Synthetic plasmid DNA contamination has been detected in Australian vials of Pfizer and Moderna Covid vaccines at levels of between seven and 145 times the allowable limit, a new study shows.
The independent study of three modified RNA (mod-RNA) vaccine vials, including lots for children and adults, was commissioned to provide evidence in a Federal Court lawsuit over the validity of the regulatory status of the vaccines.
The case, brought by legal firm P.J. O’Brien & Associates, alleges that the vaccines contain unlicensed genetically modified organisms (GMOs) in the form of synthetic DNA contamination and mod-RNA-LNP complexes which could pose an untested safety risk, including the potential for DNA integration into the human genome.
In an affidavit provided to legal firm P.J. O’Brien & Associates, molecular virologist Dr. David Speicher said that the amount of synthetic DNA he detected in all three Australian vials “far exceeded” the allowable regulatory limit set by the Therapeutic Goods Administration (TGA).
Given scientific evidence suggesting that synthetic DNA can enter the cell nucleus and potentially integrate into the human genome, “it is important to investigate whether integration can take place in primary cells in the vaccinated population”, Dr. Speicher said.
The Australian study confirms independent lab findings of high levels of residual DNA in mod-RNA Covid vaccines from Germany, the U.S. and Canada, highlighting that this is a global concern.
The study
Residual synthetic DNA is a byproduct from the mod-RNA vaccine manufacturing process, and is allowed under TGA regulations in levels of up to 10 nanograms (ng) per vaccine dose, and in fragment sizes of up to 200 base pairs (bp).
The TGA denies that Covid mod-RNA vaccines are contaminated with synthetic DNA above 10ng per dose, but as high levels had been detected in vials from other regions, the legal team behind the GMO case commissioned this study to determine residual synthetic DNA levels in Australian vials.
PJ O’Brien & Associates arranged for shipment of three vials with chain of custody, one Moderna and two Pfizer, to Dr Speicher’s lab at the University of Guelph in Canada. The vials were shipped on dry ice and stored in the lab fridge on arrival. The Pfizer vials had tamper seals intact, while the Moderna vial had been half-used.
Dr. Speicher used two methods to test for residual DNA levels – flourometry and qPCR – each with their own advantages.
qPCR is the method preferred by regulators. It captures lower readings of DNA because it can fail to pick up small fragments of DNA below 200bp and it measures less than 1% of the residual DNA plasmid, with the other 99% being extrapolated mathematically. This means the reading has greater repeatability, but it gives a less complete picture.
A Moderna patent (2014) related to “removal of DNA fragments in [the] mRNA production process” acknowledges that the qPCR method of quantifying residual DNA only detects some target DNA molecules, but “does not measure all other smaller DNA molecules that are partially digested” by the enzyme used to break them down for the filtration process.
Using qPCR, Dr. Speicher detected synthetic DNA up to 15-fold above the TGA’s limit in both Pfizer lots, but the Moderna lot was compliant.
To prepare for flourometry testing, Dr. Speicher boiled the vaccines to dissolve the lipid nanoparticles (LNPs) encapsulating both the mod-RNA and residual synthetic DNA. This allowed for increased DNA yield in the reading.
However, there is the potential for “cross talk”, where mod-RNA can be accidentally included in the reading. To reduce cross talk, Dr. Speicher treated the samples with an enzyme called RNase A to degrade the mod-RNA, ensuring that it would not be picked up in the DNA reading.
Using flourometry, Dr. Speicher detected seven to 145-fold more synthetic DNA than the TGA’s 10ng limit. All vials exceeded the limit, with Moderna having the highest DNA load of 1460ng per dose.
Dr. Speicher detected three types of residual synthetic DNA in the vaccines: spike protein, ‘ori’ (short for the origin, where the synthetic plasmid begins to be read for copying) and the gene therapy SV40 enhancer/promoter sequence. Pfizer and Moderna contained DNA from the spike and ori, but only Pfizer contained the SV40 enhancer/promoter (not to be confused with the whole Simian Virus 40, which was not present).
The spike protein DNA detected in the Pfizer vaccines was “the highest concentration levels seen in vials independently tested globally to date”, said Dr. Speicher, prompting him to run the tests a second time to make sure it wasn’t an erroneous reading.
Dr. Speicher also used vials from a previous study of mod-RNA Covid vaccines as controls to rule out any possibility of contamination or other sources of error. “The results were repeatable suggesting the result is true and valid,” he stated.
SV40 enhancer/promoter
Dr. Speicher explained in his affidavit that the SV40 enhancer/promoter is “is known to promote nuclear localisation”, meaning that it can drag DNA fragments into the nucleus of the cell after being delivered to the cytoplasm by LNPs.
Once in the nucleus, the probability of genomic integration “greatly increases” as compared to traditional vaccines, where any residual DNA is not packaged in LNPs nor accompanied by a nuclear localising sequence.
Dr. Speicher and other scientists have also pointed out that this SV40 sequence could pose a cancer risk due to its effect on tumour suppressor gene p53.
Controversially, Pfizer “chose not to mention” the SV40 enhancer/promoter on the residual DNA map submitted to regulators as it should have done, emails obtained under freedom of information show.
Genomics scientist Kevin McKernan was the first to discover the SV40 enhancer/promoter in the Pfizer vaccine, in early 2023. He documented his findings in a preprint and alerted the U.S. Food and Drug Administration (FDA).
Since McKernan made the presence of the SV40 enhancer/promoter known, regulators, including the TGA, have issued statements to the effect that the sequence is non-functional and poses no safety risk.
Nevertheless, internal emails show that at least one regulator, Health Canada, is working to get the SV40 enhancer/promoter sequence removed from Pfizer’s mod-RNA vaccine.
Limitations
Dr. Speicher acknowledged several limitations to the study. Though the vials were cool when they arrived to his lab, the dry ice had evaporated and no temperature was recorded at handover.
However, Dr. Speicher told me that it is unlikely that this would have any effect on the DNA levels in the vaccines.
“We know that DNA is stable at room temperature for months. The shipping time would have very little negative effect on the DNA levels,” he said.
While breaking the cold chain “could make the LNPs less stable and begin to degrade the modRNA” and would therefore invalidate the vaccines for use in humans, it “would not significantly degrade or change the DNA loads”, said Dr. Speicher.
The Moderna vial was not tamper-sealed, leaving open the possibility of external contamination. This is unlikely though, said Dr. Speicher, as a person tampering with the vial would have to contaminate the vaccine with the exact same series of DNA sequences detected in the other independent studies around the world, an unlikely theory that McKernan refers to as the “elf on the shelf“.
Once the vials arrived in Canada, “the shipping container was opened by me, documented, time and dated and placed in a secure fridge that can only be accessed by myself”, said Dr. Speicher.
Dr. Speicher also identified some variability between the results from the two flourometry runs, which he attributed to the “difficulty in pipetting LNPs due to aggregations and settling of LNPs”.
Regardless, Dr. Speicher emphasised that these results “clearly show that the vials from Australia have more than 10ng per dose”.
“It’s not a matter of whether or not the vaccines have more DNA than 10ng per dose but a question of how much more do they contain,“ he said.
Regulator dismisses findings
In response to independent studies of residual DNA contamination date finding residual synthetic DNA at levels over the allowable limit, the TGA says that the mod-RNA Covid vaccines are “not contaminated”, and denies that the studies are valid. The TGA says that the presence of residual DNA, including the SV40 enhancer/promoter in the mod-RNA Covid vaccines poses no safety risk, and it says that the delivery of synthetic DNA to cells all around the body in LNPs is immaterial.
See the TGA’s full arguments here.
In response to Dr. Speicher’s affidavit detailing his study of three Australian mod-RNA vaccine vials, the TGA determined the findings are “not reliable”.
A TGA spokesperson referred me to the international guideline adopted by regulators to determine whether testing methods are reliable and accurate, stating:
The TGA cannot tell from Dr. Speicher’s affidavit whether he has validated his method according to this guideline, nor whether he has used a suitably characterised reference standard. There is no information in the affidavit that Dr. Speicher has validated the method using RNAse according to the validation guidelines.
Regulatory testing is conducted within tightly controlled frameworks that ensure traceability and certainty about the integrity and provenance of test samples.
It appears that Dr. Speicher only used three vials of unknown provenance, one of which he notes had been opened by the time it reached him. All three vials had expired when the testing was conducted. The ‘chain of evidence’ provided in the affidavit only covered four hours of time and there is no temperature log with the samples.
Given the lack of controls that could ensure the accuracy of the test methods used and given considerable uncertainty around sample integrity and provenance, the results presented in Dr. Speicher’s affidavit are not reliable.
Several of the concerns raised by TGA are limitations already addressed above, namely the use of alternative methods for measuring DNA loads, lack of temperature record on arrival of the vials and the open Moderna vial.
The TGA is correct that Dr. Speicher’s affidavit does not contain the chain of custody, however P.J. O’Brien & Associates advised that chain of custody is documented and included in the prosecution brief.
Dr. Speicher acknowledges the TGA’s adopted guideline but said that “there is no compendial standard for testing DNA inside LNPs”. This is because the approved method of testing measures DNA levels in the ‘mixture’ before packaging it in LNPs, but not in the final drug product as administered, once the DNA has been enveloped in the LNPs.
“The work was done in a research laboratory following good laboratory practice and show important preliminary findings on the vials that need to be confirmed by an independent lab under forensic conditions,” Dr. Speicher said.
Oncogenic and genomic integration risks
While the TGA assures that the mod-RNA Covid vaccines are compliant with regulatory guidelines on DNA limits, Dr. Speicher’s affidavit highlights that the guidelines “do not account for multiple dosing of the same vaccine or platform, the risk of regulatory sequences [such as the SV40 enhancer/promoter], integration of small DNA fragments (7bp to 200 bp), or nuclear entry/integration”.
“While the number of these fragments entering a cell is unknown, it is known from Dean et al. (1999) that only three to 10 copies of these spike DNA fragments containing the SV40 enhancer are needed to be inserted into a single cell for the risk of insertional mutagenesis to exist,” he said.
This risk posed by millions to billions of small DNA fragments per dose was highlighted last year by cancer genomics scientist Dr. Phillip Buckhaults, from the University of South Carolina, who verified McKernan’s DNA contamination findings in his own lab.
In sworn testimony in a South Carolina Senate hearing, Dr. Buckhaults explained that by chopping residual DNA fragments into “itty bitty bits“ as part of the filtering process during mod-RNA vaccine production, the vaccine manufacturers “actually increased the hazard of genome modification in the process”.
Insertional mutagenesis (i.e., insertion of small fragments in the genome) can in turn lead to cancer formation, Dr. Speicher explained further via email.
“[That’s] why the p53 gene is so important. The SV40 promoter knocks out p53 and can cause the cell to turn cancerous. We also know from Kevin’s sequencing studies that the whole spike gene can insert into precancerous regions of chromosome 9 and 12,” he said.
The oncogenic risk is highlighted in the U.S. Food and Drug Administration’s (FDA) industry guidance, which states: “There are several potential mechanisms by which residual DNA could be oncogenic, including the integration and expression of encoded oncogenes or insertional mutagenesis following DNA integration.”
Several Moderna patents (here and here) similarly reference the risks of oncogenesis and DNA integration associated with residual DNA.
Dr. Speicher’s affidavit references new research conducted by McKernan and molecular biologist Dr. Ulrike Kämmerer showing that “integration of the DNA fragments in the Pfizer COVID-19 modRNA vaccine into the human genome is possible”.
“It is important to investigate whether integration can take place in primary cells in the vaccinated population,” he said.
Dr. Speicher told me that the next step from here will be to “dive deeper into determining if and where insertional mutagenesis is occurring” in vaccinated people, “including by comparing vaccinated and unvaccinated blood and sperm samples.”
“Sperm will be especially huge because if it is shown that the spike DNA is in in sperm cells and that cell makes an offspring than every cell in the offspring’s body could be a spike factory.”
Cancer genomics scientist Dr. Buckhaults has begun his own study to test for genomic integration in mod-RNA vaccines, which he said he hopes will “prove my concerns are unwarranted by accumulating a lot of negative data”.
McKernan intends to formally publish his Pfizer vaccine integration study with Dr. Kämmerer and has more experiments in progress to figure out if the integration is occurring in hereditary or non-hereditary chromosomes.
Battle in the court
Dr. Speicher’s affidavit will be presented as evidence in the case, Julian Fidge v. Pfizer, Moderna. The plaintiff, Victorian GP and pharmacist Dr. Julian Fidge, is seeking an injunction from the Federal Court to stop Pfizer and Moderna from distributing their mod-RNA Covid vaccines.
Dr. Fidge alleges that the vaccines contain GMOs, for which Pfizer and Moderna did not obtain the appropriate licence from the Office of the Gene Technology Regulator (OGTR) before distributing the vaccines, a serious criminal offence under the Gene Technology Act (2000).
The OGTR and the TGA deny that the mod-RNA-LNPs and synthetic DNA fragments are GMOs under Australian law, but scientific and legal experts who provided evidence for the lawsuit disagree.
The matter was due to be settled in the Federal Court, but is in a holding pattern while the Federal Court formally investigates a judge who dismissed the case on the matter of standing.
The investigation was initiated in response to a complaint raised by Dr. Fidge’s lawyers, which alleges that Justice Helen Rofe concealed her prior professional relationship with one of the defendants, Pfizer, as well as family ties to the biomedical industry, before dismissing the GMO case.
Learn more about the GMO case here.
This article was originally published on Dystopian Down Under, Rebekah Barnett’s Substack newsletter. You can subscribe here.
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Fossil fuel energy generation can operate independently!
Renewables cannot operate without Fossil fuels! Fact
Nor can they manufactured and transported with fossil fuels.
Fuels from fossils don’t exist.
Hydrocarbons – abiotic energy – does exist.
It is clean, it is plentiful, it regenerates. Ergo, heretofore, it is renewable.
It’s just a bit easier to say and describe it as fossil fuel!
80% of the worlds energy comes from fossil fuels. This will not change as time goes on. Western countries getting rid of fossil fuels is politics and nothing to do with science or climate. We in the prosperous west have apparently, according to the eco socialists at the UN, used up more than our fair share of the finite resources in the ground and we are to STOP doing that. ——To impoverish their own voters with draconian climate policies western governments fully onboard with this Sustainable Development nonsense need a fairly plausible excuse.—That excuse is “climate change”——-The greatest pseudo scientific fraud ever.
Fossils don’t make fuels. Dead dinos don’t make fuel. Devonian algae and other darwinian claptrap don’t make fuel. It is abiotic and renewable – it is called hydrocarbon energy.
I think the term “fossil fuels” applies also to dead vegetation. I haven’t heard anyone argue that all fossil fuels are abiotic and none are formed from decaying plant and animal matter. Is that what you are saying?
Let’s not get bogged down in what we call coal oil and gas. That just lets the eco socialists off the hook.
It’s almost uncanny how politicians get the big intergenerational issues wrong – every time.
The climate change fiasco is one of many slow motion train crashes. Decisions made today by the Incompetent Class won’t be felt immediately and therefore there is no natural negative feedback loop. Because of this it only encourages further virtue signalling and appalling decision making.
Furthermore, even if CO2 was responsible for any very mild warming (it really isn’t) then the U.K. contribution vis-a-vis China etc is statistically negligible. So why would they punish their own populations? Also if they are against oil and choose not to use their own, why not openly criticise the world’s oil producers to prevent ‘a boiling planet’. Such double standards.
Then we have mass immigration and Covid. Not a single correct decision anywhere. Short term knee jerk reactions ahead of proper debate and planning.
The question we return to is; are most politicians really as thick’s as mince, or are they all devious gits trying to harm the country? Cock up vs Conspiracy. It’s probably a mix. What we can say with certainty: there are vanishingly few decent and intelligent MPs left in this country.
The state is incapable of doing much well and the size and scope of the state he ought to be minimised. Politicians seldom recognise the depths of their ignorance and are consumed by personal ambition and the desire to leave a legacy.
My view is it’s a conspiracy concocted by relatively few influential people at the top, but followed unswervingly by a very large flock of sheep, consisting of those who are either as thick as mince, or those whose social status/financial well-being depend on not acknowledging the lies.
Heather Mills comes to mind. This whole shit show seemed to accelerate since 2008.
“Decisions made today by the incompetent class won’t be felt immediately” ——I know what you mean but these decisions are actually being felt. Millions are now in fuel poverty because of the huge cost of renewables paid for on people’s bills. This expensive energy that has replaced affordable energy affects the cost of everything people buy causing them more misery, since everything requires energy to manufacture. ——Yet politicians and mainstream news who have simply become climate activists tell us “Renewables are now cheaper than fossil fuels”. ——This is preposterous.
I saw an analysis some weeks ago which described the rapid succession of calamities which would follow a collapse of the National Grid. I recall that water supplies would be affected quite quickly.
I would be glad if someone could give me a reference to the report.
it would be interesting to see an analysis if how the political class will respond to significant power cuts and eventual grid collapse. Presumably we will be invited to live cold so Whitehall and the glorious NHS (oh, and the BBC) can continue to operate. But a protracted period of dull, windless weather would quickly lead to permanent damage with technical difficulties in restarting all sorts of services.
public violence would likely result as water and food become scarce. The police would be incapable of controlling crowds. What would happen thereafter.
If we were lucky enough to have thrown out the political class I wonder how a rational government could replace the destroyed reliable generating capacity. Would they need to or would we, by then, have long since become an openly fascist colony of, who?
I think it will be more insidious with energy rationing, so all but the older generations remember a time when you just pressed the switch and it worked.
However, the people at the top need mass consumption to feed their coffers and mass communication to boast of their power and I am not sure how that ties in with limited supplies.
It does seem counter productive. Why would government and energy companies want you to use less of a product —“energy”. That is where the politics comes in. The politics of Sustainable Development which takes the view that affordable energy drives Industrial Capitalism, and the Liberal Progressive UN are anti capitalist. They don’t want “Free Markets” which comes from this idea that there are too many people in the world with diminishing resources (coal oil and gas)
The same people who took us into lockdown without even considering that it would have a severe economic effect, never mind calculating what that would be, cannot be expected to apply any rigour in thinking about the economic effects of the Net Zero lunacy.
Yet the British people will go out and vote for one or the other of the same bunch of evil clowns they’ve been voting for since the Idiot Blair.
I am voting for the Reform Party. It is probably our last hope. There is now a horrible personal attack on Reform from both members of the Uni-Party, but particularly the Tories. Appauling!
When I wad a youngster the UK economy was always severely constrained by “balance of payment” crises. Strangley, it seems we can now offshore whole industries and import the goods instead with no economic repercussions.
We’ve long since discarded the idea of balancing the economy. Printing money by the creation of massive debt is all the rage nowadays.
If we scaled this down to a single household the profligacy would be self evident. Fifty thousand credit cards all maxed out by the ‘adults’ with no thought for how the kids can ever handle the debts. The house would be repossessed and the house contents sold for pennies.
It’s still a problem. A massive one. But no mainstream media wish to discuss. Because dealing with it means end to Net Zero, forever wars.
They are simply ignoring the balance of payments now, and covering it up by simply printing cash. But this cash is not real, in reality it is theft of our money by means of inflation and super-high taxes. One day the pound will collapse and guess who is bankrupted? It certainly will not be politicians, but the good solid Brits who are not on welfare! Politicians keep all their takings in forign tax havens, which needs serious investigation. Where exactly did Blairs money come from, and how much tax has he paid, for example?
Why does the Climate Party get a free pass, that smooth talking charlatan who is sometimes on GB News is a pound shop Tony Blair. For him, Net 0 (Agenda 2030) is such a great opportunity, But for who!
Vote for Reform UK
. Labour got in 100 years ago so change can happen.