EXCLUSIVE: An interview with Buckhaults about DNA contamination in covid vaccines... and the FDA responds

Earlier this year, genomics expert Kevin McKernan first discovered DNA contamination in vials of Pfizer and Moderna’s bivalent booster shots.  He published his findings in a pre-print, but the research received little attention from the mainstream media.

Observing from afar was Phillip Buckhaults, a cancer genomics expert, and professor at the University of South Carolina. Initially, he dismissed McKernan’s findings as “conspiracy” and decided to debunk the work by carrying out his own testing on the mRNA vials.

But what Buckhaults discovered shocked him --> McKernan was right! Buckhaults found billions of tiny DNA fragments in Pfizer’s mRNA vaccine, and recently testified about it before a South Carolina Senate hearing - I covered in a previous article.

I presented the findings of Buckhaults and McKernan to the US FDA.

I asked the FDA if it had begun an investigation into the issue of DNA contamination and whether it would review its guidance to industry about residual DNA in vaccines.

I also asked the FDA if it had instructed Pfizer and Moderna to conduct further testing to demonstrate the absence or presence of genome modification and whether it would issue new warnings to the public about the potential risks, now that DNA contamination in the vaccines had been established and replicated.

The FDA responded but did not answer specific questions, nor did it acknowledge the problem of contamination and potential safety issues.  In a written statement it said:

The mRNA COVID-19 vaccines authorized or approved for use in the United States are not defined as a gene therapy.

The FDA is confident in the quality, safety, and effectiveness of these vaccines. The agency’s benefit-risk assessment and ongoing safety surveillance demonstrates that the benefits of their use outweigh their risks.   

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I spoke with Buckhaults about the unfolding events. Our conversation was edited for clarity and brevity.

Prof Phillip Buckhaults, University of South Carolina

BUCKHAULTS: I didn't have any preconceived notions about there should be something bad in the vaccine, I'm not anti-vaccine, I've actually been vaccinated. And I recommended it to everyone in my family and everybody I care about, but I have been mindful of the fact that there seems to be some reports of vaccine injury out there and I would like to know what the reason is.

DEMASI: Why did you investigate this?

BUCKHAULTS: I could see anxious discussions online getting out of control.

DEMASI: Like what?

BUCKHAULTS: I saw people talking about SV40 (full virus) sequences…

DEMASI: So that’s a virus in monkeys and humans that can cause cancer?

BUCKHAULTS: Yes, and it was going to frighten people into not getting the vaccine. I wanted to put a stop to it.  My plan was to examine the vaccine to debunk the fear of SV40 being in the vaccine. One of my good friends and colleagues that I trust kept every “empty” vial of vaccine that they administered in his freezer.  Each vial had a little bit of vaccine left over.

DEMASI: What did you do with the vials?

BUCKHAULTS: I checked them first by a PCR assay that uses primers against the vector, and lo and behold, it fired very hot. A very, very high signal. So, then I happen to have a lot of nanopore sequencing capability in my lab from my COVID work. And so, we just had one of my students take everything that was in a few vials and precipitate and put it on the nanopore sequencer and son of the gun, Kevin McKernan was right, this plasmid is present in the vaccine. I proved that there is NOT SV40 full virus, but there is plasmid DNA. And that plasmid does have a little piece of SV40 in it.

DEMASI: When you say a ‘hot signal’, explain what you mean?

BUCKHAULTS: Well, on a PCR assay, water comes up at barely at cycle 40 or not at all, but the signal on the vaccine was coming up a cycle 20. That's like, a million-fold over background and that's like a ginormous signal. I was seeing about 2 billion copies per dose. One lot was 1.6 billion copies per 300 microliter dose and the other one was 2.5 billion copies per 300 microliter dose. So, the signal coming off the machine was a really hot signal - the Ct value was 20 cycles above background. That’s a lot.

DEMASI: So, the “conspiracies” were true?

BUCKHAULTS: Well, there is DNA contaminating the vaccine, but I was also able to put a stop to some of the rumours on social media about the SV40 virus being in the vaccine and that its going to give everybody cancer because that's not true. There's just a piece of SV40 promoter in the vaccine. And that's what people were seizing on, people were saying there’s a monkey virus, we're all going to turn into monkeys or get cancers next week or something. And, and I did my due diligence to tamp down that kind of fear - which was my original purpose.

DEMASI: What did you do once you discovered DNA in the vials?

BUCKHAULTS: I needed to say, look, I found this amount of DNA, it's really true, and there are many copies. We precisely measured it many, many times by PCR and I've done sequencing now about four times and it's there - lots of the DNA is chopped up into little bitty pieces, maybe one to 200 base pairs long, and the entire plasmid is represented, you can rebuild the whole the whole sequence. By PCR, I guesstimate that there's probably somewhere between 5 and 20 nanograms of this plasmid per dose for 300 microliter dose, in the two lots that I've looked at - it was the only two lots that we had here in Colombia. So the observation first reported by Kevin McKernan is absolutely true.

DEMASI: I read somewhere the FDA allows about 10ng of residual DNA to be left in the vaccine and that’s thought to be safe….?

BUCKHAULTS: I am not a regulatory expert but it appears this is a magic line the FDA arrived at before lipid nanoparticles existed. It was back when they were just injecting proteins and or attenuated viruses that they made in CHO cells and a little bit of DNA comes along for the ride, but it's naked DNA. Right? And they've done studies where they inject gobs of naked DNA into mice and never see any problems. But this isn’t naked DNA. This is different and that's what gives me pause that may be the regulatory limit is just not relevant to mRNA vaccines that have lipid-nanoparticles or LNPs, transporting the genetic material to the inside of cells.

The LNPs facilitate getting the DNA inside the cell - just inside the cell membrane. But once it's in the cytoplasm, bits of DNA go to the nucleus just by random chance. And that would happen no matter what the delivery mechanism was. Once the LNPs fuse with the membrane of cells and dump their cargo into the cytoplasm, they’ve done their job.

DEMASI: In the batches you tested, you found that most particles were less than 200 base pairs….what does that mean?

BUCKHAULTS: It matters about the size of the particles. The FDA says 10 nanograms. Now 10 nanograms could be from one molecule that's absurdly ginormous. Or it could be a whole bunch of little bitty molecules. And the hazard for genome modification is not a function of the mass. It's a function of how many independent molecules you've got. So, it's actually way worse, having a whole bunch of these little pieces in terms of a risk of some insertional mutagenesis happening. That's way worse than even having one big piece leftover. Right? I don't think there was anything nefarious about this. It just seems kind of accidentally administratively dumb. That's my own personal opinion.

DEMASI: Perhaps they were in a rush to get the vaccine out there? Operation Warp Speed…

BUCKHAULTS: Yeah, the world was on fire, and we were scared to death. So, I don't fault anyone. Rushing? It’s easy to sit back here now, in the safe comfort that the fear has passed and now, we're all sitting in our offices, and nobody's scared about the world coming to an end, and then throw rocks at what was done three years ago by people trying to save us all. I think that's really unfair. I really think that mostly people were working in good faith to try to put fire out.

DEMASI: So, how do you know that once inside the cell, DNA can travel to the nucleus and get into the genome?

BUCKHAULTS: I know that the potential for a piece of DNA to randomly insert eventually comes up. We do this in the lab all the time. We take pieces of naked DNA, put them in lipofectamine which is a solution that delivers genetic material into cells, and by magic, some of the pieces integrate into the cellular DNA, and permanently modified the cells. I've been doing this since I was a graduate student, so I know that this happens. The only question is, what is the frequency of this happening across a vaccinated population? And is that frequency high enough that we should worry about it? Or is it low enough that the good that comes from the vaccine far outweighs the risk? We just don't know what the frequency of genome modification is.

DEMASI: What does it mean for vaccinated people that the vials are contaminated with DNA?

BUCKHAULTS: People will disagree on the magnitude of the risk. We do not yet know if it means anything or not.  There's a chance that this DNA does nothing, but because I have a background in cancer genetics and cancer biology, somatic mutations are my expertise. And I think that there is a reasonable chance that if you inject pieces of DNA that are wrapped up in this transfection particle – the lipid nanoparticles - there is a reasonable chance that some of this is going to get into cells, and then integrate into the genome of cells. I think we should check and find out. 

DEMASI: If it does get into the genome, what does it mean?

BUCKHAULTS: IF genome modification is happening, It's just a matter of time before one of these fragments hits a tumour suppressor gene and initiates the beginning of cancer in a single stem cell. Also, there have been reports of myocarditis. I'm wondering if it's possible that these little bits of DNA actually encode pieces of the spike protein…..There's a lot of open reading frames in these pieces of DNA that code for peptides that don't belong in humans and are neo-antigens. And my concern is that some of these pieces of DNA could transform long lived stem cells in, maybe the myocardium, or pericardium, or maybe the liver, or lymph nodes…and now that tissue makes a long-lived expression of some neo-antigen that could be causing a long-term autoimmunity type response like myocarditis. So, they are the two things that immediately come to mind - the small possibility of cancers in people in the next five years down the road, or the possibility of autoimmunity from the production of these peptides.

DEMASI: Got it. Just so I'm clear, there haven't actually been studies or evidence of integration into a person's DNA? Am I correct?

BUCKHAULTS: No there is no evidence of genome modification, because, as far as I know, no one has looked. This is entirely a theoretical concern that in my view absolutely should be looked at.  As I mentioned, people have done all kinds of studies with naked DNA and showed that it's not a hazard. But that’s because the naked DNA gets chewed up before it can ever get into the cells. But if LNPs are delivering it to the inside of cells like they are in the mRNA vaccines, then random piece of DNA can (theoretically) integrate into the human genome upstream of some cancer promoting tyrosine kinase, or an oncogene, or even K-RAS, any of your favourite oncogenes where overexpression of the gene can create cancer.  Little bits of DNA can act like a promoter if inserted where they do not belong, or if they disrupt a transcriptional repressor gene, that’s another way that you can accidentally turn the gene expression volume knob up to 11.  Also, the SV40 promoter/enhancer is a sure-fire way of increasing gene expression, so the risks of cancer would be if the SV40 piece lands upstream of MYC, or K-RAS or EGF receptor or any of the famous cancer genes. But you don't really need that for this hazard to be there. If the SV40 wasn't there, there will still be ways that this could happen.

DEMASI: About 18 months ago, there was a study that suggested the mRNA from the vaccine could be reverse transcribed into the genome of human cells in a petri dish…..doesn’t that suggest integration into the genome can happen? what did you think about that study?

BUCKHAULTS: 18 months ago people were asking about the RNA being reverse transcribed and I dismissed it on theoretical grounds. But there were some papers that showed staining of what looked like spike expression in places that it shouldn't be in experimental animals and the best I could think of was, well, this must be some sort of an artefact because there's no way to get from RNA to genome modification. Well, we didn't know back then that there was something more than RNA in the vaccine. We did not know that there was DNA contamination.

DEMASI: So this discovery of the DNA in the vaccine might be able to explain some of those findings?

BUCKHAULTS: That's exactly right, I put two and two together when I saw Kevin's sequencing results, I thought, oh, no, maybe this is explaining those results that I unfairly dismissed. They were right. Maybe they just didn't know the mechanism.

DEMASI: The FDA has always maintained that there was no evidence that RNA could modify the genome…

BUCKHAULTS: You can see why. They’d be thinking it's an RNA vaccine, there's no way for the RNA to get transcribed and become DNA and get integrated into your cells. And that's a reasonable response based on theoretical grounds…. But I bet you most people making such assurances did not appreciate that there was DNA in the vaccine. When Kevin McKernan first posted his findings, I thought, oh, my stars, there's actually DNA in the vaccine and maybe that explains what those people saw when they thought was somehow magic reverse transcriptase, turning the RNA into DNA, and then that getting integrated into cells. There's no need for reverse transcriptase. If there's pieces of DNA in the vaccine, some of them are long enough to have the entire spike open reading frame. And there you go, your cells are now making spike protein continuously.

DEMASI: There was an autopsy study that detected spike protein in the heart and brain of a patient who died after vaccination. They confirmed the patient had never had covid infection (absence of nucleocapsid proteins). Does this suggest genome integration?

BUCKHAULTS: Yes, this is a reasonable speculation.  Spike protein in heart or brain proves the vaccine travelled away from the muscle, but does not necessarily mean genome integration happened. It could be the mRNA is being expressed there for many days before fading away. It definitely supports the hypothesis that rare myocarditis (and maybe stroke) is from immune attack on antigen created by the vax. The only nuanced difference between this and the DNA mechanism is the amount of time this immune reaction would last. If it’s against mRNA generated spike, then it will fade away with time, and hopefully fade before a critical number of those target cells are killed by the immune system. If it’s against an antigen created by DNA integrating into the genome of the transfected cell, it will last for the lifetime of that cell and be passed down to all that cells progeny. Think chronic auto-immune attack against some tissue.   

DEMASI: Do you even need genome integration to show harm?  We know from biodistribution studies that the LNPs travel all over the body and make cells produce spike protein, so couldn’t someone who was vaxxed develop myocarditis and die because of the spike protein in the tissues – or am I making a leap?  

BUCKHAULTS: No, genome integration is not the only possible mechanism for harm. It’s just the one that will leave a calling card that can last years, and so is amenable to testing people months to years after the vaccine. Your speculative leap is not crazy and is precisely what I and a few other "experts" think is a reasonable explanation for what's going on.  The vax was “sold” under the premise that expression was both local and temporary. Even if its temporary (no DNA involved) the fact that it is not really local undermines part of the sales pitch, and may be a fundamental feature of the platform.  The only tough part with this RNA-only mechanism is how to explain the large variation in adverse events.  Most people experience no adverse effects, but a few have catastrophic injury or death.  I know of no batch-to-batch variation that would change the propensity of the mRNA to land in heart, brain, or gonads vs stay put in the deltoid muscle. That could be patient to patient variation from some unknown factor.  However, the DNA based mechanism could be related to a manufacturing process in which there is wide batch-to-batch variability in the amount of DNA that makes it through and thus explain batch-to-batch variation in frequency of adverse events. This is all speculative, but reasonable hypotheses to test.

DEMASI: How should Pfizer have dealt with the problem of DNA contamination?

BUCKHAULTS: It looks like maybe they chopped up the plasmid DNA with the enzyme DNAase but they didn't purify all the bits away. So, they actually may have increased the hazard for genome modification. Because instead of having one big piece, you got like a bazillion little pieces. They turned a shotgun slug into buckshot pellets - It would have been optimal if they had chopped it up, and then done some size exclusion chromatography column that would get all the little pieces out and have only the big RNA left. And then there would not have been any chance for genome modification.  But as I said earlier, its’ easy to be critical in hindsight.  When the world was on fire, I think everyone was doing the best they could.

DEMASI: Studies have shown that spike protein has been detected in the body for several months – its long lasting – is that because of gene modification?

BUCKHAULTS: This is something that Kevin McKernan was voicing concerns about, instead of there being short pieces of DNA disrupting genes, there could be longer pieces of DNA that are long enough to contain the instructions for building an entire protein.

DEMASI: Like all the instructions to make a full spike protein in the person’s genome?

BUCKHAULTS: Yes, so what if someone got transfected with a long piece of DNA that had instructions that encoded for all of the Spike protein? And the long piece of DNA got integrated into the genome of some long lived cell type  in the myocardium? Well, now, you have that cell type making spike protein all the time. That was the one of the concerns about a mechanism for myocarditis.

DEMASI: So, you’re saying that the cells of the myocardium could be permanently transformed?

BUCKHAULTS: It’s possible that long bits of DNA that encode spike are modifying the genomes of the just a few cells that make up the myocardium and cause long term expression of Spike, because they're permanently transformed. And then the immune system starts attacking those cells…and that's what causes these heart attacks. Now, that is entirely a theoretical concern. But it’s not crazy and it’s reasonable to check.  Now, because the two batches that I looked at, had such a small percentage of the total reads that were long enough to contain all of spike that I didn't think it was a reasonable thing to worry about. The greater hazard in my view, would be from the short pieces of DNA disrupting some gene or expressing a small novel antigenic open reading frame. If there are other batches of vaccine out there that are contaminated with big chunks of DNA plasmid that code for spike protein, then absolutely that could be a problem too.

I don’t want to scare people in the general public, but I think it would be best to encourage the regulators and Pfizer and Moderna to check this quietly and fix future batches of vaccine by removing all traces of DNA.  The public should be informed when there are clear answers, but not repeatedly troubled during the process of obtaining these answers.  

DEMASI: Is it plausible that these gene mutations will be passed on to the next generation?

BUCKHAULTS: The material does migrate to ovaries so this would be a good place to look.

DEMASI: In Australia, lawyers have filed a case in the Federal Court suing Pfizer and Moderna for failing to register the product as a gene therapy – they argue that it meets the Australian legal definition of a genetically modified organism or GMO. Would you say this vaccine is a “gene therapy”?

BUCKHAULTS: It is technically true, because it has pieces of DNA in it that may be modifying the genome, but to call it gene therapy, is unfair hyperbole. It's not the intent of the therapy. The intent is to deliver the messenger RNA to make spike, and then to stimulate immunity. It might be accidental gene therapy, if my concerns are true, but it's not intentional gene therapy. I wouldn't call it gene therapy but there's a possibility of accidental genome damage.

DEMASI: What do you want to see happen?

BUCKHAULTS: I'd like to get hundreds of colleagues across the world who have the right samples and skills in their lab to just check what they've got. If interest is sparked among scientific circles then maybe additional genome jocks will investigate. For example, there are studies going on right now that may incidentally generate the answers we seek.  The National Cancer Institute (NCI) has this programme called the SMaHT program, (Somatic Mosaicism Across Human Tissues) and they're basically taking normal cells from normal people and doing single cell sequencing to see what is the rate of somatic mutations in normal cells across the lifespan. By chance, there's going to be a bunch of samples taken from vaccinated people. So, checking on this hypothesis of genome modification might be pretty easy by looking at existing samples and upcoming data.

DEMASI: How about publishing these findings in a journal?

BUCKHAULTS: We will do this when we accumulate enough data.

DEMASI: Did you notify the FDA?

BUCKHAULTS: Yes, informally. 

DEMASI: And have you had a response from the FDA?

BUCKHAULTS: No, no. And given the kind of radioactive nature of the topic, I don't expect them to say anything. The best case scenario is they'll go quietly check for genome editing - maybe they are already doing this and I just do not know about it -and then if they find something, they'll fix the production process.  But in the meantime, independent academics with samples and skills should check.

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