Abstract

The COVID-19 modified mRNA (modmRNA) lipid nanoparticle-based “vaccines” are not classical antigen-based vaccines but instead prodrugs informed by gene therapy technology. Of considerable note, these products have been linked to atypical adverse and serious adverse event profiles. As discussed in Part 1, health-related risks and drawbacks were drastically misreported and under-reported in the Pfizer and Moderna trial evaluations of these genetic products. Now in Part 2, we examine the main structural and functional aspects of these injectables. The COVID-19 modmRNA injectable products introduce a unique set of biological challenges to the human body with the potential to induce an extensive range of adverse, crippling, and life-threatening effects. Based on the fact that there is no current method to quantify host (cell-based) spike protein production in vivo following injection with these prodrugs, there is no standard “dose”. This is in part due to differences in spike protein production output, which depends on cell metabolism and transfection efficiency. It is therefore difficult to predict adverse event profiles on an individual basis, but considering that millions of adults across the world have reported severe and serious adverse events in the context of these modmRNA COVID-19 products, valid concerns are raised regarding injection of infants and younger age groups for whom COVID-19 poses only minimal risks. We address the process-related genetic impurities inherent in mass production of these products, and the potential risks posed by these contaminants. We then categorize the principal adverse events associated with the modmRNA products with a brief systems-based synopsis of each of the six domains of potential harms: (1) cardiovascular, (2) neurological, (3) hematologic; (4) immunological, (5) oncological, and (6) reproductive. We conclude with a discussion of the primary public health and regulatory issues arising from this evidence-informed synthesis of the literature and reiterate the urgency of imposing a global moratorium on the modmRNA-LNP-based platform.