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JAMA:孕妇接种新冠疫苗是获益大于风险,还是风险大于获益?

2021-07-13 MedSci原创 MedSci原创

孕妇接种BNT162b2疫苗与未接种相比SARS-CoV-2感染风险显著降低,尽管绝对风险差异很小。

怀孕期间,激素水平和免疫系统功能的改变可能会增加女性感染病毒的可能性。虽然SARS-CoV-2感染在孕妇中多为无症状或症状较轻,但也有可能导致严重的并发症如进入重症监护病房或需要机械通气等,妊娠晚期妇女SARS-CoV-2感染也与早产和产时胎儿窘迫有关。

辉瑞生物科技公司(Pfizer-BioNTech) BNT162b2信使RNA (mRNA)疫苗的3期试验显示,从第二剂疫苗接种开始的7天内,预防SARS-CoV-2感染的有效性为95%,然而,孕妇被排除在试验之外。疫苗接种与SARS-CoV-2感染的相关性也已由几项观察性研究进行了研究,但与临床试验一样,没有一项研究包括孕妇。

尽管生产商最近宣布在孕妇中进行2/3期试验,但目前还没有关于疫苗在这一人群中有效性的经验证据。因此,目前只能通过观察流行病学数据来评估妊娠期疫苗的安全性和有效性。

2020年12月19日,以色列启动了BNT162b2疫苗接种活动。虽然孕妇没有被排除在接种疫苗之外,但也被建议应该与主治医生讨论接种疫苗的可能性。一个月前,以色列卫生部发布了最新建议,鼓励孕妇接种疫苗。基于此,有研究者评估了孕妇接受BNT162b2 mRNA疫苗与SARS-CoV-2感染发生率之间的关系。该研究成果近日发表在JAMA最新期刊上。

这是一项回顾性队列研究,在以色列一家大型国家授权的医疗机构的妊娠登记处进行。从2020年12月19日至2021年2月28日,首次接种疫苗的孕妇与未接种疫苗的妇女按年龄、胎龄、居住区、人群亚组、胎次和流感免疫状况进行1:1匹配。随访于2021年4月11日结束。主要结果是在第一次接种疫苗后28天或更长的时间内,聚合酶链反应验证的SARS-CoV-2感染。

队列包括7530名接种疫苗和7530名配对的未接种疫苗的妇女,平均年龄为31.1岁(标准差4.9岁)。主要结果的中位随访时间为37天。接种组有118例SARS-CoV-2感染,未接种组有202例。在受感染妇女中,接种疫苗组105人中有88人(83.8%)有症状,而未接种疫苗组179人中有149人(83.2%)有症状。

已接种疫苗与匹配未接种疫苗孕妇的SARS-CoV-2累积发病率

随访28~70天,接种组有10例感染,未接种组有46例感染。接种疫苗组和未接种疫苗组的感染危险性分别为0.33%和1.64%,绝对差异为1.31%,校正危险比为0.22。68例患者报告疫苗相关不良事件;都不严重。最常见的症状是头痛(n=10,0.1%)、全身无力(n=8,0.1%)、非特异性疼痛(n=6,<0.1%)和胃痛(n=5,<0.1%)。

通过数据可以看出,在这个以大人群为基础的孕妇队列中,孕妇接种BNT162b2疫苗与未接种相比SARS-CoV-2感染风险显著降低,尽管绝对风险差异很小。截至2021年4月11日,卫生基金中约69%的孕妇接受了第一剂疫苗。

此外,在同一时期,以色列媒体增加了对SARS-CoV-2并发症的关注,特别是孕妇(包括因严重SARS-CoV-2并发症住院的孕妇,以及因感染SARS-CoV-2胎儿死产的报道),这不仅导致这一人群中疫苗接种的迅速增加,而且也可能增加了未接种疫苗的孕妇对社会距离建议的遵守。但另一方面,研究结果的解释受到观察性设计的限制。

参考文献:Goldshtein I, Nevo D, Steinberg DM, et al. Association Between BNT162b2 Vaccination and Incidence of SARS-CoV-2 Infection in Pregnant Women. JAMA. Published online July 12, 2021. doi:10.1001/jama.2021.11035

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    2021-11-08 小雨闲

    学习

    0

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    2021-07-15 ms3000001065708854

    但是目前接种疫苗后的胎儿正常与否还不能确定,很多接种新冠疫苗后怀孕的妇女都会选择打胎

    0

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    2021-07-13 公卫新人

    新冠肺炎,疫情何时才能消失

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1068255, encodeId=e595106825550, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=10b65509612, createdName=小雨闲, createdTime=Mon Nov 08 20:44:47 CST 2021, time=2021-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1811453, encodeId=793418114536c, content=<a href='/topic/show?id=ca0c88041e0' target=_blank style='color:#2F92EE;'>#获益大#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88041, encryptionId=ca0c88041e0, topicName=获益大)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7eeb2500172, createdName=haouestc, createdTime=Sun Jun 12 20:15:14 CST 2022, time=2022-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=999764, encodeId=644a999e6493, content=但是目前接种疫苗后的胎儿正常与否还不能确定,很多接种新冠疫苗后怀孕的妇女都会选择打胎, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c0325395133, createdName=ms3000001065708854, createdTime=Thu Jul 15 15:25:02 CST 2021, time=2021-07-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029733, encodeId=99051029e33d9, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Tue Jul 13 19:15:14 CST 2021, time=2021-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1036734, encodeId=8ce41036e342f, 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=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Tue Jul 13 19:15:14 CST 2021, time=2021-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=999157, encodeId=acae99915ed5, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210713/31e713533cca4678a00c807cbb67df6e/cb0da83b26e44ac981b26e29e8aadbd1.jpg, createdBy=70f25454477, createdName=ms7000000905968104, createdTime=Tue Jul 13 18:20:55 CST 2021, time=2021-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=999151, encodeId=051399915137, content=备孕可以打疫苗吗, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210713/e2d3c304add143c88a44a31ddeda44f9/41a81e06e4eb41749dc0937a6b74faf6.jpg, createdBy=01b55547952, createdName=黄尤艺, createdTime=Tue Jul 13 17:42:22 CST 2021, time=2021-07-13, status=1, ipAttribution=)]
    2021-07-13 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

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    2021-07-13 ms7000000905968104

    学习了

    0

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    2021-07-13 黄尤艺

    备孕可以打疫苗吗

    0

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