"Abstract
Background: ... Recently, DNA sequencing studies have revealed ... plasmid DNA at significant levels in both Pfizer-BioNTech and Moderna modRNA vaccines...
Conclusion: These data demonstrate the presence of billions to hundreds of billions of DNA molecules per dose in these vaccines. Using fluorometry, all vaccines exceed the guidelines for residual DNA set by 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 warrant 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.
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.
Discussion
Residual DNA was detected in all 27 vaccine vials surveyed. Multiple vials from the same lots produced very similar loads for all targets showing assay reliability, reproducibility, and consistency within the lots."
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