Antivaccine nonsense Bad science Medicine

“Adulteration”: The latest iteration of the antivax “toxins gambit” applied to COVID-19 vaccines

The latest antivax line is that trace amounts of residual plasmid DNA fragments constitutes “adulteration.” It’s just the “toxins gambit” twisted into a bad legal argument.

Over the last two or three weeks, I have sensed a disturbance in the Dark Side of the Force on social media, specifically that branch of the Dark Side that consists mainly of the antivaccine movement, specifically that part of the antivaccine movement most focused on demonizing COVID-19 vaccines. Perhaps you, too, have sensed it. There is a new word being applied to COVID-19 vaccines, the better to portray them as horrifically compromised, and that word is “adulteration.” It’s a new spin on a very old antivax trope, namely the “toxins gambit,” in which antivaxxers going back to time immemorial have tried to portray vaccines as disgusting witches’ brews of nastiness full of horrible “toxins“, a variant being the claim that vaccines have “fetal cells” or “fetal DNA” in them and are thus horrifically contaminated. Heck, that last one has even been used by antivaxxers about COVID-19 vaccines! (Also, don’t forget that the lipid nanoparticles in COVID-19 vaccines, if you believe antivaxxers, are also horrifically toxic—and sterilize our womenfolk, too.)

The latest variant of the “toxins gambit”—if you’ll excuse my reference to Marvel’s Loki—has consisted of fear mongering about residual plasmid DNA in the mRNA-based COVID-19 vaccines, complete with sequences from the dreaded SV40 promoter, which sounds a lot like the SV40 virus that contaminated batches of oral polio vaccines over 60 years ago and, because the virus is oncogenic in some cells, led to fears of a wave of cancer over the decades after. Fortunately, that wave of cancer never appeared, and no increase in cancer due to SV40 contamination of those batches of oral polio virus six decades ago was ever detected in epidemiological studies. I swear, there’s so much bad science and fear mongering about fragments of plasmid DNA that remain in the Pfizer and Moderna vaccines at concentrations far below what regulatory agencies consider allowable and safe (awful science by people like Kevin McKernan notwithstanding) that it makes me wonder how we could train so many supposed molecular biologists who are so clueless about, you know, molecular biology.

In any case, over the last few months, the variant of the “toxins gambit” that’s been promoted has been that the Pfizer and Moderna vaccines are “contaminated” with dreaded plasmid DNA that might somehow integrate into your genome and cause “turbo cancer” by disrupting tumor suppressor genes…or something. (Whatever they do, according to antivaxxers they’re horrible because they somehow “permanently alter your DNA! Hint: They don’t.)


Towards the latter half of last month, I started noticing a twist on the old antivax false talking point that the vaccines are so hopelessly contaminated with plasmid DNA leftover from the manufacturing process that they are dangerous, cause “turbo cancer,” and all sorts of other mean and nasty things and that twist has been to stop using the word “contamination” and instead to start using the word “adulteration” and describe the vaccines as “adulterated.” One of the earlier examples of this spin came from—who else?—that tech bro turned into the most rabid of antivaxxers, Steve Kirsch, who a couple of weeks ago posted an article to his Substack entitled The vaccines are adulterated. The FDA should take them off the market. New court ruling shows how vax manufacturers are liable. No need to read the post, as it’s basically a brag about how much engagement a Tweet/Post on the platform formerly known as Twitter that Mr. Kirsch had garnered by saying:

Note that Mr. Kirsch declares, “It’s considered adulteration,” and then says he learned this from a phone call with Robert Malone and Byram Bridle.

The origin of the claim that the vaccines are “adulterated” seems to come from the video that Mr. Kirsch posted to his Substack the next day in a post entitled Exclusive: Video interview with 3 experts reveals evidence that the drug companies knew about the SV40 promoter, yet decided to conceal it from the regulators., in which he interviewed Byron Bridle, Kevin McKernan, and Chris Martenson. Let’s just say, a brain trust, this is not. Also, wait, what? No Robert Malone? No Peter McCullough? (I couldn’t help but wonder.)

But why use the word “adulteration”? Likely, someone stumbled upon it with respect to the FDA, which is specially tasked making sure that food and drugs are not adulterated.” If you look at the history of the FDA, guarding against adulteration is one of its primary missions; so by using the word “adulteration” or “adulterated,” antivaxxers are invoking a specific responsibility tasked to the FDA from the very beginning of its existence. Indeed, a couple of days later Dr. Robert Malone specifically invoked this FDA responsibility in a Substack post entitled What is Adulteration of pseudo-mRNA vaccines, and why should you care? The intent of the messaging doesn’t get much more obvious than this:

The FDA’s job is to ensure that drugs, vaccines, medical devices and foods are not adulterated. The remedy for adulteration is immediate recall and seizure if necessary.

And, after citing McKernan’s awful science in which he cherry picked a method of measuring DNA in the COVID-19 vaccines that produced unbelievably high values, mainly because he didn’t control for crossreactivity with the much higher amount of RNA in the vaccines, Malone continued:

According to the US Congress, Adulteration is defined (in CFR Title 21CHAPTER 9SUBCHAPTER V § 351) as follows (partially redacted for focus and simplification):

From this, antivaxxers have striven mightily to demonstrate that leftover fragments of plasmid DNA, which were reported to various regulatory agencies, constitute “adulteration” and thus mandate immediate removal of the Pfizer and Moderna vaccines from the market. Indeed, Dr. Malone makes that explicit later in his post:

First, as discussed above, it is my expert professional opinion that, to the best of my knowledge (assuming the data and facts reviewed above to be true) that the products tested by Speicher et al meet the formal regulatory criteria for adulteration.

Secondly, it is my expert professional opinion that, to the best of my knowledge (assuming the data and facts reviewed above to be true) that the products tested by Speicher et al represent a significant risk of health hazard.

That’s all well and good, but Dr. Malone is an antivax crank and conspiracy theorist. Actual experts in drug safety regulation do not agree. But what the heck? Let’s see what antivaxxers are claiming. Conveniently enough, earlier this week Dr. Malone posted a followup entitled mod-mRNA “Vaccines”, DNA Fragment Risks, with the subtitle Don’t give me no lies and keep your strands to yourself. Hilarious.

“Adulteration”: Heavy lifting indeed

Before I delve into Dr. Malone’s article more, I note that it’s just another variant—whoops, there I go again!—of the claim that the ever-deluded Mr. Kirsch made, in which the term “adulteration” is made to do some seriously heavy lifting:

Health Canada did *NOTHING* to stop the vaccines after admitting the vaccines contain an active ingredient that they were never notified existed and have no clue how damaging it is. They aren’t going to stop the vaccine, they aren’t going to warn the public. And they certainly are not going to do the research into the harms being done. Nor will they even ask the drug companies to do the research. They are simply going to act like it didn’t happen and make sure that the press doesn’t write about it so nobody will know. They just want the whole mistake to go away and their hope is by ignoring it, it will just “disappear.”

Which brings us to Dr. Malone’s “take” (if you can call it that) on the “adulteration” issue in the “executive summary” of his post:

After three years of drug manufacturers and regulatory agencies insisting the COVID shots were safe, study findings by independent scientists now demonstrate that certain modified-mRNA shots may meet or exceed regulatory standards for “adulteration” with DNA fragments.  In the case of the Pfizer/BioNTech product, these fragments appear to include DNA of a particular sequence (SV40 origin-enhancer-promoter) which is biologically active in animal cells.  The presence of SV40-derived DNA fragments was not fully disclosed by the manufacturers to regulatory authorities.  

This lack of transparency raises serious questions about how these fragments and specific DNA sequences escaped regulatory consideration, and why the presence and risks of significant amounts of SV40- and bacterial-derived small DNA fragments were not discussed by the manufacturers in documents submitted to regulators. The study’s findings have been replicated by other scientists prompting several international medical organizations to call for the immediate recall of all COVID shots. 

One thing that I failed to emphasize as much in my previous posts about the “plasmid DNA contamination”—or should I say, “adulteration”?—of COVID-19 vaccines is that there is no SV40 promoter sequence in the plasmid used by Moderna to generate the mRNA for its SpikeVax. It’s only in the plasmid used by Pfizer to generate the mRNA for its Comirnaty vaccine. As an aside, I can’t help but wonder, then, why McKernan and his merry band of antivax molecular biologists fear monger pretty much equally about both vaccines? After all, the Moderna vaccine doesn’t even have SV40 sequences in it—not a single one! Even Dr. Malone admits this!

I also note that some of us have been wondering why Pfizer chose to include an SV40 promoter in the plasmid. SV40 is, as I have mentioned many times before, a strong promoter that drives a lot of expression (production) of the mRNA of whatever gene it is placed upstream of, but both Pfizer and Moderna use a cell-free in vitro transcription reaction using a bacterial T7 polymerase to generate the desired mRNA in large quantities. Getting into the possible reasons would be getting too deep into the weeds for this, although I will mention that the SV40 promoter is in front of a gene for antibiotic resistance (kanamycin) that is commonly used to allow selection for clones of cells harboring the plasmid using G418, as shown in this map taken from one of McKernan’s manuscripts:

Pfizer plasmid
Note that the SV40 promoter sequence is not only not associated with the cDNA for spike protein, but it is directed in the opposite direction, located upstream of NeoR/KanaR, the gene for resistance to neomycin/kanamycin.

I’ve also noted that there’s no way scientists could have expected that antivaxxers would have seized on any SV40 sequences in the plasmid as a strategy to fear monger. Indeed, I don’t know if, had I been involved in developing the Pfizer vaccine, I would have foreseen this development.

Dr. Malone spends considerable verbiage asserting his bona fides as a scientist, which include:

From time to time I am reprimanded by social media commentators and trolls to “stay in your lane”. I generally disregard these comments because my “lane” has broadened over the last four years, and our scope of knowledge and competency has increased as Jill and I have transitioned to becoming full time policy analysts and writers. But in the case of issues relating to DNA and RNA delivery, genomic insertional mutation risks, activation/inactivation of oncogenes, tumor suppressor genes and general mutagenesis, this has long been in my expertise portfolio. In fact, long ago Jill and I helped launch a breast cancer research program for the US Army and Uniformed Services University of the Health Sciences!

Which is all well and good, but I can add that I’m probably slightly younger than Malone (based on his history), and I’ve been NIH R01-funded and Department of Defense-funded (among other funding sources) for breast cancer research over the years. Indeed, I can’t resist repeating something I’ve noted before. Dr. Malone loves to recount how he was one of the first to examine the expression of mRNA packaged in lipid vesicles in vivo. I worked in a lab that was one of the early labs to measure in vivo expression of genes from plasmids injected into muscle. I didn’t work on that project, but thanks to lab meetings I was deeply exposed to the issues with such approaches. He also notes that he published a paper about endotoxin as a potential contaminant of the lipid vesicles used to package mRNA and DNA vaccines, which is nice, but it was also in 1996.

Now here’s where Dr. Malone gets a bit deceptive:

Beginning in 1983, I began my journey in learning the trade and craft of molecular virology in a UC Davis School of Medicine Pathology lab which focused on the molecular biology of breast cancer and the use of the Mouse Mammary Tumor Virus retrovirus to determine linkages between oncogenes, tumor suppressor genes, retroviral insertions (ergo “integration”), and murine breast cancer. This was under the direction of Pathology Professor Dr. Robert Cardiff, MD, PhD, one of the early molecular pathologists, who had just completed a sabbatical at UCSF in the laboratories of Drs. Bishop and Varmus (Nobel laureates for discovery of oncogenes). This was where I learned to extract, purify, handle and analyze both DNA and RNA from tumor and blood samples.

The way that many oncogenes and tumor suppressor genes (and many other key regulatory proteins) were first identified was to introduce genetic elements (retroviruses, transposons – “jumping genes”, or other DNA sequences) into the cells or tissues of animal models. Another way was to take naturally occurring cancers (such as chicken sarcomas), grind them up and look for tumor-associated viruses that might have picked up genetic material from the host. From this you can appreciate that pretty much anything that interferes with the integrity of animal genome DNA by inserting itself into chromosomal DNA can cause cancer.

Given this background, Dr. Malone surely knows that the small fragments of degraded plasmid DNA in COVID-19 vaccines left over from the manufacturing process are not anything like retroviruses, transposons, or viruses. They’re just naked DNA, and relatively short bits of it too. Retrotransposons, for instance, have specific mechanisms of insertion into genomic DNA in the nucleus, and no doubt Dr. Malone knows this. He nonetheless conflates tiny amounts of plasmid DNA fragments with viruses, retrotransposons, and other genetic elements that can insert into genomic DNA and cause insertional mutagenesis (mutation by inserting into a gene, sometimes a tumor suppressor).My retort to Dr. Malone is that his background going back 40 years in molecular biology tells me that he almost must certainly know that what he’s peddling is bullshit.

The rest of Dr. Malone’s article is a whole lot of misdirection and JAQing off that depends upon his audience’s lack of detailed understanding of biology, molecular biology, and genetics, because it sounds really impressive and scary if you don’t know molecular biology. Here’s an example. He cites email exchanges between antivax “journalists” and Health Canada and the European Medicines Agency, noting that “reporters have indicated to me that the regulatory agencies refused to address many of their questions.” Actually, the agencies did; the antivax reporters just didn’t like the answers. For example, here’s an example of how the EMA answered the question about SV40, the “reporter’s” questions in italics:

Has EMA confirmed the presence of a SV40 sequence in Pfizer’s COVID-19 vaccine?

An EMA spokesperson said earlier this year that “there is no evidence to indicate the presence of SV40…in the formulation of COVID-19 vaccines.”

How did EMA learn of this sequence’s presence, and when did it learn of it? Did Pfizer ever disclose the sequence to EMA?

An SV40 sequence is present in the DNA plasmid starting material of Comirnaty. In this case the sequence is not directly relevant for plasmid production in E. coli or for the mRNA production process so it is considered to be a non-functional part of the structure of the source plasmid.

SV40 is a naturally occurring virus. The virus itself is not used in the manufacture of the vaccine. Specific sequences for the non-infectious parts of SV40 are commonly present in plasmids used for manufacturing of biological active substances. The sequence for non-infectious parts of SV40 is only a small fraction of the entire SV40 sequence.

During the manufacturing process, this sequence and other plasmid DNA sequences are broken down and removed. Fragments of the SV40 sequence may only be present as residual impurities at very low levels that are routinely controlled. There is no scientific evidence that any of these SV40 fragments can act as insertional mutagens. While the full DNA sequence of the plasmid starting material was provided in the initial marketing authorisation application for Comirnaty, the applicant did not specifically highlight the SV40 sequence, as it was considered to be a non-functional part of the plasmid. They have since clarified this information in response to questions raised by EMA.

These are all legitimate and admirably clear answers. They are also all correct from a scientific standpoint. If Dr. Malone is so experienced with growing up plasmids and doing gene expression experiments using plasmids, surely he knows that SV40 is pretty close to ubiquitous in these plasmids. It’s just such a darned useful promoter if you want a high level of constitutive (constant) expression of a given gene. That’s why it’s used. The only quibble that I might have is that the SV40 promoter is, strictly speaking, not entirely “nonfunctional.” However, in the plasmid used by Pfizer it is nonfunctional with respect to producing the mRNA for the SARS-CoV-2 spike protein, the antigen used to generate the immune response.

Here comes the JAQing off from Malone:

Is this statement accurate – “The manufacturing process of mRNA vaccines is carefully designed and controlled to ensure that the level of residual DNA is below acceptable and safe levels.”? Currently available information indicates that, as a matter of established fact and public record, the current manufacturing process (Process 2) was hastily developed and implemented when the process employed to produce the initial clinical trial material was not able to support the manufacturing requirements. This statement by EMA is clearly disingenuous at best; basically just propaganda.

Except that none of this means that the process did not and does not, in fact, do exactly what EMA stated, reduce the level of residual DNA to low levels. Again, McKernan’s study was actually consistent with this. When he used qPCR to measure the amount of DNA fragments, he got levels very much below the safe limit. He had to use a method that is not as accurate for which huge amounts of mRNA crossreact to get his huge estimates for residual DNA plasmid “contamination” (or “adulteration”). Similarly, surely Malone knows that for any biological (such as a vaccine or any drug made through genetic engineering of a plasmid) the sequence of the entire plasmid used in the manufacturing process must be submitted to regulatory agencies as part of the application. (Ask yourself: Where did McKernan get the maps of the plasmids used by Pfizer and Moderna?)

Indeed, according to this article:

Kirsch has also referred to “SV40 contamination” and claimed that the vaccines are adulterated because “the manufacturers didn’t tell the FDA about the SV40 promoter.” SV40, or simian virus 40, is a monkey virus that can cause cancer in some animals, but has not been shown to cause cancer in humans. The virus is not present in either vaccine, but the Pfizer plasmid does contain some short sequences from the virus, which are not infectious and not known to cause cancer or to be harmful.

Neither Pfizer nor the FDA would tell us what Pfizer shared with the agency about its plasmid. But according to statements from other regulators, Pfizer provided the full plasmid sequence — from which anyone could have identified the SV40 components — but did not specifically note that it contained SV40 elements.

“While the full DNA sequence of the plasmid starting material was provided in the initial marketing authorisation application for Comirnaty, the applicant did not specifically highlight the SV40 sequence, as it was considered to be a non-functional part of the plasmid,” the European Medicines Agency, which helps regulate medical products in the European Union, told us in an email, referring to the brand name of the Pfizer/BioNTech vaccine. “They have since clarified this information in response to questions raised by EMA.”

The full sequence is considered proprietary information, of course, and antivaxxers take advantage of that. Moreover, even if Pfizer didn’t specifically annotate the SV40 sequence in the plasmid, the sequence was submitted as part of the sequence of the entire plasmid. Again, most molecular biologists wouldn’t even blink at an SV40 sequence in a plasmid in front of an antibiotic resistance gene. No doubt FDA scientists—and scientists at other regulatory agencies—didn’t even think twice about the SV40 sequence in the plasmid because, again, it’s such a ubiquitous sequence and it wasn’t even attached to the gene for the spike protein. That being said, regardless of the motivation or reason, I do a bit of a facepalm every time a company, doctor, or government agency does something that makes conspiracy mongering so much easier for antivax cranks.

Here’s where “biologically active” joins “adulteration” in doing some seriously heavy lifting:

The first two paragraphs of response regarding the SV40 Origin of Replication-Enhancer-Promoter sequences included in the Pfizer/BioNTech product Comirnaty are not technically correct and include an internal inconsistency. The statement “the sequence is not directly relevant for plasmid production in E. coli” appears to be incorrect. The sequence in question drives production of the RNA coding for the protein which confers bacterial resistance to Kanamycin/Neomycin, which is used to maintain the plasmid in the bacteria which manufacture it during their growth. It is also used to maintain this type of “shuttle vector” plasmid in animal cells for experimental purposes. These sequences are therefore biologically active in both bacterial and animal cells, and are directly relevant to plasmid production. This begs the question of why these sequences are even present in this plasmid, as a well designed plasmid would have removed these sequences to minimize plasmid size and maximize plasmid yield (and stability), and would have exclusively employed a more acceptable antibiotic resistance cassette. The statement “Specific sequences for the non-infectious parts of SV40 are commonly present in plasmids used for manufacturing of biological active substances.” also reveals the contradictory fallacy in the response. If commonly used, then why are they included if they serve no function?

See what I mean? Yes, the SV40 can be “biologically active” in this context, but note the “bait and switch.” Dr. Malone is implying that because the SV40 can be used to drive the production of a gene for antibiotic resistance gene in cell culture and in some bacteria (like E. coli) it must be “biologically active” when fragments of it are in the Pfizer COVID-19 vaccine. I also note that, were Malone consistent, he would express a lot less “concern” about the Moderna vaccine, which does not contain SV40 promoter. He does not. He does, however, speculate:

One interpretation of this anomaly involving presence of SV40 origin of replication and strong regulatory sequences is that this plasmid was hastily selected rather than bespoke for this manufacturing process (process 2) because the PCR-based process 1 could not support the required manufacturing throughput. So this plasmid may have been basically pulled off of a research project for use by the manufacturing process development team. That is the most benign explanation I can come up with.

This is, of course, pure speculation. Also, even if this were true, it does not mean that the process was unsafe or produced an “adulterated” vaccine—or that the SV40 sequence is “bioactive” in the vaccine, Again, this is, in essence, JAQing off and denigrating the vaccine because it wasn’t “bespoke” (if that’s even true, as only the Pfizer scientists know why they chose to go with this particular plasmid).

Speaking of JAQing off, though:

This next statement is really the absolute crux of the whole matter. We have established from this correspondence that EMA is aware that there are, in fact, contaminating DNA fragments, but that the EMA asserts that the level of contamination is safe. Then this rather odd assertion is provided: “There is no scientific evidence that any of these SV40 fragments can act as insertional mutagens.” The absence of evidence does not provide evidence of absence. This statement inverts standard regulatory policies and procedures, and is akin to a regulatory authority allowing the manufacturer to play “catch me if you can”. The proper regulatory position when the normal tension between regulatory authority and manufacturer/sponsor is maintained would have yielded the statement “rigorous long term genotoxicity and insertional mutagenesis studies have been completed and have demonstrated an acceptably low minimal risk of genomic modification.”

“The absence of evidence does not provide evidence of absence” is about as perfect example of JAQing off as I can find, because it’s true. Not only is there no evidence that any of these SV40 fragments can act as insertional mutagens, but there is not even a plausible biological mechanism by which they could act as insertional mutagens. No doubt Dr. Malone knows this, but he also knows that his audience does not know this. He also knows that his audience doesn’t know that the article from the FDA that he cites is only tangentially relevant to the question of tiny quantities of DNA fragments in an mRNA vaccine. Indeed, he cites the same guidance that McKernan did:

When last I addressed this, I looked up the reference cited, which notes:

In evaluating the potential harm of plasmid integration, it should be noted that the risk of introducing plasmids with strong regulatory regions into the host genome far exceeds that associated with random point mutations [43;50]. Moreover, the technology used to detect plasmid persistence does not examine the frequency with which short fragments of plasmid integrate. In this context, sections of DNA as short as 7 bp can affect rates of integration or recombination. Examples include the VDJ recombination signal sequence and related sequences, chi-like elements and minisatellites, ALU sequences, a recombinase signal present in hepatitis B and mammalian genomes, and topoisomerase II recognition sites [43].

I then pointed out how this section appeared to me to be talking about short sequences on an intact plasmid that serve as regulatory elements in the context of DNA vaccines, which would involve the injection of huge quantities of DNA relative to anything we are talking about with respect to sub-nanogram amounts of plasmid DNA fragments in an mRNA vaccine. The difference in the amount of DNA involved is orders of magnitude, which makes it arguably a different beast.

The rest of Dr. Malone’s post involves, if you’ll excuse me again, variants of the same sort of JAQing off. In particular, he’s annoyed with the response from the FDA, which likely recognized a bunch of cranks when it saw them, and declined to be drawn into the weeds with a detailed response. My guess is that they weighed how much the antivaxxers would have dragged them down if they provided a more detailed response and compared it with how much they would conspiracy monger with a less detailed, more generic response and decided that the more generic response would likely do less damage. Whether they were correct about that, I don’t know, but I do know that, no matter what level of detail that any regulatory agency provided in response to the antivax questions, it would never be enough, and people like Malone would just continue JAQing off.

The expected response

I’ll conclude by noting something about the last section of Dr. Malone’s response:

In sum, this information clearly documents the shoddy, biased regulatory review processes employed by these agencies concerning the rushed mod-mRNA “vaccine” regulatory oversight and approval processes. There is a clear appearance of conflict of interest associated with current practices, which stand in stark contrast to the cautious and methodical assessments of integration and genotoxicity risks which characterized previous historic regulatory authority approaches to the closely related field of DNA vaccines.

Again, mRNA vaccines and DNA vaccines are different beasts, and tiny amounts of residual DNA from the manufacturing process in an mRNA vaccine represent a different situation, given that the amount of DNA involved is orders of magnitude smaller, easily a thousand times smaller, given that the “adulteration” being hyped is on the order of at most a few nanogram (and actually much less), while DNA vaccines can involve micrograms of intact plasmid being injected. Dr. Malone conflates the two, either through ignorance or by intent. (I rather suspect the latter.)

Let’s just put it this way, look at Malone’s grand finale:

This analysis and information summary clearly documents a profound failure of all three regulatory authorities to do their most important job, to protect their citizens from risks of both inadequately tested and poorly controlled injectable products which are neither safe nor effective, and to prevent exposure of the public to adulterated pharmaceutical products. In stark contrast to the disinformation propaganda which is being offered by each of these regulatory authorities, the public deserves open, comprehensive and transparent communication of risk and/or the data demonstrating lack of risk associated with delivery of these DNA fragment (oligonucleotide) contaminant/adulterants to a wide range of cell, tissue, embryo and fetus via the most efficient non-viral systemic delivery system yet devised by man. 

The curt and dismissive regulatory responses received from each of these regulatory authorities suggest that such data do not exist, and instead biased regulatory opinion has once again been substituted for definitive data. The public should demand that regulatory authorities show the actual data supporting their assertions of safety. Both current and future generations of human beings deserve no less.

With the possible exception of the FDA’s response, I would hardly call the responses “curt,” and I wouldn’t even call the FDA’s response “dismissive.” Dr. Malone only characterizes them that way because there is no level of detailed response that would satisfy him or other antivaxxers. More detail would only have provided Dr. Malone and other antivaxxers more ammunition, while less lets them rant about the “curt and dismissive” responses. I don’t envy the press people at any regulatory agency these days, as I don’t confess to know what the right balance is between detail and more general responses that will minimize the damage that antivaxxers can do with their responses. I do strongly suspect, however, that Dr. Malone and all the antivaxxers with molecular biology backgrounds ranting about SV40 and plasmid DNA in the vaccines know exactly what they are doing and are not honest actors. The “adulteration gambit” is nothing more than the latest iteration of the longstanding antivax “toxins gambit.”

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

51 replies on ““Adulteration”: The latest iteration of the antivax “toxins gambit” applied to COVID-19 vaccines”

Nobody wants these anymore anyways. And if they push mRNA into other vaxes less people will want those. I’m glad I stayed out of the experiment, personally.

I got mine a bit more than a week ago and if they will offer a new booster next year, I will take that as well. Just got my flu and pneumococci vaccines.

I just got my booster earlier today. Hopefully it won’t wipe me out for a day or two, the way some previous boosters have. (They’ve sometimes made me tired and achy and given me chills for 12-36 hours, especially the first two in the original series.) But, then, that’s why I got my booster on a Saturday, so that if that happens I’ll have time to recover before I have to go back to work on Monday.

hi David, you do realize that if you die within the next decade, for any reason, a lot of antivaxxers will feel vindicated? tbh even prominent vaccine supporters have stopped taking additional boosters… good luck!

Got my latest shot, the flu shot, and the rsv shot a couple weeks ago. Worst thing was getting the little band aids off the next day — those were the tightest little suckers I’ve seen in a long time.

“Nobody” = over 7 million Americans as of three weeks ago. And it’s early days; we’ll see what the stats show if a new winter Covid wave occurs.

Juat Loves Biden: There, there. If the facts posted here scare you just close your eyes and think of you safe space.

I hope if anyone files suit based on Malone’s verbal effluent they are held liable for wasting the court’s time and their attorneys are sanctioned.

Any good lawyer knows that if a witness misrepresents their background – ie. “I invented mRNA vaccines! (not) – then any further testimony from them can be safely ignored. Malone seems very jealous that he wasn’t touted as the inventor so now he’s getting revenge on the industry. Sad!

And of course, he’s vaccinated himself. Don’t get high on your own supply …

Steve Kirsch: a fool with a thesaurus. First we get Mark Skidmore being “exonerated”. Now COVID-19 vaccines are “adultered”.

Kirsch’s desire to rebrand tropes with bizarre new names smells of desperation: his desparation to remain relevant and anti-vaxxers’ desperation to stay in the spotlight.

FYI Brandy Zadrozny just skewered RFKjr and his CHD annual convention:

So RFK Jr wants to force medical journals to publish retracted studies…..

That’s like forcing a book of health food recipes to include the best ways to fry lard and dip it in sugar. Yum.

The only real adulteration that I can see is the adulteration of science and medicine with an endless amount of BS ‘research’ from antivaxxers.

“The absence of evidence does not provide evidence of absence” is about as perfect example of JAQing off as I can find, because it’s true. Not only is there no evidence that any of these SV40 fragments can act as insertional mutagens, but there is not even a plausible biological mechanism by which they could act as insertional mutagens

As Bridle pointed out, no wonder Orac is afraid of open debates. He knows perfectly well that this crap would not fly in such a venue.

So Orac, Malone is JAQing off by wondering whether the FDA has actual evidence that the contamination is safe or whether they are just talking out of their ass? Orac, who really is JAQing off?

As Bridle pointed out, no wonder Orac is afraid of open debates. He knows perfectly well that this crap would not fly in such a venue.

This isn’t the gotcha you think it is. In the scientific literature and among actual molecular biologists, scientists with the relevant knowledge sets would recognize that what Bridle and Malone are peddling is bullshit. In a public Internet forum? Not so much. That’s why they crave “live public ‘debate’/’discussion'” so much. Also, as has been pointed out, they might be able to monetize it as well.

Seriously, biological mechanism matters. Absence of supporting evidence without even a whiff of a plausible biological mechanism that would lead to the phenomenon for which they are making claims makes the likelihood that they are correct almost homeopathically tiny.

Seriously, biological mechanism matters. Absence of supporting evidence without even a whiff of a plausible biological mechanism that would lead to the phenomenon for which they are making claims makes the likelihood that they are correct almost homeopathically tiny.

More arguments in favor of ‘assumption science’, Orac? Seriously, what happened with the biological implausibility that the spike would ever leave the injection site or lingers around? Orac, what are you not getting? Outside of your circle of sycophants here, you are just coming off as a joke.

The more you try to simplify things the more information is lost in the process. That’s what happens with most debates. The more knowledgeable individual, with actual background in the subject gets stuck trying to explain complex subjects and the background needed to understand them while the less knowledgeable individual doesn’t have to care about background information or understanding. All they need to do is provide an endless stream of soundbites and statements that require no background information to understand.

This means that the person who understands the subject better will always come across as the loser of such a debate and the audience will get to feel a sort of vicarious pride in knowing more than an expert – after all, they understood the soundbites that caused a supposed expert to stumble and seem to go off topic.

Most of the audience will never understand that the reason why the expert couldn’t respond was because they were trying to provide the knowledge necessary to understand why the soundbite was wrong.

Trust me, in my not at all medical related areas of expertise I frequently have people who know nothing about what they’re saying come off as looking smarter than me by boldly asserting something that is fundamentally wrong while I struggle to impart the knowledge as to why what they suggest is an extremely bad idea or, in one case, totally false.

And remember, I’m not a doctor or scientist or in any way paid by the medical industry, therefore, according to your logic I should be a far more trustworthy source than most other people here. So you all have to believe me, right?

You are completely on the mark.
Let’s try it with one example. Anti-vaxxer says people are killed by the vaccine.
The expert can do 2 things, either he says this isn’t possible, plain and simple. Or he can give a longwinded answer explaining why this is not very probable.
The anti-vaxxer then tells the story of someone he knew, that died within a few days after getting the vaccine.
What can the expert say? Correlation is not the same as causation?
And the audience, which knows nothing about vaccines and probably is anti-vax themselves, may say: “See, the anti-vaxxer is right, he gives examples and the expert has not other answer than denial, or trying to weasel out.”
Even if the audience is not anti-vax, they still are no experts, so who to believe? The person with a personal story, or the person denieing any relation with the vaccine?

@ Silex:

You are so correct!

I observe additional maneuvering that contrarians w/o relevant background use**:
in reality, their level of expertise is quite similar to their audience
who IDENTIFY with them so
— they stress that they are not the product of elite universities who come from privileged families
— they insult professionals as nerds, shills and unapproachable
— they reiterate how their success is the result of hard work, working class roots, humanitarian goals, morality and values
— some narrate how they do hard physical work “down on the farm or ranch* caring for animals, doing charity work

Sure, wealthy middle-aged or older guys worth millions doing farm work, cleaning animal stalls, repairing tractors every day!

Some of the funniest stories I’ve heard from the usual suspects are that they didn’t go to elite schools because of money ..
if they were truly such brilliant students and great athletes as they claim, they would have got in free- I knew lots of those students.
No, they weren’t accepted because of their grades, tests etc!

When I describe why I can’t accept vaccines-cause-autism I try to produce a capsule synopsis about how brain differences in autism occur prenatally and how we know this through decades of research in diverse areas of inquiry.

it’s really hard to provide all of the important details and still make the response comprehensible to a general audience

** in contrast to those who do and just lie
-btw- Malone has a horse ranch

Thisis quite different thing. Do you think that forign DNA just sneak into genome ?
As a matter of fact, Bridle do not want to debate here. Why ?

Orac writes,

“Seriously, biological mechanism matters. ”

MJD says,

Exactly, why then is there so much misdirected respectful insolence (e.g., Dr. Dangerous Bacon) when the “common man” combines accepted biological mechanisms with anecdotal evidence?

@ Idw56old,

So sorry to hear the bandage over-adhered to your skin after vaccination. Suggestion, use soap when bathing or showering. It lowers skin surface tension to decrease the bonding efficiency of the bandage adhesive.

You think that immune boosting solves everything Cytokine storm is an example of ovrboosted immune system.

Aarno Syvänen writes,

“You think that immune boosting solves everything.”

MJD says,

The word ‘everything’ is to encompassing. Now, if you were to change ‘everything’ to ‘something,’ we could be pen pals.

BTW, Orac placed MJD in auto-moderation for emphasizing everything about allergy-induced regressive autism. Thus, the concept of “everything” has brought much sorrow/suffering to MJD here at RI.

We were told that Covid vaccines contain mRNA in lipid nanoparticles.

Adulteration is defined as presence of undeclared ingredients.

Now it turns out that “oh and it also contains a little bit of DNA, and by the way this is okay”.

This is the same as having, say, sugar added to honey.

This is adulteration by definition.

EVERY biological contains “a bit of DNA” left over from the manufacturing process, either from the plasmid or whatever DNA construct used: insulin, any peptide or hormone made using recombinant DNA technologies, previously developed vaccines (e.g., HPV vaccines), you name it. Heck, live attenuated virus vaccines like MMR are chock full of DNA! Only antivaxxers are surprised that there are traces of DNA left in an mRNA vaccine, which were measured, reported, and verified. None of this is new or unexpected; that is, unless you’re an antivaxxer.

EVERY biological contains “a bit of DNA” left over from the manufacturing process, either from the plasmid or whatever DNA construct used: insulin, any peptide or hormone made using recombinant DNA technologies, previously developed vaccines (e.g., HPV vaccines), you name it. Heck, live attenuated virus vaccines like MMR are chock full of DNA! Only antivaxxers are surprised that there are traces of DNA left in an mRNA vaccine, which were measured, reported, and verified. None of this is new or unexpected; that is, unless you’re an antivaxxer.

Also, there is a specific legal definition of adulteration in the FDA regulations. This does not meet the definition.

We all have a few atoms that once were part of Julius Caesar’s body in us. That sure doesn’t make me into a Roman emperor or want to wear a toga. Insanely minuscule amounts of DNA in a COVID vaccine likewise aren’t going to do anything to me either.

Only antivaxxers are surprised that there are traces of DNA left in an mRNA vaccine, which were measured, reported, and verified. None of this is new or unexpected; that is, unless you’re an antivaxxer.

Orac, why don’t you respect your readers by telling them the full story? The DNA contained the SV-40 promoter component that was never reported to the regulator. It took McKernan to discover it and Health Canada to confirm. Now, If this was all no big deal, Orac, why do you suppose Pfizer would hide such information?

“World Council for Health” is a freshly made up bunch of anti-vax, anti-science wankers. Anyone who says otherwise is FOS.

You could cite Healh Canada itself, not some antivax group
“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.”
Imperiale confirmed that to AFP on November 1, saying it is “not unexpected that there would be a little bit of DNA” in the shot due to the manufacturing process and that such remnants are “inert” and harmless.

Aarno, when replying, it would be helpful if you stay on topic. Again, what do you make of Pfizer deliberately not reporting the SV-40 promoter sequence?

The first two COVID vaccines I got had loads of DNA in them. By design. Can Igor work out what vaccines I might have got?

Actual definition of adulteration is here:
“Economically motivated adulteration (EMA) occurs when someone intentionally leaves out, takes out, or substitutes a valuable ingredient or part of a food. EMA also occurs when someone adds a substance to a food to make it appear better or of greater value.”
You got it wrong. Not a great surpris.,

By the way, to add to my previous reply: a pound of Covid vaccine nanoparticles cost $2 billion dollars per pound.

(Pfizer, $130 for a 30 mcg dose works out to 1.96 billion dollars per pound).

So Pfizer has every incentive to adulterate its vaccines with, for example, DNA and whatever else. Whatever reasons cause unscrupulous suppliers to add sugar to honey, would apply to the Covid vaccine also due to extreme cost per pound

Funnily enough, government agencies responsible for approving vaccines test what’s actually in them. So in Australia, where in most cases the government meets the full cost of the COVID vaccine and its administration, the Australian Therapeutic Goods Administration checks batches to ensure that the vaccines meet their standards for composition and strength.

I’d be surprised if such oversight didn’t exist in similar jurisdictions, such as the USA or EU.

The link has a table of all batch testing results for COVID vaccines used in Australia.

This has to be one of the most completely idiotic things you’ve said and that’s saying quite a lot Ichor.

What did you have for dinner? Even if you’re a vegetarian, it was probably loaded with DNA, and probably some RNA, too. Aren’t you afraid of being contaminated by ingesting all that genetic material?

If anti-vaxxers aren’t complaining about getting nasty chemicals in their body, they complain about the all natural DNA, exept of cause if it is about food, because food has to be all natural.
Vaccines are not natural, so they have to be rejected. It is far better to get an all natural disease, that might kill you or leave you with nasty consequences, because we have done without vaccines for centuries. /s

… … … Absolutely brilliant! Just brilliant! Instead of cutting the merchandise with something harmless these companies that are supposedly smart enough to fool (or was it control?) all of our understanding of science and medicine are adding shit that’ll kill the customers. What a brilliant business plan!

Can you tell me why these evil geniuses are adding things that will cause harm rather than substances proven to be harmless if their goal is to save money to make more money?

And please, don’t fall back on ‘no one knows what goes on in the minds of such evil people’ is they’re so smart why is their evil plan so dumb?

It’s for the purpose of mass depopulation, which as we all know increases sales of Big Pharma drugs.

Not to mention DNA/RNA are expensive to make by comparison to…well…all kinds of other harmless crap that weighs a lot more. If you really wanted depopulation why the hell not put plutonium in them? It’s dense and deadly.

Igor really is a brain donor

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