"Abstract: Pharmacovigilance databases are showing evidence of injury in the context of the modified COVID-19 mRNA products. According to recent publications, adverse event reports linked to the mRNA COVID-19 injections largely point to the spike protein as an aetiological agent of adverse events, but we propose that the platform itself may be culpable. To assess the safety of current and future mRNA vaccines, further analysis is needed on the risks due to the platform itself, and not specifically the expressed antigen. If harm can be exclusively and conclusively attributed to the spike protein, then it is possible that future mRNA vaccines expressing other antigens will be safe. If harms are attributable to the platform itself, then regardless of the toxicity, or lack thereof, of the antigen to be expressed, the platform may be inherently unsafe, pending modification. In this work, we examine previous studies of RNA-based delivery by a lipid nanoparticle (LNP) and break down the possible aetiological elements of harm...
1. Introduction: ... This review summarises known mechanisms of harm to mRNA vaccine recipients, where we examine historical data on mRNA vaccines to determine if safety signals were apparent during production or testing. Prior to the trials on COVID-19 vaccines involving tens of thousands of people, public data exist on only 285 patients administered various mRNA vaccines, with the earliest trials finishing in 2018 and exhibiting high rates (>10%) of severe adverse events. The novelty of mRNA/LNP products must be stressed in guiding their safety assessment, as current approvals still leave many questions unanswered, and serious risks cannot be definitively ruled out based on current evidence.
In this review, we summarise what is known about the distinct components of mRNA vaccines, by reviewing the literature on past therapeutics. Additionally, we review the known safety impacts of mRNA vaccines prior to COVID-19, as well as other coronavirus vaccines, which, while using a non-mRNA platform, inform us of safety risks when vaccinating against coronaviruses."
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