Gallo Kathleen, Goede Andrean, Mura Cameron, Abel Renata, Moahamed Barbara, Preissner Saskia, Nahles Susanne, Heiland Max, Bourne Philip E, Preissner Robert, Mallach Michael
Institute of Physiology and Science IT, Charité - Universitätsmedizin Berlin Corporate Member of Freie Universität Berlin, Berlin Institute of Health, Humboldt-Universität zu Berlin, 10117 Berlin, Germany.
School of Data Science and Department of Biomedical Engineering, University of Virginia, Charlottesville, VA 22904, USA.
Vaccines (Basel). 2022 Mar 8;10(3):408. doi: 10.3390/vaccines10030408.
Background: The COVID-19 pandemic is being battled via the largest vaccination campaign in history, with more than eight billion doses administered thus far. Therefore, discussions about potentially adverse reactions, and broader safety concerns, are critical. The U.S. Vaccination Adverse Event Reporting System (VAERS) has recorded vaccination side effects for over 30 years. About 580,000 events have been filed for COVID-19 thus far, primarily for the Johnson & Johnson (New Jersey, USA), Pfizer/BioNTech (Mainz, Germany), and Moderna (Cambridge, USA) vaccines. Methods: Using available databases, we evaluated these three vaccines in terms of the occurrence of four generally-noticed adverse reactions—namely, cerebral venous sinus thrombosis, Guillain−Barré syndrome (a severe paralytic neuropathy), myocarditis, and pericarditis. Our statistical analysis also included a calculation of odds ratios (ORs) based on total vaccination numbers, accounting for incidence rates in the general population. Results: ORs for a number of adverse events and patient groups were (largely) increased, most notably for the occurrence of cerebral venous sinus thrombosis after vaccination with the Johnson & Johnson vaccine. The overall population OR of 10 increases to 12.5 when limited to women, and further yet (to 14.4) among women below age 50 yrs. In addition, elevated risks were found (i) for Guillain−Barré syndrome (OR of 11.6) and (ii) for myocarditis/pericarditis (ORs of 5.3/4.1, respectively) among young men (<25 yrs) vaccinated with the Pfizer/BioNTech vaccine. Conclusions: Any conclusions from such a retrospective, real-world data analysis must be drawn cautiously, and should be confirmed by prospective double-blinded clinical trials. In addition, we emphasize that the adverse events reported here are not specific side effects of COVID vaccines, and the significant, well-established benefits of COVID-19 vaccination outweigh the potential complications surveyed here.
新冠疫情正在通过历史上规模最大的疫苗接种运动进行抗击，迄今为止已接种超过80亿剂。因此，关于潜在不良反应以及更广泛的安全问题的讨论至关重要。美国疫苗不良事件报告系统（VAERS）记录疫苗接种副作用已有30多年。迄今为止，已提交约58万起与新冠病毒相关的事件报告，主要涉及强生公司（美国新泽西州）、辉瑞/生物科技公司（德国美因茨）和莫德纳公司（美国剑桥）的疫苗。
利用现有数据库，我们评估了这三种疫苗在四种常见不良反应（即脑静脉窦血栓形成、吉兰 - 巴雷综合征（一种严重的麻痹性神经病变）、心肌炎和心包炎）发生方面的情况。我们的统计分析还包括根据总接种人数计算优势比（OR），并考虑一般人群的发病率。
许多不良事件和患者群体的优势比（在很大程度上）有所增加，最显著的是接种强生疫苗后发生脑静脉窦血栓形成的情况。总体人群的优势比为10，在女性中增至12.5，在50岁以下女性中进一步增至14.4。此外，在接种辉瑞/生物科技疫苗的年轻男性（<25岁）中发现（i）吉兰 - 巴雷综合征风险升高（优势比为11.6）以及（ii）心肌炎/心包炎风险升高（优势比分别为5.3/4.1）。
任何基于此类回顾性真实世界数据分析得出的结论都必须谨慎得出，并且应由前瞻性双盲临床试验予以证实。此外，我们强调此处报告的不良事件并非新冠疫苗的特定副作用，而且新冠疫苗接种已确立的显著益处超过了此处调查的潜在并发症。
