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20价肺炎球菌疫苗,即将获得EMA的批准

2021-02-26 Allan MedSci原创

所有侵袭性肺炎球菌疾病例的一半以上是由20vPnC涵盖的20种血清型引起的,其中包括7种血清型(8、10A、11A、12F、15B、22F和33F)。

肺炎链球菌是一种可导致许多常见疾病的细菌,从脑膜炎、脓毒症和肺炎等严重疾病到鼻窦炎、中耳炎等更温和常见的感染

辉瑞公司今天宣布,欧洲药品管理局(EMA)已批准其20价肺炎球菌结合疫苗(20vPnC)的上市许可申请(MAA)的审查,该疫苗旨在预防18岁及以上成年人的肺炎链球菌性肺炎。EMA的人用药品委员会(CHMP)正式开始了审查程序。

辉瑞高级副总裁Kathrin U. Jansen博士说:“在欧洲和世界各地的许多国家/地区,所有侵袭性肺炎球菌疾病例的一半以上是由20vPnC涵盖的20种血清型引起的,其中包括7种血清型(8、10A、11A、12F、15B、22F和33F)”。

3项III期试验(NCT03760146,NCT03828617和NCT03835975)描述了20vPnC的安全性,并评估了20vPnC的免疫原性。这3项III期试验招募了6,000多名18岁以上的成年受试者,包括65岁及以上的成年人、未接种疫苗的成年人以及接受过肺炎球菌疫苗接种的成年人。

 

原始出处:

https://www.firstwordpharma.com/node/1804493?tsid=4

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    2021-02-28 fengyi812
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  3. [GetPortalCommentsPageByObjectIdResponse(id=1317620, encodeId=dc48131e62049, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Sun Feb 28 13:27:41 CST 2021, time=2021-02-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1485666, encodeId=9bf714856669b, content=<a href='/topic/show?id=e1ec821e823' target=_blank style='color:#2F92EE;'>#肺炎球菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82178, encryptionId=e1ec821e823, topicName=肺炎球菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e328034144, createdName=ms24272190615788285182, createdTime=Sun Feb 28 13:27:41 CST 2021, time=2021-02-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944050, encodeId=4d5094405098, content=继续来学习新内容, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200627/83a502bff6c14b759a7d0863b4068e7b/32ad40676056418ea58a94afac9c5b81.jpg, createdBy=6f475314305, createdName=水-晶, createdTime=Sat Feb 27 23:34:37 CST 2021, time=2021-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=943860, encodeId=eb9c943860e4, content=进来看看都有啥, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200627/83a502bff6c14b759a7d0863b4068e7b/32ad40676056418ea58a94afac9c5b81.jpg, createdBy=6f475314305, createdName=水-晶, createdTime=Fri Feb 26 23:41:17 CST 2021, time=2021-02-26, status=1, ipAttribution=)]
    2021-02-27 水-晶

    继续来学习新内容

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1317620, encodeId=dc48131e62049, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Sun Feb 28 13:27:41 CST 2021, time=2021-02-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1485666, encodeId=9bf714856669b, content=<a href='/topic/show?id=e1ec821e823' target=_blank style='color:#2F92EE;'>#肺炎球菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82178, encryptionId=e1ec821e823, topicName=肺炎球菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e328034144, createdName=ms24272190615788285182, createdTime=Sun Feb 28 13:27:41 CST 2021, time=2021-02-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=944050, encodeId=4d5094405098, content=继续来学习新内容, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200627/83a502bff6c14b759a7d0863b4068e7b/32ad40676056418ea58a94afac9c5b81.jpg, createdBy=6f475314305, createdName=水-晶, createdTime=Sat Feb 27 23:34:37 CST 2021, time=2021-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=943860, encodeId=eb9c943860e4, content=进来看看都有啥, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200627/83a502bff6c14b759a7d0863b4068e7b/32ad40676056418ea58a94afac9c5b81.jpg, createdBy=6f475314305, createdName=水-晶, createdTime=Fri Feb 26 23:41:17 CST 2021, time=2021-02-26, status=1, ipAttribution=)]
    2021-02-26 水-晶

    进来看看都有啥

    0

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20价肺炎球菌结合疫苗(20vPnC)的III期临床结果

辉瑞公司今日公布了III期研究(NCT03760146)的主要结果,该研究评估了20价肺炎球菌结合疫苗(20vPnC)在18岁及以上成人中的安全性和免疫原性。

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20价肺炎球菌结合疫苗(20vPnC)的III期临床结果

辉瑞公司今日公布了III期研究(NCT03760146)的主要结果,该研究评估了20价肺炎球菌结合疫苗(20vPnC)在18岁及以上成人中的安全性和免疫原性。

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