Commentary
"Abstract
... when quantifying the total DNA content in the final product, we must observe that, in addition to the mRNA active ingredient, DNA impurities are also encased in lipid nanoparticles and are therefore difficult to quantify. In fact, the manufacturer of the mRNA vaccine Comirnaty (BioNTech/Pfizer) only measures DNA impurities in the active substance by means of a quantitative polymerase chain reaction (qPCR), whose DNA target sequence is less than just 1% of the originally added DNA template. This means that no direct DNA quantification takes place, and compliance with the limit value for DNA contamination is only estimated from the qPCR data using mathematical extrapolation methods. However, it is also possible to dissolve the lipid nanoparticles with a detergent to directly measure DNA contamination in the final product by using fluorescence spectroscopic methods. Experimental testing of this approach confirms that reliable values can be obtained in this way ...
Conclusions
The available information and data indicate that the ready-to-use mRNA vaccine Comirnaty contains DNA impurities that exceed the permitted limit value by several hundred times and, in some cases, even more than 500 times, and that this went unnoticed because the DNA quantification carried out as part of batch testing only at the active substance level appears to be methodologically inadequate when using qPCR.... Because of the conditions during the production of the mRNA active substance of Comirnaty, the applied qPCR is designed so that a massive under-detection of DNA impurities appears to be the result...
Further, it should also be taken into account that DNA impurities in Comirnaty® are apparently integrated into the lipid nanoparticles and are thus transported directly into the cells of a vaccinated person, just like the mRNA active ingredient. What this means for the safety risks, particularly the possible integration of this DNA into the human genome, i.e., the risk of insertional mutagenesis, should be a secondary focus of the discussion required..."
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