double-stranded DNA contamination, integration, and migration?
Promise or Peril: COVID-19 mRNA Vaccine Issues Series (Part 5)
In this series, “Promise or Peril: Alarming COVID-19 mRNA Vaccine Issues,” we explore how the introduction of mRNA technology lacked an adequate regulatory framework, setting the stage for three major issues: 1) inadequate safety testing of lipid nanoparticles, 2) serious adverse events related to the spike protein, and 3) residual DNA- and lipid-related impurities, as well as truncated/modified mRNA species.
Previously: In Part 1, we introduced how the U.S. Food and Drug Administration (FDA) relaxed the rules for mRNA vaccines compared to mRNA therapies and discussed the available data regarding lipid nanoparticle (LNP) distribution throughout the body based on animal testing, the fact that human testing was not done, and the lack of mRNA or spike protein biodistribution data. In Part 2 and Part 3, we explored how the LNPs are constructed and how they behave in the body and potentially affect health. In Part 4 we took a deeper dive into the potential inflammatory and clotting effects of the spike protein and its subunits.
In Part 5, we turn to the third major issue related to DNA contamination with residual bacterial plasmids and truncated mRNA from the manufacturing process. Are the vaccines more contaminated than our regulatory agencies realize? Should this raise concerns about migration to the gut or their expression by cells?
The questions posed throughout this series highlight the inherent safety issues associated with a lax regulatory framework for approval of the COVID-19 mRNA vaccines. In this article, we consider how lax regulation is related to DNA and RNA contamination issues.
Summary of Key Facts