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 products 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.