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BioNTech/辉瑞向欧盟提交COVID-19疫苗滚动上市申请

2020-10-08 医药魔方 医药魔方

辉瑞Covid-19滚动上市
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10月6日，辉瑞/BioNTech宣布已经向欧洲药品管理局（EMA）提交COVID-19疫苗BNT162b2的滚动申请，EMA已经受理该申请并且人用药品委员会（CHMP）已经启动了滚动审评。在此之前，

10月6日，辉瑞/BioNTech宣布已经向欧洲药品管理局（EMA）提交COVID-19疫苗BNT162b2的滚动申请，EMA已经受理该申请并且人用药品委员会（CHMP）已经启动了滚动审评。在此之前，EMA已经在10月1日宣布启动了针对阿斯利康/牛津大学COVID-19疫苗AZD1222的滚动审评。

滚动申请和滚动审评允许申请人在临床试验仍在进行中时就提交部分已经获得的数据供监管机构审查，而不用像传统方式下提交上市申请那样等全部的疗效和安全性数据获得之后再提交，以加快临床急需药品和疫苗的批准进程。

CHMP已经开始审查BNT162b2的临床前数据。辉瑞/BioNTech后续还需陆续向EMA提交用于证明BNT162b2疫苗疗效和安全性的证据，当EMA确认提交的数据足够充分时，辉瑞/BioNTech才算完成BNT162b2的正式上市申请。

BNT162b2疫苗基于BioNTech公司专有的mRNA技术开发，辉瑞则提供了全球疫苗开发和产能方面的支持。BNT162b2疫苗含有一种经优化的SARS-CoV-2全长刺突糖蛋白，这个蛋白是病毒中和抗体的靶标，可触发中和抗体以及TH-1优势的CD4+和CD8+T细胞的产生。BNT162b2疫苗目前正在全球超过120个中心（包括美国、巴西、南非和阿根廷等国家）开展III期试验，已经入组了大约37000例受试者，其中超过28000例已经完成了疫苗的第2剂接种。

BNT162b2疫苗的I/II期阶段研究的初步数据表明，所有年龄组受试者接种疫苗后耐受性良好，不良事件为轻至中度。经过检测受体结合域结合集合的IgG浓度以及SARS-CoV-2中和滴度发现疫苗可以产生剂量依赖性的免疫原性。此外，经BNT162b2接种免疫的受试者，其体内的T细胞可以识别SARS-CoV-2 病毒刺突蛋白的更多表位。BNT162b2可以诱导产生更高水平的CD4+和CD8+ T细胞应答。

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    2021-02-14 sunylz

    #Bio#

    0

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    2021-05-18 shock_melon

    #TEC#

    0

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    2020-10-10 124987cdm26暂无昵称

    #BioNTech#

    0

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    2020-10-10 1581f8c42cm

    继续

    0

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    2020-10-09 彭儿

    学习了

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1919145, encodeId=f1cc1919145f5, content=<a href='/topic/show?id=4f26341994' target=_blank style='color:#2F92EE;'>#Bio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3419, encryptionId=4f26341994, topicName=Bio)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=12de429, createdName=sunylz, createdTime=Sun Feb 14 23:48:48 CST 2021, time=2021-02-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1652442, encodeId=7b73165244249, content=<a href='/topic/show?id=13d01e24509' target=_blank style='color:#2F92EE;'>#TEC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17245, encryptionId=13d01e24509, topicName=TEC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=852f24292001, createdName=shock_melon, createdTime=Tue May 18 18:48:48 CST 2021, time=2021-05-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1391169, encodeId=014513911697b, content=<a href='/topic/show?id=9c5e34585a' target=_blank style='color:#2F92EE;'>#BioNTech#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3458, encryptionId=9c5e34585a, topicName=BioNTech)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e3fb2500073, createdName=124987cdm26暂无昵称, createdTime=Sat Oct 10 13:48:48 CST 2020, time=2020-10-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=890935, encodeId=bdfa89093576, content=继续, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200814/81d08245657a4a7f9a1ef713c0ec5878/ec4b201a22194a319b1aeb171bc6bb3d.jpg, createdBy=41e02111625, createdName=1581f8c42cm, createdTime=Sat Oct 10 07:01:24 CST 2020, time=2020-10-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=890798, encodeId=6b23890e983f, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=466a1997767, createdName=彭儿, createdTime=Fri Oct 09 15:29:18 CST 2020, time=2020-10-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=890763, encodeId=eff5890e63db, content=安全，有效是关键, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e6785205858, createdName=1474c43fm46暂无昵称, createdTime=Fri Oct 09 10:57:18 CST 2020, time=2020-10-09, status=1, ipAttribution=)]
    2020-10-09 1474c43fm46暂无昵称

    安全，有效是关键

    0

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