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关于Moderna、辉瑞和牛津-阿斯利康新冠疫苗报告的血栓形成不良事件:欧洲药物警戒数据库中发生率和临床结果的比较

Thrombotic Adverse Events Reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 Vaccines: Comparison of Occurrence and Clinical Outcomes in the EudraVigilance Database.

作者信息

Tobaiqy Mansour, MacLure Katie, Elkout Hajer, Stewart Derek

机构信息

Department of Pharmacology, College of Medicine, University of Jeddah, Jeddah P.O. Box 45311, Saudi Arabia.

Independent Researcher, Aberdeen AB32 6RU, UK.

出版信息

Vaccines (Basel). 2021 Nov 15;9(11):1326. doi: 10.3390/vaccines9111326.

Abstract

Vaccination against COVID-19 is the cornerstone of controlling and mitigating the ongoing pandemic. Thrombotic adverse events linked to Moderna, Pfizer and the Oxford-AstraZeneca vaccine have been documented and described as extremely rare. While the Oxford-AstraZeneca vaccine has received much of the attention, the other vaccines should not go unchallenged. This study aimed to determine the frequency of reported thrombotic adverse events and clinical outcomes for these three COVID-19 vaccines, namely, Moderna, Pfizer and Oxford-AstraZeneca. A retrospective descriptive analysis was conducted of spontaneous reports for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 vaccines submitted to the EudraVigilance database in the period from 17 February to 14 June 2021. There were 729,496 adverse events for the three vaccines, of which 3420 were thrombotic, mainly Oxford-AstraZeneca (n = 1988; 58.1%) followed by Pfizer (n = 1096; 32.0%) and Moderna (n = 336; 9.8%). As serious adverse events, there were 705 reports of pulmonary embolism for the three vaccines, of which 130 reports (18.4%) were for Moderna, 226 reports (32.1%) for Pfizer and 349 (49.5%) for Oxford-AstraZeneca vaccines. The occurrence of pulmonary embolism is significantly associated with a fatal outcome ( ≤ 0.001). Sixty-three fatalities were recorded (n = 63/3420; 1.8%), of which Moderna (n = 6), Pfizer (n = 25) and Oxford-AstraZeneca (n = 32).

摘要

接种新冠病毒疫苗是控制和缓解当前大流行的基石。与莫德纳、辉瑞和牛津-阿斯利康疫苗相关的血栓形成不良事件已被记录在案,且被描述为极为罕见。虽然牛津-阿斯利康疫苗受到了诸多关注,但其他疫苗也不应被忽视。本研究旨在确定这三种新冠病毒疫苗(即莫德纳、辉瑞和牛津-阿斯利康疫苗)报告的血栓形成不良事件的频率及临床结局。对2021年2月17日至6月14日期间提交至欧洲药品管理局药物警戒数据库的莫德纳、辉瑞和牛津-阿斯利康新冠病毒疫苗的自发报告进行了回顾性描述性分析。这三种疫苗共有729496起不良事件,其中3420起为血栓形成事件,主要是牛津-阿斯利康疫苗(n = 1988;58.1%),其次是辉瑞疫苗(n = 1096;32.0%)和莫德纳疫苗(n = 336;9.8%)。作为严重不良事件,这三种疫苗共有705例肺栓塞报告,其中莫德纳疫苗130例(18.4%),辉瑞疫苗226例(32.1%),牛津-阿斯利康疫苗349例(49.5%)。肺栓塞的发生与致命结局显著相关(≤0.001)。记录到63例死亡(n = 63/3420;1.8%),其中莫德纳疫苗6例,辉瑞疫苗25例,牛津-阿斯利康疫苗32例。

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