FDA批准四价脑膜炎球菌疫苗MenQuadfi的生物制剂许可

2020-04-26 Allan MedSci原创

近日,美国食品药品监督管理局(FDA)已批准四价脑膜炎球菌疫苗MenQuadfi的生物制剂许可,用于预防2岁及以上人群的侵袭性脑膜炎。

近日,美国食品药品监督管理局(FDA)已批准四价脑膜炎球菌疫苗MenQuadfi的生物制剂许可,用于预防2岁及以上人群的侵袭性脑膜炎。

赛诺菲公司认为,脑膜炎球菌性脑膜炎可以迅速发作并具有毁灭性作用,患者可在不到24小时的时间内死亡,因此脑膜炎仍然是全球性重大卫生挑战。通过疫苗接种预防这种疾病是最好的选择。赛诺菲巴斯德执行副总裁David Loew评论说:“FDA的批准是MenQuadfi的一个重要里程碑,MenQuadfi旨在帮助人们免受脑膜炎球菌疾病的侵害”。

四价脑膜炎球菌疫苗MenQuadfi在多个年龄段的所有四个血清群中均能引起高免疫应答,并且耐受性良好。MenQuadfi目前是唯一经美国FDA批准用于2至56岁及以上人群的四价脑膜炎球菌疫苗。它将以即用型液体制剂形式提供。

 

原始出处:

https://www.firstwordpharma.com/node/1718285

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (5)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=2113722, encodeId=dec82113e22f5, content=<a href='/topic/show?id=4038103e70e2' target=_blank style='color:#2F92EE;'>#流脑疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103770, encryptionId=4038103e70e2, topicName=流脑疫苗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Thu Feb 09 05:53:01 CST 2023, time=2023-02-09, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=1839800, encodeId=d62d1839800f4, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Wed Sep 02 19:37:29 CST 2020, time=2020-09-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1826011, encodeId=18ed18260112f, content=<a href='/topic/show?id=6191692233a' target=_blank style='color:#2F92EE;'>#生物制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69223, encryptionId=6191692233a, topicName=生物制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=一叶知秋, createdTime=Sun Sep 27 06:37:29 CST 2020, time=2020-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1392857, encodeId=f4e2139285e15, content=<a href='/topic/show?id=db3a1155119' target=_blank style='color:#2F92EE;'>#MenQuadfi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11551, encryptionId=db3a1155119, topicName=MenQuadfi)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Tue Apr 28 01:37:29 CST 2020, time=2020-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1555585, encodeId=256b1555585c2, content=<a href='/topic/show?id=6e71850588a' target=_blank style='color:#2F92EE;'>#脑膜炎球菌疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85058, encryptionId=6e71850588a, topicName=脑膜炎球菌疫苗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=683c14628118, createdName=yyj067, createdTime=Tue Apr 28 01:37:29 CST 2020, time=2020-04-28, status=1, ipAttribution=)]
    2023-02-09 showtest 来自上海
  2. [GetPortalCommentsPageByObjectIdResponse(id=2113722, encodeId=dec82113e22f5, content=<a href='/topic/show?id=4038103e70e2' target=_blank style='color:#2F92EE;'>#流脑疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103770, encryptionId=4038103e70e2, topicName=流脑疫苗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Thu Feb 09 05:53:01 CST 2023, time=2023-02-09, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=1839800, encodeId=d62d1839800f4, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Wed Sep 02 19:37:29 CST 2020, time=2020-09-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1826011, encodeId=18ed18260112f, content=<a href='/topic/show?id=6191692233a' target=_blank style='color:#2F92EE;'>#生物制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69223, encryptionId=6191692233a, topicName=生物制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=一叶知秋, createdTime=Sun Sep 27 06:37:29 CST 2020, time=2020-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1392857, encodeId=f4e2139285e15, content=<a href='/topic/show?id=db3a1155119' target=_blank style='color:#2F92EE;'>#MenQuadfi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11551, encryptionId=db3a1155119, topicName=MenQuadfi)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Tue Apr 28 01:37:29 CST 2020, time=2020-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1555585, encodeId=256b1555585c2, content=<a href='/topic/show?id=6e71850588a' target=_blank style='color:#2F92EE;'>#脑膜炎球菌疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85058, encryptionId=6e71850588a, topicName=脑膜炎球菌疫苗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=683c14628118, createdName=yyj067, createdTime=Tue Apr 28 01:37:29 CST 2020, time=2020-04-28, status=1, ipAttribution=)]
    2020-09-02 bugit
  3. [GetPortalCommentsPageByObjectIdResponse(id=2113722, encodeId=dec82113e22f5, content=<a href='/topic/show?id=4038103e70e2' target=_blank style='color:#2F92EE;'>#流脑疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103770, encryptionId=4038103e70e2, topicName=流脑疫苗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Thu Feb 09 05:53:01 CST 2023, time=2023-02-09, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=1839800, encodeId=d62d1839800f4, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Wed Sep 02 19:37:29 CST 2020, time=2020-09-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1826011, encodeId=18ed18260112f, content=<a href='/topic/show?id=6191692233a' target=_blank style='color:#2F92EE;'>#生物制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69223, encryptionId=6191692233a, topicName=生物制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=一叶知秋, createdTime=Sun Sep 27 06:37:29 CST 2020, time=2020-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1392857, encodeId=f4e2139285e15, content=<a href='/topic/show?id=db3a1155119' target=_blank style='color:#2F92EE;'>#MenQuadfi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11551, encryptionId=db3a1155119, topicName=MenQuadfi)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Tue Apr 28 01:37:29 CST 2020, time=2020-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1555585, encodeId=256b1555585c2, content=<a href='/topic/show?id=6e71850588a' target=_blank style='color:#2F92EE;'>#脑膜炎球菌疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85058, encryptionId=6e71850588a, topicName=脑膜炎球菌疫苗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=683c14628118, createdName=yyj067, createdTime=Tue Apr 28 01:37:29 CST 2020, time=2020-04-28, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=2113722, encodeId=dec82113e22f5, content=<a href='/topic/show?id=4038103e70e2' target=_blank style='color:#2F92EE;'>#流脑疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103770, encryptionId=4038103e70e2, topicName=流脑疫苗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Thu Feb 09 05:53:01 CST 2023, time=2023-02-09, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=1839800, encodeId=d62d1839800f4, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Wed Sep 02 19:37:29 CST 2020, time=2020-09-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1826011, encodeId=18ed18260112f, content=<a href='/topic/show?id=6191692233a' target=_blank style='color:#2F92EE;'>#生物制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69223, encryptionId=6191692233a, topicName=生物制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=一叶知秋, createdTime=Sun Sep 27 06:37:29 CST 2020, time=2020-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1392857, encodeId=f4e2139285e15, content=<a href='/topic/show?id=db3a1155119' target=_blank style='color:#2F92EE;'>#MenQuadfi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11551, encryptionId=db3a1155119, topicName=MenQuadfi)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Tue Apr 28 01:37:29 CST 2020, time=2020-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1555585, encodeId=256b1555585c2, content=<a href='/topic/show?id=6e71850588a' target=_blank style='color:#2F92EE;'>#脑膜炎球菌疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85058, encryptionId=6e71850588a, topicName=脑膜炎球菌疫苗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=683c14628118, createdName=yyj067, createdTime=Tue Apr 28 01:37:29 CST 2020, time=2020-04-28, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=2113722, encodeId=dec82113e22f5, content=<a href='/topic/show?id=4038103e70e2' target=_blank style='color:#2F92EE;'>#流脑疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103770, encryptionId=4038103e70e2, topicName=流脑疫苗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Thu Feb 09 05:53:01 CST 2023, time=2023-02-09, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=1839800, encodeId=d62d1839800f4, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Wed Sep 02 19:37:29 CST 2020, time=2020-09-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1826011, encodeId=18ed18260112f, content=<a href='/topic/show?id=6191692233a' target=_blank style='color:#2F92EE;'>#生物制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69223, encryptionId=6191692233a, topicName=生物制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=一叶知秋, createdTime=Sun Sep 27 06:37:29 CST 2020, time=2020-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1392857, encodeId=f4e2139285e15, content=<a href='/topic/show?id=db3a1155119' target=_blank style='color:#2F92EE;'>#MenQuadfi#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11551, encryptionId=db3a1155119, topicName=MenQuadfi)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Tue Apr 28 01:37:29 CST 2020, time=2020-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1555585, encodeId=256b1555585c2, content=<a href='/topic/show?id=6e71850588a' target=_blank style='color:#2F92EE;'>#脑膜炎球菌疫苗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85058, encryptionId=6e71850588a, topicName=脑膜炎球菌疫苗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=683c14628118, createdName=yyj067, createdTime=Tue Apr 28 01:37:29 CST 2020, time=2020-04-28, status=1, ipAttribution=)]

相关资讯

中国脑膜炎球菌疫苗预防接种专家共识

中国上市的脑膜炎球菌疫苗包括脑膜炎球菌多糖疫苗、脑膜炎球菌多糖结合疫苗和联合疫苗,不同生产企业的脑膜炎球菌多糖结合疫苗的免疫程序有所不同,给实际接种工作带来困扰。本共识结合国内外研究最新进展,基于流行性脑脊髓膜炎流行特征、脑膜炎奈瑟菌菌群分布以及中国脑膜炎球菌疫苗免疫原性和安全性等研究证据,提出脑膜炎球菌疫苗预防接种建议,供预防接种人员和疾病预防控制机构人员参考使用。

拓展阅读

脑膜炎球菌疫苗MenQuadfi获得欧盟批准

脑膜炎球菌病可以在短短的一天之内夺走生命,并使幸存者患有严重的永久性残疾。

赛诺菲的脑膜炎球菌疫苗获得欧盟批准

“脑膜炎球菌性脑膜炎可在短短一天之内致人丧命,或使幸存者患有严重的永久性残疾。”

中国脑膜炎球菌疫苗预防接种专家共识

中国上市的脑膜炎球菌疫苗包括脑膜炎球菌多糖疫苗、脑膜炎球菌多糖结合疫苗和联合疫苗,不同生产企业的脑膜炎球菌多糖结合疫苗的免疫程序有所不同,给实际接种工作带来困扰。本共识结合国内外研究最新进展,基于流行性脑脊髓膜炎流行特征、脑膜炎奈瑟菌菌群分布以及中国脑膜炎球菌疫苗免疫原性和安全性等研究证据,提出脑膜炎球菌疫苗预防接种建议,供预防接种人员和疾病预防控制机构人员参考使用。