Contamination of the modified mRNA-based Covid-19 injections?
An overview of the debate on the subject
This article in a nutshell:
(Direct access to different chapters 1-7 via hyperlinks above)
(SUOMI 🇫🇮: The original article in Finnish can be read here.)
*Author's note: This is a layman's take on the subject and was originally written for Finnish audience in Finnish as an introduction to the topic. I have based it on international conversation I have been archiving since March 2023. I will therefore present the topic from my own perspective as a citizen journalist and based on the data I have archived. This is also an article that I never intended to write as I expected someone else [in Finland] to do it. However, I have not seen much of a debate in Finnish on the subject, although I think it is extremely important and it is getting late. There have also been constant new developments, so perhaps the passage of time has also been beneficial in that respect. 1. Foreign DNA in Pfizer vials?
The debate really began when American genomics researcher Kevin McKernan discovered foreign DNA in Pfizer vaccine vials during a completely different study. McKernan has a strong background in the field and recently served as a team lead in Research and Development at MIT's Human Genome Project. In early 2023, McKernan was working on a study for which he needed RNA-only reference material. He had previously obtained Pfizer's mRNA covid-injection vials and decided to use them for this purpose. However, when he sequenced the material in vials, he found that it contained foreign DNA - something he did not expect to find. McKernan himself explained the situation in an interview with Rebel News in April 2023:
“We were doing a lot of RNA sequencing on cannabis plants and something stopped working,” he says. After reaching out to the scientific community for assistance, someone sent him four vials of expired COVID-19 vaccine – two bivalent Moderna vials and two Pfizer vials.
“I paused for a minute thinking that I don’t necessarily want this but it turns out they were perfect controls to solve the problem that I was trying to address… in the process of troubleshooting that, we spiked those molecules into our RNA sequencing process and out came deep sequence overage of the vaccines. What we didn’t expect to find was all of the blueprints to make the vaccines, which were also in the vials, the DNA expression vectors which make these vaccines were contaminating the RNA that was supposed to be in the vials so at that point we knew that we had to put it out to the public because although it wasn’t something we set out to discover, we knew that someone else would care about it.”
Once he had confirmed the findings, McKernan began to look further into the matter, as he was arguably able to understand the magnitude of the potential consequences of the discovery and its longer-term significance. These concerns will be discussed in more detail below, but they relate to the integrity of the human genome, autoimmune problems, cancer, etc.
He began to open up his research on the subject in his own Substack 'Nepetalactone Newsletter', where Kevin writes under the pen name "Anandamide", in February 2023 in the article "Deep sequencing of the Moderna and Pfizer bivalent vaccines identifies contamination of expression vectors designed for plasmid...".
He published the first official research preprint on the subject in April 2023 and by June McKernan was already presenting his worrying findings at a meeting of the US Food and Drug Administration's (FDA) VRBPAC committee, which approves vaccines.
If one wants a quick and tailored-for-layman overview of the subject, pathologist Ryan Cole tries to provide it in the following. The video clip is an excerpt from a longer interview with Ryan Cole, featuring Mary Holland, chief legal counsel for Children's Health Defense, on the organization's weekly program.
Video clip on my Rumble channel here; Whole interview here.2. What can cause the contamination of these injections with foreign DNA?
As Dr. Cole explains in the video above, there are manufacturing issues behind the problem. Small amounts of the messenger RNA (mRNA) needed for injections can be produced in a carefully controlled synthetic process, but at a much higher cost. It is cheaper to produce larger batches by culturing and "growing" the required RNA in a plasmid culture, in effect a foreign DNA.
In Pfizer's case, it used cultures of coliform bacteria (e.coli), so the bacterial cells are programmed to produce the required RNA. The method appears to be commonly used, but an essential part of it is the final purification - all other impurities must be carefully filtered out when the final product is collected. One of the developers of the mRNA vaccine platform concept, Robert Malone, describes the process to the layman as follows:
The process is also explained in more detail, for example here, in section 3 "The manufacturing processes in a nutshell":
Here is the European Medical Agency’s material referred to in the article and picture. The manufacturing process has also been covered by the New York Times.
3. Injections for two different purposes through two different manufacturing processes?
A closer look at the previous image might mistakenly suggest that "process 1" and "process 2" are just different steps in the same process. However, this is not the case. I believe that the fact that Pfizer-BioNTech's Covid-19 -vaccines has been manufactured using two different production processes has - still - been largely overlooked by the general public.
The main reason why this issue has been of interest to the writer is that - as already mentioned above - vaccines for safety testing were produced in a different, smaller-scale and more controlled production process than vaccines for mass distribution to the public.
Even to the layman, it comes to mind how important it becomes in such a situation that the different 'processes' are fully comparable - how else would it be possible to draw any valid conclusions at all about the safety of the product being injected into the general public? The whole picture is puzzling to say the least.
Concern was also felt by many others. So much so, that it was also reported for the British Medical Journal, which also published the letter. The letter was penned by two Israeli academics, Josh Guetzkow, Senior Lecturer at the Hebrew University of Jerusalem and Retsef Levi, Professor of Operational Management at MIT's Sloan School of Management. Below are a few excerpts from that text:
BMJ | Rapid Response:
Effect of mRNA Vaccine Manufacturing Processes on Efficacy and Safety Still an Open Question
.. nearly all vaccine doses used in the trial came from ‘clinical batches’ manufactured using what is referred to as ‘Process 1’ ..
.. However, in order to upscale production for large-scale distribution of ‘emergency supply’ after authorization, a new method was developed, ‘Process 2’. The differences include changes to the DNA template used to transcribe the RNA and the purification phase, as well as the manufacturing process of the lipid nanoparticles. Notably, ‘Process 2’ batches were shown to have substantially lower mRNA integrity.[4,5]
The protocol amendment states that “each lot of ‘Process 2’-manufactured BNT162b2 would be administered to approximately 250 participants 16 to 55 years of age” with comparative immunogenicity and safety analyses conducted with 250 randomly selected ‘Process 1’ batch recipients. To the best of our knowledge, there is no publicly available report on this comparison of ‘Process 1’ versus ‘Process 2’ doses.
If you want to further explore the debate on the importance of manufacturing process differences in the interview format, British medical commentator John Campbell interviewed Josh Guetzkow about a year ago on his show, in episode called 'Pfizer vaccine manufacture'.
The difference between these two different manufacturing processes and its importance for product approval may yet become more of a global issue. This debate in the Danish Parliament on 4th of December 2024 was perhaps a kind of foretaste of this; here is a short extract:
The Danish Medicines Agency, by Jakob Lundsteen (case number 2024024182), in his reply to the undersigned specialist doctor Jeanne A. Rungby on 12 August 2024, admitted
· That there are no placebo-controlled randomized clinical studies on humans with material from process 2 for Cormirnaty [*Pfizer/BioNTech].
· That there was no objection from the Danish Medicines Agency when Pfizer switched from process 1 to process 2.
Similarly, the viewer is left wondering about a conversation at the UK's 'Covid-19 inquiry' hearings in late January 2025, in which Hugo Keith KC, the lead lawyer on the inquiry team, questioned Lady June Munro Raine, head of the UK's Medicines and Healthcare products Regulatory Agency (MHRA). It is prudent to note that the Lady is speaking under oath here:
Mr. Keith: Some have suggested that the batches which were delivered to the United Kingdom for use amongst its population, which were then handed out, were not the same batches, or rather were batches that were produced by a different manufacturing process on the part of the manufacturer, as has been – as had been tested by the MHRA? So bluntly, the suggestion has been made, you tested and authorized and certified a certain number of vaccines made by process, manufacturing process A, and then the manufacturers actually delivered vaccines to British population produced as a result of a different manufacturing process, and one, by inference, which had not been tested. Is that right?
Dame Raine: Well, my understanding is that the manufacturing process would have been the same.
Excerpt from the hearing on my Rumble channel1The controversies surrounding manufacturing processes are addressed in detail in a review carried out in collaboration with several experts:
The authors of the review conclude:
This review aims to address significant anomalies and discrepancies that have surfaced from the examination of the data from the Pfizer/BioNTech C4591001 trial, which could have profound implications for public trust and regulatory standards, should they not be adequately and transparently investigated.
At the end of the article, the authors rightly call for a full audit of the clinical trial process for injections:
4. Concerns raised by the contamination findings?
The main concerns raised by the contamination seem to relate to 1) the foreign plasmid DNA and to 2) the sequences of the parts of SV40 virus. These issues have already been specified in several studies, e.g.
David Speicher et al. : DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines...
Ulrike Kämmerer et al. : BioNTech RNA-Based COVID-19 Injections Contain Large Amounts Of Residual DNA Including An SV40 Promoter/Enhancer Sequence
In addition and as an example, the international NORTH Group, which campaigns to elevate these concerns, has compiled relevant literature on the subject in its letter to decision-makers. The data is presented in the scientific summary of the letter. The summary states:
The NORTH group's scientific summary is one of the most comprehensive compilations of legitimate concerns about DNA contamination that I have found so far. The NORTH summary summarizes a few key issues:
It highlights the undetermined risk of, for example, damage to human DNA, genetic instability, hereditary changes, cancer, immune system disorders, etc.
It also highlights the fact that the likelihood, magnitude and complexity of these risks are still largely unknown at this stage!
This is precisely the reason why concerned experts are calling for the withdrawal of the injections - at least temporarily - and for further research to focus on the problem.
4.1 Problems with residual DNA?
NORTH continues on the risks of plasmid residual DNA:
Critically, the artificial plasmid DNA contains sequences that allow it to replicate in both bacteria, and in the case of Pfizer’s vaccine; in human cells, thereby posing a significant but entirely unnecessary health risk ..
And in relation to the previous point: the issue is that something quite different from what was originally intended to be produced by the injections may be multiplying in human cells.
In the context of the whole debate, it is good to understand that such large amounts of contaminants found in injections are unreported, i.e. either the manufacturer has not informed the 2regulators and health authorities about them or the regulators and health authorities have not informed the public. Therefore, the confirmation of the contamination problem also has a direct impact on the public's perception of the credibility and reliability of health authorities. This in turn, I believe, will easily lead to the admission of the case being delayed until the very end.
The NORTH Group's factsheet highlights the long-term risks associated with heredity:
Risk of integration into the human genome. LNPs are known to be taken up by all organs of the body including the brain, heart, liver, ovaries, and testes and therefore can transfer their contents to the cells of these organs. Hence, the injected material does not necessarily remain at the site of intramuscular injection as was widely claimed.
Kevin McKernan and Professor Ulrike Kämmerer have provided preliminary findings that addition of Pfizer’s COVID-19 vaccine to a human ovarian cell line (OvCar3) can result in integration of the residual plasmid DNA into human DNA. Furthermore, Dr. Phillip Buckhaults, Dr. Wafik El-Diery, Dr. Jessica Rose, and Kevin McKernan have all expressed their concern that residual plasmid DNA could trigger serious side effects, autoimmune diseases, and cancer. ..
.. It must be noted that DNA integration is not necessary to induce cancer-associated pathways. The genetic risks to people who have received these products, as well as their offspring, are uncharted.
I think the last sentence there is the crucial one - the longer-term effects and possible hereditary effects are not known. I would assume that this is one reason why, for example, gene therapy products require up to 15 years of research before they can be marketed to the general population.
This is why the debate on the difference between mRNA vaccines and gene therapy products is becoming increasingly relevant (see below this post for a short summary of X- posts about the topic). Similarly, this second post also provides context for the discussion on the topic (it includes screenshots and links to related documents on the US Securities and Exchange Commission website).
It also seems that the problems of residual DNA ending up in vaccines in general have been known for some time. A key question in this context seem to be whether the maximum threshold limits set, for example, are appropriate - especially in the context of a completely new transport mechanism based on the LNP envelope?
The very early warnings about mod-mRNA injections also take on a whole new context in the light of this contamination problem. In the summer of 2021, I translated a letter containing such warnings, excerpted below.
(I headlined the translation in my blog as: ‘An informative contribution to the debate on Covid- vaccines and vaccine criticism - letter to the editor’). Here are some excerpts from the original version:
Medical researcher Boruch Weiss, Dr. Joel Groden, M.D., and Dr. Zev Zelenko, M.D. addressed a letter to the editor of the Israeli Yated Ne'eman newspaper, answering an attack on COVID shot criticism.
“.. And, as Dr. Peter McCullough pointed out, all the regular steps in testing a new medical therapy, such as studies for genotoxicity (causing damage to DNA), teratogenicity (causing birth defects), and carcinogenicity (causing cancer), were skipped. ..
.. “Anecdotal” evidence in the form of many, many reports from our communities has been coming in which tragically seem to corroborate the doctors’ warnings about danger to fertility and pregnancy, and mandate caution for the childbearing population. Dr. McCullough – not an “anti-vaxxer” by any stretch of the imagination – states conclusively that women of childbearing age should not take this vaccine.
5) While Mr. Birtz echoes the claim of numerous experts that what we need to be most concerned about are the long-term effects of the shot, Dr. Berman states that “the potential for long term side effects not yet discovered are not associated with vaccines.” Actually, that is incorrect, and the potential for long-term problems are indeed the reason that typical vaccines go through long-term safety trials.
But the even bigger issue here is, that this shot is not a vaccine.
A traditional vaccine takes a weakened or dead bit of virus and puts it in the body to create an immune response, thus stimulating antibody production to have in store for when the person may be exposed to the live virus in the future. The Pfizer and Moderna are mRNA shots, which are gene therapy. Calling them “vaccines” makes people feel safe, but there’s nothing traditional about them. ..”
4.2 Partial sequences of simian virus SV40?
Another key concern relates to a monkey virus called Simian Virus 40 [SV40]. Further examination of the MRNA-injection vials also confirmed that they contained sequences of SV40 virus. So we are not really talking about the sequence of the whole virus here, but part of it (SV40 promoter-amplifier):
.. This piece of DNA (known as the SV40 promoter-enhancer) was not declared to the regulatory authorities as being part of the vaccine manufacturing process. Had Pfizer declared this component in their manufacturing process, it is likely that this would have led to greater scrutiny, since the SV40 virus is associated with cancer and the SV40 promoter-enhancer itself has potent biological activity. Hence, the presence of this sequence in the Pfizer product presents a much more serious risk than the presence of only excessive DNA. ..
— Lay summary, NORTH Group
A study published in December 2024 in Science, Public Health Policy and the Law on the findings of the SV40 promoter included the following part:
The World Council of Health in its article 'Health Canada Confirms Presence of Plasmid DNA in mRNA Vaccines, Including the SV40 Sequence' also clarifies the concerns about the SV40 promoter sequence, as "debunkers" have tried to use it as a weapon in the debate by stressing on several occasions that "the full sequence of the virus has not been found":
.. While there is ongoing debate about whether or not the promotor sequence itself induces cancer, there is no doubt that it can facilitate the entry of potentially oncogenic (cancer causing) factors into our cells and can also facilitate the access of plasmid DNA into the nuclei of cells, potentially causing ‘insertional mutagenesis’ (a mutation resulting from the insertion of exogenous DNA into the genome). ..
In the following one-minute video clip, English pathologist Clare Craig further summarises a key implication of the SV40 viral sequence: its presence most likely increases the risk of cancer:
Video clip on my Rumble and full interview here: 'The People's Vaccine Inquiry Ireland'And here, Australian holistic doctor Ian Brighthope talks more widely on the subject:
Excerpt from ‘The Great Debate LIVE from The Perth Convention and Exhibition Centre’
Video clip in my Rumble; whole conference here.Together, both the plasmid residual DNA and SV40 promoter sequences thus represent a wide range of risks that should be identified and investigated as a matter of priority. In NORTH Group’s letter:
5. Similar results around the world
5.1 United States
After Kevin McKernan published his findings, many other experts in the field and in laboratory sphere wanted to confirm - or in some cases certainly alternatively "debunk" - McKernan's findings. This led to results confirming the contamination of mRNA injections starting to emerge from all over the world.
One of the earliest and most significant cases was when American cancer genomics expert and University of South Carolina professor Phillip Buckhaults addressed the issue in his expert testimony to a state senate committee on 12th of September 2023. Buckhaults, who had earlier been supportive towards MRNA technology and who spoke in cautious terms, confirmed that he himself had verified the contamination in his studies. Here is an extract of a few minutes from Buckhaults' speech - speech, which lasted more than half an hour in total.
Source of video clip | Buckhaults' full speech here | Full Senate session hereLike other experts, he raised concerns about heredity issues and the increased risk of cancer, among other things. Buckhaults says that each dose of the vaccine contains up to billions of DNA fragments packaged in lipid envelopes, which are able to penetrate inside cells.
The latest rather extraordinary twist in the US was when a group of high school students confirmed the contamination of injections in an experiment conducted in an FDA laboratory, under the supervision of FDA staff. The results were also published in the peer-reviewed 'Journal of High School Science'. I picked up some excerpts from the article Maryanne Demasi wrote (below) on the subject here.
5.2 Canada
In Canada, Dr David Speicher, a clinical microbiologist and virologist at the University of Guelph, came to similar conclusions. He and an international team examined a total of 27 mRNA vaccine vials (19 from Moderna; 8 from Pfizer). Among other things, Speicher's team found the following:
Speicher stated:
This work highlights the need for regulators and industry to adhere to the precautionary principle, to provide sufficient and transparent evidence that products are safe and effective, and to disclose the details of their composition and method of manufacture.
Health Canada was the first public body to comment on the DNA contamination findings in October 2023. Health Canada said it had been aware of the presence of residual DNA previously and had since confirmed the presence of the SV40 subsequence. Health Canada's response was received via email by the Epoch Times, which had inquired about the matter. In its response, the agency pointed out that the manufacturer had not informed it in advance that the residual material in the injections would contain SV40 sequences or other residues containing functional DNA.
Naturally, this was news that was hastily refuted in a series of "fact-checks". Later, the agency sort of rounded things up:
"The SV40 promoter enhancer sequence was found to be a residual DNA fragment in Pfizer-BioNTech COVID-19 vaccine," the agency told AFP. "The fragment is inactive, has no functional role, and was measured to be consistently below the limit required by Health Canada and other international regulators."
In Canada, some of the actual material obtained through Freedom of Information requests, including a series of articles on emails, can be found here. Material was also published on the X-platform.
5.3 Australia
It was rather peculiar that in Australia, when they wanted to investigate the possible contamination of injections, all the laboratories there refused to do research on the subject. In the end, the Australians decided to send the samples to David Speicher in Canada.
The final report submitted by Speicher shows that residual DNA was again found in all the Australian vaccine vials tested, and at levels above the permitted limit. The Australian samples were submitted for testing in May 2024 and the final report of the investigation is dated 9 September 2024. Both the excessive amount of residual DNA and the presence of the SV40 virus promoter sequence were detectable by different testing methods.
It should also be noted that the Australian samples were tested by the request from the law firm PJ O'Brien & Associates, which has filed a lawsuit on behalf of its client against the Australian government. Dr Speicher's affidavit is submitted as evidence in the case of 'Julian Fidge v Pfizer, Moderna'. Plaintiff, Victorian general practitioner and pharmacist, Dr. Julian Fidge, is seeking an injunction in federal court to prevent Pfizer and Moderna from distributing mod RNA Covid vaccines. The case has been written about by Australian investigative journalist Rebekah Barnett and others.
Here is also a video clip of Katie Ashby-Koppens, a lawyer involved in the case, explaining how Australian laboratories refused to test for DNA contamination.
In Australia, decision-makers were informed by a letter signed by Russell Broadbent, an independent MP for the federal electorate of Monash.
5.4 Germany
The German findings were announced in September 2023. In the wake of McKernan and Buckahults' research, the contamination was confirmed by German biologist Jürgen O. Kirchner. Kirchner personally acquired five unopened vials of BioNTech/Pfizer vaccine and submitted them for analysis to Professor Brigitte König's laboratory at Leipzig University Hospital in Magdeburg. Professor König found massive DNA contamination, up to 354 times the 10 nanogram dose limit recommended by the WHO and applied in the EU. Like Kevin McKernan, he also found traces of whole bacterial plasmids.
Kirchner wrote to both the Paul Erlich Institute, which has responsibility on pharmacovigilance in Germany and the Minister of Health, Karl Lauterbach, to inform them on the findings. The results (below) were attached to the letters.
For an excellent overview of the German case, see this report by the German television channel MDR from December 2023. (X-post; clip is in German with the English subtitles)
Source: @_aussie17 on X - hereKirchner and Professor König published their findings in the study "Methodological Considerations Regarding the Quantification of DNA Impurities in the COVID-19 mRNA Vaccine Comirnaty®" in March 2024.
It is noteworthy that McKernan and Speicher, among some others, were not entirely in agreement with the authors of the study regarding some of the methods used.
5.5 France
The results in France were announced in November 2024 when Didier Raoult, Professor of Microbiology at the University of Aix-Marseille Medical School, published a related research paper "Confirmation of the presence of vaccine DNA in the Pfizer anti-COVID-19 vaccine". The study found contamination, which once again clearly exceeded the limit values. The authors were concerned about the possibility that foreign DNA sequences could integrate into the human genome - a concern they said is particularly acute because they are passed on in LNP "packaging". The authors called for further research.
(*as a general remark: many experts have pointed out that the threshold values applied so far are inappropriate because they do not explicitly take into account the new efficient transport mechanism using nanolipid technology, which increases the risks. The previous limit values were defined in terms of naked DNA in relation of its half-life and degradation rate).
Below is an extract from the conclusions of the study:
Didier Raoult, the author of the paper, has been the target of repeated attacks, especially since he advocated early treatment of coronavirus and drugs such as Hydroxychloroquine in the early stages of the pandemic. These issues and Raoult's controversial reputation were also discussed, for example in this Unherd’s article from 2020.
In the next clip, he talks about the contamination of Covid-19 -injections on French television:
Source video clip in RumbleLittle by little, more and more studies confirming contamination have been trickling in from all over the world, at an accelerating pace. The problem was also addressed in a South African study in August 2024. The latest one that caught my eye was the following preprint paper from Hungary, 'The Unique Features and Collateral Immune Effects of mRNA-Based COVID-19 Vaccines: Potential Plausible Causes of Adverse Events and Complications'.
6. The response from public authorities and governments?
Various efforts have been made to bring the problem of contaminated vaccines to the attention of policy makers. Those following the issue and those concerned about it have been talking about it on social media for almost two years now. I also started my own thread on the subject on the X-platform in March 2023 and it currently has some 135 posts under it as a collection.
In Australia, meanwhile, the issue was - perhaps somewhat surprisingly - pushed forward gaining huge momentum by a city council (In my X there are again various posts linked below this post, as a thread).
Awareness of the problem has also been raised by various international organisations and consortia. At the end of last year, the international NORTH group sent a comprehensive letter with scientific arguments to decision-makers in various countries, including Finland. The responses to this letter were then followed up by another letter with the most recent evidence.
But what then has been the response from the policy makers? In fact, the answers have been amazingly congruent if not identical. The overall message seems to be that whatever is discovered about vaccines, there is nothing to worry about because:
vaccines have already been tested in the past,
safety requirements are high,
so many have already been given, etc.
Moreover, from a more general point of view, a key element in the various responses has been to conflate (or deliberately misunderstand) the part of the concerns dealing with the SV40 virus component (whole virus vs. promoter sequence). In this context, Dr Jessica Rose describes in her Substack a case where the medical journal Cureus rejected - not retracted, but outright rejected - a study on contamination. Here is an extract from Dr Rose's response to the journal:
Rejection #4 from Cureus: our DNA paper is getting rejected before it gets a chance to get retracted!
With all due respect, it appears that the Cureus Editorial Team did not read our manuscript thoroughly.
I have taken the time to point out some errors in your rejection statement.
"there is no SV40 protein present"
We discuss the presence of SV40 promoter/enhancer sequences in the vials as contaminant DNA, not SV40 protein. As we also discuss in our paper, the SV40 enhancer, containing regions like the 72 bp repeats, recruits various transcription factors in the cytoplasm. These factors, which have nuclear localization sequences (NLSs), bind to DNA, forming a complex that can then be recognized by the nuclear import machinery as a substrate for nuclear entry.
— Dr. Jessica Rose, in a response to journal Cureus
So this was not the first attempt to publish this study - it was now rejected for the 4th time! One of the authors of the study, David Speicher, has also described the whole saga of the publication effort in detail in his Substack3:
Responses from the national level have also been limited so far. On 13 January 2025, the NORTH group consisted of representatives from twenty countries. At that point, only 4 countries had responded to the letter sent to decision-makers in all 20 countries - Finland was one of these 4 (Finland's response will be also presented below with some others).
6.1 USA
An apt example of this lack of concern is an email response from the US Food and Drug Administration (FDA), in which the FDA says there is no reason to recall injections and that residual DNA is not a problem. According to the FDA:
"The available scientific literature supports the conclusion that covid vaccines are effective and safe"
.. indeed - the available scientific literature..
Of course, such arguments will not appease those who understand that the concerns raised are based on scientific, laboratory-based evidence - so shouldn't the answers be based on equally detailed scientific evidence? Many have also pointed out that, particularly in the context of public health, the burden of proof should lie primarily with the party claiming that a product given to public is safe - and not the other way round.
6.2 Canada
The same type of response was given by Health Canada, the Canadian health authority. Anna Maddison, Senior Media Relations Advisor at Health Canada and Public Health Canada, said:
“Health Canada initially authorized the Pfizer-BioNTech COVID-19 mRNA vaccine in December 2020 and subsequently has authorized updated versions, including the most recent vaccine targeting the XBB Omicron subvariant in September 2023. Each assessment included a determination that the vaccine met the Department's stringent regulatory safety, efficacy and quality requirements for use in Canada. ..
.. In the manufacture of any vaccine, residual elements that are part of the standard manufacturing process may remain. There are strict limits and controls for the presence of these residual fragments to ensure that there is no effect on the safety or effectiveness of the vaccine. ..
“The Pfizer-BioNTech COVID-19 vaccine does not contain simian virus 40 (SV40). The presence of the SV40 promoter enhancer sequence is not the same as the presence of the whole virus itself.” [Emphasis added by Health Canada.]
Any claims that the presence of the SV40 promoter enhancer sequence is linked to an increased risk of cancer are unfounded. There is also no evidence to support that the presence of the full SV40 in any vaccine increases the risk of cancer or the acceleration of cancer in individuals.”
However, the article also contains a pertinent comment by researcher David Wiseman in relation to the previous statement. He states:
“THEY HAVE NO EVIDENCE ONE WAY OR THE OTHER [Wiseman’s emphasis] since they did no studies and no cancer studies were required.”
6.3 Australia
The Australian drug regulator TGA even went so far as to slander scientifically-based concerns about mRNA spike contamination as "misinformation" and downplayed their scientific validity. The next bulletin was published in October 2024 (emphasis by me):
Addressing misinformation about excessive DNA in the mRNA vaccines
.. these recent studies fail to apply the required scientific rigor expected in pharmaceutical testing. As such, the results are not robust or reliable, and are creating confusion and concern regarding the safety of vaccines. ..
.. The TGA reassures the public that all COVID-19 vaccines approved in Australia have been rigorously assessed and meet our high standards for safety, quality, and efficacy. ..
.. Vaccination against COVID-19 is one of the most effective ways to reduce the risk of death and severe illness from infection. The protective benefits of vaccination far outweigh the potential risks. ..
.. To date, neither the TGA nor any international regulator has established a causal link between COVID-19 vaccines and any type of cancer.
There has been no evidence of mRNA vaccines or biological medicines used in Australia resulting in integration of residual DNA into human DNA genome. This includes products such as insulin, which are injected multiple times a day for life-long treatments. ..
.. Evidence from the more than 13 billion vaccine doses given worldwide shows that COVID-19 vaccines have a very good safety profile in all age groups. The benefits of the approved vaccines far outweigh the possible risks.
However, in the light of what I have presented so far, several questions immediately arise in relation to the previous statement;
Have these specific causal links even been studied? There have been no cancer studies on covid injections, have there?
Has the possible integration of residual DNA into the human DNA genome even been studied by the authorities? How could there even be any evidence if this has not been done?
(As a side note - more likely, if we were in the gene therapy category from a regulator’s point of view, that would have been studied)
In relation to the TGA, however, the story got more interesting. A few months after that, last December, new internal TGA communications were obtained through a Freedom of Information request, revealing what was being said behind the closed doors. I went through the material presented by Rebekah Barnett in my own long X-thread, from which I now take a few excerpts (comments above the pictures are mine):
The Australian regulator, the TGA, was aware of the risks at management level, but prioritized its own credibility and success in influencing public opinion over the safety of the public.
"TGA has repeatedly stated that elements of the modRNA vaccine cannot enter the cell nucleus and cannot integrate into the genome. Internal emails show that agency executives know this is not the case."
The consensus of the previous debate was: "It is possible, but unlikely" Barnett points out that this is in stark contrast to the Agency's public communication.
(Editor’s note: Certainly a challenging place for a decent person to work..)
Remnants of conscience forced them to resort to ambivalent evasion. However, one staff member acknowledges that what is not sought is not found ..
Also, despite the hesitation expressed by another expert, the position is upheld. In addition:
"Based on the FOI request, TGA was unable to provide evidence that it had investigated scientific findings related to the testing of human genetic alterations caused by modRNA vaccination."
For me at least, this was not the most relieving reading. Rebekah Barnett's original thread can be found here:
https://x.com/dystopian_DU/status/1869286361024680376
And in the article:
6.4 Germany
In Germany, the issue of contamination of mod mRNA-based Covid injections was addressed by Health Minister Karl Lauterbach in December 2023. When Martin Sichert, a member of the German Bundestag, asked the minister what the German government intended to do about DNA contamination in Covid vaccines, the minister decided to play it smart and stated unequivocally with almost Napoleonic strategic touch:
Right honorable member, I cannot answer your question. It is unscientific. You refer to contamination in the DNA of the vaccines. The vaccines are manufactured with RNA, not with DNA.
Even I myself was amazed that a politician of that level would dare to say anything like that in public, but then again - there was Waterloo too..
But just for the record, let me directly add a corrective remark from the author of the article in question, Robert Kogon:
But, as is well known, the mRNA which serves as the active drug substance in the most-widely-used COVID-19 vaccine, that of the German company BioNTech and its American partner Pfizer, is manufactured precisely from plasmid DNA. The extensive DNA contamination which has been discovered in batches of the BioNTech-Pfizer vaccine by numerous researchers, including in Germany, consists precisely of residual DNA from the mRNA manufacturing process.
In a tweet about the above dialogue at the Bundestag, Representative Sichert described Lauterbach as "dangerously ignorant about his favorite subject, new mRNA vaccines":
https://twitter.com/Martin_Sichert/status/1729903381932650877
6.5 Denmark
The Danish debate reported in this article was already referred to earlier in the chapter on Pfizer's two different mRNA injection production processes (process 1 and process 2). On that same occasion, Lars Boje Mathiesen, Member of Danish Parliament, stated that he believed that the Danish Minister of Health was not up to date on the contamination issue.
from the article:
.. The Minister of Health is not aware that these vaccines are particularly dangerous, as serious side effects rarely occur. She repeats several times that the probability of DNA residues being dangerous to humans is unlikely, hypothetical and without risk to the human genome. ..
.. The minister is speaking here against better judgment. One year ago, she received and acknowledged a letter of concern from the undersigned specialist doctor Jeanne A. Rungby, in which the problem of DNA contamination of the vaccines is described with a particular focus on the risk of cancer in vaccine recipients(7). The minister answered roughly the same as the answer to Lars Boje Mathiesen to this letter.
As she had not understood the seriousness, she received another letter from the undersigned specialist Jeanne A. Rungby in early 2024. This letter was thoroughly elaborated with explanations of the meaning of DNA, SV40 and also the difference between process 1 and process 2 (5). This letter was also acknowledged. ..
.. The minister resolutely replies that there is no scientific documentation for Lars Boje Mathiesen's theories, which she also calls misinformation.
She has, however, received the updated scientific documentation, as an international group, the NORTH Group, submitted a letter of concern to both the Prime Minister and the Minister of Health on 25 November this year, drawing attention to the serious risks associated with the excessive amounts of synthetic DNA , which is found in USA, Canada, Germany and Australia (7). The letter is signed by more than 432 scientists, doctors, lawyers and politicians from around the world.
Added to this is a completely new study by Kämerer et al from 3 December 2024 (8), whose results confirm and expand the already published reports of residual DNA findings in far too large amounts ..
6.6 Sweden
In Sweden, the issue was discussed in a parliamentary debate on 29.11.2024 between Elsa Widding MP and Jakob Forssmed, Minister of Social Affairs and Health. A Swedish Substack author commented on the debate he watched:
Forssmed does not respond to the criticism presented from the North Group's letter about the risks of the DNA contamination and the scientific evidence on the matter. ..
.. When Elsa Widding points out the lack of security and the lack of testing before launching the covid mRNA product, not much happens from Forssmed's side. Forssmed does not respond to Widding but throws nonsense claims at Elsa Widding and calls the scientific evidence from the North group coalition unscientific claims and misinformation.
The debate can also be watched with English subtitles on YouTube.
6.7 Finland
What comes to the decision-makers of my own country, it must at least be said that they too responded to the contamination concerns. In this case, it is a response to the first letter of concern sent by the NORTH group. The response was delivered by e-mail through member of parliament Pia Sillanpää. It is my understanding that the letter of concern itself was also sent to the Ministry of Social Affairs and Health by e-mail by the same MP.
I understand that the ministry then asked The Finnish Institute for Health and Welfare (THL) to compile a response, which in turn was sent back to MP Sillanpää by a representative of the Ministry of Social Affairs and Health. As I understand, the reply was not officially published anywhere by the Finnish authorities. There are also no signatories to the reply, although the sender (ministry’s representative) has agreed to its publication and stated it is the official position of ministry.
The undersigned is bound here to note that this is a rather peculiar pattern in itself in the context of leadership and accountability when public servants and authorities are concerned..
Below are some extracts from the response, which is consistent with those from other countries - almost identical:
In other words, the product is effective and safe because it has gone through centralized testing, evaluation and controls. And again, the 13 billion doses of vaccine given worldwide are cited as proof of safety. The rest of the response is below:
I find the last part of the answer more interesting. It labels contamination concerns as "an attempt to instill fear"; states that residual DNA "is not a risk in the light of research" and that vaccine DNA cannot alter human DNA or cause diseases such as cancer.
Once again, the biggest question for myself is, have such in-depth studies ever been done or even wanted to be done?
And then at the end: 'The human habitat is full of DNA from other organisms, which we obtain through food and water' .. One has to ask how apt such a comparison is in the case of a synthetic drug that is 1) packaged in a lipid envelope and 2) possibly contains a viral promoter sequence that is known to enhance the penetration of plasmid residues into the nucleus of cells, and is used in gene therapy in order to achieve just that?
The above would of course be irrelevant if the contamination findings were scientifically proven to be wrong. However, nowhere has there been a response that does so. Even in the Finnish reply, the only linked reference referred to the Global Vaccine Data Network entity. Digging into the background of this organization reveals that it was set up specifically to monitor the safety of Covid-19 injections globally and is funded by the Bill and Melinda Gates Foundation and the US Centers for Disease Control and Prevention (CDC) among the others.
I was also not too surprised to find a statement by one of the American doctors leading the organization, published by the University of Auckland (the birthplace of the organization). It suggests, to some extent, that one of the main purposes of the whole organization has been to dispel 'vaccine hesitation', i.e. - to lead information influence campaign.
Here is an excerpt from that publication (highlighting added by me):
NZ scientists to lead largest-ever vaccine monitoring study
.. While vaccine hesitancy and anti-vaccine communication have become global, the ability to respond to such concerns has remained largely fractured, without coordination between countries,” said Emeritus Professor Steve Black of the University of Cincinnati, a pediatric infectious disease specialist and the other co-director of the GVDN. “This project is a game-changer. Through its scale, transparency, timeliness and open communication, it will contribute to vaccine confidence around the world. ..
— Steve Black, Emeritus Professor of the University of Cincinnati, a paediatric infectious disease specialist and the other co-director of the GVDN
7. Problems and unanswered questions
Having followed the debate so closely, I myself feel that there have been few answers to the questions. On the contrary - in some cases, the positions and behavior of the authorities and politicians on this issue have opened up new, perhaps nearly equally worrying questions. A good example of this are the comments of Lauterbach in Germany and the internal communications of the Australian TGA obtained by freedom of information request.
Concerned experts point out in particular that the authorities do not seem to take into account the new transport mechanism of mRNA-based Covid-19 vaccines based on the nanolipid envelope, and even compare the residual DNA inside that envelope to naked DNA, which is ingested "via other routes from the environment". According the critics - thanks to the new transport mechanism, the "payload" (and everything else that comes with it) is now protected in a completely different way in these modified RNA-based injections.
This also raises the question of the appropriateness of defined threshold levels of residual DNA, etc., which have been established with traditional vaccines in mind. Kevin McKernan, in a presentation to Congress, stated:
So those regulations were written when vaccines were grown in eggs and in other cell cultures DNA of the cell line that was present in the vector of the host. This is very high copy number of DNA of a gene therapy vector, which has these nuclear targeting sequences and has DNA in it that replicates inside of a million cells. So when it gets into the cell, it can make more of itself.
That's a very different contamination than what they considered when they wrote those 10 nanogram regulations. They also wrote those 10 nanogram regulations under the pretense of a 10 minute half-life of naked DNA in the blood.
The same view is shared by Dr. Janci C. Lindsay, an American toxicologist and molecular biologist:
The current regulatory standards for DNA contamination are woefully inappropriate as they do not consider the source, i.e. whether it is intact, replicable plasmid, or residual chopped-up random DNA. The standards do not account for the newer LNP delivery system, which delivers this DNA even into the nucleus of cells. They do not consider the type of DNA and if there is a strong regulatory element such as an intact promoter, especially one that is known as a strong promoter of mammalian gene expression, such as SV40.
As I was writing this, I came across a post that puts the problem in almost beautiful terms (I have highlighted the “crystallization” part):
Another key problem, which this article has also had to return to several times, is the question of what has and what has not been studied. The problem is touched on here by Alexandra Henrion-Caude, a French professor of viral immunology:
After more than two years of implementation of these vaccines, no work has been able to describe the lack of genotoxicity nor carcinogenicity. Research organizations, like the regulatory bodies in Europe, the European Medicines Agency (EMA), and in the United States, the Centers for Disease Control and Prevention (CDC), have on the contrary admitted that they have no information.
Dr. Panagis Polykretis, PhD in structural biology, gives an emphatically apt statement:
It is astonishing that this contamination was only identified after billions doses have already been inoculated. Given that such experiments are relatively straightforward (as demonstrated by students successfully completing the work), why weren’t these tests conducted earlier?!
What then would be required to allay these concerns; what should we expect from regulators and authorities? Sucharit Bhakdi, Professor Emeritus of Microbiology from Thailand, who has made his career in Germany, is unequivocal:
ALL RNA injections must be stopped worldwide on the spot and forbidden until the major issues have been resolved. These are:
1. The guarantee that NO batch contains LNP-packaged DNA
2. The guarantee that NO ‘vaccine’ will induce immune-mediated damage (self-attack).
Expert of molecular and biology and biochemistry Jessica Rose, who holds PhD in computational biology, has also called for the absolute necessity of large-scale studies to ensure the safety of mRNA injections:
Ultimately, we need to find out (like yesterday) if any of this DNA got integrated into any human genomes. In addition to testing a lot more vials, filling in the data gaps for the dose response curve to prove causal effects of DNA:SAEs (if they exist), we need to test injected people’s stem cells and germ line cells for integration of any of this DNA. Once we can prove in a large enough sample of injected individuals that integration did not occur, we can finally breathe a sigh of relief and definitively state that integration of this foreign contaminant DNA is not an issue.
NOT BEFORE.
However, a lot has happened since Dr. Rose's statement in autumn 2023.
In November 2024, the American Dr Phillip Buckhaults, previously mentioned in the article, confirmed under laboratory conditions that plasmid DNA from mRNA vaccines can indeed integrate into the genome of normal human cells. This was also reported by investigative journalist Maryanne Demasi in her article 'Evidence is one step closer to proving that DNA integration occurs in humans after mRNA-covid vaccination'.
the plasmid DNA that is contained within mRNA vaccines can integrate into the genome of normal cells. i knew this could happen, but some were unconvinced, so we took the time to prove this in the lab.
— Phillip Buckhaults
There was also new, once again worrying news from Australia just before Christmas last year. Traces of plasmid contamination of MRNA spikes have now also been detected in the blood of vaccinees. See this recent article for a discussion of the issue:
From Maryanne’s article:
These samples were originally collected to study immune responses, but [Sandeep] Chakraborty accessed the data repository and conducted his own sequencing analysis.
He uncovered concerning findings in the blood samples of the 75 South Australians who had received mRNA COVID-19 vaccines.
Alongside the spike protein sequence that you would expect to find from the vaccine, there were also gene fragments encoding for “SV40” and “Kanamycin” - genetic sequences unique to the plasmid DNA used in mRNA vaccine production.
A team of Australian experts has been briefing politicians and authorities on the issue. Here is an excerpt from the letter sent to policy makers:
1.1
We write to you with the utmost urgency regarding recent findings that significantly amplify the concerns surrounding the synthetic DNA contamination in the Pfizer and Moderna COVID-19 vaccines.
1.2
This new evidence confirms the same synthetic DNA contamination found in Australian sourced Covid-19 vials is in the blood of South Australian participants in a peer-reviewed study.
1.3
Given the detailed nature of the information contained in this letter, this letter is coauthored by experts in their field, drawn from the many co-signatories to this letter.
1.4
We urge you and the Senators copied on this correspondence to take immediate action to bring this critical development to the attention of the Prime Minister, the Minister for Health, and Professor Tony Lawler, Chief Medical Officer and Deputy Secretary of the Health Products Regulation Group.
The above thread has also raised the debate on the implications of all this for blood banks. In the case of Australia, for example, the key question is once again how can potential risks to that be identified if they are not even investigated? Richard Davis, a retired anesthetist and former member of the South Australian Red Cross Blood Transfusion Committee, commented in an interview:
If the Red Cross is not documenting the vaccination status of donors, how can it possibly track any harm?” asked Dr Davis.
Further, the Red Cross should not claim there is no evidence of risk to recipients when such effects may take years to manifest.
/END
Heartfelt thanks for proofreading, criticism, suggestions and support to my fellow Finns:
Hanna Parikka
Janne Blommendahl
Tuomas Kaasalainen!
Subject-related:
*) [1 Feb 2025] Citizen petition demands FDA revoke approval of Covid-19 mRNA vaccines - The petition is now open for public comment.
A Citizen Petition submitted to the US Food and Drug Administration (FDA) on 20 January 2025 is calling for the suspension or outright revocation of Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax Covid-19 vaccines.
The petition alleges violations of regulatory processes, raises serious safety concerns, and ultimately concludes that the vaccines were “unlawfully approved.”
Filed by lawyer Katie Ashby-Koppens of PJ O’Brien & Associates, the petition is spearheaded by former barrister Julian Gillespie, alongside Chief Scientific Officer and Founder of Medicinal Genomics Kevin McKernan, computational biologist Dr Jessica Rose, virologist Dr David Speicher, and pharmacy consultant Maria Gutschi. ..
.. The petition highlights serious safety concerns regarding DNA contamination in the Pfizer and Moderna mRNA vaccines.
Multiple studies are cited, including one conducted at the FDA’s own White Oak lab, reporting residual DNA levels between 6 and 470 times above the regulatory limit of 10 nanograms per dose.
The petition notes that the DNA fragments are encapsulated in lipid nanoparticles (along with mRNA), shielding them from immune detection, and allowing foreign DNA to enter human cells, including their nuclei.
This process risks genomic integration, self-replication, potentially leading to cancers such as leukaemia and heritable genetic alterations.
Further concerns revolve around the presence of Simian Virus 40 (SV40) promoter sequences found in vaccine vials, which may bind to tumour-suppressing proteins like p53, neutralising the body’s ability to prevent cancerous growths.
The risks extend to transgenerational harm, with synthetic DNA potentially affecting germline cells, causing developmental disruptions, miscarriages, or malformations.
Part added 25th Feb 2025.
11 March 2025 | Wording mistake corrected: “pharmaceutical companies” meant to be nad replaced by → “regulators and health authorities”
Paragraph added 2nd Feb 2025.