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Before there were safe and effective COVID-19 vaccines authorized for use, such as the vaccines by Pfizer/BioNTech, Moderna, and Johnson & Johnson here in the US, as well as AstraZeneca in Europe and elsewhere, those of us who have been countering the antivaccine movement for many years now were warning about the sorts of disinformation that antivaxxers would spread about them. We were largely correct, too, but I can’t really say that it took any particular brilliance or foresight to have been so correct. We simply knew that there is no truly new trope, pseudoscience, or disinformation in the antivaccine narratives and conspiracy theories; so all we did was to predict the repurposing of tried-and-not-true antivax lies. And so it came to pass beginning as soon as the vaccines neared approval under an emergency use authorization (EUA) by the FDA that antivaxxers repurposed all their old tropes for COVID-19 vaccines, claiming that they were loaded with “toxins” (the lipid nanoparticles in the mRNA-based vaccines, given that they can’t contain aluminum, don’t you know?); blaming every death reported to the Vaccine Adverse Event Reporting System (VAERS) database on vaccines, when VAERS is not designed to determine causation and we would expect a large baseline number of deaths in the time periods covered by random chance alone; claiming that vaccines cause Alzheimer’s and prion disease; blaming the vaccines for cancer; resurrecting the favorite old trope of “shedding” from the vaccinated in the most risible manner possible; invoking evolution to predict the selection of more deadly coronavirus variants that could wipe out humanity; warning that the vaccines can “permanently alter your DNA“; and that they make females infertile. I will admit that there were a couple of new ones, albeit variations on a theme. For instance, because of the new mRNA- and adenovirus-based technologies used to develop the current crop of vaccines, antivaxxers have falsely referred to them as “experimental gene therapy” rather than vaccines, and, because vaccination in the shoulder can lead to transient inflammation of the lymph nodes under the arm, which has led to some unnecessary biopsies after mammography for breast cancer screening, antivaxxers have tried to claim that the vaccines cause breast cancer. So I guess I should say that there’s almost nothing new under the sun.

This is why I was not particularly surprised to see the “toxins” gambit with respect to COVID-19 vaccines rear its ugly head again, in particular with respect to the lipid nanoparticles in the vaccines. I was, however, slightly impressed with how antivaxxers had combined it with the “vaccines cause sterilization” trope again. (Or maybe they were combining the “vaccines are sterilizing our women” trope with the toxins gambit. I guess it doesn’t matter that much which is the case.) Since I keep seeing the study that antivaxxers mangle coming up again and again and again on antivaccine social media, I decided that I had to address this new marriage of two antivaccine tropes. Let’s just say that they’re two crappy tastes that taste crappy together.

It begins, as is often the case, on Twitter

I first recall seeing the antivaccine narrative, claiming that lipid nanoparticles from COVID-19 vaccines accumulate in the ovaries and other tissues, showing up on Twitter from “Nurse Erin”:

Conspiracy theorists being conspiracy theorists, “Nurse Erin” says that the claim that lipid nanoparticles from the Pfizer vaccine “adhere” to the ovaries is based on a “leaked confidential” study from Pfizer (of course). It turns out that “Nurse Erin” is an antivaccine nurse named Erin Marie Olszewski, who caused a minor ruckus last summer after having worked as a traveling nurse during the first surge of the pandemic last spring. She wrote a book about it, Undercover Epicenter Nurse: How Fraud, Negligence, and Greed Led to Unnecessary Deaths at Elmhurst Hospital. (That longtime antivaccine activist J.B. Handley, who has more recently—and not unexpectedly—joined the COVID-19 conspiracy theory antimask grift train, wrote the foreword should tell you all you need to know about this book, as should the endorsement by Joe Mercola.) In it, Ms. Olszewski claimed that people who had tested negative for COVID-19 were being diagnosed as having COVID-19 anyway, put on ventilators, and “drugged up with sedatives”. In the process, besides spinning conspiracy theories, she also appears to have engaged in what sounds like a massive violation of HIPAA by videotaping medical records, and including them in a conspiracy video with minimal redaction. Unsurprisingly, doctors and nurses at Elmhurst understandably felt betrayed and took pains to debunk “Nurse Erin’s” disinformation.

In any event “Nurse Erin” appears to have gotten her “information” from here:

Amusingly, fly tried to appear “reasonable”:

But antivaxxers were having none of it:

Which brings me to Byram Bridle, who, if the above Tweets are to be believed, is the person who “discovered” this “confidential” Japanese study. Before that, he had been spreading misinformation about the “deadly spike protein” produced by COVID-19 vaccines:

I’ll just refer you to my extensive discussion from two weeks ago of the studies being misrepresented by antivaxxers.

Enter Byram Bridle

While I saw narratives based on this same study showing up on Twitter a lot, leave it to Mike Adams to turn up the conspiracies to 11, with an article titled “Horrifying study reveals mRNA vaccine nanoparticles are circulated throughout the entire body: Brain, heart, liver, ovaries, testes and more“:

Not surprisingly, everything the establishment tells us about covid vaccines has been a calculated lie. One of the biggest and most treacherous lies is that “mRNA vaccine shots stay in the arm and don’t circulate nanoparticles around the body.” Now we know that is a complete lie, as new research conducted in Japan shows that Lipid NanoParticles (LNPs) containing the mRNA code are widely circulated around the body after vaccination, reaching the brain, spleen, large intestine, heart, liver, lungs and other organs.

The study paper, originally written in Japanese and auto-translated into English, can be found at this link on Natural News servers (PDF).

Labeled, “Pfizer confidential,” the study is known as a bio-distribution study that uses luciferase enzymes and radioisotope markers to accurately track the distribution of Pfizer’s mRNA LNPs across the body.

Of course, Adams also cites Dr. Bridle, who, as it turns out, is an associate professor and viral immunologist in the Department of Pathobiology in the Ontario Veterinary College at the University of Guelph, and apparently the main source of this new “variant” (sorry, couldn’t resist using the word) of the “toxins gambit.” (Dr. Bridle is a rather…appropriate…name for a faculty member at a veterinary college.) As you might guess, he is an antivaxxer, antimasker, and COVID-19 conspiracy theorists and has made a number of false claims about vaccines dating back to the early days of the pandemic. He is also engaged by Elders Without Borders as an expert witness on behalf of Adam Skelly (owner of Adamson BBQ), and has testified against the effectiveness of masks, against lockdowns, and against the “experimental” vaccines (which he reasons are unnecessary with his proposed treatment – ivermectin).

Perhaps Bridle’s most famous quote was cited by Adams:

In short, the conclusion is we made a big mistake. We didn’t realize it until now. We saw the spike protein was a great target antigen. We never knew the spike protein, itself, was a toxin and was a pathogenic protein. So, by vaccinating people, we are inadvertently inoculating them with a toxin, and in some people this gets into circulation. And when that happens in some people, it can cause damage, especially with the cardiovascular system. I don’t have time, but many other legitimate questions about the long-term safety there for this vaccine. For example, with accumulating in the ovaries, one of my questions is, “will we be rendering young people infertile, some of them infertile?” So, I’ll stop there.

You’ll see the first part of that paragraph everywhere, usually represented as a “provaccine” scientist saying, “We made a big mistake.” Of course, the hilarious part is the huge mistake Bridle makes in the paragraph above, conflating lipid nanoparticles with the spike protein. (More on that later.)

Most relevant to this post, he has made claims that the spike protein made by vaccines:

  • Is horribly toxic. (Wrong.)
  • “Has implications for blood donation.” (Given the transient, infinitesimal amount of spike protein from the vaccine that gets into the circulation, wrong.)
  • Has “implications for infants that are suckling.” (No, spike protein made by vaccines is detectable transiently in the blood at levels that are at the lower limits of a very sensitive assay, and a number of studies show that the vaccine itself is not passed through breast milk.)
  • Causes gastrointestinal bleeding in infants consuming the breast milk of their vaccinated mothers, based on VAERS reports. (Again, anyone can submit a report of any adverse reaction to VAERS, and antivaxxers have been weaponizing those reports, implying causation where there is none—or even a real correlation.)
  • Endangers fertility. (Not true, as I discussed before. Spike does not resemble the placental protein syncytin, the previous “mechanism” invoked by antivaxxers when fear mongering about COVID-19 vaccines and fertility. The new “mechanism” of Dr. Bridle’s promoted by Ms. Olszewski will be addressed in the next section.)

One also notes, as is often the case for scientists who spread misinformation about COVID-19 vaccines, an undisclosed conflict of interest:

A second emphasis of the lab is the study of host responses to viruses. An area of focus is developing a better understanding of the mechanisms underlying virus-induced cytokine storms. Dr. Bridle’s research team has identified a critical role of signaling through the type I interferon receptor in the negative regulation of an extensive network of cytokines. Cytokine responses to viruses are often very different between females and males and the Bridle lab group is seeking to understand why. At the intersection of these two programs, is a research initiative aimed at modifying the research team’s optimized cancer vaccine platforms to target severe acute respiratory syndrome coronavirus (SARS-CoV)-2, which is the causative agent of the coronavirus disease identified at the end of 2019 (COVID-19). The long-term goal is to have a flexible technological platform to rapidly develop vaccines against highly pathogenic coronaviruses that may emerge in the future.

Yes, Dr. Bridle is trying to develop his own vaccine and treatments for COVID-19. Sound familiar? It should. For example, Geert Vanden Bossche, who is also spreading misinformation about COVID-19 vaccines, owns a company that is trying to develop a vaccine based on a technology to activate natural killer cells. This is a form of antivaccine grift that goes all the way back to Andrew Wakefield, who, as you might recall, had his own measles vaccine under development at the time he published his case series linking the MMR vaccine to autism in 1998. The idea seems to be to attack current vaccines as dangerous and ineffective, feeding the antivaccine movement, to pave the way for your own vaccine. Indeed, a year ago Dr. Bridle received a $230,000 grant from the provincial government to develop a vaccine using the very same spike protein that he’s been demonizing, although that might be the “big mistake” he has been confessing to.

About that biodistribution study

Now that I’ve established the origin of the antivaccine misuse of the biodistribution study, at least as closely as I can, let’s take a look at the claims of Ms. Olszewski, Mr. Adams, and Dr. Bridle themselves and compare them to the actual study, so helpfully stored at so many antivaccine websites. The original report is in Japanese, but there is what appears to be a machine-translated version available.

The first thing to note is that this biodistribution study is in rats, not humans. Wistar Han rats received a 50 μg dose of lipid nanoparticles labeled with 3H, which is radioactive. Radioactivity was measured in various organs at 0.25, 1, 2, 4, 8, 24, and 48 hours post-injection.

The second thing to note is that this study was only of the lipid nanoparticles, not the full vaccine containing the mRNA for the SARS-CoV-2 spike protein. The dose used was 50 μg. The human vaccine contains 0.43 mg ALC-0315=(4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), ALC-0159=0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3- phosphocholine, and 0.2 mg cholesterol. That is basically ~0.46 mg lipids or 460 μg. Let’s just round it up to 500 μg (0.5 mg). That’s approximately 10x the dose given to the rats. However, for the typical “70 kg” male, 0.5 mg represents a per-weight dose of 0.0071 mg/kg, or 7.1 μg/kg. Let’s compare to the rats, which generally weigh around 200 g (0.2 kg), give or take, at 8 weeks, which is the usual age rodents are used for experiments. That would translate to a per-weight dose of ~250 μg/kg. Even if you used much older rats, who can weigh as much as twice as much, that would still translate to a dose of 125 μg/kg. So we’re looking at a lipid nanoparticle does of ~18-35x higher (as a rough estimate) than the typical adult human dose. That’s not unexpected. Biodistribution studies frequently use much higher doses than the human dose, the better to be able to detect distribution in low uptake organs, which, it turns out, the ovaries are.

As pointed out by multiple sources, the peak accumulation in the ovaries was 0.095% (or less than 1:1,000 of the total dose of lipid nanoparticle):

Not that this has deterred antivaxxers:

Because, of course, it hasn’t.

At this point, I can’t help but also point out that there have been actual studies of COVID-19 vaccines and ovarian function. In one such study, for example, researchers studied women undergoing oocyte retrieval for in vitro fertilization. They found no detrimental effect on ovarian follicular function. Another study of women undergoing in vitro fertilization demonstrated that the Moderna COVID-19 vaccine has no detectable effect on the percentage of clinical pregnancies resulting from the procedure. Yet another study has shown that vaccination against COVID-19 has no effect on immunological tolerance of the fetus by the mother. Still another study failed to find any effect on embryo implantation rates between SARS-CoV-2 infection seropositive, SARS-CoV-2 vaccine seropositive, or seronegative women.

It is true that most of these studies are still on preprint servers and haven’t completed peer review yet to be published in a peer-reviewed journal, but the evidence thus far is strongly supportive of the conclusion that neither COVID-19 infection nor vaccination against COVID-19 has any effect on female fertility. While it is true that these studies all examine women undergoing in vitro fertilization procedures and the women who took part are thus not representative of all reproductive age women, these results are even worse for the claim that COVID-19 vaccines cause infertility. Why? Most of these women (surrogates and cases of male factor infertility excluded) undergo in vitro fertilization because of difficulty conceiving, and one would expect such women to be more, not less, susceptible to anything that might impact female fertility. And, as was pointed out by others, several female participants got pregnant during Pfizer’s phase 3 trial, and the only adverse pregnancy outcome was in the placebo group.

But what about the rest of the biodistribution?

As Yuri Deigin pointed out, only around 0.1% of the dose of lipid nanoparticles went to the ovaries. More importantly, 53% stayed at the injection site in the muscle, which is good, given that the whole point of an intramuscular injection is for the lipid nanoparticles to get the mRNA contained within into muscle cells near the injection cite, there to set up shop and provide the template for producing spike protein. Another “popular” site was the nearest lymph node basin, which explains why enlarged axillary lymph nodes (lymph nodes under the arm) have been observed in some women undergoing screening mammography too soon after vaccination, leading radiology and breast cancer specialists to tweak their mammography guidelines to minimize the chance of unnecessary axillary lymph node biopsies. At peak, only 0.02% made it to the brain.

Another thing about Dr. Bridle’s statements that bothered me as I read them. He has conflated spike protein with lipid nanoparticles, not just once, but repeatedly. For example, in this article:

“It’s the first time ever scientists have been privy to seeing where these messenger RNA [mRNA] vaccines go after vaccination,” Bridle explained. “Is it a safe assumption that it stays in the shoulder muscle? The short answer is: absolutely not. It’s very disconcerting.”

Bridle argues that unlike traditional vaccines that stay mostly in the vaccination site at the shoulder muscle, the Japanese study showed how the spike protein of the coronavirus enters the bloodstream and circulates around the body for several days after a person gets inoculated with the vaccine.

The spike protein then accumulates in organs and tissues such as the spleen, bone marrow, liver, adrenal glands, and in “quite high concentrations” in the ovaries.

No, the Japanese biodistribution study shows nothing of the sort. It only looked at where the lipid nanoparticles go. It is true that some of experiments looked at the distribution of lipid nanoparticles containing an mRNA coding for Luciferase, a protein that exhibits bioluminescence allowing for visualization where the mRNA ended up. One interesting finding is that, after an intravenous injection, the predominant organ where the lipids in the lipid nanoparticles (ALC-0315 and ALC-0159) end up is the liver. Both lipids are eliminated rapidly from the plasma by several logs, such that by 300 hours (12.5 days) after injection very little is detectable. In the liver, however, the ALC-0315 takes around six weeks to be eliminated from the liver. One wonders, one does, why antivaxxers aren’t going ballistic about this finding. Maybe it’s because, at the peak, the amount of lipid nanoparticles detected in the liver was only 18%. Who knows? Maybe it’s because saying that lipid nanoparticles cause female infertility is more scary than saying they take a while to be eliminated from the liver.

More tellingly, though, antivaxxers are portraying the Japanese biodistribution study as though it were some sort of “secret” document. (“Confidential”! Secret!) However, it has been public for some time. It’s been publicly available for several months on the Japanese Pharmaceutical and Medical Devices Agency website, and the European Medicines Agency assessment report on the Pfizer vaccine repeatedly references results from the study.

The bottom line is that there is no evidence that the lipid nanoparticles in the Pfizer vaccine (or any of the COVID-19 vaccines) accumulate at significant quantities in the ovaries, much less cause female infertility. This new claim is nothing more than a repackaging of the previous claim that COVID-19 vaccines cause miscarriages and female infertility because of the supposed resemblance of sequences in the spike protein and the placental syncytin protein causing the immune response from the vaccine to attack syncytin, which was a repackaging of old antivaccine claims that vaccines sterilize women. Spike protein does not sufficiently resemble syncytin to cause miscarriages and infertility, and the lipid nanoparticles in the vaccines do not accumulate in the ovaries, much less cause female infertility.

In fact, this new version of the “vaccines are going to sterilize our womenfolk” disinformation leads me to conclude that just as aluminum became the new mercury as the science became clear that mercury in the thimerosal preservative that used to be in some childhood vaccines does not cause autism, lipid nanoparticles are the new polysorbate-80. Does anyone remember polysorbate-80 (also called Tween-80) or Triton X-100, detergents and emulsifiers used in some pharmaceutical products? Antivaxxers used to blame polysorbate-80 found in Gardasil for premature ovarian failure and female infertility. I first wrote about it nearly 13 years ago!

Everything old is indeed new again, with antivaxxers easily repurposing lipid nanoparticles into the role previously held by emulsifiers as the “culprits” in vaccines sterilizing women, all with a dollop of the “toxins” gambit. I can only speculate what farcical molecular “mechanism” antivaxxers will think of next to blame COVID-19 vaccines for sterilizing our womenfolk.

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Posted by David Gorski

Dr. Gorski's full information can be found here, along with information for patients. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. If you are a potential patient and found this page through a Google search, please check out Dr. Gorski's biographical information, disclaimers regarding his writings, and notice to patients here.