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欧洲药品管理局(EMA)批准的新冠疫苗接种后的死亡情况:是否已证实存在因果关系?

Death after the Administration of COVID-19 Vaccines Approved by EMA: Has a Causal Relationship Been Demonstrated?

作者信息

Maiese Aniello, Baronti Arianna, Manetti Alice Chiara, Di Paolo Marco, Turillazzi Emanuela, Frati Paola, Fineschi Vittorio

机构信息

Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, Institute of Legal Medicine, University of Pisa, Via Roma 55, 56126 Pisa, Italy.

Department of Anatomical, Histological, Forensic and Orthopedic Sciences, Institute of Legal Medicine, Sapienza University of Rome, Viale Regina Elena 336, 00161 Rome, Italy.

出版信息

Vaccines (Basel). 2022 Feb 16;10(2):308. doi: 10.3390/vaccines10020308.

DOI:10.3390/vaccines10020308
PMID:35214765
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8875435/
Abstract

More than eight billion doses of COVID-19 vaccines have been administered globally so far and 44.29% of people are fully vaccinated. Pre-authorization clinical trials were carried out and the safety of vaccines is still continuously monitored through post-commercialization surveillance. However, some people are afraid of vaccine side effects, claiming they could lead to death, and hesitate to get vaccinated. Herein, a literature review of COVID-19-vaccine-related deaths has been carried out according to the PRISMA standards to understand if there is a causal relationship between vaccination and death and to highlight the real extent of such events. There have been 55 cases of death after COVID-19 vaccination reported and a causal relationship has been excluded in 17 cases. In the remaining cases, the causal link between the vaccine and the death was not specified (8) or considered possible (15), probable (1), or very probable/demonstrated (14). The causes of deaths among these cases were: vaccine-induced immune thrombotic thrombocytopenia (VITT) (32), myocarditis (3), ADEM (1), myocardial infarction (1), and rhabdomyolysis (1). In such cases, the demonstration of a causal relationship is not obvious, and more studies, especially with post-mortem investigations, are needed to deepen understanding of the possible pathophysiological mechanisms of fatal vaccine side effects. In any event, given the scarcity of fatal cases, the benefits of vaccination outweigh the risks and the scientific community needs to be cohesive in asserting that vaccination is fundamental to containing the spread of SARS-CoV-2.

摘要

截至目前,全球已接种超过80亿剂新冠疫苗,44.29%的人口已完全接种。疫苗在获得批准前进行了临床试验,并通过上市后监测持续监测其安全性。然而,一些人害怕疫苗副作用,声称可能会导致死亡,因此对接种疫苗犹豫不决。在此,根据PRISMA标准对与新冠疫苗相关的死亡病例进行了文献综述,以了解接种疫苗与死亡之间是否存在因果关系,并突出此类事件的实际程度。已报告55例新冠疫苗接种后死亡病例,其中17例已排除因果关系。在其余病例中,疫苗与死亡之间的因果联系未明确说明(8例)或被认为有可能(15例)、很可能(1例)或极有可能/已证实(14例)。这些病例的死亡原因包括:疫苗诱导的免疫性血栓性血小板减少症(VITT)(32例)、心肌炎(3例)、急性播散性脑脊髓炎(ADEM)(1例)、心肌梗死(1例)和横纹肌溶解(1例)。在这些病例中,因果关系的证明并不明显,需要更多的研究,尤其是尸检研究,以加深对致命疫苗副作用可能的病理生理机制的理解。无论如何,鉴于致命病例稀少,接种疫苗的益处大于风险,科学界需要团结一致,坚称接种疫苗是遏制SARS-CoV-2传播的根本。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5caf/8875435/f74503f57d17/vaccines-10-00308-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5caf/8875435/d7ad1da9e30f/vaccines-10-00308-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5caf/8875435/cd05279386fe/vaccines-10-00308-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5caf/8875435/1cb1860fca89/vaccines-10-00308-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5caf/8875435/f74503f57d17/vaccines-10-00308-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5caf/8875435/d7ad1da9e30f/vaccines-10-00308-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5caf/8875435/cd05279386fe/vaccines-10-00308-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5caf/8875435/1cb1860fca89/vaccines-10-00308-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5caf/8875435/f74503f57d17/vaccines-10-00308-g004.jpg

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