In Part 5 of this series, 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
- Concerns have been raised about DNA contamination in the mRNA COVID-19 vaccines. The specific concern is the presence of higher-than-expected residual DNA plasmids used in the original mRNA production. Independent investigations suggest that the Pfizer mRNA vaccine may have high levels of DNA contamination, potentially exceeding regulatory limits.
- There are theoretical risks associated with plasmid DNA expression and migration to the gut, which could affect human health and the microbiome. Concerns have also been raised about the quality control and manufacturing oversight of mRNA vaccines.
- The European Medicines Agency (EMA), Europe’s drug regulatory authority, noted the presence of truncated and modified RNA as impurities in the mRNA COVID-19 vaccines, raising the need for oversight.
- Related to the manufacturing process, a Danish study compared the rate of adverse events to the batch size (number of doses in a batch) and found a correlation.