Amidst the ongoing COVID-19 pandemic, concerns have been raised about the safety and composition of certain COVID-19 vaccines. A collaborative study conducted by the University of Guelph, Synechion, Inc., and Medicinal Genomics has shed light on the presence of DNA fragments in mRNA-based COVID-19 vaccines developed by Pfizer/BioNTech and Moderna.
The study focused on the manufacturing process of these vaccines, which involved the use of a DNA template obtained through polymerase chain reaction (PCR) and cloned into a bacterial plasmid vector. Through DNA sequencing, the researchers discovered significant levels of plasmid DNA in both Pfizer and Moderna vaccines, raising questions about the consistency of residual DNA levels across different batches.
The study also found varying amounts of plasmid DNA per dose, with Pfizer doses containing 0.28 – 4.27 ng/dose and Moderna doses containing 0.01 – 0.34 ng/dose. Additionally, the presence of the SV40 promoter-enhancer-ori sequence in Pfizer vaccines suggests a potential dose-response relationship between the amount of DNA per dose and the frequency of serious adverse events (SAEs).
The presence of DNA fragments in these vaccines raises concerns about their safety and potential long-term effects. Current guidelines recommend limiting residual DNA in vaccines to below 10 ng/dose, but the study shows that all tested vaccines exceeded this limit. This calls for a reassessment of regulatory guidelines, considering the evolution of vaccine manufacturing processes.
To address these concerns, it is recommended that regulatory agencies revisit and update existing guidelines, taking into account the latest developments in vaccine manufacturing processes. Manufacturers should also provide transparent information about vaccine composition and manufacturing processes to ensure public trust and confidence. Further research is needed to replicate and expand upon the study’s findings, as well as to monitor adverse events in vaccine recipients.
In conclusion, the presence of DNA fragments in COVID-19 vaccines highlights the importance of transparency, further research, and reassessment of regulatory guidelines. Vaccine safety remains a top priority, and it is crucial to ensure rigorous oversight and continual evaluation to maintain the effectiveness of vaccines in the global fight against the pandemic.