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Communication

Communication on Methodological Considerations Regarding the Quantification of DNA Impurities in the COVID-19 mRNA Vaccine Comirnaty®. Methods Protoc. 2024, 7, 41

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Submitted:

26 November 2024

Posted:

29 November 2024

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Abstract
The purpose of this communication is to clarify criticisms that have arisen in the context of our publication "Methodological Considerations Regarding the Quantification of DNA Impurities in the COVID-19 mRNA Vaccine Comirnaty®" (Methods Protoc. 2024, 7, 41 [1]). In the meantime, a preprint has appeared entitled "Quantification of objective concentrations of DNA impurities in mRNA vaccines" (Kaiser et al. [2]), which attempts to refute our findings. However, it does not succeed in doing so with the necessary persuasiveness. First of all, it is particularly important that Kaiser et al [2] have confirmed that our results are reproducible when the quantification is carried out using the Qubit® technology in accordance with the manufacturer's instructions, which is exactly what we did. However, it is then claimed by Kaiser et al [2] that the magnitude of the DNA impurities we have shown would be an effect of high amounts of RNA present in the samples. As a proof they quantified a defined concentration of DNA in the presence of very high concentrations of RNA with the Qubit® methodology. However, even the presence of 250 ng/µL RNA resulted only in a comparatively small increase in the DNA value of 0.655 ng/µL and this is far from explaining the DNA concentrations of 12 to 17.8 ng/µL that we have measured in several batches of Comirnaty®. Further, the preprint [2] mentioned that experiments with DNA extracted from the vaccine would show that the very low legal limits for DNA in Comirnaty® are met. However, the authors of this critique have failed to demonstrate that the extractions they performed are indeed quantitative, i.e. reflect the actual DNA contamination. However, based on the related published literature, this must be denied. With this in mind, we can finally confirm that both our methodology and our data, as published in our above-mentioned article [1], imply that DNA impurities as measured with Qubit® by us in Comirnaty® are reliable according to the manufacturer's premises for this DNA quantification technology. In this sense, the DNA values presented in the Kaiser et al. preprint [2] after extraction procedures are obviously artificial effects of the extractions performed and therefore do not represent the true DNA contamination of the concerned Comirnaty® batches.
Keywords: 
Subject: Medicine and Pharmacology  -   Pharmacology and Toxicology
Copyright: This open access article is published under a Creative Commons CC BY 4.0 license, which permit the free download, distribution, and reuse, provided that the author and preprint are cited in any reuse.
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