针对该抗原蛋白的免疫应答，从而达到免疫目的的新型基因工程疫苗。而不是病原体的减弱形式的灭活苗。
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biotechprimer
 
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cbc.ca
 
DNA疫苗使用后不仅能够诱导良好的体液免疫反应，还可诱导较强的细胞免疫应答之外，DNA疫苗相比mRNA 疫苗也更具稳定且更易于储存，具有环境友好和可靠的生物安全性等特点。
 
这是印度第二种获得批准的自主研发新冠疫苗，Cadila 声称这种疫苗可用于对抗最新的变异毒株，包括具有高度传染性的德尔塔变种，增加了该国抗击病毒的能力。
 
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republicworld
迄今，印度新冠病例已超3230 万例，并造成超过43万人死亡，尤其是在几个月前毁灭性的第二波疫情期间。加快接种速度——众所周知可以减少住院和死亡——是在这个人口稠密的国家避免未来病毒浪潮的关键。因为这个世界上受灾第二严重的国家正寻求加强其免疫工作以抵御可能的第三波感染。
 
据BBC，18日报道，世界卫生组织确认，印度Covishield新冠疫苗出现假货，并向全球发出医疗警告。作为印度主打的Covishield疫苗，其在印度本土使用最为广泛，目前已注射超4.86亿剂。
 
目前，印度只有9％的人口完成了疫苗的完全接种，现在已经总计批准了六种疫苗在该国使用。
 
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目前主要DNA新冠疫苗与mRNA新冠疫苗
 
世卫组织官网信息显示，全球范围有多个团队正在从事DNA新冠病毒疫苗研发，包括美国Inovio Pharmaceuticals，中国艾棣维欣生物，意大利生物技术企业Takis与美国应用DNA科学公司等机构的合作团队、印度药企Cadila公司等。
 
其中Inovio Pharmaceuticals与中国疫苗企业北京艾棣维欣生物双方早在 2020 年 1 月起开始共同开发 INO-4800/pGX9501。艾棣维欣在中国启动该疫苗的第1期和第 2 期临床试验，Inovio 在美国完成了第 1 期和第 2 期临床试验。因此，双方将在本次合作约定的范围内平均分担全球第 3 期临床试验的费用。
 
艾棣维欣将拥有在中国大陆、香港、澳门以及台湾在内的大中华区域、以及其他亚洲国家开发、生产和商业化该疫苗的权利。
 
INO-4800是一种透过电穿孔传递的质体DNA疫苗，包含新冠病毒刺突蛋白的 S1 和 S2 亚基。INO-4800由优化的DNA质粒组成，通过专有技术智能装置直接递送到体内细胞，产生可靠、安全、可耐受的免疫反应。
 

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seekingalpha
INO-4800在室温下可保持稳定一年以上，在摄氏37度条件下可保持一个月以上，在常规冰箱温度中保质期预计达五年，而且在运输或储存过程中无需行冷冻。它也是满足上述全部要求的唯一的一种核酸疫苗，这对群体大规模接种而言是重要的考量因素。
 
DNA疫苗与mRNA疫苗同属于核酸疫苗，核酸疫苗继传统减毒疫苗、灭活疫苗和基因工程亚单位疫苗之后被行业内称为“第三代疫苗技术”。
 
20 世纪90年代初，美国威斯康星大学的约翰· 沃尔夫( John Wolf) 等意外地发现，在小鼠的肌肉内注射含有外源基因的外源重组质粒后，质粒能够在体内稳定表达编码的蛋白质至少2个月。
 
DC．Tang 等发现质粒不仅可以表达蛋白质，也可以诱导免疫反应。1993年，B.Wang发现艾滋病毒DNA疫苗诱导能够产生很好的抗 HIV 感染免疫反应，MLiu 和 H Robinson 等证明 DNA 疫苗诱导的抗流感免疫反应可以保护动物免受病毒攻击。之后，这项 DNA疫苗技术逐渐蓬勃发展。
 
我国已于2018年批准了中国农业科学院哈尔滨兽医研究研制的用于预防H5亚型禽流感的DNA疫苗，获得国家一类新兽药证书，这也是我国获得批准的首个DNA疫苗产品。
 
复旦大学金翔综述文章指出，经过十几年的改进，DNA 疫苗递送效率大幅度提升，尤其在应对严重急性呼吸综合征( SARS) 、高致病性流感、中东呼吸综合征( MERS) 、寨卡热( ZIKA) 、裂谷热等突发性传染病方面，DNA 疫苗在临床中的初步效果得到了验证。
 
DNA 疫苗特点有安全性好、可诱导体液免疫和细胞免疫研发和生产周期短，能快速供应稳定性高，适合战略储备及运送至偏远地区生产成本低。
 
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https://www.who.int/biologicals/DNA_vaccines_R_WHO.BS.2020.2380_12_May_2020.pdf
 
2020 年8月，WHO更新了DNA 疫苗研发的指导原则 (WHO/BS / 2020．2380) ，充分肯定了 DNA 疫苗的重要性，认为 DNA 疫苗最突出的优点是: 
 

  • ① 制备DNA疫苗只需要进行核酸物质的重组操作，无需和蛋白质等生物分子打交道，所以制备快速和简单，并不需要考虑蛋白质抗原结构、修饰、稳定性及工艺过程带来的变化等因素。

  • ② 使用编码的基因片段不复制和不整合，不良反应极少。

  • ③ 编码的基因片段在机体 细胞中表达，可以同时激活细胞免疫反应和体液免疫反应。

  • ④ 在室温下稳定和易于大规模生产。

  • ⑤ 对病毒突变位点快速修改后的制备。

 
我们认为，DNA疫苗有潜力继mRNA疫苗之后成为又一个聚焦热点，产业化将极大加速。
 
然而，DNA 疫苗目前仍然有不少问题需要解决，如大肠杆菌生产 DNA 疫苗中经常使用的抗生素可能会残留到DNA疫苗产品中，尽管通过纯化步骤可以去除绝大部分，但微量的残留仍然是一个风险因素。其安全性、有效性、及伦理风险仍有待观察。
 
参考文献：
Smith, T.R.F., Patel, A., Ramos, S. et al. Immunogenicity of a DNA vaccine candidate for COVID-19. Nat Commun 11, 2601 (2020). https://doi.org/10.1038/s41467-020-16505-0
金翔,俞庆龄,张璐楠,何悦,程鑫,刘晓雁,王宾. 针对新型冠状病毒的DNA疫苗研究进展[J]. 中国新药杂志,2020,21:2425-2433.
https://zeenews.india.com/india/zydus-cadilas-covid-vaccine-zycov-d-first-jab-for-children-in-india-gets-approval-2386955.html
https://www.medsci.cn/article/show_article.do?id=1f22210528a8

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    2021-08-23 guguangxiang

    #紧急#

    0

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    2021-08-22 皮皮2021

    加油

    0

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    2021-08-22 陈姗

    ！

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1523361, encodeId=4558152336189, content=<a href='/topic/show?id=1a1de7006b0' target=_blank style='color:#2F92EE;'>#紧急#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77006, encryptionId=1a1de7006b0, topicName=紧急)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b88211514540, createdName=guguangxiang, createdTime=Mon Aug 23 23:04:11 CST 2021, time=2021-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010301, encodeId=f30a1010301b3, content=加油, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e895468972, createdName=皮皮2021, createdTime=Sun Aug 22 15:03:34 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010296, encodeId=40131010296e8, content=！, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfed5581097, createdName=陈姗, createdTime=Sun Aug 22 14:53:15 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029892, encodeId=b61410298924c, content=新冠肺炎，疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Sun Aug 22 11:04:11 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010262, encodeId=a4ec10102621d, content=优秀, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3c2b1620925, createdName=泽9867, createdTime=Sun Aug 22 10:50:05 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010243, encodeId=eb881010243c9, content=学习！, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210703/9c448fe1b3b54fd7bc9477662f4861bb/4bdadad22bfd46f2921aabb4c40265d3.jpg, createdBy=a8d81938466, createdName=weigq, createdTime=Sun Aug 22 09:33:15 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010219, encodeId=33f7101021972, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210604/0144bfea4ffa499e849a2e74797b5fb2/bb75638200fd450e9511b0b3dd092ba8.jpg, createdBy=8d772453344, createdName=涂涂0518, createdTime=Sun Aug 22 08:08:44 CST 2021, time=2021-08-22, status=1, ipAttribution=)]
    2021-08-22 公卫新人

    新冠肺炎，疫情何时才能消失

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1523361, encodeId=4558152336189, content=<a href='/topic/show?id=1a1de7006b0' target=_blank style='color:#2F92EE;'>#紧急#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77006, encryptionId=1a1de7006b0, topicName=紧急)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b88211514540, createdName=guguangxiang, createdTime=Mon Aug 23 23:04:11 CST 2021, time=2021-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010301, encodeId=f30a1010301b3, content=加油, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e895468972, createdName=皮皮2021, createdTime=Sun Aug 22 15:03:34 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010296, encodeId=40131010296e8, content=！, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfed5581097, createdName=陈姗, createdTime=Sun Aug 22 14:53:15 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029892, encodeId=b61410298924c, content=新冠肺炎，疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Sun Aug 22 11:04:11 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010262, encodeId=a4ec10102621d, content=优秀, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3c2b1620925, createdName=泽9867, createdTime=Sun Aug 22 10:50:05 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010243, encodeId=eb881010243c9, content=学习！, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210703/9c448fe1b3b54fd7bc9477662f4861bb/4bdadad22bfd46f2921aabb4c40265d3.jpg, createdBy=a8d81938466, createdName=weigq, createdTime=Sun Aug 22 09:33:15 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010219, encodeId=33f7101021972, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210604/0144bfea4ffa499e849a2e74797b5fb2/bb75638200fd450e9511b0b3dd092ba8.jpg, createdBy=8d772453344, createdName=涂涂0518, createdTime=Sun Aug 22 08:08:44 CST 2021, time=2021-08-22, status=1, ipAttribution=)]
    2021-08-22 泽9867

    优秀

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1523361, encodeId=4558152336189, content=<a href='/topic/show?id=1a1de7006b0' target=_blank style='color:#2F92EE;'>#紧急#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77006, encryptionId=1a1de7006b0, topicName=紧急)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b88211514540, createdName=guguangxiang, createdTime=Mon Aug 23 23:04:11 CST 2021, time=2021-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010301, encodeId=f30a1010301b3, content=加油, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e895468972, createdName=皮皮2021, createdTime=Sun Aug 22 15:03:34 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010296, encodeId=40131010296e8, content=！, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfed5581097, createdName=陈姗, createdTime=Sun Aug 22 14:53:15 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029892, encodeId=b61410298924c, content=新冠肺炎，疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Sun Aug 22 11:04:11 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010262, encodeId=a4ec10102621d, content=优秀, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3c2b1620925, createdName=泽9867, createdTime=Sun Aug 22 10:50:05 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010243, encodeId=eb881010243c9, content=学习！, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210703/9c448fe1b3b54fd7bc9477662f4861bb/4bdadad22bfd46f2921aabb4c40265d3.jpg, createdBy=a8d81938466, createdName=weigq, createdTime=Sun Aug 22 09:33:15 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010219, encodeId=33f7101021972, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210604/0144bfea4ffa499e849a2e74797b5fb2/bb75638200fd450e9511b0b3dd092ba8.jpg, createdBy=8d772453344, createdName=涂涂0518, createdTime=Sun Aug 22 08:08:44 CST 2021, time=2021-08-22, status=1, ipAttribution=)]
    2021-08-22 weigq

    学习！

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1523361, encodeId=4558152336189, content=<a href='/topic/show?id=1a1de7006b0' target=_blank style='color:#2F92EE;'>#紧急#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77006, encryptionId=1a1de7006b0, topicName=紧急)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b88211514540, createdName=guguangxiang, createdTime=Mon Aug 23 23:04:11 CST 2021, time=2021-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010301, encodeId=f30a1010301b3, content=加油, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e895468972, createdName=皮皮2021, createdTime=Sun Aug 22 15:03:34 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010296, encodeId=40131010296e8, content=！, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfed5581097, createdName=陈姗, createdTime=Sun Aug 22 14:53:15 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029892, encodeId=b61410298924c, content=新冠肺炎，疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Sun Aug 22 11:04:11 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010262, encodeId=a4ec10102621d, content=优秀, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3c2b1620925, createdName=泽9867, createdTime=Sun Aug 22 10:50:05 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010243, encodeId=eb881010243c9, content=学习！, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210703/9c448fe1b3b54fd7bc9477662f4861bb/4bdadad22bfd46f2921aabb4c40265d3.jpg, createdBy=a8d81938466, createdName=weigq, createdTime=Sun Aug 22 09:33:15 CST 2021, time=2021-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1010219, encodeId=33f7101021972, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210604/0144bfea4ffa499e849a2e74797b5fb2/bb75638200fd450e9511b0b3dd092ba8.jpg, createdBy=8d772453344, createdName=涂涂0518, createdTime=Sun Aug 22 08:08:44 CST 2021, time=2021-08-22, status=1, ipAttribution=)]
    2021-08-22 涂涂0518

    学习

    0