NEJM:史上大规模真实世界研究,颠覆对新冠疫苗副作用的认知

2021-08-30 “生物世界”公众号 “生物世界”公众号

新冠病毒(SARS-CoV-2))引起的新冠肺炎(COVID-19)大流行已过去 1 年多,全球范围内正在进行数量空前的大规模疫苗接种工作。

新冠病毒(SARS-CoV-2))引起的新冠肺炎(COVID-19)大流行已过去 1 年多,全球范围内正在进行数量空前的大规模疫苗接种工作。3期临床试验表明,几种新冠疫苗,包括辉瑞/BioNTech的BNT162b2 mRNA疫苗被证明是有效的,但存在许多潜在的不良事件风险,包括阑尾炎、超敏反应、急性心肌梗塞和脑血管意外。然而,由于参与者人数少且样本人群比平均水平更健康,需要进行更大规模的安全性评估。

以前,人们通过被动监测系统进行疫苗安全性的信息收集,这依赖于接种疫苗的个人自愿主动报告,会造成记录不完整。而当前的主动监测系统可以将大型电子健康记录数据库中的目标不良事件发生率与背景历史发生率进行比较,有助于突出可疑趋势。但主动监测系统因缺乏严格构建的对照组从而制约了确定疫苗接种与不良事件因果关系的能力。

2021年8月25日,以色列Clalit研究所与哈佛大学的研究团队合作在《新英格兰医学期刊》(NEJM)上发表了题为:Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting 的研究论文。

该研究使用以色列最大的医疗保健组织的综合数据库来评估 BNT162b2 mRNA疫苗的安全性,发现该疫苗与大多数不良事件的风险升高无关。特别是,发生心肌炎的风险实际上在未接种疫苗的感染者中更高。

新冠病毒感染后,心肌炎这种潜在严重不良事件和许多其他严重不良事件的风险大大增加,而该疫苗实际上降低了这些风险。这项研究表明 BNT162b2 mRNA疫苗非常安全,这些数据有利于个人决策,打消公众对疫苗安全性的疑问。

图为了提供解释疫苗安全性结果的必要背景,本研究首次检查了接种疫苗的个体和感染冠状病毒的未接种疫苗的个体之间的各种不良事件。因此,进行了两个单独的分析:疫苗接种队列和新冠感染队列分析。

疫苗接种队列纳入了1736832人,中位年龄为43岁。随后,研究团队根据广泛的社会人口、地理和健康相关属性,将884828名16岁及以上接种疫苗的个体与884828名未接种疫苗的个体仔细匹配。接种者的中位年龄为38岁,48%是女性。研究团队比较了两组在接种任一疫苗后三周内发生的25次潜在不良事件的发生率。该分析是从2020年12月20日,即以色列全国疫苗接种运动的启动到2021年5月24日进行的。

与未接种疫苗组相比,接种组发生不良事件的风险显着高于未接种组的:心肌炎在接种组中每100000人发生2.7次,淋巴结病在接种组中每100000人发生78.4次,阑尾炎在接种组中每100000人发生5.0次,带状疱疹感染在接种组中每100000人发生15.8次。疫苗接种对诸如贫血、急性肾损伤、颅内出血和淋巴细胞减少等不良事件具有显着保护作用。

为提供上述疫苗安全性结果的背景,研究团队进行了一项单独的分析——新冠感染队列分析。共有233392人(中位年龄 36 岁)符合纳入感染队列的条件。该分析估计了173106名未接种疫苗的感染冠状病毒的个体中相同的25种潜在不良事件的发生率,而173106名仔细匹配的对照组则没有感染了冠状病毒。该分析从2020年3月1日(以色列COVID-19大流行的开始)到 2021年5月24日进行。

研究团队发现心肌炎与疫苗有关,但很少见,每100000名接种者中有2.7例。相比之下,在未接种疫苗的冠状病毒感染者中,每100000名感染者中竟有11例心肌炎病例。

与疫苗接种相关的其他不良事件是淋巴结病(淋巴结炎症或肿胀),这是一种轻微的副作用,是对疫苗接种的标准免疫反应的一部分,在未接种疫苗的冠状病毒感染者中,每 100000人中有78个病例,而在接种疫苗者中,每100000人中只有5个病例。

与疫苗相关的不良反应数量相对较少相比,未接种疫苗的冠状病毒感染者严重不良事件发生率很高,包括:心律失常(相比接种疫苗者增加3.8倍,每100000名感染者出现166例)、肾损伤(增加14.8倍;每100000名感染者出现125例)、心包炎(增加5.4倍;每100000名感染者出现11例)、肺栓塞(增加12.1倍;每100000名感染者出现62例)、深静脉血栓形成(增加3.8倍;每100000名感染者出现43例)、心肌梗塞(增加4.5倍;每100000感染者出现25例)和中风(增加2.1倍;每100000感染者出现14例)。

总之,这项新冠病毒疫苗相关副作用的最大规模的真实世界研究数据表明,BNT162b2 mRNA疫苗与大多数不良事件的风险升高无关,发生心肌炎等严重风险实际上在未接种疫苗的感染者中更高。这项研究表明BNT162b2 mRNA疫苗非常安全,这些数据有利于个人决策,打消公众对疫苗安全性的疑问。

原始出处:

Noam Barda, Noa Dagan, Yatir Ben-Shlomo, et al. Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. NEJM, August 25, 2021, DOI: 10.1056/NEJMoa2110475.

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    2021-11-12 ylz8403
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  4. [GetPortalCommentsPageByObjectIdResponse(id=1824371, encodeId=35c018243e13c, content=<a href='/topic/show?id=56a932e7800' target=_blank style='color:#2F92EE;'>#副作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32778, encryptionId=56a932e7800, topicName=副作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Fri Nov 12 06:46:51 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2043458, encodeId=f4532043458ae, content=<a href='/topic/show?id=13304400293' target=_blank style='color:#2F92EE;'>#大规模#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44002, encryptionId=13304400293, topicName=大规模)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3fce464, createdName=ylz8403, createdTime=Fri Nov 12 16:46:51 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1295330, encodeId=450f12953303d, content=<a href='/topic/show?id=0425e2636b8' target=_blank style='color:#2F92EE;'>#真实世界#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72636, encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Wed Sep 01 10:46:51 CST 2021, time=2021-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1013176, encodeId=f4ae10131e614, content=放心了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210703/9c448fe1b3b54fd7bc9477662f4861bb/4bdadad22bfd46f2921aabb4c40265d3.jpg, createdBy=a8d81938466, createdName=weigq, createdTime=Tue Aug 31 13:16:39 CST 2021, time=2021-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1013136, encodeId=e1811013136da, content=持续关注中, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJ0TlgZcthhEzvk4s2e7CXEaLf2QAQIJz1QRAH2dJbsHdibYAGYU0J4D2VnScVbDavKfCS1FyYyqJA/132, createdBy=f8cc2363285, createdName=王翔, createdTime=Tue Aug 31 10:26:30 CST 2021, time=2021-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029915, encodeId=f21010299155a, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Mon Aug 30 22:46:51 CST 2021, time=2021-08-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035740, encodeId=67301035e4017, 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=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Mon Aug 30 22:46:51 CST 2021, time=2021-08-30, status=1, ipAttribution=)]
    2021-08-31 weigq

    放心了。

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1824371, encodeId=35c018243e13c, content=<a href='/topic/show?id=56a932e7800' target=_blank style='color:#2F92EE;'>#副作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32778, encryptionId=56a932e7800, topicName=副作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Fri Nov 12 06:46:51 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2043458, encodeId=f4532043458ae, content=<a href='/topic/show?id=13304400293' target=_blank style='color:#2F92EE;'>#大规模#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44002, encryptionId=13304400293, topicName=大规模)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3fce464, createdName=ylz8403, createdTime=Fri Nov 12 16:46:51 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1295330, encodeId=450f12953303d, content=<a href='/topic/show?id=0425e2636b8' target=_blank style='color:#2F92EE;'>#真实世界#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72636, encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Wed Sep 01 10:46:51 CST 2021, time=2021-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1013176, encodeId=f4ae10131e614, content=放心了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210703/9c448fe1b3b54fd7bc9477662f4861bb/4bdadad22bfd46f2921aabb4c40265d3.jpg, createdBy=a8d81938466, createdName=weigq, createdTime=Tue Aug 31 13:16:39 CST 2021, time=2021-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1013136, encodeId=e1811013136da, content=持续关注中, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJ0TlgZcthhEzvk4s2e7CXEaLf2QAQIJz1QRAH2dJbsHdibYAGYU0J4D2VnScVbDavKfCS1FyYyqJA/132, createdBy=f8cc2363285, createdName=王翔, createdTime=Tue Aug 31 10:26:30 CST 2021, time=2021-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029915, encodeId=f21010299155a, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Mon Aug 30 22:46:51 CST 2021, time=2021-08-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035740, encodeId=67301035e4017, 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=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Mon Aug 30 22:46:51 CST 2021, time=2021-08-30, status=1, ipAttribution=)]
    2021-08-31 王翔

    持续关注中

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1824371, encodeId=35c018243e13c, content=<a href='/topic/show?id=56a932e7800' target=_blank style='color:#2F92EE;'>#副作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32778, encryptionId=56a932e7800, topicName=副作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Fri Nov 12 06:46:51 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2043458, encodeId=f4532043458ae, content=<a href='/topic/show?id=13304400293' target=_blank style='color:#2F92EE;'>#大规模#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44002, encryptionId=13304400293, topicName=大规模)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3fce464, createdName=ylz8403, createdTime=Fri Nov 12 16:46:51 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1295330, encodeId=450f12953303d, content=<a href='/topic/show?id=0425e2636b8' target=_blank style='color:#2F92EE;'>#真实世界#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72636, encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Wed Sep 01 10:46:51 CST 2021, time=2021-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1013176, encodeId=f4ae10131e614, content=放心了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210703/9c448fe1b3b54fd7bc9477662f4861bb/4bdadad22bfd46f2921aabb4c40265d3.jpg, createdBy=a8d81938466, createdName=weigq, createdTime=Tue Aug 31 13:16:39 CST 2021, time=2021-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1013136, encodeId=e1811013136da, content=持续关注中, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJ0TlgZcthhEzvk4s2e7CXEaLf2QAQIJz1QRAH2dJbsHdibYAGYU0J4D2VnScVbDavKfCS1FyYyqJA/132, createdBy=f8cc2363285, createdName=王翔, createdTime=Tue Aug 31 10:26:30 CST 2021, time=2021-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029915, encodeId=f21010299155a, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Mon Aug 30 22:46:51 CST 2021, time=2021-08-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035740, encodeId=67301035e4017, 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=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Mon Aug 30 22:46:51 CST 2021, time=2021-08-30, status=1, ipAttribution=)]
    2021-08-30 公卫新人

    新冠肺炎,疫情何时才能消失

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1824371, encodeId=35c018243e13c, content=<a href='/topic/show?id=56a932e7800' target=_blank style='color:#2F92EE;'>#副作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32778, encryptionId=56a932e7800, topicName=副作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Fri Nov 12 06:46:51 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2043458, encodeId=f4532043458ae, content=<a href='/topic/show?id=13304400293' target=_blank style='color:#2F92EE;'>#大规模#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=44002, encryptionId=13304400293, topicName=大规模)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3fce464, createdName=ylz8403, createdTime=Fri Nov 12 16:46:51 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1295330, encodeId=450f12953303d, content=<a href='/topic/show?id=0425e2636b8' target=_blank style='color:#2F92EE;'>#真实世界#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72636, encryptionId=0425e2636b8, topicName=真实世界)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5b34252, createdName=chenshujs, createdTime=Wed Sep 01 10:46:51 CST 2021, time=2021-09-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1013176, encodeId=f4ae10131e614, content=放心了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210703/9c448fe1b3b54fd7bc9477662f4861bb/4bdadad22bfd46f2921aabb4c40265d3.jpg, createdBy=a8d81938466, createdName=weigq, createdTime=Tue Aug 31 13:16:39 CST 2021, time=2021-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1013136, encodeId=e1811013136da, content=持续关注中, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTJ0TlgZcthhEzvk4s2e7CXEaLf2QAQIJz1QRAH2dJbsHdibYAGYU0J4D2VnScVbDavKfCS1FyYyqJA/132, createdBy=f8cc2363285, createdName=王翔, createdTime=Tue Aug 31 10:26:30 CST 2021, time=2021-08-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1029915, encodeId=f21010299155a, content=新冠肺炎,疫情何时才能消失, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=公卫新人, createdTime=Mon Aug 30 22:46:51 CST 2021, time=2021-08-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035740, encodeId=67301035e4017, 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=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Mon Aug 30 22:46:51 CST 2021, time=2021-08-30, status=1, ipAttribution=)]
    2021-08-30 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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截至北京时间2021年8月25日7时01分,Worldometers世界实时统计数据显示,全球累计确诊新冠肺炎(COVID-19)病例超过21318万例,新增609,254例,达到213,903,73