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Quantification of Objective Concentrations of DNA Impurities in Mrna Vaccines
Quantification of Objective Concentrations of DNA Impurities in Mrna Vaccines
Our results reproducibly confirm DNA:RNA mass ratios of 1:1000 which is consistent with the specifications of the approved mRNA vaccine product. We demonstrate that earlier published claims of 534-fold higher amounts of DNA impurities in vaccine mRNA prodcuts are not correct and a consequence of extraordinary high RNA and lipid concentrations. According to our data, gathered by applying different, orthogonal methods, we provide evidence that the concentration of product-related DNA impurities in both approved mRNA vaccines, BNT162b2 (Comirnaty) and mRNA-1273 (Spikevax) coincide with the approved mRNA specifications.
fsnestel·papers.ssrn.com·
Quantification of Objective Concentrations of DNA Impurities in Mrna Vaccines