New peer-reviewed article by German scientists further trashes regulatory oversight of the DNA contamination issue.

You were lied to - or they never looked. Why?

I was just made aware of a new paper (click on picture below) in the journal “methods and protocols”, which describes itself as “an international, peer-reviewed, open access journal aiming to establish and describe new experimental techniques in the fields of Life Sciences, Chemistry, and Biomedical Sciences, published bimonthly online by MDPI”.

The main author is Brigitte Konig, Professor of Medical Microbiology and Virology at the University of Leipzig, Infectious Immunology and Infectious Epidemiology.

Here are the bullet points - mostly reproduced verbatim from the abstract plus a few other extracts from the full text.

• DNA impurities can impact the safety of genetically engineered pharmaceuticals; thus, a specific limit value must be set for them during marketing authorisation.

• This particularly applies to mRNA vaccines, as large quantities of DNA templates are used for their production.

• Furthermore, 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.

• Does the target sequence, which is only 69 base pairs long, actually remain in a quantity that is proportional to the other sequences remaining after DNase digestion and the subsequent filtration steps? If the proportionality is not given, any extrapolation is bound to be wrong.

• 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.

• 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, as explained above.

The results of these scientists’ own measurements are illustrated by this figure¹:

The green line indicated the regulatory limit for DNA contamination. This study basically shows that much more DNA is measurable once the LNPs have been digested (by Triton-x-100²). The fact that the additional DNA found is much less in expired compared to non-expired batches supports this, as it is assumed the LNPs break down over time.

Remember that the scale is logarithmic. The batch at the bottom has nearly 500 times the permissible limit of DNA.

This is a damning indictment of the regulators and manufaturers, who have played fast and loose with the health of billions of people.

Yet this particular issue is just one of many now emerging. This sums up the way I feel about what has been done to people, as I wrote here.

1. Figure legend reads:
Figure 2. Quantification of total DNA in batches of Comirnaty^® using Qubit^® fluorometry without and with the addition of Triton-X-100 as a detergent to disintegrate the lipid nanoparticles contained in the vaccine formulation. The measured values shown as bars in the figure refer to the total DNA content in ng per dose of ready-to-use diluted Comirnaty^®. These measurement results must be compared with the limit value for the total DNA content of 10 ng DNA per dose for Comirnaty^®. One dose consists of 300 µL of ready-to-use vaccine. In all batches, it was found that the measured DNA value increased considerably after treatment with Triton-X-100. As expected, this could only be a consequence of the dissolution of the lipid nanoparticles and the resulting release of the DNA that was bound in them. In batches 1 to 4, which had all expired, it was found that after treatment with Triton-X-100, between 16 and 81% of the maximum measured DNA value had become accessible for measurement due to the dissolution of the lipid nanoparticles, while in batches 5 to 7, which still had a shelf life of 11 to 13 months, this was even as high as between 93 and 97% of the total DNA. This indicates that the lipid nanoparticles from expired batches may have largely disintegrated even without treatment with a detergent, whereas this was only caused by Triton-X-100 in the batches with a longer shelf life. Irrespective of this, however, very high DNA values were measurable in all batches after Triton-X-100 treatment, with these values ranging from 360 to 534 times the permissible DNA limit or 3600 to 5340 ng DNA per dose. * Threshold of 10 ng of DNA/dose (300 µL of ready-to-use Comirnaty). ** Total DNA ng/dose after treatment with 1% Triton-X-100.

2. A detergent - see here.