Suspected Cardiovascular Side Effects of two Covid-19 Vaccines

K. Lehmann
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引用次数: 7

Abstract

Fatalities or cardiovascular side effects of vaccines were rather uncommon in the past. So far, numerous reports of side effects and deaths associated with Covid-19 vaccination have been accepted behind the background of the pandemic situation and the priority vaccinated elderly population at the beginning of the vaqccination campaign. Cardiac and heart circulatory disturbances resp. cardiovascular side effects associated with the application of Covid-19 vaccines have not been recognized up to now with the exception of thrombotic/embolic side effects and cases of myo-/pericarditis. But the mechanism of action suggests that downregulation of ACE2 by non-neutralised spike proteins may have cardiovascular effects.The objective of this analysis was to determine the total number of reported adverse events and fatalities and to record suspected important cardiovascular adverse events up to the cut-off date in European countries. Therefore, a current review/analysis of spontaneously reported fatalities as well as of adverse events after application of Covid-19 vaccines has been performed. Data were retrieved from the EudraVigilance web reports of the European Medicines Agency (EMA), partly also from the safety reports of the German PEI. Covid-19 vaccine-associated suspected side effects and related deaths are alarming. Surprisingly, numerous cardiovascular reactions were reported, many of which were life-threatening. Cardiac and heart circulatory caused fatalities alone accounted for about 33% of all ComirnatyR vaccine-related deaths. The second most important side effects were vascular thrombotic/embolic side effects, often also associated with serious consequences. Based on their quality and quantity, these side effects seem to be characteristic for spike-producing vaccines and do not appear to be substance-specific. Further investigations are needed to clarify the approximately 3.5 times more frequent cases of sinus vein thrombosis and the some different frequent cases of thrombotic/embolic events after VaxzevriaR. The hypothesis could be confirmed. Because of their importance and their sometimes life-threatening consequences, cardiovascular side effects need to be better communicated.Limitations of the investigation result from the individual reporting and recording procedure, the lack of detailed individual information and the lack of an appropriate comparison population.
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两种新型冠状病毒疫苗的疑似心血管副作用
在过去,疫苗造成的死亡或心血管副作用相当罕见。到目前为止,在大流行形势和疫苗接种运动开始时优先接种老年人群的背景下,已接受了许多与Covid-19疫苗接种相关的副作用和死亡报告。心脏和心脏循环紊乱。除了血栓性/栓塞性副作用和心肌炎/心包炎病例外,迄今尚未认识到与Covid-19疫苗应用相关的心血管副作用。但作用机制表明,非中和刺突蛋白下调ACE2可能对心血管有影响。本分析的目的是确定欧洲国家报告的不良事件和死亡总数,并记录截止日期前可疑的重要心血管不良事件。因此,目前对应用Covid-19疫苗后自发报告的死亡病例和不良事件进行了回顾/分析。数据来自欧洲药品管理局(EMA)的EudraVigilance网站报告,部分也来自德国PEI的安全报告。Covid-19疫苗相关的疑似副作用和相关死亡令人震惊。令人惊讶的是,报告了许多心血管反应,其中许多是危及生命的。仅由心脏和心脏循环引起的死亡就占所有comirnatr疫苗相关死亡的33%左右。第二个最重要的副作用是血管血栓/栓塞副作用,通常也与严重后果相关。根据它们的质量和数量,这些副作用似乎是产生尖刺的疫苗所特有的,而不是物质特异性的。需要进一步的研究来澄清,在VaxzevriaR后,窦静脉血栓形成的发生率增加了约3.5倍,以及一些不同的血栓/栓塞事件的发生率。这个假设可以被证实。由于它们的重要性和有时危及生命的后果,心血管副作用需要更好地沟通。调查的局限性是由于个人报告和记录程序,缺乏详细的个人信息和缺乏适当的比较人群。
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