DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: Exploratory dose response relationship with serious adverse events.
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Description: These data demonstrate the presence of billions to hundreds of billions of DNA molecules per dose in the modRNA COVID-19 products tested. Using fluorometry, all products tested exceeded the guidelines for residual DNA set by the FDA and WHO of 10 ng/dose by 188 – 509-fold. However, qPCR detected residual DNA content in all products tested were below these guidelines emphasizing the importance of methodological clarity and consistency when interpreting quantitative guidelines. The Cq scores for the most recent XBB.1.5 Moderna vaccine suggest that DNA residues have not been reduced from previous vaccine versions. The preliminary evidence of a dose-response effect of residual DNA measured with qPCR and SAEs warrants confirmation and further investigation. Our findings extend existing concerns about vaccine safety and call into question the relevance of guidelines conceived before the introduction of efficient transfection using LNPs. With several obvious limitations, we urge that our work is replicated under forensic conditions and that guidelines be revised to account for highly efficient DNA transfection and cumulative dosing. This work highlights the need for regulators and industry to adhere to the precautionary principle, and provide sufficient and transparent evidence that products are safe and effective, and disclose the details of their composition and method of manufacture.