New revelations about the DNA contamination in Pfizer's vaccines.
By Jeanne Rungby, specialist doctor
A new study from Leipzig, published on May 8, 2024, has confirmed that the detection of DNA contamination in Pfizer's Covid-19 vaccines exceeds the limit values more than 500 times compared to the permitted limit values given by the European Medicines Agency, EMA(1 ).
Just over a year ago, it emerged in the media that independent researchers, including Kevin McKernan, had found up to 500 times too much DNA from Coli bacteria in the vaccines from Pfizer and Moderna (see references to source 1). Other researchers followed with their own findings, including the Canadian group led by David Speicher and the American cancer researcher Phillip Buckhaults, who presented his findings to the South Carolina Senate (see references to Source 1 and the letter to the Secretary of Health).
This sparked outrage and anger around the world. In Australia, a lawsuit was filed against the Australian authorities because this DNA content, including a partial sequence, SV40, was not declared (6). Worldwide, countless lawsuits have been filed due to the lack of informed consent regarding the content and harmful effects of these vaccines (6).
In Denmark, a letter of concern was sent to the Minister of Health, addressing these new findings(2). We will get into the minister's response later.
These contaminations with DNA pieces, short and long, found in the vaccines meant a risk of changing the human genome and thus in some cases cancer in the vaccinated. DNA in the vaccines can also trigger anaphylaxis and other severe allergic reactions. This finding must be seen in the light of the fact that these DNA, like the active substance (mRNA), were packed in fat bubbles (NLP, nanolipids), which aimed to bring the contents into the cells, where the production of spike proteins started, which after being presented on the surface of the cells should generate an immune defense which would supposedly protect against Covid-19.
The two independent researchers, Brigitte König and Jürgen O. Kirchner from Leipzig and Magdeburg, have undertaken the task of making quantitative measurements of the DNA contamination in the Covid-19 vaccines (Comirnaty). Using fluorescence staining and spectroscopy, the researchers have found these large amounts of DNA. They thus confirm the previously described findings by McKernan and Speicher et al, which are described in the letter of concern to the Minister of Health November 2023 (2)
But did the Danish Medicines Agency not know that there were these large amounts of DNA in the vaccines before they gave the marketing authorization? We will return to that later.
The two independent researchers have used a different method for measuring the total amount of DNA in the vaccines than the EU's official laboratories, the Paul Erlich Institute, (PEI). We will also come back to that later.
First, some basic knowledge about the mRNA technology:
DNA and RNA are both nucleic acids and therefore chemically so similar that separating the two is very difficult. The addition of highly concentrated DNA templates, which are linear plasmids, to the broth used to produce an mRNA vaccine therefore presents a particular challenge for mRNA vaccines in general in terms of quality assurance. It is important to remove DNA but not mRNA. The active substance in the form of mRNA has only low stability compared to DNA. Even exposure to room temperature can lead to degradation of RNA, where DNA remains stable for decades under the same conditions in the absence of degrading enzymes. When DNA is to be removed, it is done by first adding a soap (Triton-X-100), which releases DNA from the fat balls. Then an enzyme, DNase, is added that cuts the DNA into smaller pieces, requiring agitation that cannot avoid damaging the mRNA. The soup is then allegedly filtered.
The established limit value of 10 ng. DNA per the dose corresponds exactly to the WHO recommendations for genetically modified drugs, given before the intake of the nanolipids. The fact that this threshold value was met successfully in the production of the vaccine was generally accepted as a given after its approval.
However, much now suggests that the DNA in the vaccines was not removed according to the regulations and that the real total amount of DNA therefore exceeded the limit values.
This finding gave rise to doubts among the researchers about which method the European authority laboratory, the Poul Erlich Institute (PEI) had used for the quantification of DNA. Could the method be wrong?
How could these polluting amounts go under the radar?
The Poul Erlich Institute (PEI) has both the control test for the active content (mRNA) in some batches (not all) and for DNA in some batches. However, they used two different methods for testing the mRNA and DNA content respectively. Here it is important to know that both mRNA and DNA are packed in fat balls (nanolipids).
When testing for the amount of mRNA, they first treated the vaccine with a form of soap (Triton-X-100) that dissolves the nanolipids that the mRNA was packaged in. This released all the mRNA for measurement. They have then added the fluorescent green dye, which binds to the mRNA. Finally, they have done spectrometry, by which the total amount of mRNA can be determined.
Adding the soap was essential for a correct measurement.
One would then expect PEI to use the same method to determine the total amount of DNA in the vaccines
PEI, on the other hand, chose to use another method for determining the amount of DNA, qPCR (DNA quantification). In this measurement, PEI has consistently underestimated the amount of DNA in the vaccines, failing to use soap to release all DNA from the fat packet. They also chose to target the qPCR to a small subsequence of the full plasmid DNA that was used in process 2. The subsequence was approx. 1% of the full plasmid DNA (DNA template). The remaining 99% remained undetermined.
This form of manipulation of data is called scientific misconduct and will be grounds for the deprivation of titles or the rejection of scientific articles for publication.
It thus appears that PEI - against their better judgment - has consistently used a control method that has underestimated the amount of DNA contamination in these vaccines.
PEI was fully capable of understanding that measurement of the full amount of mRNA required for preparation with soap included those mRNAs that were encapsulated in fat (NLP). Why did they omit the same for DNA?
And how could this escape the regulatory authorities, in the Danish Medicines Agency?
Were they incompetent or corrupt?
According to the authors, qPCR is suitable if you want to identify the presence of specific sequences. If, on the other hand, you want to quantify the total amount of DNA in the vaccine, the method is incorrect. Soap and fluorescence spectrometry, as performed for the quantification of mRNA, must be used here.
The authors conclude that PEI's control is designed so that there has been a massive under-registration of the DNA contamination and that this "should be the subject of extensive expert discussions and considerations".
One could sharpen the tone and think that this should have a legal consequence for all control authorities involved.
In particular, the legal aftermath should apply to the authority that, on the basis of this described insufficient control, has given the product an approved certificate for marketing. In the case of Denmark, it is the Danish Medicines Agency.
It should be taken into account that part of this DNA in Pfizer's Covid-19 vaccines also contains a partial sequence of SV40, which is used in gene therapy to draw DNA right into the cell nuclei of a vaccinated person, where a change is desired of the chromosomes, e.g. in cancer cells. What does this mean for the security risks, especially the possible integration of this DNA into the human genome ie. the risk of mutations in the human genome.
In other words, the vaccines seem to contain all the ingredients for altering the human genome. According to the authors, this should be a secondary focus of the necessary discussion, which must go far beyond what could have been considered years before the so unexpected introduction of mRNA drugs on the global market(1).
On 5 February 2024, I sent my second letter to the Minister of Health (3) because I had not received a satisfactory answer from the Minister regarding the DNA contamination of these vaccines.
The minister's first response was as follows (selected statements):
"It is well known that there can be very small amounts of DNA residues in medicines where DNA or other biological material is used in the manufacture. Pfizer's and Moderna's Covid-19 vaccines contain a very small residual amount of DNA from the manufacturing process…. it is not new to professionals that there can be small DNA residues in medicines , ... It has been known since biological medicines began to be manufactured in the mid-1980s. Many years ago, the WHO and the pharmaceutical authorities introduced maximum limits for how much residual DNA may be in a vaccine/drug dose.”
My answer in the second letter and new questions (selected statements):
I assume that the Danish Medicines Agency is referring here to the WHO's guidance from 1998, which sets maximum limits for residual DNA content below 10 ng/dose for parenteral (into the blood) injection. If this guidance is being referred to, it is irrelevant as it predates the current generation of large scale produced vaccines based on modified mRNA packaged in NLP.
DNA content risks are different when injecting an mRNA-based product made using genetically modified organisms with potential plasmid DNA contamination combined with nanolipid particles (NLP) that protect both RNA and DNA from immune attack when present in the bloodstream.
NLP is traditionally used to transport their contents to cells throughout the body, including across the blood-brain barrier, across the placental barrier (the barrier in the placenta) and across the barriers that protect the germ cells, i.e. egg and sperm cells.
Outdated maximum limits, based on previous vaccine technologies, for the content of DNA packaged in LNP, cannot therefore be reused in connection with current covid-19 vaccines. It is at best a misunderstanding that the agreed limits for naked DNA can be used in connection with DNA contained in NLP. The whole point of the NLP packaging is to bring the contents across the cell membrane and into the cytoplasm of cells.
Some of my questions to the Minister of Health (3) were roughly as follows:
1. What is the limit value in the EU for DNA contamination in connection with the Covid-19 vaccines, taking into account that the contents are packed in LNP?
2. Has this limit increased or decreased compared to previous limit values for vaccines produced with a different technology? Documentation required.
3. Have the EU's official laboratories carried out distribution studies (pharmacokinetic studies) of the contents of the vaccine itself (BNT162b2) including NLP?
4. Have the EU's official laboratories carried out integration studies, where the detected DNA residues from the production process are integrated into the human genome, including eggs and sperm cells as well as in cancer cells.
In another response from the minister, it reads:
"You actively break down and remove the DNA template from the vaccine, but you cannot completely remove everything. There will thus always be small quantities of traces left. The companies that manufacture medicines must be able to document that their manufacturing process can remove DNA residues to a very low level (below a set limit). As part of the manufacturing process, there must also be active controls that demonstrate that the accepted DNA limits are being met. It is considered highly unlikely and highly hypothetical that trace amounts of plasmid DNA found in the plasmid for the COVID-19 vaccines could adversely affect the human genome or otherwise pose a health risk to humans. Based on global experience with many different biological medicines since the mid-1980s, it is, in the opinion of the Danish Medicines Agency, highly unlikely that DNA residues in vaccines pose a health risk to humans. … There are still no signals that the vaccines can cause cancer.”
The Minister of Health does not answer the specific questions.
You get the impression that the authorities have put the fox in charge of the chickens by having the producer themselves document that they have removed all DNA residues.
The new findings from Leipzig document that the method, qPCR and non-use of soap, used on PEI to determine DNA is designed to severely underestimate the amount.
Why has the Danish Medicines Agency approved these vaccines?
Doesn't the Danish Medicines Agency know that qPCR is insufficient as a measurement method?
Why haven't the Minister and the Danish Medicines Agency started investigations when they first got this information about severe contamination with DNA in the vaccines?
Why do they continue to recommend and even develop on this failed technology?
In addition, no integration studies seem to have been carried out according to my 4th question. The minister apparently has no intention of carrying out these integration studies in vaccine-damaged patients or in newly-occurring cancers after vaccination against Covid-19.
Another one of my questions requires follow-up.
5. Has there been an increased incidence of different types of cancer in the Danish population in different age groups since the vaccination campaign for Covid-19 was started? Data base wanted?
Here was the minister's reply:
"There are still no signals that the vaccines can cause cancer."
At about the same time as the minister gave this answer, a new peer-reviewed study covering 123 million Japanese people was published, which showed significantly more cancer cases after mRNA gene therapy vaccines against Covid-19 (8 April 2024, 5).
A group of researchers in Japan wanted to investigate how the mortality rates in the different age groups developed during the pandemic (2020-2022). At the same time, they assessed whether there was a correlation with the occurrence of different types of cancer.
Official statistics of observed age-adjusted mortality from Japan were used to compare with expected mortality based on pre-pandemic (2010–2019) data.
No significant excess mortality was observed during the first year of the pandemic (2020). However, an increase in cancer deaths was observed in 2021 after mass vaccination with the first and second vaccine doses.
In addition, significant excess mortality was observed for all cancers with a predominance of specific types of cancer (including ovarian cancer, leukemia, prostate cancer, lip/oral/pharyngeal cancer, pancreatic cancer, and breast cancer) after mass vaccination with the third dose in 2022.
It must seem obvious that a study based on 123 million people is statistically immeasurably strong. This study cannot be dismissed as not being of significant importance also for Denmark, where vaccine adherence is close to Japan's. In other words. This study is not available any stronger and should therefore give rise to the Minister initiating an impartial investigation into the incidence of cancer in Denmark.
Perhaps the minister will give a new and corrected answer, with this knowledge in mind?
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