Categories
Antivaccine nonsense Medicine

The latest antivaccine lie about COVID-19 vaccines: “They’re gene therapy!”

There’s a new antivaccine talking point in town, and it’s just as much disinformation as other antivaccine talking points. It’s the claim that mRNA COVID-19 vaccines are not really vaccines but “medical devices,” “gene therapy,” or “experimental biologics” and that they were falsely classified as vaccines in order to bypass safety testing. Here, we discuss why this claim is utter nonsense based on the highly deceptive use of terminology.

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 RI, 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. Medical devices are subject to less stringent regulation than vaccines. If Moderna and Pfizer really wanted less stringent regulation, they’d do everything they could to have their vaccines classified as 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 (at most) 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 The Vaccine Reaction, 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.

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]

103 replies on “The latest antivaccine lie about COVID-19 vaccines: “They’re gene therapy!””

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.

It would seem that this guy hasn’t even bothered to read the simplified descriptions of how the mRNA vaccines work – not by causing recipient cells to make proteins that “”stop, prevent, …” but by causing recipient cells to make antigen protein. I suspect he also fails to realize that viruses all use host cells to make the proteins the viruses need – 29 of them in the case of SARS-CoV-2. Every one of those proteins requires mRNA from which it is translated.

I’m surprised that these types do not go apoplectic about the viral vector vaccines that actually stuff foreign DNA in to recipient cell nuclei – cDNA that gets transcribed to mRNA*. But given that they apparently don’t have a clue about how the mRNA vaccines work it doesn’t surprise me that they have no clue about how the vector vaccines work.

On the subject of viral vector vaccines: I’ve seen a lot of people claim these are ‘traditional” vaccines. I’m not aware of any viral vector vaccine that has been in use either widely or for any significant length of time. The only one I can find that even exists as an vaccine for an infectious disease is for Ebola. Does anyone know of others?

I’ve seen a lot of claims in comments on articles on the CBC website that the mRNA vaccines are gene therapy. It wasn’t until a couple of days ago that I came to realize that Mikovits the Menace was the source.

*we need an emoji (emojus?) that causes an ominous pipe organ chord in a minor key to be played

Viral vector vaccines: I spent a couple of months manufacturing one that was hoped to work against HIV (it didn’t). I think there were actually several adenovirus-based HIV vaccines that didn’t pan out.

Now I worry that my immune system will react against the adenovirus and not the payload if I get the J&J vaccine, but I haven’t been able to find any information on it. Anyone have any ideas?

Someone here once said “adenovirus vector vaccines are dumb” or words to that effect.

And there was that botched study where some participants (all under 55) recieved half an initial dose and appeared to fair better — It was speculated that the first relatively large dose was training the body against the adenovirus and the second dose was just that less effective because of it. Or, in the data, all the recipients of the ‘botch’ were under 55. Or, they just say that because they can’t meet promised output (unlikely).

https://www.sciencemag.org/news/2021/02/south-africa-suspends-use-astrazenecas-covid-19-vaccine-after-it-fails-clearly-stop

https://arstechnica.com/science/2021/02/scary-22-vaccine-efficacy-in-south-africa-comes-with-heaps-of-caveats/

But, hey, it’s cheap, $3 a dose. So that is what we’ll get here. I want the new stuff my parents got, dammit. When everybody gets dosed with the cheap crap then they will make me rip my respirator off just like any time before I would’ve been shot as a robber.

I thought these escaped bioweapons were supposed to have a ‘corrector codon’ or something so crap like this doesn’t happen? Almost makes me think it wasn’t a lab.

The vector used for the J&J has been talked about a little on TWiV. I can’t remember which adenovirus or numbers, but in some places some very large fraction of the population is seropositive to it. In spite of that the vaccine seems to perform quite well.
The vector is of course replication-incompetent so it has to be grown in something that supplies what the virus lacks in order to replicate – retinal cells from reports I’ve seen.

Sputnik V uses two different human adenoviruses, one for each dose, with the notion of avoiding the problems with immune response to the vector. Oxford-AstraZeneca uses the same chimpanzee adenovirus for both doses (low numbers of humans who are seropositive to it in one African country which I can’t remember). There is speculation that the result seen in the trials due to an incredibly stupid error where better efficacy appeared to result from using a half dose for prime and full dose for boost might have been due to the half dose resulting in lesser immune response to the boost dose vector. Ox-AZ in a recent paper reported that efficacy appears to be considerably higher when the boost dose is delayed to 12 weeks instead of the intended 4 weeks. Immune dynamics re: spike protein? re: vector??

I’m curious what AZ will do if, or more likely when, the need for subsequent boosters arises. Use a different vector? Hope immunity to the chimp virus wanes faster than that to the spike protein?

The incredibly stupid error to which I refer is that somebody at Oxford or AZ measured the amount of vector in a batch of vaccine and found it to be twice as high as reported by the contract manufacturer in Italy. Instead of questioning how such a huge difference could be exist and questioning measurement methods, they assumed that the manufacturer was wrong and gave half the amount. The manufacturer was correct. Ox or AZ used spectrophotometry and found out later that an excipient in the vaccine absorbed at the same wavelength as the virus. Stupid, stupid, stupid error. At a 10% measurement discrepancy you start being concerned. At a 2:1 difference you don’t stop investigating until you know exactly why.

Doug wrote: “I’m curious what AZ will do if, or more likely when, the need for subsequent boosters arises. Use a different vector? Hope immunity to the chimp virus wanes faster than that to the spike protein?”

A good bet would be to try to minimize immunity to the vector by using one dose of a human adenovirus vector in combination with a dose of the chimpanzee adenovirus vector, as in the trial starting next month:

https://clinicaltrials.gov/ct2/show/NCT04684446? term=astrazeneca+sputnik&cond=Covid19&draw=2&rank=1

@brian
Using different vectors seems like a sensible strategy.

I understand that it is possible to do things that reduce the immunogenicity of the vectors, but I presume it isn’t easy or perhaps it interferes with the infectivity somehow, otherwise I would expect we’d be seeing it used.
But I still wonder how boosters a year or two hence might be managed. If immunity to the vectors holds up well for that long then it suggests to me that a new vector might have be used each year for several years before using any of them again.

There are lots of adenoviruses to chose from, but we may need a global clearing house if different manufacturers use different vectors and we see introduction of more vector vaccines. It’s a bit of messy problem that the mRNA vaccines circumvent.

I got a chuckle from this line in the trial description:
“Ages Eligible for Study: 18 Years to 130 Years (Adult, Older Adult)”
Yup. 130 would tend to qualify as “older adult” on this planet.

@Tim, That was probably me, I have changed my position based on the results of the recent vaccine trials. (My previous opinion was based on the crummy outcomes of some different vaccine trials.)

@doug: good to know.

@ JustaTech,

The Goat Lentivirus did. Or rather it would have.

It just proceeded to development (again) in October 2019.

@ Christine: What?

I’ve never worked with lentiviruses. I was talking specifically about adenoviruses.

mRNA has been in animal trials for awhile now they have tested it on SARS MERS and Zicca viruses and in all 3 of those previous animal trials they were halted because of catastrophic failures where the animals all died after being reintroduced to the pathogen and they failed to have an immunological response to the virus. But now we’re supposed to believe that it’s gonna be any different when used on humans? Yeah no thanks I’m not living in fear of a virus that has a 99.97% survival rate and I’m not taking an experimental vaccine that failed miserably in 3 previous trials on animals.

Well, given that over 100 million doses have been administered in the US alone and we’ve seen nothing like this phenomenon, I’d say we long ago demonstrated that this is not a problem with COVID vaccines.🙄

I’m guessing that Sean was trying to channel Dolores Cahill, in a mangled fashion.

And…

I’m a nursing supervisor and I’ve been offered position working with covid testing and vaccination center and it was great pay as well but I matter of factly told them thanks for the offer but I can’t accept it because I would never willingly give that shot to a patient when I wouldn’t take it myself because I believe it will cause harm after reading the studies testing same thing for SARS MERS and Zicca viruses on animals and all 3 studies failed when all of the animals died after receiving mRNA treatment once they were reintroduced to the viruses it killed them.

@Sean There is a study of mRNA vaccine for Zika virus:
Pardi, N., Hogan, M., Pelc, R. et al. Zika virus protection by a single low-dose nucleoside-modified mRNA vaccination. Nature 543, 248–251 (2017). https://doi.org/10.1038/nature21428
None of mice died. Your fatality rate is as imaginary, of course

I have encountered this claim before. Each time, I have investigated, and so far have been unable to find any animal trials of mRNA vaccines for these three diseases that ended as described (this, of course, does not mean they don’t exist). I did, however, find mention of a number of more traditional vaccine candidates that had the problems mentioned (though none of them ended with all of the the animals dying). In fact, many of the articles indicated that the mRNA vaccines were less likely to cause ADE reactions than traditional vaccines.

The animal studies concerned me too. All one has to do is an advanced search, to find endless concerning animal studies.some may claim they worked out the “bugs”, since then, but there’s definitely problems that cropped up in the earlier animal studies and with the earlier form of SARS.

https://www.cidrap.umn.edu/news-perspective/2004/12/sars-vaccine-linked-liver-damage-ferret-study

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3335060/

https://www.newscientist.com/article/dn23563-threatwatch-could-a-mers-vaccine-make-people-sicker/

“Early efforts to make SARS vaccines, using whole, killed viruses or viral proteins, seemed promising. The vaccine candidates rapidly induced antibodies that, in cell culture, neutralised the virus. When vaccinated animals were exposed to SARS, the virus didn’t replicate in their lungs. But several labs noticed that the animals still experienced a lung inflammation resembling a severe allergy.

This rang alarm bells. Experimental vaccines for animal coronaviruses have had this effect, and it has also been seen with viruses from other families. Most notoriously, it occurred in the 1960s with vaccines for measles and respiratory syncytial virus (RSV), a common infection in babies. Vaccines containing killed viruses were tested in children and appeared safe, but when the children encountered live measles or RSV, they got sicker than unvaccinated children. Both vaccines were abandoned, and developers have been wary of the effect ever since.

Last year Robert Couch of Baylor College tested four experimental SARS vaccines in mice. All the vaccinated animals resisted infection, yet exposure to the SARS virus led to a severe lung inflammation similar to that seen with the RSV vaccine. The same thing, he reported, has been seen with many other experimental SARS vaccines.”

The problem seems to be that rather than aiding the destruction of the invading virus, the antibodies switch sides. Malik Peiris of the University of Hong Kong found that antibodies to a vaccine made from the main surface protein of SARS allow the virus to enter immune cells, where they can trigger a destructive immune attack on the lung.

Read more: https://www.newscientist.com/article/dn23563-threatwatch-could-a-mers-vaccine-make-people-sicker/#ixzz6tzaYq2Ak

https://abcnews.go.com/Health/sars-virus-vaccine-experts/story?id=19168004

But it’s more than a matter of time and money. Coronaviruses, prickly pathogens that invade the body through the respiratory tract, are notoriously difficult when it comes to vaccine development, according to Atmar. Some of the candidate vaccines for SARS caused lung damage in mice exposed to the virus.

“We don’t know why. And that’s the problem,” said Atmar, co-author of a 2012 study published in the journal PLoS One. “The concern is that if these vaccines were to be used in people, they could end up causing harm.”

I have noticed the failure in reassurances out there, and also one notable thing missing in these discussions is explaining to lay people, how these earlier problems were “worked out”.

The articles you site are all ancient history as far as the science is concerned. If there were a safety signal from antibody-dependent enhancement, it very likely would have been seen in the phase 3 studies, which involved over 70K subjects between the Moderna and Pfizer vaccines, and if it wasn’t seen in those studies would CERTAINLY have been detected after >240 million doses had been administered in the US alone. ADE was a concern early in the development of these vaccines based on past experience, but, here and now in 2021, it is a non-issue.

It’s not like they would be ecstatic about the lack of adjuvants thus “safer”. As for me, I’m excited about the new tech. The one I have no idea about and sounds a little more scary would be self-amplifying mRNA. Like a screeching microphone in an audio feedback loop, how does it know how to dampen itself??

“so very, very concerned about the polyethylene glycol (PEG)”

Meh, I’ve been puffing on it’s cousin, polypropylene glycol, for years. Interestingly enough, some vape mixes do contain polyethylene glycol (known as PEG 400) and I had to move on away from my favorite brand when they switched to it because it did give me a sore throat with every session.

I have a question which I hope is, at least, interesting: I have several small spots of some flavor skin cancer* and one of them is right exactly where the needle would go in on the side of the bulgy part of the upper arm. If some of the cancer bits just happened to get dragged into the muscle, is it possible that it might get caught up in the local inflammation and immune training going on and then there would be more of an immune response to those spots? If that sounds like a bad idea, I’ll just tell them to use the other arm.

*I was given a course of Risperdol in 2015 and a few things happened in rapid succession. Hormones went wild with prolactin particularly greatly elevated, disbiosis causing weight gain, and these spots which just happened to appear where I placed the nicotine patches which had to be rotated because they caused a red, slightly elevated welt over time. All five known spots {save the one in the ear lobe} were where I placed the patches. they are small with the largest, roughest, and most elevated being about 3mm oblong. Also, some biological switch was flipped and never went back — hair started growing in gross places like in the ears and on … things.

As for medical device safety, I came across this today: https://thedailywtf.com/articles/the-therac-25-incident and though it a good cautionary tail about testing regulations, and implementations.

The technician had run this process so many times she started keying in the prescription. She’d become an extremely fast typist, at least on this device, and perhaps too fast. In the field for beam type, she accidentally keyed in “X”, for “x-ray”. It was a natural mistake, as most patients got x-ray treatments, and it wasn’t much of a problem: the computer would see that the turntable was in the wrong position and refuse to dose the patient. She quickly tapped the “UP” arrow on the keyboard to return to the field, corrected the value to “E”, for electron, and confirmed the other parameters.
.
.
To trigger the overdose, you needed to type quickly, the kind of speed that an experienced operator might have. The physicist practiced until he could replicate the error, then informed AECL. While he was taking measurements to see how large the overdoses were, AECL called back. They couldn’t replicate the issue. “It works on my machine,” essentially.
.
.
With that information, the root cause was easier to understand: there was a race condition. Specifically, when the technician mistyped “X” for x-ray, the computer would calculate out the beam activation sequence to deliver a high-energy beam to create x-rays. When the technician hit the “UP” arrow to correct their mistake, it should’ve forced a recalculation of that activation sequence—but if the user typed too quickly, the UI would update and the recalculation would never happen.
.
.
.
On one hand, this is a simple instruction that would effectively prevent the ETCC incidents from reoccurring. On the other, it’s terrifying to imagine a patient’s life hanging on a ripped up keycap and electrical tape.

I don’t know if that would even be classified as a ‘device’ as it doesn’t go in/on the body.

Interestingly enough, some vape mixes do contain polyethylene glycol (known as PEG 400) and I had to move on away from my favorite brand when they switched to it because it did give me a sore throat with every session.

I hope you’re not running subohm — VG is the appropriate choice there.

Ha! No, just an old Kanger Protank II* checking in. 4 wraps of 30 guage around a toothpick starts it at ~1.3 ohms. Mine is currently at 1.8 Dang, time for a rebuild of the little micro-coil; which I hate because, well, micro. And my hands shake.

I’m mostly VG; The juice starts out as 24 mg/ml 50/50 PG/VG which I then cut with VG. About 1/3 juice to 2/3 VG. I can just hear the calls of “bull” from they-that-vape all over RI now as there is no way a Kanger micro build would give anything but burn hits at that viscocity.

Burn hits are bad. Overheating the PG makes all kinds of nasty formaldehyde. Ahh! The trick is to thread a syringe needle through the cotton and wallow out the center. This also has the advantage of pushing the cotton up between the turns {I don’t bother squeezing them together as I don’t have a butane micro-torch}.

*sitting atop a single 18650, this thing makes surprisingly thick vapor. No, I can’t compete against some 23 watt cloud-chaser; but, if there were a ‘weight class’, I think I’d come out pretty close to the top when it is acting right.

GuuH! My mom. All through the night, must bring juice, with ice, on call. 5 gallons a day. “I have to pee” every 20 minutes. It has to be assisted because she has grown so fat. I’m beginning to think there might be some problem here. I say to dad, “get her into the hospital so they can observe this blubbering that only occurs ‘off and on’ ” — 24/7 unless in the car going to the doctor. Ohh, no because then we can not visit, “I called”, he sais — “Ya’ll are vaccinated!”, I exclaim. “no matter, it’s Alabama” and we all know how mental health services are up in here, think Won Flew Over The Coccos Nest. And that Indian that totally rekd a sink.

I’ve caught her $not blubbering while browsing facebook on her phone but as soon as I make the slightest noise……..

TMI, I know. Just file it under “Tim”

That song has aged well in the last 40 years.

A bit too well, given my current situation. Have I mentioned that it was choreographed by “Toni Basil”? (Probably.)

I’m partial to the live version myself, because reasons.

People say the vaccine make us grow scales. I say that is a good thing. Scales repel the coming fire. Give me the scales. Essential oils are hot gull shit.

Dr. Bill says a third jab may be needed…. https://www.cbsnews.com/news/covid-vaccine-variants-third-shot-bill-gates/

Dr. Scott, “believed the vaccines currently being distributed in the U.S. would offer “reasonable protection” against the new variants, even if they are less effective against the new strains. Still, he said, it may also be necessary to administer booster shots in the fall.” What is “reasonable protection”? Is one mask “reasonable protection”? Is social distancing “reasonable protection”?

Dr. Scott believes. Faith in science seems to increase during stressful times. Interesting. https://www.sciencedirect.com/science/article/pii/S0022103113001042

Bill Gates dropped out of Harvard and AFAIK has not earned any degrees or been awarded an honorary degree. Your concern for accuracy is noted /s

I’m sure he has more urgent concerns at the moment.

https://www.youtube.com/watch?v=JNS3ADqdgy8

Also I remember last spring/early summer when vaccine development and testing were ramping up there was a lot of uncertainty about how well the vaccines would protect against infection and disease and how long that protection would last based on the short protection the body generates against common cold coronaviruses. Doctor Fauci expressed that he would be quite happy if an annual shot was required like the flu shots.

So if we have to administer an annual booster shot with updated mRNA to cope with new circulating variants, it would hardly be the disaster you make it out to be.

Since our results on millions of patients so far show the biggest safety concern is a small number of severe allergic reactions which have all been well treated and not led to any deaths, I would be quite happy to get an annual Covid-19 shot at the same time as my annual flu shot.

It would be good if the U.S. government could negotiate a lower price for these vaccines. But it already funded production of materials for several of them. And it is paying directly or indirectly (Medicare/Medicaid) for the Covid-19 vaccines. So cost to the consumer is moot.

And Dr Fauci supports development of antivirals as well.

https://bestlifeonline.com/antiviral-drugs-fauci-news/

Fauci said experts are “putting a lot of effort” into developing “direct, acting antiviral drugs” for people who are severely ill from COVID. Someone who is symptomatic might get a 7- to 10-day course to prevent them from getting sicker and having to go to the hospital. Fauci believes having antiviral drugs at the ready would help curtail the COVID pandemic.

I’ve been keeping an eye on molnupiravir (EIDD-2801) for a while now.

https://clinicaltrials.gov/ct2/show/NCT04405739

I’m hoping it might also prove effective against influenza virus. But the trials have only reached phase 2 so far.

@ Natalie

Which explains why he discourages anything for treatment other than the vaccine.

You never tire of lying?
Last year, Fauci was willing to support potential drug treatments – provided there was some evidence being them.
It’s funny. You were then lambasting him for being a Pharma shill.

Oh, I see. You have a miracle treatment in mind. Do share. With evidence.

Why you take medical advice from Bill Gates ? Cite some doctor, if you want authority.
Third dose may be needed, if virus variant is so different that current vaccines are not effective enough. They are surely not added if not needed.
If scientist says that she or he believes something, this mean that there is some evidence. Like this:
Wu K, Werner AP, Moliva JI, Koch M, Choi A, Stewart-Jones GBE, Bennett H, Boyoglu-Barnum S, Shi W, Graham BS, Carfi A, Corbett KS, Seder RA, Edwards DK. mRNA-1273 vaccine induces neutralizing antibodies against spike mutants from global SARS-CoV-2 variants. bioRxiv [Preprint]. 2021 Jan 25:2021.01.25.427948. doi: 10.1101/2021.01.25.427948. PMID: 33501442; PMCID: PMC7836112.
A preprint for sure, but it seems that UK variant is covered, but South Africa variant is more problematic.

Thanks for the argument by headline, Natalie.

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

https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/what-gene-therapy

mRNA doesn’t get into the cell’s nucleus and doesn’t have the ability to modify the cell’s DNA even if it did. Ergo, it is not gene therapy.

Although I can understand why the American Society of Gene and Cell Therapy would want to tout the success of these vaccines.

@ Squirrelelite – The article states, “Both vaccine candidates use mRNA to program a person’s cells to produce many copies of a fragment of the virus. The fragment then stimulates the immune system to attack if the real virus tries to invade the body”. Well, it is “programming” a person’s cells whether or not it is in the cells nucleus.

So, I guess the American Society of Gene and Cell Therapy are being misleading in their proclamation. Go figure.

OT…I didn’t thank you for the NM travel tips. I hope to make it down there one day…in the winter or preferably during spring.

Good day and good health to you!

@Natalie,

It just shows how details matter. Our cells use mRNA to tell their production machinery to make proteins countless times every day. The mRNA vaccines use that mechanism to produce the antigen proteins. Viral vector vaccines tuck that protein into an otherwise benign virus. And some vaccines like the Novavax which I forgot to mention just inject the proteins directly. All of those yield an immune response and have been shown effective. But, none of those change the cell’s DNA itself.

I saw news of some major tourist event being cancelled again this year, but couldn’t find the link. But New Mexico’s hard work on controlling the coronavirus is showing results and travel restrictions have been relaxed.

https://www.abqjournal.com/2358182/governor-to-update-public-health-measures-this-afternoon.html?utm_source=newsletter&utm_medium=email&utm_campaign=daily-headlines

My wife got her second dose of the vaccine this week, but I’m still on the waiting list.

So, I guess the American Society of Gene and Cell Therapy are being misleading in their proclamation. Go figure.

One might note the wholesale lack of scientists in their leadership. A few laywers, some marketing people, etc. They also hide their membership list.

@ Narad

One might note the wholesale lack of scientists in [American Society of Gene and Cell Therapy] leadership.

After that squealer about mRNA as gene therapy, I am oddly not surprised.

@ Squirrelelite writes, “I’ve been keeping an eye on molnupiravir (EIDD-2801) for a while now.” – Had to look under that rock and what did I find, between Emory Univ., Ridgeback Biotherapeutics (Mrs. Wendy Commins Holman), Ridgeback Capital Management (Mr. Wayne Holman, hedgefund mgr. and hubby) and MERCK, again it’s all about the $$$…more shady characters sucking up tax payers money.
https://www.washingtonpost.com/business/2020/06/11/coronavirus-drug-ridgeback-biotherapeutics/

I thought it was Merck’s money? Perhaps if the previous administration had been willing to fund treatment research, they wouldn’t have had to be so creative in their financing.

But the long lead up to the trial doesn’t suggest they are cutting any corners.

In any event, we will gave to await the results.

@ Natalie White

First, as usual, you literally don’t know what you are talking about, that is, genetics. Not surprising when you accused undersecretary of health and human services, a transgender person, of not “believing in chromosomes.”

As for “again it’s all about the $$$”. You do shop at supermarkets? They sell potato chips, coca cola, candy AND brocolli, carrots, apples, etc. I choose the latter; but the companies that produce all of the aforementioned make a profit and the supermarket makes a profit. In other words, making a profit says absolutely nothing about the value of the product. Do you know anyone with diabetes, especially Type1 but some Type 2. I strongly suggest you convince them to forego insulin because the company makes a profit on it. One can be angered that they have increased price three-fold over past decade and Congress has authority to step in; but hasn’t so far; so, excess profit; but even original price involved profit. And the Heads of Army and Air Force testified before Congress that they didn’t need nor want a new tank or a new jet plane; but, especially Republicans voted literally 100s of billions of dollars to manufacturer them. Thus, giving HUGE PROFITS to arms industry.

When a company looks to government for funding for research, they believe it will lead to something worthwhile, that will benefit people. They don’t begin knowing it worthless or harmful. If, after investing effort and funds, turns out not to be so great, they do best to market anyway, that’s capitalism; but this isn’t just drugs, it is consumer goods. And often the products do turn out to be beneficial. You focus on profits from vaccines; but the yearly revenue from ALL vaccines sold in world is less that just statins, which are overprescribed. And you are critical of government funding of biotech; but in 2008 we bailed out at cost of trillions of dollars dishonest banks, e.g., created fraudulent subprime mortgages, packaged, sold to stock market and almost brought down entire world economy. Not only did we bail them out; but they kept their jobs and collected bonuses. So, you ignore that ALL companies try to make profits, maximize them, and thus “profits” say NOTHING about the value of the product, you ignore that our government spends monies that increase profits for many far more questionable companies and focus on vaccines and some other medical developments, which you show over and over again you don’t even understand the basics of the science underlying them, e.g., immunology, microbiology, epidemiology, etc. etc.

I suggest you stop commenting for awhile, find some intro free courses online on genetics, microbiology, immunology, and epidemiology, they exist and stop making a fool of yourself.

Given how dense you are, I repeat: All companies exist to make profits. Trying to make a profit doesn’t say anything about the value of a product. Our government supports in various ways many different companies and industries, all existing to make a profit. And you focus on things, as if they exist in a vacuum, things you don’t even understand the basics, vaccines, etc.

@ Joel screeches, “You do shop at supermarkets?” Why yes I do, however, I don’t see your point. No one is forcing me to eat chips. I can pick what I want. Food is required to live…vaccines are a preventative and not required to live.

Screech, “Do you know anyone with diabetes, especially Type1 but some Type 2.” Why yes I do, however, I don’t see your point. Insulin is required to live…vaccines are a preventative and not required to live. Screech, “One can be angered that they have increased price three-fold over past decade and Congress has authority to step in” Yes, I agree it is outrageous and wrong!

Screech, “And the Heads of Army and Air Force testified before Congress that they didn’t need nor want a new tank or a new jet plane; but, especially Republicans voted literally 100s of billions of dollars to manufacturer them. Thus, giving HUGE PROFITS to arms industry.” Yes, Joel, yes, I agree – totally wrong!

Screech, “but in 2008 we bailed out at cost of trillions of dollars dishonest banks, e.g., created fraudulent subprime mortgages, packaged, sold to stock market and almost brought down entire world economy.” YES again, I agree…that was messed up, the rats scattered and no one was held accountable!

I think you and I agree on more than we disagree, at least from the examples you provided. This is what you do. I think it is called “whataboutism”. I don’t bring stuff like this up because it is not relevant. You seem to do it as a distraction or a “well everyone else is doing it” thus lowering the bar.

As far as your advice…you do you and I’ll do me.

Good day.

@ Natalie White

While we may agree on many points, you entirely missed the point of my previous comment. Yes, insulin saves lives, vaccines prevent illness; but my point was and is that you continuously focus on $$$ when critiquing vaccines. Whether you agree or disagree with their value, the fact that companies manufacturing them make a profit is basically irrelevant. If you could actually show you understand how vaccines function in our bodies, what are the underlying sciences, and why you are against them, then, at least, you would sound reasonable. And you have made it absolutely clear that you don’t understand the basics of genetics.

Let me give an analogy for vaccines, what the military call “war games” or “field training exercises.” These are created to be as close as possible to actual warfare without people getting seriously injured or killed. Without them, many more soldiers would be seriously injured or killed when in a real war zone, totally unprepared. Doing calisthenics, hand-to-hand training, and marksmanship doesn’t come close to real life situations.

So, what do vaccines do? They create “war games”/”field training exercises” for our immune systems. When a new microbe enters our bodies our first line of defense is the innate immune system. Sometimes it can stop an invasion; but usually not; but it can slightly slow it up and it sends signals to our adaptive immune system, B-cells that create antibodies and t-cells rev up; but it takes time for the adaptive immune system to be alerted, activated, and produce sufficient soldiers to deal with the new invader, usually around 10 days. In some cases, this is enough to either stop the invader in its tracks or weaken it sufficiently to reduce damage; but in some cases, the invader so overwhelms our bodies that it is too late, either we die or suffer serious disabilities. However, even in the best of cases, e.g., measles,, kids can suffer quite a bit for a week and even in the 1950s over one million cases per year, 50,000 hospitalizations, up to 500 deaths, and up to 1,000 permanently damaged. Extrapolate to our much larger population and more than double the aforementioned. However, with the advent of antibiotic resistant infections, the death and disability numbers would probably be even higher. Thanks to the vaccine we had literally no homegrown cases for many years until antivaccinationists like you popped up.

So, what does a vaccine do? Simply presents a killed microbe or severely weakened one or key recognizable part of microbe that can alert the innate immune system which in turn alerts the adaptive immune system. The adaptive immune system includes memory cells that remain and that don’t need to be alerted, etc.; but even a slight invasion by the vaccine-presented microbe results in a rapid reaction and even higher levels of antibodies, etc. so that many times we don’t even know we have been invaded; but, sometimes we still suffer mildly from something that could have been more severe. And, as with the best trained armies in the world, sometime just not enough.

And we have kids and others who have immune problems, e.g., cancer, autoimmune diseases, so we protect them by vaccinating others. Anti-vaccine parents have been interviewed that they can’t concern themselves with other children, just their own. First, remember the measles outbreak at Disneyland? What if a parent whose child was undergoing chemotherapy for leukemia promised to take them to Disneyland? If that child was exposed to measles it could have been devastating. Or even taking kid to supermarket or local park. We live in communities. We have both rights AND responsibilities. If the tables were turned and an antivaccinationists child developed leukemia, was treated, and then died from exposure to non-vaccinated child, I wonder what they would then think? I like the phrase: “There but for the Grace of G-d Go I.” Besides just human compassion and caring for our fellow man, the tables could easily have been turned.

If we allow individuals to choose to vaccinate or not their children, then we run the risk of more and more doing so, eventually putting many at risk. Vaccines confer an extremely low serious risk profile; but our Vaccine Court is designed to deal with this; but, if one or two children harmed by MMR, without the vaccine, would be thousands. In 1965 an outbreak of rubella caused almost 40,000 to suffer, either miscarriages/stiilbirths, one or more or deafness, blindness, seizure disorders, mental retardation, and finally microcephaly, born with shrunken brain only to live a few hours. Since vaccine, almost no cases. Rubella/German measles, has about 12 day incubation time, so if woman exposed up to 12 days before becoming pregnant or during first two trimesters, 99% chance fetus will suffer one or aforementioned.

There is a Jewish saying of Rabbi Hillel, a contemporary of Jesus: “If I am not for myself, who will be for me? If I am only for myself, what am I? If not now, when?”

And Hillel also stated: “Do not do unto others what you would find unacceptable if done unto you.” Quite similar to what Jesus said.

So, you focus on vaccine profits which worldwide sales of all vaccines is less than sale of statins as if “profit” means they confer no benefit and cause harm. You ignored the point I was making. Not surprising.

Though I know you won’t bother, a good short introduction to immune system which explains how vaccines work: Lauren Sompayrac. “How the Immune System Works” Inexpensive from amazon.com or probably at local public library.

@ Natalie White

Just to make absolutely clear, my examples, e.g., supermarkets was to point out that everything sells for a profit, thus, your harping on vaccine profits says absolutely nothing about whether they are beneficial or not. You obviously missed completely the point I was making. Not surprising! ! !

Joel…I know how the immune system works and I also understand the way a vaccine is DESIGNED to work. Whether or not the vaccines do what they are supposed to do without damage to some is where I am. No matter how much you and the others try to dismiss it, VAERS is not all fraudulent or questionable entries! You gloss over this fact and treat those who have been injured as liars, malingerers, or collateral damage.

Now you bring religion into it? After your previous comments? Hahaha!!! Yes, I completely missed your point because you “what about” frequently and you go on and on and on and on….it’s your MO.

@ Natalie White

You write: “No matter how much you and the others try to dismiss it, VAERS is not all fraudulent or questionable entries! You gloss over this fact and treat those who have been injured as liars, malingerers, or collateral damage.”

No, I don’t treat everyone who claims to have been injured by vaccines as liars, malingerers, or collateral damage. You really are full of shit. AND YOU CONTINUE TO IGNORE THAT YOU MISSED THE ENTIRE POINT I WAS MAKING, NAMELY THAT THE PROFIT OF A PRODUCT SAYS NOTHING ABOUT ITS VALUE.

What you call going on and on, I call backing up my position with multiple examples, something I learned to do at an early age. As for bringing in religion, the point I was making is that we are part of a community with both rights and obligations.

However, I’ve written about VAERS. And, as my paper below makes clear, I don’t believe that all entries in VAERS are fraudulent or questionable. You do know that it was reports to VAERS on the first rotavirus vaccine and intussusception that led to its being halted and then removed from the market in record time? Similar reports to FDA on other drugs have literally taken years to remove from market; but vaccines are held to a much higher standard. You really are despicable, seeing world in black and white, attacking others by projecting your all or none approach on them. Below is what I wrote on another blog BMJ Rapid Responses, Note that most VAERS reports are for minor events and the CDC has teams that investigate even a few reports of a serious adverse reaction; but VAERS is only one of several CDC systems and the WHO includes reports from many different nations. And if you go to CDC website, you will find under every vaccine list of minor adverse events and though rare, list of serious adverse events and the Vaccine Court lists a number of adverse events that if occur plaintiff doesn’t have to “prove” caused by vaccine, Court automatically rules in their favor. If event not on list, plaintiff can proceed and there are law firms advertising willingness to represent claims of vaccine injuries because Vaccine Court pays lawyers a reasonable guaranteed hourly fee and also pays for witnesses. So, lawyers willing to take cases that have low chance of winning. If lawyers should sue in regular court could take years with no guaranteed outcome, so they could come away with nothing. And, despite what people believe, there are ways one can still sue vaccine manufacturers in regular court. Not worth my while going into. The main difference between me and you is that you assume that anecdotes of vaccine injury are valid and I have spent over 40 years looking at the research. Do you understand Post Hoc Ergo Prompter Hoc, just because something occurs after something else, doesn’t mean caused. In fact, studies have found that parents, e.g.,of autistic kids, change alleged time of first noticed behavior. There is an excellent recent book by prize-winning investigative journalist Brian Deer “The Doctor Who Fooled the World” who discusses this and more in detail. Anecdotes, subjective perceptions of time, etc are not dispositive. And I doubt you really understand the basics of immunology. There is nothing in life without risk; but the risk from vaccines is minuscule compared to the actual diseases, especially for those with autoimmune disorders, cancer, etc. and, as i wrote, they have as much right as others to go to Disneyland, supermarket, etc.

MY ARTICLE ON POST-MARKETING SURVEILLANCE, INCLUDING VAERS

Wrong About Post-Marketing Surveillance of Vaccine Adverse Events. Response to Jacob Puliyel, John Stone, Allan Cunningham, etc.

Puliyel (2019) writes: “In the new causality assessment, only reactions that have previously been acknowledged in epidemiological studies to be caused by the vaccine, are classified as a vaccine-product–related-reactions. Reactions observed for the first time during post-marketing surveillance (Phase 4 clinical trial) are not considered
as consistent with causal association with vaccine’. All new serious adverse reactions are labelled as coincidental events inconsistent with causal association,’ or ‘unclassifiable’ and the association with vaccine is not acknowledged.

According to the WHO manual (2013) referred to by Puliyel: “The selection of cases for causality assessment should focus on:

“Serious AEFI1 that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect; The occurrence of events above the expected rate or of unusual severity; Signals generated as a result of individual or clustered cases as these could signify a potential for large public health impact.
WHO recommends that other AEFI should also be assessed if the reviewing team or review committee decides that causality needs to be determined as a special case or in order to conduct special studies. Such AEFI could include:

AEFI that may have been caused by immunization error (e.g. bacterial abscess, severe local reaction, high fever or sepsis, BCG lymphadenitis, toxic shock syndrome); Significant events of unexplained cause occurring up to 30 days after a vaccination (and that are not listed on the product label); Events causing significant parental or community concern (e.g. hypotonic hyporesponsive episode (HHE), febrile seizures).”

I strongly recommend reading either of the WHO manuals (2013;2018). It will be obvious that Puliyel’s claims that post-marketing surveillance doesn’t take new serious adverse reactions seriously is just plain WRONG.

Stone (2019) writes: “It might be interesting to contrast the US’s Vaccine Adverse Event Research System which has over the same period accumulated 717,653 reports [2] (reports are not confirmed cases but neither actually are compensated cases, which are “no fault” awards). Moreover, this is a passive database and as Peter Doshi
has observed “inaccessible to most users”.

Cunningham (2019b) writes: “I recently did a VAERS search for “acute flaccid myelitis” (AFM). Their database includes just 4 case reports of AFM since August 2014. The number of cases of acute flaccid myelitis confirmed by the CDC during the same period is 567. This is one more example of the vast underreporting of potential adverse effects following vaccination.”

I went to the Vaccine Adverse Event Reporting System (VAERS) website (CDC. About; see also: VAERS, 2017), then their Request page. First, scroll through the Symptoms list, quite extensive. However, acute flaccid myelitis was not listed. So, I used several other search terms with the following results:

Myelitis = 256
Myelitis Transverse = 381
Paralysis Flaccid = 59

However, there is a gross misconception on how VAERS works and ignoring that it is just one of several surveillance systems. Briefly, VAERS is an underreported system, though studies have found that serious adverse reactions are reported at higher rates (e.g., Rosenthal, 1995). The CDC has teams who monitor VAERS. If there are even a small number of a serious adverse event reported, they investigate. “Although underreporting
is a limitation, VAERS is capable of detecting possible safety problems through disproportionality analyses and other methods (Shimabukuro, 2015).” According to Moro: “Signal detection/hypothesis generation . . . Detect new, unusual, or rare adverse events (Moro, 2015, page 17). The vast majority of the VAERS reports are for minor adverse events, short-lived fever, sore arm, etc (VAERS,
2017).

The Vaccine Safety Datalink is a “real-time” link to several large HMOs with membership topping 2 million.Every vaccine, including lot number, child or adults age, gender, comorbidities, and medical problems following vaccinations are available. And there is another project, the Clinical Immunization Safety Assessment (CISA)Project (CDC, 2018).
So, while not super easy to use, VAERS is accessible and Cunningham’s finding of only 4 cases indicates a poor limited search strategy. The CDC uses a wide net of numerous sources, both passive and active. As an aside, Cunningham (2019a) claims vaccines responsible for a number of adverse reactions which I clearly refuted
(Harrison, 2019 abcd).

Wendy Stephen (2019) and others criticize that clinical trials and post-marketing surveillance detected narcolepsy as an adverse event to the Pandemrix vaccine; yet, delayed informing the public, etc. This is a rather complicated topic, not as straight forward as Stephen and others would like, so, I will attempt to write a Rapid
Response just focusing on this topic.

References:

CDC. About The Vaccine Adverse Event Reporting System (VAERS). Available at:
https://wonder.cdc.gov/vaers.html

CDC. Request page. [note need to click “I agree” on About page at bottom, then “I agree” a second time]
Available at: https://wonder.cdc.gov/vaers.html

CDC (2018 Oct 19). Vaccine Safety Publications. [check out Vaccine Adverse Events System, Vaccine Safety Datalink, Clinical Immunization Safety Assessment (CISA) Project and CDC Vaccine Safety Publications by Year].
Available at: https://www.cdc.gov/vaccinesafety/research/publications/index.html

Cunningham AS (2019a May 9). Unlimited tolerance of vaccines? BMJ Rapid Responses. Available at:
https://www.bmj.com/content/364/bmj.l1481/rr-21

Cunningham AS (2019b Jun 8). Thank you BMJ! BMJ Rapid Responses. Available at:
https://www.bmj.com/content/365/bmj.l4044/rr-4

Harrison JA (2019a May 9). Response to Allan S. Cunningham. BMJ Rapid Responses. Available at:
https://www.bmj.com/content/364/bmj.l1481/rr-22

Harrison JA (2019b May 16). Response 2 to Allan S. Cunningham. BMJ Rapid Responses. Available at:
https://www.bmj.com/content/364/bmj.l1481/rr-29

Harrison JA (2019c May 15). Response 3 to Allan S. Cunningham. BMJ Rapid Responses. Available at:
https://www.bmj.com/content/364/bmj.l1481/rr-26

Harrison JA (2019d). Response 4 to Allan S. Cunningham. BMj Rapid Responses. Available at:
https://www.bmj.com/content/364/bmj.l1481/rr-33

Moro PL (2015 Oct 15). Signal detection and signal strengthening in CDC’s vaccine safety monitoring systems.
CDC Vaccine Safety/VAERS Webinar. Available at: https://health.mo.gov/living/wellness/immunizations/pdf/vaerscisa101515.pdf

Puliyel J (2019 Jun 2). The New WHO Causality Assessment Algorithm Needs Revision to Restore Public Trust.
BMJ Rapid Responses. Available at: https://www.bmj.com/content/365/bmj.l2268/rr-0

Rosenthal S, Chen R (1995 Dec). The Reporting Sensitivities of Two Passive Surveillance Systems for Vaccine Adverse Events. American Journal of Public Health; 85: 1706-1709. Available at:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1615747/pdf/amjph00450-0108

Shimabukuro TT, Nguyen M, Martin D, DeStefano F (2015 Aug 26). Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine; 33(36): 4398-4405. Available at:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632204/

Stephen W (2019 May 31). Re: Checking social media for vaccination misinformation: five minutes with . . .Claire Milne. BMJ Rapid Responses. Available at: https://www.bmj.com/content/365/bmj.l2351/rr-2

Stone J (2019 Jun 23). Re: US data on vaccine injury pay-outs show strong immunisation safety record – is this a useful measure? BMJ Rapid Responses. Available at: https://www.bmj.com/content/365/bmj.l4294/rr

VAERS (2017 Oct). VAERS Data Use Guide. Available at:
https://vaers.hhs.gov/docs/VAERSDataUseGuide_October2017.pdf

WHO (2013 Mar). CAUSALITY ASSESSMENT OF AN ADVERSE EVENT FOLLOWING IMMUNIZATION (AEFI).
Available at: https://www.who.int/vaccine_safety/publications/aevi_manual.pdf?ua51

WHO (2018 Jan). CAUSALITY ASSESSMENT OF AN ADVERSE EVENT FOLLOWING IMMUNIZATION (AEFI)
Second Edition. Available at: https://apps.who.int/iris/bitstream/handle/10665/259959/9789241513654-en.
..
Competing interests: No competing interests
01 July 2019
Joel A Harrison
Long-Retired Epidemiologist
I have NEVER worked for the FDA, NIH, CDC, any pharmaceutical company, nor ever purchased pharmaceutical stocks
U.S.A.

Nats, that was pointed out years ago without your frosting of smarm, and there was a course correction for a while. I presume it’s just a muscle-memory thing.

But Nat, the point is that VAERS entries are not reports of vaccine caused injury. They are reports of events happening after vaccination. The best use of VAERS is to detect signals that something is happening. In order for it to mean anything, there have to be enough events of the same type to stick their head above the background noise of the expected number of the same event in the same timescale.

The weird stuff is just people being stupid or, at best, trying to show the weak points in the system.

I know how the immune system works

Great! Could you clear up the business with G-coupled receptors for everyone?

@ Natalie White:

You write: “I know how the immune system works and I also understand the way a vaccine is DESIGNED to work.”

Really. What course did you take in immunology? Or what book or books did you read? What education do you have? What is your occupation? Too ashamed to tell???

You call my comments “diatribes”. You put “screeches” in front of some of the things I said. You accuse me and others of “trying to dismiss VAERS, that it is not all fraudulent or questionable entries! You gloss over this fact and treat those who have been injured as liars, malingerers, or collateral damage”

Something I’ve NEVER done and I then gave you a comment I wrote on VAERS, including it was through VAERS that the first rotavirus was withdrawn. You can’t restrain yourself from grossly exaggerating, even making up, what others opinions are. You are a combination of stupidity and intellectual dishonesty.

You have downplayed the current pandemic since the beginning. I guess 500,000 deaths, at least 400,000 in excess than any of previous five years, and 100s of thousands more suffering long COVID, plus hospitals at overflow capacity, means nothing to you. What do you think of the COVID vaccines?

So, again, what course did you take on immunology or what books did you read? I have four undergraduate textbooks that I read and over 400 articles that I have read over the years. What level of education do you have? What is your occupation?

I’ll be quite honest. I didn’t have much of a career. I have a PhD, four Masters degrees, and an NIH 3-year Post-Doctoral research fellowship; but I lived in five other countries, Sweden, Canada, Israel, Phillipines, and Japan, and travelled a lot. Had a few jobs funded by someones grants; but then left work to take care of my mother when she was diagnosed with cancer. I didn’t want to move again, applied for a number of jobs in my home town, only available were for Masters level positions and they didn’t trust I would stay, though one project leader wanted to hire me; but director didn’t. Was offered some positions on grant funded projects in various places, usually for 2 to 3 years; but didn’t want to sell family home, put everything in storage, and move every few years, so retired early. However, I’ve always been a book worm and loved learning, so read lots, audited a few courses at local colleges, took some free courses online, and before pandemic went to local library book sales where I usually found a couple/three books for $1 each on subjects ranging from history to economics to various sciences. What I do, besides reading, is try to make sure I cover various approaches, so, for instance, in economics I’ve read Adam Smith, David Ricardo, Milton Freidman, John Kenneth Galbraith, Karl Marx, F.A Hayek, John Maynard Keynes, etc. in other words, the major works of conservative, libertarian, liberal, and socialist figures. And I read a lot of papers and books by antiscoience types, plus monitor their blogs. Just me and my dog, so I’ve lots of time. So, I have a lot of formal and informal education; but not much of a career, though friends, now gone, used to contact me for suggestions and advice on their various research projects and they had large amounts of grants and lots of publications, so, they seemed to value my input. Unfortunately, having never smoked, just sampled alcohol a few times, never used any recreational drug other than caffeine, been vegetarian most of life and always active, jogging, swimming, biking, walking, moderate weight lifting, some Aikido, I have unfortunately outlived almost all of my friends, a few left in Sweden, a couple in my hometown, and one in Texas. So goes it.

And I look forward to dying, as long as not too painful and prolonged. Destruction on planet, climate change, plastic overall, pollutants in air we breath, destruction of wildlife, polarization with people like you who think they know; but don’t, violence, 4% of world’s population 25% of incarcerated with credible estimates that 100,000 are totally innocent and a criminal justice system that bends over backwards not to overturn a conviction, so innocence projects can only take on a few cases, often taking 15 years to free one person, even though evidence on appeal at early stage should have been enough. And on and on it goes and things will only get worse. The only health care system in world funded by taxpayers, then turned over to for-profit companies, etc. Oh well. Read Elizabeth Rosenthal’s “An American Sickness” documents the greed and dishonesty and brutality of American health care and we rank poorly in infant mortality, etc. Yep, we have excellent facilities and many excellent caring health care personnel; but the system is SICK,

A sick world and you and Sophie Amsden are just perfect examples of pawns in the system, not even knowing how foolish your thinking is.

@ JustaTech,

You said “I think there were actually several adenovirus-based HIV vaccines that didn’t pan out.”

And that’s correct. None of the HIV vaccines that were attempted, including adenovirus-based ones, have worked, since they were attempted going back to the 1990s. Adenovirus did not; but the Goat Lentivirus HIV vaccine did. Not only did it work but it stopped the progression of HIV into AIDS. Fauci pulled the funding of it during development, after he “had to” add his name to the HIV pharmaceutical “cocktail” that made him millions. $36 Million right off the bat I believe, in 1997. (oh but he DONATED it all, lol)

Now that the cocktail’s patents have ran their course, the Goat Lentivirus HIV vaccine (which has been patented since 1997 but never developed) has proceeded to development.

Adenovirus did not; but the Goat Lentivirus HIV vaccine did.

Oh, where’s Abby Smith when you need her? Perhaps you could hork up something more than naked assertions, CK. You know the drill — MEDLINE only.

Oh man, I miss reading Abby’s writings.
Especially when I was working on HIV vaccines (some adenovirus based) in oh, 2009.

Something tells me that CK won’t come up with anything about CAEV from 1997 or 2021. Mostly because no one uses whole vectors that way anymore. It’s a little of this and a little of that to make nice bespoke vectors.

@ Christine Kincaid

I did a quick and dirty search and found only one peer-reviewed journal article on Goat Lentivirus AIDS vaccine:

Chebloune Y et al. (2015 Apr). Cowpox Helped Against Smallpox; Will the Goat Lentivirus (Caprine Arthritis Encephalitis Virus) Help Against HIV-1? AIDS research and human retroviruses. Available at: https://www.researchgate.net/publication/274570722

Can you supply any valid references to back your claim? Please give detailed titles and URLs.

As for Fauci making $36 million, I found the following:

Ford T (2021). Anthony Fauci Net Worth. Net Worth Post. Available at: https://networthpost.org/net-worth/anthony-fauci-net-worth/

It gives $6 million.

And Anthony Fauci (2019). Executive Branch Personnel Public Financial Disclosure Form. Available at: https://assets.documentcloud.org/documents/7014520/Fauci-Disclosure.pdf

Not easy to go through.

In any case, can you supply any valid references to back your claim? Please give detailed titles and URLs.

And Fauci may be in an influential position, not counting the four Trump years; but I find it highly unlikely that he alone could have had the influence on vaccines and cocktails you claim. Really, no one in press at time would have discovered and reported, leading to mass scandal. Anyone who has followed AIDS knows that AIDS organizations are powerful and would have reacted, etc. etc. etc.

If you are going to make such incriminating statements, the least you can do is back them up! ! !

Actually. lentivirus vectored HIV vaccines still very preclinical
Gallinaro A, Borghi M, Pirillo MF, Cecchetti S, Bona R, Canitano A, Michelini Z, Di Virgilio A, Olvera A, Brander C, Negri D, Cara A. Development and Preclinical Evaluation of an Integrase Defective Lentiviral Vector Vaccine Expressing the HIVACAT T Cell Immunogen in Mice. Mol Ther Methods Clin Dev. 2020 Feb 4;17:418-428. doi: 10.1016/j.omtm.2020.01.013. PMID: 32154327; PMCID: PMC7056611.
Copy
Down

@ Aarno Syvänen

Thanks! I missed that one in my quick and dirty search. Now added to folder on HIV vaccines.

@ Natalie White

You write: “@ Joel writes, “Post Hoc Ergo Prompter Hoc”… Post hoc ergo propter hoc. You can also shorten to “post hoc fallacy” if that makes it easier for you to remember. Just thought you oughta’ know if you’re gonna use it to be all propa’ like.”

Wow, I shred your comments, ask what education and occupation you have and all you can do is this??? You really are pathetic.

@ Narad writes, “Nats, that was pointed out years ago without your frosting of smarm, and there was a course correction for a while.” Frosting of smarm? No Cheeky. I mentioned it to him because he continues to write “prompter”. You corrected him about a little over a year ago. I compare it to having a conversation with someone and not letting them know they have spinach in their teeth. He doesn’t seem to take criticism too well but he’s very good at dishing it out.

Good day.

@ Natalie White:

You write: “He doesn’t seem to take criticism too well but he’s very good at dishing it out.”

Wow, the pot calling the kettle black. What a hypocrite. And you still haven’t explained what courses or books you’ve read on immunology to back you claim you understand immunology. And what education do you have and what is your occupation? Too ashamed to admit. Just someone who doesn’t know what they are talking about; but attacks anyone who counters their BS.

Correcting someone who is open-minded, which is what happens in scientific circles is not the same as refuting someone like you who thinks you can just make statements and attack others.

As I’ve written about Christine Kincaid, she appears be quite intelligent and understands science; but on certain subjects, closes her mind. Most people have a blindspot; but CK refuses to even consider she has one, while you, on the other hand, seem to be one huge blindspot.

Bad Day to You

Frosting of smarm? No Cheeky.

Fine. Replace “frosting of smarm” with “lame appropriation.”

@ Natalie White

You write: “Now you bring religion into it? After your previous comments? Hahaha!!!”

Yep, I quote the Jewish rabbi Hillel: “If I am not for myself, who will be for me? If I am only for myself, what am I? If not now, when?”

However, it could have been said by anyone. No mention of G-d, reward, punishment, etc. simply that we live in communities, we have rights and obligations. If each one only looks out for themselves, we all suffer, each and every one of us. It is communities that build our roads, ensure safety of food and water, etc. I guess, as brilliant as you are, that you have a complete lab at home and continuously test water and food, etc.???

So, no I didn’t bring religion into, I simply quoted a religious figure with a quote that could have been given by an atheist.

You just don’t know when to stop displaying what a huge ass you are.

As for religion, I have read a lot about them, including Islam. And if I had lived in Palestine at time of Jesus, I would probably have been a follower, not because of claims of eternal life; but because of what he taught and was a role model for, love, justice, charity, compassion, etc. And if I had lived in Arabia at time of Mohammed, I would probably have been a follower, not because of promise of heaven or fear of hell; but, again, for what he taught and was role model for. As the exact opposite of groups like ISIS, Mohammed strictly forbade the harming of non-combatants, especially woman and children. And when the Moslems took Jerusalem they let stand the churches and synagogue and didn’t harm either group, unless they directly were violent. In fact, prior to the Crusades, Moslem soldiers ensured the safety of pilgrims to the Holy Land. The Crusades weren’t about protecting Christian shrines; but simply Pope Urban II wanted to unite “Christendom” under his aegis and, at the time, every Baron, Duke, King, etc. was waging constant war against each other, so he directed their BRUTAL energies outward. By the way, when the Crusaders took Jerusalem in 1099 they slaughtered everyone, Moslem, Jew, even Christians. When Moslems retook in 1187, they allowed churches to stand, and allowed Jews and Christians to live as usual and continue their worship. The brutality of groups like ISIS, claiming to be Islam is as accurate as prior to the fall of the iron curtain, East Germany was called the German Democratic Republic, which is was neither. Today’s violent Moslem groups, a minority of Moslems, who, by the way, kill far more Moslems than anyone else, represent a tribal mentality as a reaction to how the West treated the Middle East for 100s of years. A great book is Karen Armstrong’s “Holy Wars”. Several very negative book reviews have appeared, all written by professors at evangelical colleges; but I’ve read other books and articles that corroborate what she writes.

Well, a bit of a tangent; but, given just how ill-informed you are on things, I would guess you think ISIS, Al Qaeda, etc represent Islam. Well, they don’t and if Mohammed were to come back to today, they would behead him, just as if Jesus came back during the Inquisition they would have burned him at the stake or if he came back at certain racist or anti-semitic rallies they would beat him up or kill him. It isn’t just ignorance of science that permeates our modern world; but ignorance of the actual teachings of religious figures, ignorance of what is really transpiring, relying often on social media, together with, as I wrote earlier, lack of understanding of the basics of science and critical thinking.

Just one anecdote. A long time ago when I lived in Texas I would eat lunch with a fellow researcher. One time, don’t remember how it came up, he told me a quote from Jesus. Well, I owned both the King James and Modern version of Bible, went home, looked up, and Jesus said the exact OPPOSITE. So, next day took them to work, showed quotes to him and without hesitation he said: “That’s not what Jesus meant.” In other words, we should take what Jesus and Bible says literally, EXCEPT . . .! ! !

I’m sure people like Natalie White can identify with him.

Oh Joel…you spend so much time and energy chastising those who don’t agree with you! I don’t think it is good for your health – both mental and physical.

I don’t share much personal information because this is a public format. Just because you choose to do it, doesn’t mean it is reciprocal or that you can demand it from others.

Good day and good health to you.

@ Natalie White

As usual, you don’t even try to enter into an actual dialogue, showing you read what I wrote and in a logical manner supporting your position. Thanks for once more saying absolutely nothing, for displaying what an absolute DISHONEST MORON YOU ARE!

You are incapable of actually defending your position. And I could care less about you as an individual; but people like you and Greg, unfortunately, represent a large segment of our population.

As I asked Greg, if the Pandemic surges and evermore die, and it is found that those vaccinated survived, will you admit you were wrong about the seriousness of COVID and vaccines?

@ Natalie White

You write: “I don’t share much personal information because this is a public format.” Yet, you claim to understand immunology, etc. What harm would occur if you simply told what course you took or name a book or two? Just an excuse to admit you don’t understand immunology, just as your absolutists attacks on anyone who doesn’t accept every posted item on VAERs. ignoring what I and others write.

Age of Autism actually has an Editor, John Stone, who openly brags he has NOT tried to learn immunology, microbiology, etc. etc. One of your roll models?

@ Natalie White

You write: “you spend so much time and energy chastising those who don’t agree with you!”

NOPE, I spend time and energy refuting bogus claims, explaining logically and scientifically and backing with references. Do you even understand the difference?

And, for one who keeps posting, spending so much time and energy chastising others, without actually supporting your claims, just continued example of your hypocrisy or, perhaps, stupidity in not even realizing what you are doing!

This is almost fun. A bit of comic relief from boredom, though it does take me from reading worthwhile books, currently reading science writer David Quammen’s (2018). The Tangled Tree: A Radical New History of Life. My third book on history of science of genetics, along with several undergraduate textbooks.

@ EVERYONE

Despite everything, if COVID infections plummet and stay that way, I WOULD BE DELIGHTED. I would NOT regret my position, based on a life-time of training and education and careful extensive reading since January on Corona viruses and COVID. But science is based on probabilities and there is always possibility some factor may exist that was not accounted for. Viruses mutate, sometimes becoming more virulent, more transmissible; but also in the opposite direction. There may exist some genetic predispositions that account for most serious cases and deaths, etc. etc. So, as opposed to people like Natalie White, Greg, Sophie Amsden, etc. I base my position on careful analysis, based on knowing and understanding the appropriate tools.

Why would I be DELIGHTED if my position turns out to be wrong:

Many innocent decent people will survive and/or not suffer the loss of their loved ones and hospitals will be able to schedule elective procedures
People will be able to get back to their normal lives, jobs, social gatherings, etc.
Personally, I will be able to go to YMCA gym which I went to six days a week to swim and weight-lift, a great facility
At the Y there were people from all over the world, including an Iraqi Jew, Iraqi Chaldean Christian, and Sunni and Shia Iraqis, all really nice people and people from Africa, etc. We often had coffee after working out or went to lunch.
Though almost ALL of my friends have died, not from COVID, the few I have left in my hometown I have only had sporadic contact via phone. We used to meet for lunch or sometimes dinner. Which we will be able to do again.
And I might start walking my dog more during daylight. Right now, walk him at 5 am and 8:30 pm, few people on streets at time.

So, all in all, based on current knowledge, I will continue to wear mask and shelter-in-place; but would be delighted if things change; but not if political decisions ignore science and open up too soon.

As for the likes of Natalie White, Greg, Sophie Amsden, etc. who can’t defend their positions, citing one or two newspaper articles or one “expert” not a defense, if things get much worse, I doubt they would ever admit they had been wrong. And, if things do improve they will pat themselves on the back, thinking they are so intelligent. In other words, they won’t admit if they are wrong and will take credit for ill thought out positions. Unfortunately, how too many people “think”.

I gave URL to PBS Firing Line interview with Dr. Michael Osterholm. For anyone with an open mind, I suggest you watch it. Natalie and Greg certainly won’t, both because they aren’t interested in anything that disagrees with them and it is around 25 minutes, beyond their attention span.

And for anyone else: Michael T Osterholm (2017). Deadly Enemy: Our War Against Killer Germs (with a new preface on coronavirus COVID-19). Little Brown Books.
Entire book about history of pandemics. A great read.

And check out his website: Center for Infectious Disease Research and Policy (CIDRAP). I won’t give URL because delays posting of comments.

Strange, because I just found the following on the FDA website: https://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/immunogenicity-gene-therapy-products

Scientific Overview

Adeno-associated virus (AAV) is a small virus that can be used as a transduction vector in gene therapy. AAV is among the most widely used vectors for gene delivery and is used in a growing number of FDA applications and clinical trials worldwide.

Due to the viral origin of AAV, the capsids can induce cellular and humoral immune responses that trigger neutralization of the vector with anti-AAV antibodies, which prevents transduction in patients. Over 90 percent of humans have preexisting binding antibodies to some AAV serotypes. Some of these antibodies are neutralizing and may cause loss of efficacy even on the first dose. Therefore, there is a critical need to improve our understanding of risks of AAV immunogenicity and to develop technologies for evaluating and mitigating this response.

Our research program focuses on characterizing and understanding the immunological components that play a role in the immune response against AAV vectors. To study these immunological components in human cells we established a highly sensitive, high-throughput T cell assay to characterize common factors in AAV that impact T cells from various human samples and diverse HLA backgrounds. We use these methods to study the impact of post-translational modifications in recombinant AAV on the immune response.

Using this data, we are developing new methods to sensitively and efficiently monitor cellular and humoral immune responses against AAV capsids. These methods will help to ensure the safety and efficacy of gene therapies during their development and use.

Wikipedia
The Oxford–AstraZeneca COVID-19 vaccine, codenamed AZD1222,[5] and sold under the brand name Covishield and Vaxzevria among others,[19] is a COVID-19 vaccine developed by Oxford University and AstraZeneca given by intramuscular injection, using as a vector the modified chimpanzee adenovirus ChAdOx1

Makes me feel the author of this article has no clue, because according to Wikipedia, they are using a chimpanzee adenovirus, which I’m assuming is referred to as the “Adeno-associated virus (AAV)” in the previous article, which also states used as a transduction VECTOR in GENE THERAPY!

Probably why it’s called a VECTOR vaccine.

Makes me feel the author of this article has no clue, because according to Wikipedia, they are using a chimpanzee adenovirus

Screw on your thinking cap real tight and ask yourself why.

If these mRNA vaccines really are “gene therapy”, you should be able to describe what gene defect they target, how the mRNA material gets into the nucleus once it is absorbed by the cell and how changing the tiny number of cells that actually absorb the material from one vaccine dose can have a therapeutic benefit for the whole body. And, of course, there would be a whole series of studies demonstrating that for these particular mRNA’s.

But your basic argument is something like this.

These delivery methods have been investigated for possible use in gene therapy. Therefore, any further use of them must be for gene therapy.

Let me offer an analogy. Nowadays, most trains are pulled by diesel-electric engines which use a diesel internal combustion motor to run an electric generator which provides power to an electric motor which directly drives the wheels that propel the engine. Development on these engines started before World War I. But until the 50’s, their use was limited to railyard switching and local commuter lines to reduce pollution in cities like New York.

One of the more interesting experimental tanks developed by Germany in World War II was the Porsche Tiger. It used two V10 gasoline engines to power an electrical generator to run the electric motor that actually propelled the 60 ton tank at whopping 22 mph. Only about 10 were ever produced.

But if someone saw one ot them and followed your reasoning, they would argue.” That can’t be a tank. It has a hybrid combustion-electric motor. It must be a switch engine!”

Angela, ORAC was speaking specifically of mRNA vaccines, which are not gene therapy. As he pointed out below, there are other ways of getting a cell to make the desired protein, such as the adenovirus method:

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.)

That method, as you discovered, is considered gene therapy. But this post was about mRNA vaccines.

@Billy: “Many resources in the article below.”

Yes. Yes, there are.

What a pity none of them are any good.

Funny because they were literally touted as gene therapy as they were being developed BY the msm

Why was the definition of vaccine changed or at least added to?

It’s interesting what the dictionary admits…LOL

https://www.merriam-webster.com/dictionary/vaccine

Definition of vaccine
a preparation that is administered (as by injection) to stimulate the body’s immune response against a specific infectious disease:
a: an antigenic preparation of a typically inactivated or attenuated (see ATTENUATED sense 2) pathogenic agent (such as a bacterium or virus) or one of its components or products (such as a protein or toxin)
b: a preparation of genetic material (such as a strand of synthesized messenger RNA) that is used by the cells of the body to produce an antigenic substance (such as a fragment of virus spike protein)

How far is a “preparation of genetic material” from gene therapy? I mean at this point it’s kind of mere quibbles. Genetic material is being manipulated even if it is not totally “gene therapy” in the traditional sense.

Some people do remember the definition was different before. I definitely do.

Once very concerning factor out there, are the numbers of people who believe Covid vaccines are just like traditional vaccines.

Are you under the misapprehension that MW is prescriptivist rather than descriptivist?

Anyway,

Once very concerning factor out there, are the numbers of people who believe Covid vaccines are just like traditional vaccines.

They’re vaccines. What’s “very concerning”?

It’s not gene therapy if it doesn’t, and isn’t meant to, change your genes. mRNA vaccines don’t. They use your cell machinery, the ribosome, to make a single protein from the virus, which your immune system makes a reaction to. It doesn’t touch your DNA; the DNA in your cells is in your nucleus, a different part of the cell.

It’s new technology, but it does what vaccines do and always did: it teaches your immune system to respond to a germ by presenting it with enough information to create the response, without the risks of the germs. That’s what vaccines do. This is just a new way to do it. In the past, recombinant technology, for example, was a new (and safer) way to make vaccines.

The fact that a vaccine is made in a new way doesn’t make it less a vaccine, and does not make it more dangerous. In fact, often new ways can be safer.

Orac did, in fact, write on this in detail. For example: https://respectfulinsolence.com/2021/02/16/latest-antivaccine-lie-about-covid-19-vaccines-theyre-gene-therapy/

In the past, recombinant technology, for example, was a new (and safer) way to make vaccines.

And chickens with six breasts, according to a T-shirt from the days of yore.

Why do you think that the CDC change their definition of the term ‘vaccination’ in 2014?

July 9 2014
Vaccination: Injection of a killed or weakened infectious organism in order to prevent the disease.
https://web.archive.org/web/20140709164130/http://www.cdc.gov/vaccines/vac-gen/imz-basics.htm

Oct 10 2014
Vaccination: The act of introducing a vaccine into the body to produce immunity to a specific disease.
https://web.archive.org/web/20141010112625/http://www.cdc.gov/vaccines/vac-gen/imz-basics.htm

You’re a hack propaganda writer. I know you’re not dumb enough to believe what you write in this article yet here you are publishing intellectual sleight of hand that’s gonna get people killed. Or maybe you do believe it. Either way congratulations, you’re a piece of shit.

Hi, what I struggle with is that if the spike protein is the dangerous element of COVID-19 then a medication that instructs our cells to make spike proteins is also going to be dangerous, no? Because they say it is different to injecting dead virus because the molecules of the medication are moving away from the injection site and so other cells can be instructed to make spike protein. Where does the instructing stop? Does the medication k is which cells it shouldn’t instruct to make spike protein?

Comments are closed.