Szebeni Janos
Nanomedicine Research and Education Center, Department of Translational Medicine, Semmelweis University, 1089 Budapest, Hungary.
SeroScience LCC, 1125 Budapest, Hungary.
Pharmaceutics. 2025 Mar 31;17(4):450. doi: 10.3390/pharmaceutics17040450.
The mRNA- and DNA-based "genetic" COVID-19 vaccines can induce a broad range of adverse events (AEs), with statistics showing significant variation depending on the timing and data analysis methods used. Focusing only on lipid nanoparticle-enclosed mRNA (mRNA-LNP) vaccines, this review traces the evolution of statistical conclusions on the prevalence of AEs and incidents associated with these vaccines, from initial underestimation of atypical, severe toxicities to recent claims suggesting the possible contribution of COVID-19 vaccinations to the excess deaths observed in many countries over the past few years. Among hundreds of different AEs listed in Pfizer's pharmacovigilance survey, the present analysis categorizes the main symptoms according to organ systems, with nearly all of them being affected. Using data from the US Vaccine Adverse Event Reporting System and a global vaccination dataset, a comparison of the prevalence and incidence rates of AEs induced by genetic versus flu vaccines revealed an average 26-fold increase in AEs with the use of genetic vaccines. The difference is especially pronounced in the case of severe 'Brighton-listed' AEs, which are also observed in COVID-19 and post-COVID conditions. Among these, the increases in incidence rates relative to flu vaccines, given as x-fold rises, were 1152x, 455x, 226x, 218x, 162x, 152x, and 131x for myocarditis, thrombosis, death, myocardial infarction, tachycardia, dyspnea, and hypertension, respectively. The review delineates the concept that genetic vaccines can be regarded as prophylactic immuno-gene therapies and that the observed chronic disabling AEs might be categorized as iatrogenic orphan diseases. It also examines the unique vaccine characteristics that could be causally related to abnormal immune responses which potentially lead to adverse events and complications. These new insights may contribute to improving the safety of this platform technology and assessing the risk/benefit balance of various products.
基于mRNA和DNA的“基因”新冠疫苗可引发广泛的不良事件（AE），统计数据显示，这取决于所采用的时间点和数据分析方法，存在显著差异。仅聚焦于脂质纳米颗粒包裹的mRNA（mRNA-LNP）疫苗，本综述追溯了关于这些疫苗不良事件发生率及相关事件统计结论的演变，从最初对非典型、严重毒性的低估，到近期声称新冠疫苗接种可能是过去几年许多国家超额死亡的原因之一。在辉瑞药物警戒调查列出的数百种不同不良事件中，本分析根据器官系统对主要症状进行了分类，几乎所有器官系统都受到了影响。利用美国疫苗不良事件报告系统的数据和一个全球疫苗接种数据集，对基因疫苗与流感疫苗引发的不良事件发生率和发病率进行比较，结果显示使用基因疫苗后不良事件平均增加了26倍。这种差异在严重的“列入布莱顿监测表”的不良事件中尤为明显，这些不良事件在新冠及新冠后情况中也有观察到。其中，相对于流感疫苗，心肌炎、血栓形成、死亡、心肌梗死、心动过速、呼吸困难和高血压的发病率增加倍数（以x倍上升表示）分别为1152倍、455倍、226倍、218倍、162倍、152倍和131倍。该综述阐述了基因疫苗可被视为预防性免疫基因疗法的概念，以及观察到的慢性致残性不良事件可能可归类为医源性罕见病的观点。它还研究了可能与异常免疫反应存在因果关系的独特疫苗特性，这些异常免疫反应可能导致不良事件和并发症。这些新见解可能有助于提高该平台技术的安全性，并评估各种产品的风险/收益平衡。
