NEJM:mRNA新冠疫苗在孕产妇群体中的反应

2021-06-17 MedSci原创 MedSci原创

导语:孕妇到底该不该接种新冠疫苗?

    导语:孕妇到底该不该接种新冠疫苗?

 

     在美国,第一种获得批准许可的新冠疫苗是mRNA疫苗:BNT162b2 (Pfizer–BioNTech) 和 mRNA-1273 (Moderna)。2020年12月,这些疫苗获得了美国食品和药物管理局 (FDA) 的紧急使用授权 (EUA)。疫苗分两剂,辉瑞-BioNTech的两针疫苗间隔3周,Moderna的两针疫苗则间隔 1 个月,并被美国食品药品监督管理局 (FDA) 和免疫实践咨询委员会 (ACIP)推荐使用。

    一直以来,孕妇被排除在临床试验之外,并且关于妊娠期间安全性的数据也十分有限。 然而,与未怀孕的育龄人群相比,患有Covid-19的孕妇患重症(例如,导致入住重症监护室、体外膜肺氧合或机械通气)和死亡的风险增加。此外,与没有新冠的孕妇相比,患有新冠肺炎的孕妇出现不良妊娠结局(例如早产)的风险可能更高。美国疾病控制与预防中心 (CDC)和ACIP、美国妇产科学院及美国儿科学会已发布指导意见,指出不应禁止孕妇接种新冠疫苗。


    对孕妇进行授权后监测,对于确认这些使用mRNA、脂质纳米颗粒和最先进制造工艺制造的新型新冠疫苗的安全性是十分必要的。此外,建立他们的安全概况对于告知有关针对孕妇接种新冠疫苗的建议至关重要。

 
    研究人员报告了来自三个美国疫苗安全监测系统的孕妇mRNA新冠疫苗安全性的初步结果。这三个系统分别为“v-safe疫苗接种后健康检查”监测系统、v-safe 怀孕登记、疫苗不良事件报告系统 (VAERS)。


    此次报告中,共有35,691名年龄在16至54岁之间的v-safe参与者被确定为怀孕。与非孕妇相比,孕妇注射部位疼痛的报告频率更高,而头痛、肌痛、寒战和发烧的报告频率较低。在v-safe妊娠登记处登记的 3958 名参与者中,827人完成了妊娠,其中 115 人 (13.9%) 流产,712 人 (86.1%) 活产(主要是第三次接种疫苗的参与者)。 不良新生儿结局包括早产(9.4%)和小于胎龄儿(3.2%);没有新生儿死亡报告。 尽管没有直接可比性,但已完成妊娠的 Covid-19 疫苗接种者的不良妊娠和新生儿结局的计算比例与在 Covid-19 大流行之前进行的涉及孕妇的研究中报告的发生率相似。 在向 VAERS 报告的221起与妊娠相关的不良事件中,最常报告的事件是自然流产(46 例)。


    报告结果表明,初步发现在接受mRNA新冠疫苗的孕妇中没有显示出明显的安全信号。 然而,有必要进行更多的纵向随访,包括对在妊娠早期接种疫苗的大量妇女进行随访,以告知孕产妇妊娠和婴儿的结局。

 

原文链接:https://www.nejm.org/doi/full/10.1056/NEJMoa2104983?query=featured_home

Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
Tom T. Shimabukuro, M.D., Shin Y. Kim, M.P.H.

June 17, 2021 N Engl J Med 2021; 384:2273-2282 DOI: 10.1056/NEJMoa2104983

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    2022-01-22 xjy13
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    2021-06-25 GY058774

    有意义

    0

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    2021-06-17 公卫新人

    新冠肺炎,疫情何时才能消失

    0

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    2021-06-17 旺医

    顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1717074, encodeId=72b41e1707453, content=<a href='/topic/show?id=f8a98002eb1' target=_blank style='color:#2F92EE;'>#群体#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80027, encryptionId=f8a98002eb1, topicName=群体)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6c0832353243, createdName=xjy13, createdTime=Sat Jan 22 11:53:59 CST 2022, time=2022-01-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=976778, encodeId=aa269e6778c3, content=有意义, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210326/ff8ca31266094a0b96cc76af821329a9/d16b54784def45618f5a6696eae074c6.jpg, createdBy=e00e5468294, createdName=GY058774, createdTime=Fri Jun 25 13:06:14 CST 2021, time=2021-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029610, encodeId=7fff1029610df, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Thu Jun 17 12:53:59 CST 2021, time=2021-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035671, encodeId=8f6b10356e164, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Jun 17 12:53:59 CST 2021, time=2021-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=974347, encodeId=4e099e434704, content=谢谢 , beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201118/644810206ca744f48355b4fc9381cc58/9cfe32903b6a495d8bdfc124267ba3d3.jpg, createdBy=ef782028905, createdName=种鱼的猫猫, createdTime=Thu Jun 17 11:28:36 CST 2021, time=2021-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=974329, encodeId=890b9e432924, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210303/66c17b62a9f144ea8281a5b0894d47e4/c6a5dc1e748547fbb2995fbdb3ecbb88.jpg, createdBy=5dee5415333, createdName=卜小布, createdTime=Thu Jun 17 10:38:22 CST 2021, time=2021-06-17, status=1, ipAttribution=)]
    2021-06-17 种鱼的猫猫

    谢谢

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1717074, encodeId=72b41e1707453, content=<a href='/topic/show?id=f8a98002eb1' target=_blank style='color:#2F92EE;'>#群体#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80027, encryptionId=f8a98002eb1, topicName=群体)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6c0832353243, createdName=xjy13, createdTime=Sat Jan 22 11:53:59 CST 2022, time=2022-01-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=976778, encodeId=aa269e6778c3, content=有意义, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210326/ff8ca31266094a0b96cc76af821329a9/d16b54784def45618f5a6696eae074c6.jpg, createdBy=e00e5468294, createdName=GY058774, createdTime=Fri Jun 25 13:06:14 CST 2021, time=2021-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029610, encodeId=7fff1029610df, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Thu Jun 17 12:53:59 CST 2021, time=2021-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035671, encodeId=8f6b10356e164, content=顶刊就是顶刊,谢谢梅斯带来这么高水平的研究报道,我们科里同事经常看梅斯,分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Jun 17 12:53:59 CST 2021, time=2021-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=974347, encodeId=4e099e434704, content=谢谢 , beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201118/644810206ca744f48355b4fc9381cc58/9cfe32903b6a495d8bdfc124267ba3d3.jpg, createdBy=ef782028905, createdName=种鱼的猫猫, createdTime=Thu Jun 17 11:28:36 CST 2021, time=2021-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=974329, encodeId=890b9e432924, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210303/66c17b62a9f144ea8281a5b0894d47e4/c6a5dc1e748547fbb2995fbdb3ecbb88.jpg, createdBy=5dee5415333, createdName=卜小布, createdTime=Thu Jun 17 10:38:22 CST 2021, time=2021-06-17, status=1, ipAttribution=)]
    2021-06-17 卜小布

    学习了

    0