Article
Quantification of residual plasmid DNA and SV40 promoter-enhancer sequences in Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada
6 Sept 2025
Abstract excerpt
For some of the COVID-19 vaccines, the drug substances released to market were manufactured differently than those used in clinical trials. Manufacturing nucleoside-modified mRNA (modRNA) for commercial COVID-19 vaccines relies on RNA polymerase transcription of a plasmid DNA template. Previous studies identified high levels of plasmid DNA in vials of modRNA vaccines, suggesting that the removal of residual DNA...
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