I had been debating whether to write about something other than COVID-19 this week, given how thoroughly the pandemic has come to dominate the blog (at least my contributions), to the point where it seems that I write about little else. On the other hand, there’s a topic that’s been bugging me, a niggling annoying bit of antivaccine disinformation that I keep seeing as it pops up hither, thither, and yon in antivaccine social media and on antivax websites and blogs, to the point where I finally feel as though I have to break down and address it. Such is life.
What I’m referring to is the claim that I’ve been seeing that the existing COVID-19 vaccines developed by Moderna and by Pfizer/BioNTech and currently being distributed under an emergency use authorization (EUA) by the FDA are not, in fact, really “vaccines” at all. Why? Because they are not “traditional” vaccines based on killed organism, proteins, or weakened versions of pathogenic viruses, but mRNA-based vaccines. This claim tends to take on one of two flavors. The first is that mRNA vaccines are not “vaccines” but rather “medical devices”. This one is the easiest one to dispose of which is why I will deal with it first. The second is that mRNA vaccines are not “vaccines” at all, but rather “gene therapy”, which sounds more plausible if you don’t know molecular biology but is also very much incorrect. According to antivaxxers, the consequences of mRNA vaccines being “gene therapy” are horrible complications, specifically that they will “prematurely kill large amounts of the population and disable exponentially more”.
mRNA vaccines are a medical device, not a vaccine? Nope!
I first came across the claim that mRNA-based COVID-19 vaccines are not really vaccines at all from a very familiar antivaccine propaganda blog that I’ve followed as part of my effort to stay on top of all the latest antivaccine talking points since its very inception, Age of Autism. It comes courtesy of an antivaccine quack named Dr. Ken Stoller and was posted a couple of weeks ago to the AoA website under the title, ‘Pfizer, Moderna et al Covid Products are Medical Devices Not “Vaccines”‘.
Who is Ken Stoller? Although I couldn’t find any instance of our having written about him here, I knew who he was and did find other mentions of him. Let’s just say that he’s been antivaccine for a long time, with the first time I remember ever having encountered him being in 2006. Sadly, he is a pediatrician (and regular readers know how much contempt I have for antivaccine pediatricians like “Dr. Bob” Sears and “Dr. Paul” Thomas). He even has his own Whale.to entry! (If you don’t know what that means, let’s just say that only the most…out there…cranks get the honor of their own Whale.to entry.) Dr. Stoller also got a mention when he was investigated by the San Francisco attorney’s office for issuing “medical exemptions” based on conditions not scientifically supported as valid reasons for a medical exemption to school vaccine mandates, because, well, in the age of SB 277, the California law passed in 2015 to eliminate personal belief exemptions and other nonmedical exemptions to school vaccine mandates, antivax grifters gonna grift. Basically, although Dr. Stoller didn’t reach the heights of antivaccine exemption grift that, say, Dr. Tara Zandvliet did (she wrote one-third of all the medical exemptions in the entire San Diego Unified School District!), but he did write a lot of dubious “exemptions.” Apparently his legal case is still going on, as his lawyer Rick Jaffe (who, I note, was Stanislaw Burzynski’s lawyer) is still soliciting funds for his legal defense, while the antivaccine doctors group Physicians for Informed Consent has been supporting him.
Basically, Dr. Stoller is into all manner of autism quackery and pseudoscience, be it vaccines as a cause of autism, hyperbaric oxygen to treat autism (Dr. Stoller loves hyperbaric oxygen treatments, or HBOT), chelation therapy, and many others. And conspiracy theories. Naturally, he believes that “They” are keeping you from learning about the evidence that vaccines cause autism and that his quackery works to reverse it.
Unfortunately (or maybe fortunately), Dr. Stoller’s claims regarding COVID-19 mRNA vaccines are rather ridiculous even on the surface:
You are not antivax if you are against the COVID-19 injections
You are not anti-vax because the COIVD injections are not vaccines.
Yes, they are being called vaccines, but this is to bypass the regulatory requirements for a medical device.
This ‘vaccine’ is actually a medical device that has never been used in humans before and rushed to market without any appreciation for what it will do either in the short term or long term.
This injection is also being called a vaccine to gain more acceptance, because most people assume that all vaccines are safe and effective. That’s what the CDC tells us. So if it is a vaccine, it must be safe and effective for ending the pandemic.
I’m sorry, but Dr. Stoller’s claim is just plain silly. You don’t get to redefine terms to suit your narrative, try as you might. I’ll explain why he’s so off-base in a minute. First, I need to let him let out sufficient rope to hang himself—or at least to hang his argument, although I can’t help but note that he makes the claim that the short term adverse event rate is 80%. I don’t know where he got that number for the overall adverse event rate, but Moderna’s reported data, for example, would seem to…contradict…that number.
Actually, it’s very clear where Dr. Stoller got that number. He looked at reports of local reaction and pain at the injection site and—well, duh!—over 80% of people reported pain or swelling at the injection site. True, that’s an “adverse event”, but it’s an adverse event that nearly all vaccines produce. Minor pain and swelling at the injection site are to be expected and are considered minor adverse events. In fact, the rate of significant or non-minor adverse events has been very low for both vaccines. None of that stops Stoller from asking disingenuously, “But if the short-term adverse event rate is 80 percent, what is in store for the long term?” Oh, I don’t know. Maybe that all those sore shoulders will get better over several days.
Let’s dive into the “core” (if you can call it that) of Stoller’s claim, which, as many antivaxxers can’t resist, he can’t help but preface by comparing COVID-19 vaccination to the Tuskegee syphilis experiment, but only a “billion-fold” worse:
While this is an over simplification, a vaccine, as defined by the CDC & FDA, is procedure that introduces into the body a foreign protein or weakened virus or bacteria and activates the immune system to make antibodies to same. In theory, to be effective, those antibodies actually have to perform in a useful manner.
If it works as advertised, a vaccine gets in your body and programs itself to attack the infection should it cross your path. It has to stimulate both immunity and disrupt transmission by definition, but the COVID-19 injection does not encourage your body to program your immune system. Instead, it is the program.
This mRNA injection bypasses that step and takes over the programming of our cells to make proteins it wants to make, which presumably will stop, prevent or modulate the infection in question – in this case the COVID-19 virus.
This is, of course, utter nonsense. Yes, in general vaccines can use either protein (or protein fragments) from a pathogenic organism, be it a virus, bacteria, or other organism that provoke an immune response that can protect against the whole organism when the body encounters it. Such proteins or protein fragments that can provoke a specific immune response are known as “antigens”. (The acellular pertussis vaccine is a good example of this form of vaccine.) One other major form of “traditional” vaccines against viruses (a “live-attenuated” vaccine) uses a weakened form of the pathogenic virus that can infect your cells but cannot cause the disease that the full-strength natural (or “wild type”) form of the virus can. The measles vaccine is a good example of this latter form.
Here’s how the CDC actually does define a vaccine, a definition that is easily found on the CDC website under Immunization: The Basics:
Vaccine: A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease. Vaccines are usually administered through needle injections, but can also be administered by mouth or sprayed into the nose.
Vaccination: The act of introducing a vaccine into the body to produce immunity to a specific disease.
Immunization: A process by which a person becomes protected against a disease through vaccination. This term is often used interchangeably with vaccination or inoculation.
And here’s the FDA’s definition of a vaccine:
Vaccines work by mimicking the infectious bacteria or viruses that cause disease. Vaccination stimulates the body’s immune system to build up defenses against the infectious bacteria or virus (organism) without causing the disease. The parts of the infectious organism that the immune system recognizes are foreign to the body and are called antigens. Vaccination exposes the body to these antigens.
Some vaccines contain weakened versions of a bacteria or virus, other vaccines contain only part of the bacteria or virus. Some vaccines contain only the genetic material for a specific protein and direct the body to produce a small amount of that protein. The body’s immune system reacts defensively once it detects this protein.
After vaccination, the immune system is prepared to respond quickly and forcefully when the body encounters the real disease-causing organism.
See what I mean? The definition of “vaccine,” be it the FDA’s or the CDC’s definition, does not require that the compound injected be a protein or a weakened virus. The definition is far more general than that, and under the definition above the Moderna and Pfizer/BioNTech mRNA vaccines are without a doubt, well, vaccines, as they do exactly what the CDC definition of “vaccine” states: They are products that “stimulate a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.” The fact that they do it using a method other than simply injecting protein isolated from the pathogenic microorganism or injecting or giving by mouth a weakened form of the pathogenic microorganism is completely irrelevant. That the Moderna and Pfizer/BioNTech vaccines use mRNA wrapped in lipid nanoparticles to introduce mRNA coding for a the SARS-CoV-2 spike protein in order to induce a person’s own cells to make that protein and thereby stimulate the immune system to react against it does not make it any less of a vaccine than an “old-fashioned” vaccine like the whole-cell pertussis vaccine, which basically used killed whole bacteria.
To be honest, I feel kind of silly even having to explain this here on SBM, but I keep seeing this talking point, whether it comes from Dr. Stoller or is a variant of the same talking point showing up elsewhere in the antivaccine griftosophere. Worse, Dr. Stoller seems very confused. In brief, he can’t seem to make up his mind whether the current mRNA COVID-19 vaccines are a “medical device” or a “gene therapy” (or even just a “treatment”, rather than a vaccine). I’ll use his confusion as an introduction to the next section and an explanation of why the “gene therapy” trope is just that, a trope, as I pivot to an article by über-quack “natural health entrepreneur” Dr. Joe Mercola entitled “How COVID-19 ‘Vaccines’ May Destroy the Lives of Millions“. Before I do, though, I can’t help but suggest that COVID-19 vaccines will “destroy” those lives by preventing people from catching a potentially deadly disease that’s currently spreading like wildfire through a mostly immunologically-naïve population.
I also can’t help but address Dr. Stoller’s conclusion:
In truth this is a medical device, and it should undergo the safety evaluations any medical device needs to undergo.
Seriously, this is most definitely not what Dr. Stoller wants, and it’s clear that he has no clue about medical device regulation. Dr. Stoller is either unaware or lying about the longstanding problem that the approval process for medical devices is much more lax than it is for drugs, vaccines, and biologics. Indeed, this is such an issue that problems with the laxness in the standards for medical device approval have made the news rather frequently over the last few years. (Books have been written about this problem.) That’s because medical devices are regulated under a different law than drugs, vaccines, or biologics:
Devices are subject to weaker standards than drugs because they’re regulated under a different law. The Medical Device Amendments of 1976 was intended to encourage innovation while allowing for a range of review standards based on risk, according to legal expert Richard A. Merrill. An array of corporate lobbying has since prompted Congress to ease regulations and make it easier for devices to get the FDA’s OK (here’s one 2015 example).
Seriously, as conspiracy theories go, Dr. Stoller’s is even dumber than usual, particularly given how he seems to conflate gene therapy with biologics with medical devices.
COVID-19: A “gene therapy”? (Betteridge’s law of headlines applies)
Before I deal with Mercola, let me first conclude my discussion of Dr. Stoller’s rather clueless confusion. First, Dr. Stoller makes a simple, “Well, duh!” observation but frames it in such a manner as to make it seem terrifying if you don’t know molecular biology:
This mRNA injection bypasses that step and takes over the programming of our cells to make proteins it wants to make, which presumably will stop, prevent or modulate the infection in question – in this case the COVID-19 virus.
Yes, that is how mRNA vaccines work—sort of. mRNA vaccines do introduce a specific mRNA coding for the desired protein antigen into the recipient’s muscle cells; that much is true. The mRNA then serves as a template for the cell’s ribosomes to make that protein; that much is also true. I’ll also add here that there are other ways of achieving this same result, inducing the vaccine recipient’s own cells to make antigen. Putting the cDNA (the DNA with the gene for a protein) coding for the desired protein antigen in an adenovirus vector that can’t replicate is another method. (Indeed, that’s how the COVID-19 vaccine candidates from Johnson & Johnson and AstraZeneca work.)
Note, though, how Dr. Stoller, in his effort to portray mRNA vaccines as “therapy” (specifically a “gene therapy”), obfuscates by saying that the recombinant proteins made by the vaccines “presumably” will “stop, prevent or modulate the infection in question”. First, there’s no “presumably” about it; the mRNA vaccines work. Second, the goal is to prevent severe disease from the infection by provoking an immune response and providing “immune memory”, so that the immune system, when encountering SARS-CoV-2 again, will be able to rapidly ramp up a response to shut the virus down before it can cause disease. That’s how all vaccines designed to prevent viral diseases work! There’s nothing special about the COVID-19 vaccines in that aspect, Dr. Stoller’s risibly feverish effort to suggest otherwise notwithstanding. Note further how he tries to redefine prevention as “treatment”:
In actuality, all the COVID-19 injection does is provide a treatment to supposedly modulate the severity of the COVID-19 illness should you get it and become symptomatic.
In other words, it is a treatment – a genetic treatment that has never been used in humans before.
And if it is only a treatment that neither prevents infection nor transmission, in truth, it is no better than any of the other treatments floating around like Ivermection/Zinc/Vit D/HCQ/Vit C/ HBOT/ozone, etc.
Note the false equivalence. It is true that vaccines can be “treatments”. The rabies vaccine is a good example, as are various experimental vaccines against a variety of cancers. However, such vaccines are also preventatives. The rabies vaccine, when given before exposure to rabies, is prevention; when given after, it can be treatment designed to ramp up the immune system before the virus can take hold. Dr. Stoller is either ignorant of that distinction or cynically misrepresenting it because he knows that his antivax and COVID-19-denying followers don’t understand or know about it. (Take your pick.) More amusing to me is how he compares it to a variety of quack or unproven treatments for COVID-19, in order to downplay it. Wait, what? Don’t COVID-19 quacks think that all (or at least several) of the treatments disparaged by Dr. Stoller are very effective against COVID-19? It’s also odd that he didn’t mention dexamethasone, which is one treatment for COVID-19 that has been validated in randomized clinical trials, unlike the rest that he mentioned.
Or maybe not:
We do know that there are other treatments and if this were just called a ‘treatment’ people would ask how it stacks up to the other available treatments.
I would argue it is not even a biologic because it is so clearly gene manipulation – direct gene manipulation – something that has never ever taken place before in the history of mankind.
The problem with Dr. Stoller’s claim is that the mRNA vaccines are indeed vaccines by any reasonable definition. But what about “biologics”? According to the FDA, biologics “include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.” Under that definition, sure, the mRNA vaccines are considered biologics, but so what? That doesn’t make them any less vaccines, as biologics can be vaccines; in fact, vaccines are, by definition, a form of biologic because they either contain biologic material (killed virus or bacteria, weakened virus, etc.) or, in the case of mRNA vaccines, recombinant nucleic acids designed to make protein. Dr. Stoller is again either ignorant or showing contempt for his reader. As for “gene manipulation”? Do I really have to get into that again? I guess I do, but I’ll wait until I deal with one last aspect of Stoller’s little rant, namely how Dr. Stoller sees conspiracies everywhere:
Obviously the COVID-19 injection is the treatment the so-called experts want you to have because not only are they so invested in it for economic and political reasons, but because it allows them to exercise even more control over the population, which is what this has been all about anyway.
I’m surprised he didn’t mention microchips in the vaccine, 5G, and Bill Gates, but whatever. I commend him for his restraint.
Unfortunately, a much louder voice is amplifying the same conspiracy theory, namely Joe Mercola. To do that, he cites Judy Mikovits. Does anyone remember Judy Mikovits? She was all the rage in COVID-19 conspiracy circles in May (which in the course of the COVID-19 pandemic seems like ancient history now) with her “plandemic” conspiracy theory that claimed that the pandemic was planned. That’s not a great look, but Mikovits does have a PhD and used to be a scientist; so that makes it easy for Mercola to portray her as an expert when in fact she is a pseudoexpert:
The COVID-19 vaccine really isn’t a vaccine in the medical definition of a vaccine. It does not improve your immune response to the infection, nor does not limit you from getting the infection. It’s really an experimental gene therapy that could prematurely kill large amounts of the population and disable exponentially more.
“I’m just beside myself with anger over this synthetic gene therapy, this chemical poison, and what they’re doing worldwide,” Mikovits says. “We’re already seeing deaths from this shot. It’s illegal. It shouldn’t be done. It should be stopped right now. It should have never been allowed to happen, yet we see it being forced on the most vulnerable populations.”
Indeed, news and social media reports suggest recipients are starting to drop like flies. Many die of unknown causes within days, sometimes hours of getting the first or second shot.
I won’t go into the bit about “dropping like flies” other than to point you to my previous discussions of how, when tens of millions of people are vaccinated in a short period of time, the law of large numbers dictates that there will deaths and bad things that happen to some of them unrelated to the vaccine by random chance alone and that the only way to tell if such events might be related to the vaccine include epidemiology to determine if there is an increase of such adverse reactions above the expected baseline and careful scientific investigation. Antivaxxers, of course, automatically assume that any death within a month of vaccination against COVID-19 must have been caused by the vaccine.
Mercola adds to the misinformation spread by Stoller by mischaracterizing the mRNA vaccines. First, he goes out of his way to portray them as “artificial” and “unnatural”:
The messenger RNA (mRNA) used in many COVID-19 vaccines are not natural. They’re synthetic. Since naturally produced mRNA rapidly degrades, it must be complexed with lipids or polymers to prevent this from happening. COVID-19 vaccines use PEGylated lipid nanoparticles, and PEG is known to cause anaphylaxis. Lipid nanoparticles may also cause other problems.
And:
However, if they call their drugs vaccines, they can bypass the safety studies. All of a sudden, they expect us to believe that all of these safety issues have been resolved? Another problem is related to how long the mRNA remains stable in your system. It’s encased in nanolipid to prevent it from degrading too rapidly, but what happens if the mRNA degrades too slowly, or not at all?
The idea behind mRNA vaccines is that by tricking your body into creating the SARS-CoV-2 spike protein, your immune system will produce antibodies in response. But what happens when you turn your body into a viral protein factory, thus keeping antibody production activated on a continual basis with no ability to shut down?
And:
So, just how long will the synthetic RNA in COVID-19 vaccines be maintained within your body, causing your cells to produce this aberrant protein? Mikovits believes it will escape degradation for months, years, maybe even for life in some cases.
No, no, no, no, no!
Let’s start with the same talking point used by Stoller and parroted by Mercola, the claim that Moderna and Pfizer called their products “vaccines” in order to “bypass safety studies”? This is, quite simply, a lie. (I’m assuming that Mercola is not so ignorant or stupid not to know that what he is saying is incorrect, but I suppose I do have to concede the possibility that I’m giving him too much credit. Basically, he’s either ignorant or a liar. Judge for yourself and take your pick.) It is, of course, true that neither vaccine has obtained full FDA approval yet, having been allowed by the FDA to be distributed under an EUA because of the emergency of the pandemic, but it is not true that either vaccine “bypassed safety studies”. I mean, seriously: There were over 70,000 subjects in the phase 3 studies of the two vaccines that led to their approval under an EUA, producing scads and scads of safety data. Post-EUA pharmacovigilance monitoring of these vaccines is unprecedented in its intensity.
But what about the “synthetic” mRNA? Yes, the mRNA in both vaccines is indeed chemically modified. The reasons are simple, as I discussed before in my usual ridiculous level of detail. First, RNA is unstable, as Mercola mentioned. In regular aqueous solution (in this case, water with some buffer and salt) RNA rapidly degrades at room temperature (or even in the refrigerator) and can degrade too quickly even at -20°C. The second, and more important, reason is that mRNA has a short half-life in cells, normally on the order of hours or even minutes. (I used to measure mRNA half-life for the gene I cloned back in the 1990s, and it was regulated by stimuli that dramatically shortened or lengthened its half-life in the cell from four hours to around an hour hour.) Basically, the modification of the RNA in both vaccines is designed to make them more stable, but not infinitely stable, which is what Mikovits and Mercola are claiming. No biological molecule, modified or not, lasts forever, which is what the RNA would have to do to “turn your body into a viral protein factory, thus keeping antibody production activated on a continual basis with no ability to shut down”. Seriously, does Mercola know anything about molecular biology? Indeed, from Moderna, for example:
The delivered mRNA does not enter the cell nucleus or interact with the genome, is nonreplicating, and is expressed transiently. The estimated half-life for mRNA after injection is approximately 8 to 10 hours, before degradation by native RNases in the body, but the duration of effect also depends on the half-life of the expressed protein, which persists in the body for several days. mRNA vaccines have been used to induce immune responses against infectious pathogens such as cytomegalovirus (CMV), human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3), Zika, and influenza virus.
Basically, with a half-life of ten hours, the mRNA will be completely gone within a few days and the protein completely gone after, at most, a few weeks. The Pfizer mRNA vaccine is similar. Again, does Mercola understand anything about basic molecular biology? Apparently not, or he’s lying.
Meanwhile, Mikovits adds to the deceptive fear mongering claiming that the mRNA vaccines are “permanent genetic alteration”:
So, taking a synthetic messenger RNA and making it thermostable — making it not break down — [is problematic]. We have lots of enzymes (RNAses and DNAses) that degrade free RNA and DNA because, again, those are danger signals to your immune system. They literally drive inflammatory diseases.
Now you’ve got PEG, PEGylated and polyethylene glycol, and a lipid nanoparticle that will allow it to enter every cell of the body and change the regulation of our own genes with this synthetic RNA, part of which actually is the message for the gene syncytin …
Syncytin is the endogenous gammaretrovirus envelope that’s encoded in the human genome … We know that if syncytin … is expressed aberrantly in the body, for instance in the brain, which these lipid nanoparticles will go into, then you’ve got multiple sclerosis.
The expression of that gene alone enrages microglia, literally inflames and dysregulates the communication between the brain microglia, which are critical for clearing toxins and pathogens in the brain and the communication with astrocytes.
And:
Making matters worse, the synthetic mRNA also has an HIV envelope expressed in it, which can cause immune dysregulation. “This is a nightmare,” Mikovits says. “I’m angry, as this should never be allowed.”
As we discussed in previous interviews, SARS-CoV-2 has been engineered in the lab with gain-of-function research that included introducing the HIV envelope into the spike protein.
Note that truly ignorant claim again about syncytin. I dealt with that one once before when I discussed why, contrary to antivaccine fear mongering, COVID-19 mRNA vaccines will not render women infertile. The Cliffs Notes version is that the mRNA for the SARS-CoV-2 spike protein used in these vaccines does not make a protein with amino acid sequences sufficiently similar to sequences in syncytin to provoke a crossreacting immune response to syncytin that could render women infertile or do any of the things claimed by Mikovits. Moreover, the claim that sequences from the gene encoding the HIV-1 envelope protein are in the COVID-19 spike protein is an antivax distortion. Basically, the amino acid sequences in the spike protein that antivaxxers call “HIV-1 envelope sequences” are in fact amino acid sequences so short that they are commonly found in many proteins, as I discussed a while back. mRNA vaccines making spike protein are not going to lead to “immune dysregulation” due “HIV-1 envelope” because it doesn’t express HIV-1 envelope. One wonders how Mikovits ever managed to do science back in the day before she became a conspiracy theorist and crank.
Then, of course, because antivaxxers will always go for the “toxins” gambit, Mercola and Mikovits are so very, very concerned about the polyethylene glycol (PEG) in the lipid nanoparticles that envelope the mRNA used in the vaccines:
Another common side effect from the vaccine we’re seeing is allergic reactions, including anaphylactic shock. A likely culprit in this is PEG, which an estimated 70% of Americans are allergic to. “These instantaneous effects are almost certainly the PEG and that lipid nano particle, the toxic particle that’s being injected,” Mikovits says.
In the longer term, she suspects we’ll see a significant uptick in migraines, tics, Parkinson’s disease, microvascular disorders, different cancers, including prostate cancer, severe pain syndromes like fibromyalgia and rheumatoid arthritis, bladder problems, kidney disease, psychosis, neurodegenerative diseases such as Lou Gehrig’s disease (ALS) and sleep disorders, including narcolepsy. In young children, autism-like symptoms are likely to develop as well, she thinks.
Yes, although PEG hasn’t been used in an approved vaccine before, it has for a long time been used in a number of products, including toothpastes, shampoos, and some drugs with a good safety record. Indeed, the claim above that 70% of Americans are allergic to PEG is utter BS on its surface because if that were true allergists would be swamped with a tsunami of patients with allergic reactions to a wide variety of common household products. It is true that PEG has come under suspicion as a possible cause of the small number of anaphylactic reactions observed after COVID-19 vaccination, as a recent report in Science notes:
Severe allergy-like reactions in at least eight people who received the COVID-19 vaccine produced by Pfizer and BioNTech over the past 2 weeks may be due to a compound in the packaging of the messenger RNA (mRNA) that forms the vaccine’s main ingredient, scientists say. A similar mRNA vaccine developed by Moderna, which was authorized for emergency use in the United States on Friday, also contains the compound, polyethylene glycol (PEG).
PEG has never been used before in an approved vaccine, but it is found in many drugs that have occasionally triggered anaphylaxis—a potentially life-threatening reaction that can cause rashes, a plummeting blood pressure, shortness of breath, and a fast heartbeat. Some allergists and immunologists believe a small number of people previously exposed to PEG may have high levels of antibodies against PEG, putting them at risk of an anaphylactic reaction to the vaccine.
Others are skeptical of the link. Still, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) was concerned enough to convene several meetings last week to discuss the allergic reactions with representatives of Pfizer and Moderna, independent scientists and physicians, and the Food and Drug Administration (FDA).
NIAID is also setting up a study in collaboration with FDA to analyze the response to the vaccine in people who have high levels of anti-PEG antibodies or have experienced severe allergic responses to drugs or vaccines before.
A report published ten days ago by the CDC notes:
During December 21, 2020–January 10, 2021, monitoring by the Vaccine Adverse Event Reporting System detected 10 cases of anaphylaxis after administration of a reported 4,041,396 first doses of Moderna COVID-19 vaccine (2.5 cases per million doses administered). In nine cases, onset occurred within 15 minutes of vaccination. No anaphylaxis-related deaths were reported.
And two weeks before that the CDC reported:
During December 14–23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine (11.1 cases per million doses); 71% of these occurred within 15 minutes of vaccination.
In other words, these reactions are rare, managed relatively easily, and not outside the range of what is normally observed after other, older vaccines. Moreover, the risk of anaphylaxis from the vaccine, which hasn’t killed anyone, is certainly far, far smaller than the risk of death from COVID-19, which has already killed over 450,000 people or 130/100,000 people in the US in just one year and hospitalized millions, or 417/100,000 people since the beginning of the pandemic.
As for the central claim of Mercola and Mikovits that these vaccines are “permanent genetic alterations” that “may last for life,” I will refer you back to what I wrote long ago about that claim showing why the Moderna and Pfizer/BioNTech vaccines will not “permanently alter your DNA“. Again, anyone who’s ever taken Molecular Biology 101 will understand why this is the case, but apparently Joe Mercola and Judy Mikovits either did not or are lying. Again, read their words and take your pick.
Nor are these vaccines “gene therapy”. According to the FDA:
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.
And the types of gene therapy:
- 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.
Oh, dear. mRNA is not any of those. The not-so-dynamic duo might make a better case that the J&J or AstraZeneca vaccines are “gene therapy”, but so what? Those vaccines will not “permanently alter” the DNA of the recipients’ cells either.
The bottom line is that grifting antivaxxers like Ken Stoller, Joe Mercola, and Judy Mikovits are using claims about COVID-19 vaccines that are grossly incorrect or obviously deceptive to spread fear and doubt about COVID-19 vaccines in the middle of a pandemic by combining new disinformation about COVID-19 vaccines with very old antivaccine tropes (i.e., false claims that vaccines will “permanently alter your DNA,” cause autoimmune disease, render women infertile, or in other ways be more dangerous than the disease) in order to frighten people. In doing so, they have blood on their hands because for every 100 people whom they frighten out of vaccinating and who as a result contract COVID-19, it’s likely that there will be one death.
ADDENDUM:
Unsurprisingly, the onslaught still continues today, except that in this case Vaxxter, the house organ of Barbara Loe Fisher’s hoary antivaccine organization with an Orwellian name—the National Vaccine Information Center (NVIC)—published an article entitled Moderna, Pfizer Test mRNA Experimental Biologics on Children, because calling the Pfizer and Moderna vaccines “experimental biologics” and raising the specter of “experimentation” on children are so much scarier than referring to it as testing COVID-19 vaccines in children.