No, mRNA COVID-19 vaccines do NOT “hack the software of life”

If there’s one thing that I’ve learned over the years combatting science denial, quackery, and antivaccine propaganda and conspiracy theories, it’s that words matter and messaging is important. At no time in my life have I seen this more than now, in the middle of a pandemic, and I’d like to do something a little different from what I normally do here on SBM and discuss an example. It’s an example in which early messaging used years ago to promote and sell a promising new technology has been weaponized by antivaxxers and COVID-19 minimizers to demonize COVID-19 vaccines. You might recall a post of mine from two months ago, when I discussed how mRNA-based COVID-19 vaccines by Pfizer/BioNTech and Moderna are not “gene therapy”. Think of this as a follow-up looking at how that claim by antivaxxers came about, plus the idea that such vaccines “hack” your genes.

Actually, there are three highly related claims that antivaxxers have been using to sow fear, uncertainty, and doubt about mRNA-based vaccines:

• mRNA-based vaccines “permanently alter your DNA.” (No, they don’t.)
• mRNA-based vaccines are not vaccines, but “gene therapy.” (No, they are not. They are vaccines.)
• mRNA-based vaccines are like a “software update” for your body or “hack” your genes, or biology, or the “software of life.” (A very bad analogy, as I will discuss below.)

As I discussed before, the claim that vaccines can “permanently alter your DNA” is not a new claim. Antivaxxers have been making this claim almost as long as I’ve been paying attention to the antivaccine movement and its disinformation. So it should come as no surprise that antivaxxers dusted off this hoary old disinformation chestnut to use on COVID-19 vaccines. There was no way that anyone could have stopped antivaxxers from making that claim. In contrast, the proliferation of disinformation that mRNA-based vaccines are “gene therapy” like “a software upgrade for your body” is largely a self-inflicted wound that derives from early hype over the new technology by Moderna. Don’t believe me? Take a look at this article by über-quack and “alternative health” entrepreneur Joe Mercola, entitled “COVID-19 Vaccines Likened to ‘Software Updates’ for Your Body“, where Mercola basically tells you where antivaxxers got these talking points from.

First, though, as an aside I can’t help but mention that, so prolific is Mercola’s empire of antivaccine and COVID-19 disinformation, that I could, if I so desired, devote my entire blog output, both here and at my not-so-super-secret other blog, to nothing other than countering Mercola’s misinformation, disinformation, distortions, and lies, and I would still not be able to keep up. The same could be said about antivaxxer Robert F. Kennedy, Jr.’s website Children’s Health Defense. Between the two of them, Mercola and RFK Jr. produce a veritable tsunami of antivax propaganda far beyond what science advocates can keep up with. That’s what we’re dealing with here, and they are far from alone.

Now let’s get into the details.

Quoth Mercola: Moderna said its vaccine is a “gene therapy product”

In this post, Mercola makes a number of claims, the first of which is that lipid nanoparticle-encapsulated mRNA has been described as “gene therapy” in filings by Moderna and that BioNTech’s SEC filing states that in the U.S. and Europe, mRNA therapies are classified as “gene therapy medicinal products”. And it’s true. Liposomal mRNA has been developed to be used as a gene therapy, but that’s not all it’s been developed and used for. Intent and method matter, which is no doubt why Mercola contorts himself and his words to deny that these vaccines function as “vaccines” in order to claim that they are “treatments”, all while weaving dark conspiracy theories (of course):

However, despite being a recognized form of gene therapy since its inception, vaccine makers are now frantically trying to deny that this mRNA technology is gene therapy. One reason for this, suggested by David Martin, Ph.D.,¹ might be because as long as they’re considered “vaccines,” they will be shielded from liability.

Experimental gene therapies do not have financial liability shielding from the government, but pandemic vaccines do, even in the experimental stage, as long as the emergency use authorization is in effect. Another reason might be because they fear people won’t line up for experimental gene therapy. It has a very different connotation in people’s minds (as it should).

A third possibility is that they know full well that you cannot, ethically, mandate gene therapy in the way you can mandate vaccines. Mandatory public health measure directives are typically based on the idea that it’s acceptable for some individuals to be harmed as long as the measure benefits the collective.

Well, the COVID-19 “vaccines” are only designed to lessen symptoms of COVID-19. They do not prevent infection or spread, and since the vaccinated individual is the only one receiving a potential benefit, “the greater good” argument falls apart.

Who knows, there may be other factors at play that we’ve not realized as of yet, but whatever the reason, they really do not want you to think of these injections as gene therapy. They want you to accept them as any other conventional vaccine.

First of all, Mercola is a bit behind the times, data-wise. While it is true that the original clinical trials that resulted in the approval of these two vaccines could not determine if they prevented infection or transmission but only if they prevented COVID-19 disease (which, by the way, they were highly effective at doing), time hasn’t stood still, nor has science. A mere two days before Mercola posted the above, the CDC published a study of interim estimates of vaccine effectiveness among health care personnel, first responders, and other frontline workers. Guess what the conclusion was? The study found that the Moderna and Pfizer vaccines were, in fact, very effective at preventing infection. Nearly four thousand people were studied, and it was found that, under real-world conditions, mRNA vaccine effectiveness of full immunization (≥14 days after second dose) was 90% against SARS-CoV-2 infections regardless of symptom status (meaning that the vaccine prevented asymptomatic infection as well). Even better, vaccine effectiveness of partial immunization (≥14 days after first dose but before second dose) was 80%, meaning that just one dose of either of these vaccines likely still provides substantial protection against infection. Is the study perfect? Of course not. More data will be required. The study is, however, excellent evidence that both of these vaccines function as, to rub it in Mercola’s face, highly effective vaccines.

Why would this distinction matter, though, other than to fuel Mercola’s conspiracy theory that, if only these “gene therapy treatments” could be reclassified as vaccines, big pharma could profit? First, it’s useful to look at the FDA’s definition of gene therapy, given that the FDA is the agency that would have to approve and license any new “gene therapy”:

Human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use ¹. Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Gene therapies can work by several mechanisms:

• Replacing a disease-causing gene with a healthy copy of the gene
• Inactivating a disease-causing gene that is not functioning properly
• Introducing a new or modified gene into the body to help treat a disease
• Gene therapy products are being studied to treat diseases including cancer, genetic diseases, and infectious diseases.

There are a variety of types of gene therapy products, including:

• Plasmid DNA: Circular DNA molecules can be genetically engineered to carry therapeutic genes into human cells.
• Viral vectors: Viruses have a natural ability to deliver genetic material into cells, and therefore some gene therapy products are derived from viruses. Once viruses have been modified to remove their ability to cause infectious disease, these modified viruses can be used as vectors (vehicles) to carry therapeutic genes into human cells.
• Bacterial vectors: Bacteria can be modified to prevent them from causing infectious disease and then used as vectors (vehicles) to carry therapeutic genes into human tissues.
• Human gene editing technology: The goals of gene editing are to disrupt harmful genes or to repair mutated genes.
• Patient-derived cellular gene therapy products: Cells are removed from the patient, genetically modified (often using a viral vector) and then returned to the patient.

In order to preempt anything Mercola might have claimed about this definition having been “changed” to accommodate Moderna and Pfizer’s vaccines, I used the almighty Wayback Machine at Archive.org to find a version of this page from June 2019. It’s basically the same. Nothing about mRNA is mentioned. Another reason why mRNA-based COVID-19 vaccines are not gene therapy is that gene therapy is designed to “treat a disorder by inserting a gene into a patient’s cells instead of using drugs or surgery”, either by replacing a mutated copy of the gene with a good copy, inactivating a gene that is making too much of its product or otherwise not functioning properly, or to induce cells to make a therapeutic protein. Here’s the thing. The SARS-CoV-2 spike protein, which is what the Moderna and Pfizer vaccines induce cells to make, is not a therapeutic protein. It does not treat or modulate disease. It is being used solely as an antigen to stimulate an immune response by the body against a viral protein, and only over the short term, long enough to stimulate that response.

So why did Moderna include this passage from the 2020 Moderna SEC filing, quoted by Mercola and every antivaxxer I’ve seen making this claim? Here’s what I mean:

Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism.

To be honest, I found that passage by Moderna to be a head-scratcher, because nowhere could I find evidence that the FDA considered mRNA products to be a “gene therapy product”, and even sources that discuss RNA-based products along with gene therapy tend to separate the two based on mechanism. On the other hand, I noted the care with which Moderna stated that mRNA vaccines might be considered a “gene therapy product,” not “gene therapy”. Here’s what I mean. What does “gene therapy” of any sort make? mRNA, that’s what, and that mRNA is then translated into protein. Thus, mRNA is the product of gene therapy, not the gene therapy itself, because mRNA doesn’t actually alter genes and DNA. (More on that later.)

Going through this, I rather suspect that this was done out of an abundance of caution, as evidenced by the next part of the paragraph in Moderna’s SEC filing:

In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products, or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one pharmaceutical product to the next, and may be difficult to predict.

Unfortunately, this backfired in that it allowed Mercola and David Martin (who makes the same sort of claim and who was a big part of the Plandemic 2 conspiracy video and who’s made the false claim that mRNA-based vaccines are “legally gene therapy“) to run with this sort of stuff straight into conspiracytown:

Well, the pandemic allowed them to sneak mRNA gene therapy under the proverbial radar so that they don’t have to conduct more stringent gene therapy safety testing. Instead, they were handed the global population for the largest testing imaginable, and all without liability when something goes wrong — provided it’s viewed as a “vaccine,” that is.

Of course, I can’t be too hard on Moderna. Even in a global pandemic, how many corporations are sufficiently aware of how antivaxxers misuse and twist language to make sure not to use language like this? Moreover, this SEC filing is from June, which was still relatively early in the pandemic and was likely written at least a month earlier. The message that COVID-19 vaccines based on RNA would “alter your DNA” had not yet become widespread because these vaccines were still in early clinical trials and there was much skepticism over whether they would ultimately turn out to be effective, even among scientists.

In any event, as I said before, intent matters, as does the specific gene product being coded for by the mRNA. The SARS-CoV-2 spike protein is neither a human gene, nor is it therapeutic. It’s intended only as an antigen to stimulate an immune response; making it part of a vaccine, not a “gene therapy”. This can’t be repeated often enough.

Of course, it should also be noted that Moderna did make a distinction between its vaccines and gene therapy, and even Mercola had to acknowledge that and try to tear it down. First, here’s Moderna’s SEC filing:

Gene therapy products have the effect of introducing new DNA and potentially irreversibly changing the DNA in a cell. In contrast, mRNA is highly unlikely to localize to the nucleus, integrate into the DNA, or otherwise make any permanent changes to cell DNA. Consequently, we expect that our investigational medicines will have a different potential side effect profile from gene therapies.

This explains why Mercola has to go so far as to invoke highly dubious and speculative science to claim that, no, really, mRNA from a vaccine can alter your DNA, and he gets rather ridiculous about it:

However, some doctors still worry that mRNA injections might be able to reverse-transcribe into your genes and alter your DNA on a permanent basis. One is Dr. Richard Urso, an ophthalmologist, who shared his concerns on a December 2020 episode of The Shepard Ambellas Show.^3,4

He claimed the mRNA of retroviruses (which are part of our genome) have been shown to have the ability to transcribe into your DNA, and if it can do that, vaccine mRNA might be able to do this as well. According to Urso, if this turns out to be correct, the result of mRNA vaccination might be lifelong COVID-19.

This is pure handwaving, a claim that, because one type of virus, a retrovirus, can reverse transcribe its RNA to DNA and integrate that DNA into our genome, that must mean that a completely different type of virus that only shares the use of RNA as its genetic material. (A clear, simple explanation of how coronaviruses replicate can be found here.) It’s pure speculation. Even worse is the claim that, if the coding sequence for the spike protein were to be integrated into the human genome, it would result in lifelong COVID-19. As an aside, I can’t help but note that Dr. Urso is an ophthalmologist known for his promotion of hydroxychloroquine to treat COVID-19. He has no special expertise in molecular biology that I’ve been able to find. Indeed, his handwaving and his claim that an integrated gene for the spike protein would cause “lifelong” COVID-19 tells me that, without my even having to look him up.

Merola also quotes someone named Doug Corrigan, PhD, who does have a PhD in Biochemistry and Molecular Biology, which is why he should know better than to cite a December study posted to the preprint server bioRxiv that claims to show that SARS-CoV-2 RNA can be reverse-transcribed and integrated into the human genome. First, as always, with preprint articles, I note that this has not gone through peer review, which makes me wonder why it’s still on bioRxiv nearly four months after it was posted. It might be worth a post going into more detail as to why this study’s conclusions are not supported by its experiments and data, but This Week In Virology spent much of a recent episode explaining why this study doesn’t show what its authors claim it shows, and Ed Nirenberg delved into the methodology to come to the same conclusions, noting:

A preprint has emerged claiming that there is evidence that SARS-CoV-2 is reverse transcribed and integrated into the human genome. None of the evidence it provides justifies such a conclusion, and it demonstrates a failure to understand fundamental aspects of coronavirus biology and frankly the limitations of the methods used to make that conclusion. Furthermore there even appears to be an attempt by the preprint authors to make their data more difficult to scrutinize because it is available only upon request and not included in the paper. Its findings, even if true (something I have significant doubts about), have no relevance for mRNA vaccines.

It is always a red flag to me when the authors don’t make their datasets from such experiments easily available, but I especially like where Nirenberg sums it up:

On the point of what this means for an mRNA vaccine: literally nothing. This paper has absolutely nothing to do with them. If you’re wondering what would happen if the RNA from a vaccine were accidentally picked up by this proposed mechanism and integrated into the host cell, any of the following scenarios:

• The sequence would behave like a processed pseudogene, lacking any ability to recruit host transcription machinery and would sit in the genome, quiescent. 
• If the sequence somehow inserted downstream of a promoter sequence that could recruit transcription machinery, the cell would express spike protein, be recognized by the immune system, and then be killed. 
• If the sequence inserted itself into the middle of gene (specifically in the middle of an exon), you would get a mutant protein that had sequences from SARS-CoV-2 that would be processed by antigen-presenting machinery and trigger a T cell response that killed the cell. 

But antivaxxers like Mercola have to latch on to this study because they can’t make the argument that mRNA-based COVID-19 vaccines are a “gene therapy,” not a vaccine, if they can’t show even a ghost of a mechanism by which the RNA from such vaccines could alter cellular DNA.

“Hacking the software of life”: Salesmanship versus cranks

It might be a bit harsh of me to say that the “mRNA vaccines are gene therapy” narrative by antivaxxers is a self-inflicted wound. However, it is not at all harsh to point out how Moderna scientists and executives selling their technology provided antivaxxers with language that they could easily weaponize against COVID-19 vaccines. In particular, Mercola makes a lot of this 2017 talk by Dr. Tal Zaks, chief medical officer of Moderna, in which he likened mRNA vaccines to “hacking the software of life”:

https://youtu.be/FU-cqTNQhMM

I groaned as I read the transcript:

“We’ve been living this phenomenal digital scientific revolution, and I’m here today to tell you that we are actually hacking the software of life, and that it’s changing the way we think about prevention and treatment of disease,” Zaks said.

“In every cell there’s this thing called messenger RNA or mRNA for short, that transmits the critical information from the DNA in our genes to the protein, which is really the stuff we’re all made out of. This is the critical information that determines what the cell will actually do. So, we think of it as an operating system …

“So, if you could change that … if you could introduce a line of code, or change a line of code, it turns out that has profound implications for everything, from the flu to cancer …

“Imagine if instead of giving [the patient] the protein of a virus, we gave them the instructions on how to make the protein, how the body can make its own vaccine,” he said.

It’s even in the Moderna mission statement:

Recognizing the broad potential of mRNA science, we set out to create an mRNA technology platform that functions very much like an operating system on a computer. It is designed so that it can plug and play interchangeably with different programs. In our case, the “program” or “app” is our mRNA drug – the unique mRNA sequence that codes for a protein.

I really, really despise computer analogies for what are core molecular biology concepts, even as I can see why they’re attractive to tech entrepreneurs. In any event, see how fast this particular analogy has been weaponized by antivaxxers, leading to Leo Hohmann, for instance, writing posts like “Will you allow Big Pharma to install its ‘computer operating system’ into your body?” Just Google “Moderna hacking the software of life” and see what you come up with. You’ll see stuff like:

It gets worse, though, and Mercola gleefully takes advantage of Moderna’s loose analogies:

Zaks further differentiates conventional vaccines and mRNA vaccines by explaining that when using a conventional vaccine, you have viral protein floating around outside the cell, whereas the mRNA approach reprograms the cell to create that viral protein inside of itself.

“What’s more alarming?” he asks. “A stranger prowling the neighborhood, or somebody who just broke into your ground floor and tripped the alarm? That’s what happens with an mRNA vaccine. You’ve tripped the alarm wire and now the cell is dialing 911, it’s calling the police — at the same time that it’s making the protein, saying ‘That’s the bad guy.’ That’s how an mRNA vaccine works.”

Zaks also refers to the company’s mRNA shots as “information therapy,” which is just another way of saying gene therapy because mRNA is a carrier of genetic code. (For clarification, code in your natural mRNA matches your DNA, whereas vaccine mRNA has no equivalence inside your genome since it’s coming from the outside. Vaccine mRNA still carries “genetic code,” though, just not anything found in your body before.)

Zaks’ analogy to a prowler doesn’t even make a lot of sense biologically or as an analogy. He seems to be likening the RNA from a vaccine to being a “prowler” compared to the “prowler” of the virus outside of the cell. It’s no wonder that antivaxxers can so easily turn such language against COVID-19 vaccines, as it Zaks seems to be implying that the body is more alarmed by RNA in its cells than it is from foreign protein circulating in the body. As for “information therapy”, my only thought reading that dates back to the early 1980s: Gag me with a spoon.

Seriously, I wish Moderna would lose this particular analogy. It’s done (and continues to do) so much harm. I understand why it is attractive to view mRNA as “software”, but in reality it’s not. If you really wanted to pursue the analogy, I’d say that DNA is the software, mRNA is the compilation of that software, and the protein is the output, but even that’s a strained analogy. However you look at that analogy, though, it allows Mercola to pull off a favorite old antivaccine trope, one that was resurrected for COVID-19 vaccines, namely that vaccines are “transhumanism“, a claim by antivaxxers that I first noticed in 2012.

Seriously, look at Mercola run with this:

In true technocratic, transhumanist Fourth Industrial Revolution fashion, Zaks and other mRNA pushers view the body as your hardware, your genetic code as software and these mRNA injections as software updates. As noted by Patrick Wood in a recent Technocracy News article:¹⁵

“Pure and simple, this is unvarnished, raw transhumanism … Scientists think they can rewrite the genetic code [his words, not mine, for all you out there who still don’t believe these mRNA vaccines change the genetic code just because some ‘fact checker’ says they don’t], believing they can improve on a person’s God-given genetic makeup is entering dangerous territory … These scientists truly believe that the human body is nothing more than a machine that can be hacked into and reordered according to some programmer’s instructions … Who’s to say they won’t correct one problem and create something far worse?”

And, of course, according to Mercola, transhumanism due to COVID-19 vaccines is part and parcel of the “Great Reset”, a conspiracy theory claiming that the pandemic was engineered by the global elites to allow for a “reset” in which they take control of the world economy. I can’t help but note that “the Great Reset” is another example of how poorly chosen words basically give conspiracy theorists a gift. “The Great Reset” really is a plan first proposed by the World Economic Forum exploring how countries might recover from the COVID-19 pandemic. I mean, seriously? Who thought of this term? Who at Moderna thought it would be a good idea to present their treatments as “hacking the software of life”, given all the negative connotations of hacking?

Again, words matter. While I can’t be too hard on Moderna for being cautious in its SEC filing and using language that reflected regulatory uncertainties of the time, I can blame Tal Zaks and the leadership of Moderna for using such easily weaponized analogies, such as “hacking the software of life” to sell its product to investors. I can blame the World Economic Forum for coming up with a term like the “Great Reset”. These words matter, and these words have been a gift to COVID-19 conspiracy theorists and a burden to those trying to counter disinformation.