I keep saying that, when it comes to specific claims made in the service of antivaccine misinformation, pseudoscience, and conspiracy theories, everything old is new again. Whether it’s claims that vaccines cause horrible outcomes that include death (as in “dying suddenly,” too), infertility, neurologic damage, cancer, and chronic disease, are loaded with “toxins” and foreign DNA and/or “fetal cells,” will “permanently alter your DNA,” and generally don’t work, old antivax tropes have been furiously repurposed against COVID-19 vaccines beginning even before the vaccines were granted emergency use approval (EUA) and released to the public in December 2020. (It’s been a coordinated campaign, right from the beginning, too.) One might argue that it’s easy to see the parallels in a more general manner, such as how the claim that COVID-19 vaccines cause young people to “die suddenly” of clots compared to old claims that HPV vaccines caused young women to “die suddenly” of…something, but sometimes the resurrected tropes can be bizarrely specific. Such is the case with the latest antivax claim that’s been circulating around the antivax crankosphere, most recently at quack tycoon Joe Mercola‘s website in an article entitled Green Monkey DNA Found in COVID-19 Shots. The strange specificity comes from how the narrative repeats an old narrative about the SV40 supposedly being found in COVID-19 vaccines.
I’ll explain in a moment, but first, let’s take a trip down memory lane.
SV40 and polio vaccines c.1959-1963
Longtime regular readers might remember how, a decade ago, one antivax narrative that had bubbled up to the surface was the claim that contamination of early batches of the oral polio vaccine with SV40 virus in the early 1960s had been responsible for a wave of cancer decades later. Other variants of this claim are that the polio vaccine was responsible for creating AIDS. And, guess what? One early conspiracy theory about COVID-19 vaccines was that the spike protein produced in cells using its mRNA contained HIV sequences, making COVID-19 vaccines…AIDS? It was very similar to a decades-old conspiracy theory that AIDS had arisen because of oral polio vaccines. The entire claim was utterly ridiculous because the purported HIV nucleotide sequences were so short that a lot of genes from coronaviruses contain them, but unfortunately that didn’t stop Nobel disease sufferer Luc Montagnier, who won his Nobel Prize for the co-discovery of the virus that causes AIDS, to fall for it, even though he really should have known better. This was bad, even for someone who had become an antivax crank years before the pandemic hit.
I referred to this as a zombie meme, because it seemingly lives forever, feeds on fear, and is very difficult to kill once and for all (which is probably why it’s still resurfacing now). I’ve also noticed that, for COVID-19 vaccines, when a lot of these zombie memes reappear they seem to come back in even stupider forms. This example is no different, as you will see. First, let’s see what Mercola claims in his “fact checked” post:
In the video1 above, Dr. Steven E. Greer interviews microbiologist Kevin McKernan — a former researcher and team leader for the MIT Human Genome project2 — and Dr. Sucharit Bhakdi about the DNA contamination McKernan’s team has found in the Pfizer and Moderna mRNA shots.
As it turns out, spike protein and the mRNA are not the only hazards of these injections. McKernan’s team have also discovered simian virus 40 (SV40) promoters that, for decades, have been suspected of causing cancer in humans, including mesotheliomas, lymphomas and cancers of the brain and bone.3 The findings4,5,6,7 were posted on OSF Preprints in early April 2023. As explained in the abstract:8Several methods were deployed to assess the nucleic acid composition of four expired vials of the Moderna and Pfizer bivalent mRNA vaccines. Two vials from each vendor were evaluated … Multiple assays support DNA contamination that exceeds the European Medicines Agency (EMA) 330ng/mg requirement and the FDAs 10ng/dose requirements …
As noted by Greer,9 this means that governments and drug companies “have misled the world to a far greater extent than previously known.” If these findings are correct, it would also mean that “the so-called ‘vaccines’ are actually altering the human genome and causing permanent production of the deadly spike protein,” and this internal production of spike protein would, in turn, “trigger the immune system to attack its own cells,” Greer says.
In the interview, McKernan explains how the DNA contaminants found in the COVID jabs can result in the genetic modification of the human genome, and Bhakti reviews how and why the shots can trigger autoimmune diseases.
That sure sounds scary, doesn’t it?
Those of you with some molecular biology chops have surely immediately identified the main issue with McKernan’s claim that contamination of COVID-19 vaccines with SV40 promoter will lead to a wave of cancer, just as it was feared initially that the SV40 contamination of those early batches of polio vaccines would do. (Spoiler alert: They appear not to have resulted in a wave of cancer that can’t be explained by the normal aging of the population, but it took decades to work that out.) Basically, Mercola (and, apparently, Kevin McKernan, who, if he really is a microbiologist, should know better) are counting on the likelihood that the vast majority of people who read this claim about SV40 in COVID-19 vaccines don’t know the difference between a virus, a gene, and a promoter sequence. First, let’s recap what happened with the oral polio virus. Then I will discuss this new variation of the SV40 claim being peddled by Kevin McKernan, Sucharit Bhakti, and Joe Mercola.
It is indeed true that in the late 1950s batches of polio vaccine were found to have been contaminated with a monkey virus known as SV40, which stands for “Simian Vacuolating Virus 40” or “Simian Virus 40.” (It was the 40th simian virus that discovered by pioneering vaccine researcher Maurice Hilleman, hence the name.) In contrast to the oral polio vaccine, the polio vaccine developed by Jonas Salk and Albert Sabin in the 1950s was produced by growing polio virus in kidney cells derived from Asian rhesus monkeys. However, Salk’s polio vaccine was a killed vaccine, in which the viral particles were inactivated with formaldehyde and the killed virus injected to produce an antibody response against the polio virus that prevented infection with live polio virus. Sabin’s virus, on the other hand, was a live virus vaccine and was contaminated with SV40 from the cells in which it was grown.
In 1959, a researcher at the National Institutes of Health named Bernice Eddy noticed that monkey kidney cells were dying without obvious cause. (Note that she was also a critical player in the Cutter incident, in which she discovered that the vaccines manufactured by Cutter Laboratories had live polio virus in them.) She made extracts of the cells and injected them under the skin of 23 newborn hamsters; within nine months 20 of them developed large tumors. Meanwhile, Hilleman and his collaborator Ben Sweet isolated the virus responsible and found SV40 was found in both the Sabin and Salk vaccines. It didn’t help that Eddy had brought her findings to Dr. Joseph Smadel, chief of the NIH’s biologics division, who made a huge mistake and dismissed the tumors as harmless “lumps.”
By 1961, there was significant concern among U.S. Public Health Service officials, as researchers had found that as many as one-third of polio vaccines were tainted. As a result, although there was no evidence at the time that SV40 was harmful to humans, it was ordered that manufacturers find a way to eliminate SV40 from all future vaccines, which they promptly did. New procedures were developed to neutralize any SV40 and SV40-free African green monkeys were then used to produce the bulk of the vaccine instead of rhesus monkeys. Showing that no good deed goes unpunished, conspiracy theorists latched on to the African green monkeys as the vector through which the AIDS virus was brought into the U.S. via the new polio vaccines. (Sound familiar?) By 1963, SV40 had been eliminated from the nation’s polio vaccine stock. However, by then millions of people had received the vaccine.
But does SV40 cause cancer in humans? In a word, as far as we can tell, no. Even early on, there were indications that this was unlikely. First of all, followup studies demonstrated that while injecting SV40 would produce tumors, ingesting it did not. Other studies showed that children receiving Sabin’s oral polio vaccine did not develop antibodies to SV40, as one would expect if they were being exposed. SV40 apparently passed through children’s GI tracts without ever causing an SV40 infection.
As the years went by, there were studies that reported finding SV40 in human tumor samples, which was obviously worrisome. The most prominent of these studies were by Michael Carbone at the NIH. In the late 1980s, he tested 48 human mesotheliomas and found SV40 by PCR in 28 of them. In 1990s, PCR “unleashed a wave of SV40” discoveries, including a variety of bone, brain, and hematopoietic malignancies, so much so that in 1997 the National Cancer Institute set up an SV40 working group. Now, from the perspective of 2023, it is pretty clear that the SV40 contamination of early polio vaccines almost certainly did not result in a wave of cancer, but the myth that vaccines cause cancer had been forged. It would recur again and again, including now.
SV40 promoter is not SV40 virus
This brings us to McKernan. You’ll note that in his article Mercola recounts much of the history of SV40 in the oral polio vaccine, albeit from a very slanted perspective in which the SV40 contamination definitely caused harm and was covered up.
First, let’s make it clear that the SV40 that contaminated those early batches of polio vaccine over six decades ago was SV40 virus. Just as the simian cells produced polio virus for the vaccine, they were also producing whatever other viruses with which the cells might have been infected, namely SV40. It was not until techniques were developed to separate SV40 from the live attenuated polio virus strains being produced that it could be assured that oral polio vaccines were free from SV40 contamination. What McKernan is referring to is not a whole SV40 virus. There is no virus in mRNA-based COVID-19 vaccines. It is not even a gene. The gene in the mRNA in the Pfizer and Moderna mRNA-based vaccines is a modified form of the spike protein from COVID-19.
Here’s a diagram of the relationship between a promoter and a gene from the National Human Genome Research Institute:
But what is an SV40 promoter? In brief, a promoter is a DNA adjacent to the start site of transcription (the gene sequence that codes for the protein). Promoters are usually around 100–1000 base pairs long, and their sequences are highly dependent on the gene and product of transcription, type or class of RNA polymerase recruited to the site, as well as the species of organism in which the gene is found. Promoters can be complex, but this is the general idea. The promoter sequence near the start site is where the proteins that transcript the DNA into RNA bind, as well as regulatory proteins that can crank up or turn down the production of the mRNA from that gene. The SV40 promoter is over 300 base pairs long and is also a strong promoter that drives high levels of mRNA (and, subsequently, protein expression), which is why it is so often used in molecular biology. In brief, molecular biologists often want their DNA plasmid constructs to make large amounts of gene product when introduced into cells. So SV40 promoter sequences are practically ubiquitous in any laboratories that have plasmids (circular DNA constructs into which gene sequences are introduced and that can enter cells to make mRNA from those gene sequences).
Second, McKernan’s fear mongering about having found stretches of double-stranded DNA reminds me very much of one Sin Han Lee, who used an incredibly sensitive nested PCR assay prone to false positives to “prove” that there was “fetal DNA” in Gardasil, even though what he discovered, if legit, was such an incredible small quantity of DNA left over from the cell line used in the manufacture of the vaccine as to be harmless. What McKernan appears to be doing is very much of a piece with that old antivax fear mongering about “DNA in Gardasil” from 12 years ago.
Third, I will note right up front that I am not expert in next generation sequencing techniques like the ones used in the preprint by McKernan. Rather than dive too deeply into the weeds of his methodology, for primarily a lay audience I view it as simpler just to say that McKernans surely knows better, given his qualifications. He must know that an SV40 promoter is a very different thing from SV40 virus. SV40 virus can cause cancer in various animal models by producing large and small T-antigen early in the viral replication cycle. These antigens bind and block important tumor suppressor proteins, such as p53, pRb, p107, and p130/Rb2. If he doesn’t, all I can ask, given that he’s ostensibly a genomics guy is: WTF happened to him? No, I strongly suspect that he knows that what he’s peddling is fear mongering bullshit and that it will sound scary to people who know that short bits of SV40 promoter DNA cannot cause cancer or do all the horrible things that McKernan insinuates that it can. For that, you need the large and small T-antigens, which the whole virus makes after it infects cells. The SV40 promoter is just the tool that the virus uses to make sure that it can make many copies of itself once it infects cells.
Oh, no! There’s double-stranded DNA in a vaccine!
But what about the finding of dreaded “double-stranded DNA” in the vaccine, based on this figure from Pfizer featured in his Substack:
Where does this DNA come from? To make mRNA, it’s necessary to use a DNA template, usually a plasmid, and minute traces of that DNA can be left over from the manufacturing process, just as happened for Gardasil, although the DNA left over was from the template used to produce mRNA and then protein for the vaccine. Traces of plasmid DNA are not dangerous, no matter how much McKernan tries to hand wave and fear monger, and the FDA limits are, as he admits in his Substack, more or less arbitrary. They’re also likely the height of caution. Not that that stops McKernan from trying to make it sound scarier than it is:
This limit likely did not consider the potency of this dsDNA contamination if it was packaged in an LNP. Packaged dsDNA is more potent as a gene therapy.
We now know this DNA is packaged and transfection ready. Even lower limits should be applied if the DNA is packaged in transfection ready LNPs.
LNPs are lipid nanoparticles. One notes that McKernan never actually demonstrates that the DNA contamination that might be in the LNPs actually drives the expression of…anything. In fact, he damned well must know that it’s almost certainly mostly fragments, but that, even in the worst case scenario in which it’s fun plasmid, it can’t do anything other than make more mRNA encoding the spike protein to be added to the mRNA introduced into the cell by the LNPs of the vaccine.
To cover this up, he basically admits that the promoter isn’t the virus, but furiously hand waves to try to make it sound as dangerous as he can:
The presence of double-stranded DNA also brings up another major concern, and that is the possibility of genomic integration.
“At least on the Pfizer side of things, it has what’s known as an SV40 promoter. This is an oncogenic virus piece. It’s not the entire virus. However, the small piece is known to drive very aggressive gene expression.”
And the concern that people, even at the FDA, have noted in the past whenever injecting double-stranded DNA, is that these things can integrate into the genome,” McKernan says.”
While McKernan’s paper does not present evidence of genome integration, it does point out that it’s possible, especially in the presence of SV40 promoters:19”
“There has been a healthy debate about the capacity for SARs-CoV-2 to integrate into the human genome … This work has inspired questions regarding the capacity for the mRNA vaccines to also genome integrate. Such an event would require LINE-1 driven reverse transcription of the mRNA into DNA as described by Alden et al.”
dsDNA [double-stranded DNA] contamination of sequence encoding the spike protein wouldn’t require LINE-1 for Reverse Transcription and the presence of an SV40 nuclear localization signal in Pfizer’s vaccine vector would further increase the odds of integration.”
I note two things. First, McKernan does admit (well into the discussion) that SV40 promoter is not SV40 virus. However, Mercola at least must know that all anyone seeing his interview is likely to hear is “SV40.” Related to this, it is indeed true that SV40 can “drive very aggressive gene expression.” That’s why it’s used in plasmids and genetically engineered viral vectors to drive the expression of genes introduced into these constructs! However, even if SV40 promoter sequence from the vaccine could integrate into the genome of the cells the mRNA enters, so what? It would have to integrate right in front of just the right gene (e.g., an oncogene, or a gene that can, when too much of its product is made, induce cancer). Since McKernan’s experiments didn’t even address whether the SV40 sequence from residual DNA from the manufacturing process can actually integrate into the genome, he has to fear monger by saying it’s “possible.” Perhaps it is, but it’s also quite unlikely, and even if it did it would be primarily in muscle cells, which are what we call “terminally differentiated” and do not divide and replicate.
As for a “healthy debate” about LINE-1? I note that McKernan misrepresents this “healthy debate” (which wasn’t healthy at all). It wasn’t about whether LINE-1 could facilitate the SARS-CoV-2 virus integrating into the human genome. Rather, it was bad science used to fuel antivax claims that LINE-1 could facilitate the integration of the nucleotide sequence for spike protein from the mRNA-based vaccines into the genome. How? First, LINE-1 stands for Long INterspersed Element-1, a DNA sequence known as a retrotransposon, a mobile DNA element. Basically LINE-1 can copy itself and whatever sequence resides within it through an RNA intermediate and then integrate into the genome. About a year ago, antivaxxers were claiming that the mRNA from spike protein was being integrated into LINE-1, replicated, and then integrated into the genome of the human cells. This claim was based on a highly artificial set of experiments using human cancer cell lines. It’s not the sort of thing that is likely to happen in the real world. However, the antivax claims about LINE-1 allow McKernan to blithely say that what he’s proposing is scarier than fear mongering based on “permanent alteration” of your DNA by the vaccine through LINE-1 because what he is proposing doesn’t need LINE-1 to happen.
As if that’s not enough, beware the scary double-stranded DNA:
As for how SV40 promoters ended up in the mRNA shots, it appears to be related to poor quality control during the manufacturing process, although it’s unclear where in the development SV40 might have sneaked in. Quality control deficiencies may also be responsible for the high rate of anaphylactic reactions we’ve been seeing. McKernan tells Greer:
“It’s in both Moderna and Pfizer. We looked at the bivalent vaccines for both Moderna and Pfizer and only the monovalent vaccines for Pfizer because we didn’t have access to monovalent vaccines for Moderna. In all three cases, the vaccines contain double-stranded DNA contamination.
If you sequence that DNA, you’ll find that it matches what looks to be an expression vector that’s used to make the RNA … Whenever we see DNA contamination, like from plasmids, ending up in any injectable, the first thing people think about is whether there’s any E. coli endotoxin present because that creates anaphylaxis for the injected.
And, of course … there’s a lot of anaphylaxis going on, not only on TV but in the VAERS database. You can see people get injected with this and drop. That could be the background from this E. coli process of manufacturing the DNA …”
Of course it’s residual DNA expression vector. Also, it should be noted that the source of the vaccine subjected to analysis is not really disclosed other than the preprint mentioning that it came from “four expired vials of the Moderna and Pfizer bivalent mRNA vaccines.” Note that RNA is very unstable, even the RNA with chemically modified uracil bases used in the vaccines to make the RNA less unstable and hours instead of minutes to degrade at room temperature. In contrast, DNA is much more stable in aqueous solution, which very much leaves open the possibility that the ratio of DNA to RNA in the vaccines in this analysis artificially inflated by degradation of much more of the mRNA than the DNA under the conditions tested. Indeed, the preprint notes:
The total RNA levels are less than the anticipated 30ug (100ng/µl) and 100ug (200ng/µl) doses suggesting a loss of yield in DNA and RNA isolation, manufacturing variance or RNA decay with expired lots.
Again, we have no idea of the provenance of the vials before they expired or how McKernan got them, at least not from his paper or Substack that I can find. Who knows how they were stored before he got them?
As for endotoxin, bloody hell. Injectable products are tested for endotoxin contamination! Remember when I discussed how antivaxxers were so “concerned” about how the rollout of COVID-19 vaccines would require so much more blood from horseshoe crabs, which are captured and partially bled before being rereleased and whose bloodletting leads to the death of a certain percentage of the crabs? Antivaxxers were claiming that vegans shouldn’t use the vaccine because of this. But why is this crab blood harvested? It’s because the blood contains a substance that allows the detection of endotoxin in injectable products. Antivaxxers weren’t really concerned about the environment or how increased demand for horseshoe crab blood might endanger the species. They just latched onto something “icky” sounding to fear monger about vaccines. But I digress. The point is that the vaccines are tested for endotoxin, as are most injectables. If McKernan doesn’t know that, he should.
He should also know this:
However, the key point is that the presence of the contaminating DNA is only the first in a long chain of events.
This DNA then has to get from the site of injection into cells, so the low amount of DNA is likely to get further diluted in the process. Thus, it is unlikely that there is enough of the contaminating DNA to get into many cells in large enough quantities.
Next, the DNA has to cross the cell membrane, enter the cell/cytosol, and then go from the cytosol of the cell into the nucleus—a separate compartment for the DNA and closely associated proteins—this is like entering a fortress. To do this, there has to be enough DNA, which has not degraded in any way (double-stranded, and ends protected in some way—for instance, circular DNA of plasmids). Not surprisingly, a lot of the DNA is likely to be lost in transit.
This, in fact, is a challenge that DNA vaccines need to overcome. This additional step (an extra membrane to cross cytosol-to-nucleus) is actually thought to be the reason that DNA vaccines produce a lower immune response as compared to mRNA vaccines.
Once in the nucleus, this piece of DNA must be intact and have the features necessary to subvert the machinery of a cell, which must be a dividing cell (a non dividing cell would be an endpoint), and integrate into the DNA, bypassing all the checkpoints in place to prevent DNA damage… the same mechanisms that prevent tumours every time a cell makes a copy of itself.
So, there are multiple molecular checks to ensure that such incorporation of DNA into the genome is rare. Having said that, some DNA viruses and viruses such as HIV are able to do it, so it is not entirely improbable. While integration can occur, it would be quite unlikely and one necessary step may be necessary for this piece of DNA to make copies of itself within the nucleus of a human cell, i.e., replication competence. Most of the COVID-19 vaccines are based on non-replicating vectors; this means that they do not have the sequences necessary to make copies of themselves even if they did get into a human cell.
Basically, it’s very difficult to get robust gene expression in living human muscle cells by injection even large amounts of plasmid into skeletal muscle, much less get appreciable integration of that DNA into the genome of those cells.
But wait! according to McKernan and Bhakti, even if the minute amounts of contaminating double-stranded DNA containing the dreaded SV40 promoter don’t get into the genome and thereby “permanently alter your DNA,” they’re still dangerous:
Dr. Bhakdi raised an important point. Even though the dsDNA is packaged in an LNP and contains nuclear localization sequence from SV40 promoters, the sequence doesn’t need to be localized to the nucleus for problems to occur.
He correctly points out that even cytoplasmic transfection can present risks in dividing cells. During cell division, the nucleus disassembles and exchanges cellular components with the cytosol.
Even if this were true, the muscle cells into which the vaccine is injected do not divide, as I mentioned before. It’s all hand waving.
Reading Mercola’s article and some of the Substack entries by McKernan, I can’t tell for sure if he’s either become such a true believer that he’s forgotten much of what he used to know about basic molecular biology in search of confirmation of his belief that COVID-19 vaccines are dangerous or if he’s lying. I suspect, but can’t know for sure, that it’s the latter, but take your pick. His narrative, in which he does concede almost as an aside that SV40 promoter is not SV40 but flips back to fear mongering about the promoter to make it sound as though it can cause cancer makes me think it’s the latter, as does his invocation of LINE-1 nonsense in order to tout his claim as being more likely because it doesn’t require LINE-1.
It’s also why McKernan ignores these very basic considerations:
This commentary has used the terms “unlikely” and “low probability” instead of “impossible” since organisms such as viruses have learnt how to break every rule in their host cell’s playbook to get ahead in the evolutionary race. This is why studies that look at different aspects of this process—starting from how much contaminating plasmid is present in the vaccine vial; is the load high enough to reach the cells; how many cells take up the DNA; does it get to the nucleus at all; does it persist there; does mRNA from the vaccine get converted to DNA within the body; when does it get cleared in different cell types, etc.—need to be done, rigorously and in multiple systems, especially as we gear up to use these vaccine technologies for more and more diseases. Presently, studies that raise alarms about the “integration” of COVID-19 vaccines and contaminating DNA, do not provide sufficient evidence across all these aspects to be taken seriously.I can’t help but contrast how McKernan does the exact opposite. Instead of using nuanced language, he does his damned to imply that “possible” (even if just barely possible and also highly unlikely) automatically equates to “definitely happens.”
That’s because McKernan’s study was never designed to be taken seriously by scientists, which is probably why he published it as a preprint, rather than waiting for it to be accepted to a peer-reviewed publication (which will be a difficult task for him to accomplish). It was very likely designed to be used to spread fear, uncertainty, and doubt about vaccines, which is why he is doing videos on Rumble and interviews with an antivax crank like Joe Mercola rather than trying to convince his scientific colleagues at academic conferences and in the peer-reviewed biomedical literature.
As for the fear mongering about SV40 in COVID-19 vaccines, truly everything old is new again, sometimes in surprisingly specific ways.