Quantification of residual plasmid DNA and SV40 promoter-enhancer sequences in Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada
Quantification of residual plasmid DNA and SV40 promoter-enhancer sequences in Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada
....Total DNA ranged 371–1,548 ng/dose and 1,130–6,280 ng/dose in Pfizer and Moderna products, respectively. Specific DNA of multiple plasmid DNA targets ranged 0.22–7.28 ng/dose for Pfizer, and 0.01–0.78 ng/dose for Moderna. The SV40 promoter-enhancer-ori (0.25–23.72 ng/dose) was only detected in Pfizer vials. Oxford Nanopore sequencing of one vial found mean and maximum DNA fragment lengths of 214 bp and 3.5 kb, respectively. These data demonstrate the presence of 1.23 × 108 to 1.60 × 1011 plasmid DNA fragments per dose encapsulated in lipid nanoparticles. Using fluorometry, total DNA in all vials tested exceeded the regulatory limit for residual DNA set by the US Food & Drug Administration (FDA) and the World Health Organization (WHO) by 36–153-fold for Pfizer and 112–627-fold for Moderna after accounting for nonspecific binding to modRNA......
https://www.tandfonline.com/doi/full/10.1080/08916934.2025.2551517#abstract
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