mRNA Vaccines and the Biodistribution of Lipid Nanoparticles By Brian Simpson

In the beginning Pfizer and Moderna created the mRNA vaccine, but, all was not good. It was said by the health authorities that there was no problem about injecting mRNA into the body, as it would not spread throughout the body, let alone combine with the DNA. But the Japanese to their eternal credit were highly sceptical and requested a pre-clinical biodistribution study, done on an animal model. It was found that the vaccine did not stay at the injection site, but spread throughout the body, to the heart, ovaries and brain. Herein was the potential for the adverse effects that we are seeing reported. Dr. Byram W. Bridle, Associate Professor of Viral Immunology in the Department of Pathobiology at the University of Guelph, was at ground zero on this and has been a strong Covid vax critic. Here is an update on the biodistribution issue. The short of the long is that it was known from the beginning that the mRNA vaccines were problematic in this respect, and should have been never pushed upon a gagged and bound public.

 

https://viralimmunologist.substack.com/p/a-moratorium-on-mrna-vaccines-is?s=r

 

“Do you remember when public health and government officials assured everyone that the mRNA ‘vaccines’ function like traditional vaccine technologies? …meaning that they largely remain in the shoulder muscle where they are injected, with some portion going to the draining lymph nodes where an immune response is initiated.

Well, back in May 2021, I, along with some international colleagues, looked at a document that Pfizer had submitted to the Japanese health regulatory agency. It was a pre-clinical biodistribution study. This means it was an experiment done with an animal model to predict where the vaccine formulation might go when injected into people. What I saw was startling. Most of Pfizer’s vaccine spread throughout the body instead of staying at the injection site. This also meant there was the potential for toxicities that would never occur with traditional vaccines that largely remain at or close to the injection site. To ensure people could make a fully informed decision about whether to take the jab I went public with this information in a radio interview.

I wasn’t surprised by the systemic distribution of the vaccine per se. Being a vaccinologist, I knew that lipid nanoparticle delivery systems were originally designed to spread far and wide throughout the body with the hopes they could be a vehicle for gene therapy and/or drug delivery. Instead, my surprise came from the fact that the data confirmed my historical understanding and contradicted public health messaging that the mRNA jabs behaved like traditional vaccines. Public statements by health officials made me assume the lipid nanoparticles had somehow been modified to stay at the injection site, which was news to me. This highlights one of the first rules of thumb when practicing science. Transparently presented raw and/or peer-reviewed data are the cornerstones of objective science; not personal proclamations or data disseminated via media releases. In May 2021 I realized two things: 1. There was a lack of transparency about data supporting COVID-19 inoculations. 2. Incorrect messaging was being relayed to the public. As an academic public servant with relevant expertise, I spoke up when enquiries came from the public. I spoke the truth then and continue to do so.

As a result of this, a public campaign to impersonate and discredit me was mounted; it has not stopped and has likely caused irreparable harm to my career. Nobody involved in these personal attacks has ever been willing to talk to me about the scientific basis for my concerns. It is unfair to discredit a scientist based on a short interview for a lay audience in which only a tiny fraction of the messaging could be relayed. My challenge to detractors then remains the same now: if you want to prove that I don’t know what I am talking about, then debate me in a moderated public forum. I contend that a real-time back-and-forth discussion of the science will show that I know exactly what I am talking about; I’m not sure the same would hold true for most of those participating in the smear campaign against me. In that interview back in May 2021 I was asked if there might be a link between mRNA vaccines and cases of myocarditis that were being observed at increased frequency, especially among young males. My answer was yes and I started to present some potential mechanistic explanations for this, including Pfizer’s Japanese version of their biodistribution study.

Now, myocarditis is a publicly acknowledged side-effect of mRNA vaccines. Sadly, I have not received an apology from anyone who attacked me. Forgiving people is much easier when apologizing and seeking forgiveness is part of the resolution process. But this is no longer popular in our society, so I continue to struggle with forgiving those who relentlessly harass me. I need to do this to effectively move on.

In the meantime, the US Food and Drug Administration has been ordered by a court to release the data that they reviewed when authorizing Pfizer’s vaccine for emergency. Health Canada almost certainly would have reviewed the same information. It is unfortunate that the scientific community is only now starting to see reasonably transparent core data that were used to justify the rushed rollout of SARS-CoV-2 inoculations; an only due to a court order.

On March 1, 2022 an English version of the biodistribution study was released. It contains much more information than the Japanese version I had looked at. Also, this accurate English language translation has revealed inappropriate biases in the conclusions drawn by the study director. You can obtain the document from the website of Public Health and Medical Professionals for Transparency. Once at the website, enter the search term “185350”, which is the study number. What follows is a step-by-step breakdown of this study to help you understand its implications (page #s refer to this hyperlinked report).

Taking a Close Look at Pfizer’s Full Report of the Biodistribution Study

The study looked at the distribution of lipid nanoparticles (LNPs) manufactured by Acuitas Therapeutics, British Columbia, Canada. LNPs are essentially very tiny bubbles of fat that are used to deliver genetic material into our cells. In the case of Pfizer’s ‘vaccine’, the payload is a messenger RNA molecule that encodes the spike protein from SARS-CoV-2, which is the causative agent of COVID-19. When the mRNA gets into a cell, it uses the existing manufacturing capacity of the cell to make copies of the spike protein.

Of concern, Pfizer was never required to run a biodistribution study with the same ‘vaccine’ formulation that is being used in people. Instead, the study focused on the LNPs, which carried a mRNA encoding a protein that can be used in imaging studies; not the spike protein. Unfortunately, the expression of this protein was not evaluated, so we can not assess where the protein ended up in the body; only where the LNPs went.

Page 6: The title of the study is “A Tissue Distribution Study of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats.” Rats are a commonly used animal model for pre-clinical research. In this case, three males and three females were euthanized at each of multiple timepoints to harvest a variety of tissues to quantify the amount of LNPs in them. The mRNA in this study encoded ‘luciferase’; a protein that can be used to visualize where the mRNA is being converted into proteins. However, this analysis was not done in this particular experiment. “[3H]-labelled” means the LNPs were tritiated, or tagged with tritium. Tritium is a radioactive form of hydrogen. This allowed the LNPs to be quantified in tissues by measuring radioactivity. “ALC-0315” is a fat-based molecule that helps to compact mRNA into a nanoparticle and also promotes the introduction of the mRNA into a cell. “ALC-0159“ is a molecule that contains polyethylene glycol (PEG). You might have heard a lot about PEG in the context of COVID-19 ‘vaccines’ since it is the component that has been most associated with causing anaphylactic shock (a severe hyperacute allergic reaction) in some recipients. It serves a couple of functions:

1. This is the commonly mentioned purpose: It helps to stabilize the mRNA molecules; if mRNA degrades before it gets into a cell, the protein that the immune system is supposed to target will never be produced.
2. This is the other function of PEG that you may never have heard about (but those who have followed mRNA vaccine technologies have known about for many years): It helps the LNPs avoid the immune system to promote wide-spread dissemination throughout the body. Yes, you read that correctly. But, don’t take my word for it. Check out this published peer-reviewed science as a few examples:

Watters, R.J., Kester, M., Tran, M.A., Loughran, T.P. & Liu, X. Chapter five - Development and Use of Ceramide Nanoliposomes in Cancer. In: Düzgüneş, N. (ed). Methods in Enzymology, vol. 508. Academic Press, 2012, pp 89-108

Suk, J.S., Xu, Q., Kim, N., Hanes, J. & Ensign, L.M. PEGylation as a strategy for improving nanoparticle-based drug and gene delivery. Advanced drug delivery reviews 99, 28-51 (2016)

Gabizon, A. & Martin, F. Polyethylene glycol-coated (pegylated) liposomal doxorubicin. Rationale for use in solid tumours. Drugs54 Suppl 4,15-21 (1997)

Papahadjopoulos, D. et al. Sterically stabilized liposomes: improvements in pharmacokinetics and antitumor therapeutic efficacy. Proc Natl Acad Sci U S A 88, 11460-11464 (1991) Check out this quote: “This effect is substantially greater than that observed previously with conventional liposomes and is associated with a more than 5-fold prolongation of liposome circulation time in blood.”

Systemic distribution of LNPs was needed to try to replace genes in cells throughout the body, including the brain in order to treat things like Alzheimer’s disease and Parkinson’s disease. It was also necessary to deliver chemotherapeutic drugs to cancers that could have metastasized anywhere in the body, including the brain. However, this is not anywhere close to how a traditional vaccine technology behaves. Also, this wide distribution is accomplished by helping the LNPs avoid uptake by phagocytic cells, which are the cells of the immune system that promote induction of immune responses! I postulate that the mRNA inoculations would function better as vaccines if mRNAs could be stabilized without PEG.

Page 11 (section 5; Introduction): I have two serious concerns about this part.

1. The aim of the study was to evaluate a single dose of the surrogate ‘vaccine’. This is very odd and suggests this experiment was run as an afterthought and was overly rushed. The proper way to do this type of study is to test a range of doses. The ideal situation is to reach a dose that is too high (e.,it causes undesirable results) while simultaneously capturing ‘safe’ doses. This helps to inform proper dosing for subsequent studies, including those conducted with humans.
2. Something is revealed here that was never revealed in the Japanese version of the document; namely that the first attempt to run the study was a failure due to overt toxicity. Rats were supposed to receive 100 μg of mRNA, but the study had to be truncated because the selected dose was causing obvious harm to the rats (see section 7.1 on page 19 of the report). The results were not formally discussed but some raw data were provided in the appendices. The study director noted that “a subsequent review of the data showed concentrations[of LNPs] were well detected in tissues”. The treatment caused an acute body weight loss of ~7% . Of the three males that were due to be euthanized at 48-hours post-inoculation, the treatment proved lethal for one, which was euthanized at 30 hours. Of the remaining two rats, they were showing clear signs of distress at 48 hours. As stated, “Additionally, animals 019M and 020M were hunched and piloerect from approximately 30 h post-dose onwards”. “Onwards” means up to 48 hours when they were euthanized to harvest tissues. In other words 3/3 (100%) of the rats were clearly sick by 30-hours post-jab and we have no idea whether this would have got worse or resolved beyond 48 hours.

Only males were tested at the 100 μg dose, so we don’t know what it would have done to females.

I have a real problem with this experiment. I conduct these kinds of studies all the time. If only a single dose of a treasured new medical intervention is going to be tested, one would always try to predict a dose that is going to place it in the ‘best light’. As such, Acuitas and Pfizer must have been confident in the safety of the 100 μg dose. The fact that they were wrong on this gamble is disconcerting and does not speak well of their knowledge of the safety margin of their own product.

The study director contacted Acuitas to tell them the study was failing and the decision rendered was to repeat it at half the dose; multiple doses were still not considered, nor was expansion of the scope of the study done, despite obvious safety concerns, and signals that the experiment was too short. On the basis of this failed first attempt and an unwillingness to adjust course, regulatory agencies never should have let Pfizer proceed with their vaccine until a large array of safety questions were addressed experimentally.

Page 14 (section 6.3): Urine and fecal samples were collected but never analyzed (also see section 6.9.4). This is a shame considering the world-wide debate about potential shedding of mRNA ‘vaccine’ components and/or the spike protein they encode.

Page 15 (section 6.7): Blood cells were discarded from the blood samples. Therefore, the amount of LNPs in blood cells was presumably estimated by taking the total in whole blood and subtracting the amount in the plasma. This is unfortunate because an inappropriate conclusion was drawn about the irrelevance of blood cells as a destination for the LNPs. This is discussed below.

Pag 16 (section 6.8): It appears that some samples were analyzed while fresh; others were frozen, stored at -20oC for an unknown period of time, thawed and then analyzed. This would not be ideal for the stability of mRNAs, which might be one reason they and their protein products were not assessed in this study. These may also be less than ideal conditions for LNPs, but, presumably, they were OK for the radioactive tritium, which is what was measured. However, none of these issues were discussed nor were data provided to alleviate the concerns.

Page 18 (section 6.11): The wrong bones were taken from some rats so the correct ones were harvested from frozen and thawed carcasses. Again, it would be helpful to see analyses of LNP concentrations in tissues with and without a freeze-thaw to assure that they are equivalent. This should be standard practice when analyzing samples that have been handled differently.

Page 19 (section 7.1): Another aspect unique to the FDA’s version of the Pfizer biodistribution study is that it provides separate data for males and females. The data were pooled in the Japanese version, which hid important sex differences. Because the 100 μg dose of RNA was overly toxic, the study was truncated and re-started with a dose of 50 μg of RNA. However, the clinical observations reveal something disturbing. Even at this lower dose, the mRNA ‘vaccine’ proved to be acutely toxic to one of the three females that was monitored beyond 24-hours post-injection. No obvious signs of illness were observed with the three males that were allowed to live past 24 hours (the endpoint was 48 hours). Some may say it was only one female rat, but it is 1/3 (33.3%) of the female rats. Further, it is unknown whether others would have become visibly sick had the observation period been extended beyond 48 hours; especially when one understands that concentrations of LNPs were still rising in many female tissues (discussed below). Remember, in Canada, AstraZeneca’s COVID-19 ‘vaccine’ was deemed to be too unsafe for adults when public statements suggested it was causing dangerous blood clots in 1:55,000 people. So, writing off a 1:3 incidence of obvious toxicity in the pre-clinical study was unwise.

Also, although the numbers of rats used were far too small to draw any firm conclusions, these results suggest the mRNA ‘vaccine’ may have been more toxic in females, which could be due to a sex- or size difference. This is yet another reason why the study should have been repeated several times to build up the statistical power for proper analyses.

Biodistribution

Now for the biodistribution data. Table 1 spanning pages 23-24 is the same as the one in the Japanese document that I highlighted in May 2021. More telling, however, is table 2, spanning pages 25-26, because this separates the data for males and females. In assessing these data I will highlight some conclusions that were drawn by the study director.

Page 20: “The overall injection site concentrations and % dose values were higher in males than in females. Since concentrations in other tissues were broadly similar between the sexes, it is likely that the higher injection site values in males were a result of its more consistent identification and collection in males.” This fails to account for the fact that concentrations in tissues tended to peak or plateau at relatively early time points in males and were still climbing at the last time point in females. It also doesn’t consider the possibility that the LNPs might have been accumulating at higher concentrations than males in tissues that were not evaluated in the study.

Page 20: “the greatest mean tissue concentration and, in most instances, % of injected dose was found remaining in the injection site at each time point in both sexes.” Although technically true, the percentage of the injected dose was higher in the livers of males and females at 8- and 48-hours, respectively. Further, this statement is highly misleading in that it draws attention away from the obvious. We were told that most of the dose would stay at the injection site. However, there was only one out of seven time points in males (i.e., 1-hour post-injection) where most of the dose was at the injection site (69%). For the other seven time points and at all times in females, only a minority of the dose was detected at the injection site. In females, as little as 7% of the injected dose remained at the site of inoculation. This means the vast majority of the dose went somewhere else. Where did it go? The short answer is everywhere. When I publicized these data from the Japanese study, many people tried to get the public to focus on the low percentages of the overall dose in most tissues. They were missing the point. These low percentages were because the ‘vaccine’ had spread so far and wide throughout the body; a little bit sprinkled everywhere. Indeed, near the top of page 21, the study director concluded “Over 48 hours, [3H]-08-A01-C01 [this is the surrogate vaccine] distributed from the injection site to most tissues”. It is cherry-picking to try to compare the percentage of the total dose in something like the tiny adrenal glands to the large muscle in which the ‘vaccine’ bolus was injected. When the public were told that most of the dose remains at the injection site but only 7% of it could be detected there at a mere 15 minutes post-injection, then the messaging was wrong.

The proper way to assess distribution of a drug when telling people that most of the bolus is supposed to remain at the injection site would be to assess the percentage at the injection site versus ‘not at the injection site’. Here is this assessment for males (everything above the grey line represents the fraction of the dose that went somewhere else)…

 

Here is how much of the dose remained at the injection site in females…

 

The average proportion of the dose at the injection site across all time points for both sexes was only 29.7%. On this basis I would not conclude that most of the dose stayed at the injection site.

Also, focusing on the percentage of the dose that went to individual tissues loses sight of the fact that it is the concentration that matters. And the concentrations of LNPs in many tissues cannot be defined as insubstantial, especially when a safe concentration has never been established. Here is an illustration that I put together to highlight why the percentage of the total dose should not be used as a distraction from the concentration of the drug…

 

Here is an analogy to provide additional help...

Think about the risk of an accidental drug overdose in two people. One is a 250-pound man, the other is a 50-pound boy. They each accidentally consume the same high dose of a drug. In other words, 100% of the dose was found in the body of the man and 100% of the dose was found in the body of the boy. The percentage of the dose is equal but are they at equal risk of experiencing toxicity from an overdose? Obviously not. The tiny boy is at enhanced risk because the same high dose in a smaller body equals a higher concentration of the drug. The percentage of the drug given to the boy would have be scaled back a lot to avoid toxicity.

Looked at another way, let’s say the boy has consumed the minimum dose of a drug that causes toxicity. Would the same dose cause toxicity in the man? No, it would require a higher dose to be toxic.

In the same fashion, that is why dosage recommendations are lower for younger/smaller people. To prove this, go to your medicine cabinet and pull out a bottle of Aspirin or Tylenol or something similar. Look at the recommended dose for a child versus an adult. Children need lower total doses to achieve the same concentration of the drug once it is distributed in their body. Adult doses can potentially be toxic in children.

This same principle applies to the biodistribution of the lipid nanoparticles used to make mRNA vaccines. If a toxic dose were to be reached in the liver, the dose needed to cause toxicity in the vastly smaller ovaries would be much lower. Because the concentration of a drug is what matters.

Interestingly, the study director ignored that fact that the two-times higher dose of the mRNA ‘vaccine’ (100 μg) resulted in approximately two-times higher concentrations (that were toxic) in the various tissues as compared to the 50 μg dose; a classic dose-response effect. The percentage of the total doses reaching the tissues was almost equivalent between the 50 μg and 100 μg doses, but the latter proved more toxic because the concentrations were higher.

Page 20: “Mean plasma concentrations peaked by 4 hours post-dose in males and by 1 hour post-dose in females”. This is evidence of rapid systemic distribution with the kinetics accelerated in females.

Pages 20-21: “Concentrations were higher in plasma than in blood, with mean blood:plasma ratios generally ca. 0.5-0.6, indicating that the majority of the total radioactivity is associated with the plasma fraction.” Page 22: “and [3H]-08-A01-C01 did not associate with red blood cells.” But approximately one-third of the LNPs circulating in the blood were found in the cell fraction! Plus, the study director’s conclusion is based on the assumption that the ratio of cells to plasma in whole blood is ~50:50, but it is not; plasma represents a higher percentage. Here is a nice illustration from the University of Washington, Dept. of Laboratory Medicine, Specimen Procurement Section:

 

This means the amount of the LNPs in the cellular fraction was more likely ~40% of the total dose in the blood. How can one write this off as irrelevant? Further, the conclusion was that red blood cells weren’t a significant destination of the LNPs. Not only do the data contradict this assertion, it also fails to recognize that white blood cells and platelets make up <1% of whole blood. What if all the LNPs in the cellular fraction were in the white blood cells and/or platelets? This would represent a very high concentration of LNPs. Why wasn’t this studied? Instead, the cellular fraction was discarded. This is a very important question because white blood cells constitute a major component of the immune system. If they were to be negatively impacted, this would impede the vaccination effect. And if they aren’t killed but take up the mRNA, they would express the spike protein, which would then make them a target for spike-specific antibodies and/or T cells. Also, there have been reports of bleeding, blood clots, and thrombocytopenia (low platelet counts) post-‘vaccination’. The common factor with all of these is that they involve platelets, another component of the cellular fraction that was ignored. The question regarding the impact of LNPs on cells in the blood should have been addressed before there was any consideration of proceeding into human trials.

Page 22: The study director drew this overall biased conclusion: “The concentrations of [3H]-08-A01-C01 were greatest in the injection site at all time points”. Pardon me?!? Am I supposed to forget the statement on page 20 of the report, “the greatest mean tissue concentration and, in most instances, % of injected dose was found remaining in the injection site at each time point in both sexes”. This statement could only be applied to the data where results for males and females were pooled (i.e., the only data shown in the Japanese document), thereby hiding the fact that the % of the injected dose was higher in the liver than at the injection site at different times in males versus females.

Page 22: “The concentrations of [3H]-08-A01-C01 were greatest in the injection site at all time points, with levels peaking in the plasma by 1-4 hours post-dose and distribution mainly into liver, adrenal glands, spleen and ovaries over 48 hours.” I was lambasted by colleagues when I expressed concerns about biodistribution of LNPs to ovaries after seeing the Japanese document. But in the version of the document that was released by court-order, the study director concludes that the ovary is a main target organ for distribution of the LNPs! This concern is only enhanced when one looks at the kinetics of this biodistribution to the ovaries…

 

…the concentration of LNPs were rising almost exponentially at the conclusion of the study. How high would it have gone?

Page 21: “Maximum concentrations (Cmax) in liver and spleen were observed at 8 hours post-dose in males and 48 hours post dose in females, but were broadly similar and appeared to plateau at 8 hours post-dose when considering variability.” This conclusion needs to be corrected. The highest concentrations in female livers and spleens were observed at 48-hours post-treatment. But there is no way of knowing that these were maximal concentrations. In fact the data suggest that maximum concentrations could be reached some time after 48 hours…

 

 

This idea of capturing a concentration plateau is based on averaging the values from males and females. In many of the male tissues, apparent peaks or plateaus appear to have been captured within 48 hours post-injection. However, the kinetics were different in females, with concentrations still rising in many cases. If one averages the post-peak values of males with rising values from females, it gives the false impression that a plateau has been captured. This is very important because one of the key purposes of a biodistribution study is to determine when peak concentrations occur. Concerns related to potential toxicities can obviously not be allayed if only pre-peak concentrations have been captured; and this appears to be what happened with the females. Look at the following LNP concentrations over time in various tissues, with an emphasis on females (I already showed several other tissues above) and ask if you feel confident that a peak or plateau was captured. On other words, how confident are you that the concentrations would go no higher beyond 48 hours?

 

 

 

 

 

 

 

 

 

 

 

I question whether a peak was reached in male muscles…

All the Data are Indicative of Systemic Distribution

If a drug gets into the blood, one of the first places you should look for uptake is the spleen. This is because the spleen filters the blood. Indeed, with Pfizer’s ‘vaccine’ we see a rapid influx of LNPs into the blood and subsequent seeding of the spleen. Also, lymph nodes are designed to drain fluids from local tissues. So, if a drug seeds a tissue, one would expect to find it in the regional lymph nodes. In this study, the LNPs were found in two lymph nodes that were studied. These lymph nodes drain distinct tissues (one drains the jaw region and the other drains fluids around the intestines). Although it was not stated, I assume the surrogate ‘vaccine’ was likely injected into one of the large muscles of the hind legs as this is what is commonly done. If true, the most relevant draining lymph node would be the popliteal node. Surprisingly, it looks like lymph nodes draining the injection site were not evaluated. The fact that two ‘irrelevant’ lymph nodes had LNPs accumulating in them is suggestive of widespread dissemination into various tissues. I hypothesize that LNPs would have been found in most, if not all the lymph nodes in the rats. These results confirm a distribution pattern that is very different from traditional vaccine technologies where the dose would be concentrated at acute time points at the injection site, with some taken to the local draining lymph nodes.

6% of the Dose was in the Blood at Two Hours Post-Injection

No attempt was made by those conducting the biodistribution study to estimate the total amount of the dose of LNPs that were circulating in the blood, so I did this. We know the concentration per milliliter in the blood of males and females at each timepoint. So I took the average concentration across both sexes and picked the peak, which was at two hours after treatment. I estimated the total blood volumes (BV) in males and females using the formula BV (mL) = 0.06 x body weight + 0.77, which was derived from this study using the same strain of rats. After plugging in the relevant numbers, I came up with a total average dose of blood-borne lipids of 1,290 μg; or ~6% of the total dose. This is substantial considering it represents a single time point in a dynamic tissue in which the LNPs are entering and exiting the blood throughout the duration of the study.

How the Study Should Have Been Conducted

As an expert in pre-clinical experimentation, I can assure you that Pfizer’s biodistribution study was of poor quality. It appears to have been rushed, with many corners cut, possibly in an effort to meet a deadline at ‘warp speed’. If one of my graduate students presented the data in Pfizer’s biodistribution study to their advisory committee and proposed to include it in their thesis, they would immediately be advised that it represented no more than a preliminary experiment; the type that is used to design much more informative and conclusive experiments. They would be required to expand its scope and repeat it multiple times. Here are some things I would recommend:

1. The experiment should have been conducted independently at least three times to ensure the findings could be replicated and to provide sufficient statistical power to facilitate objective analyses.
2. The experiment should have been run longer; specifically, until peak concentrations were clearly captured in all tissues.
3. More doses should have been evaluated to determine when unwanted effects began and whether they could be mitigated.
4. More tissues should have been assessed since there was evidence of extremely broad distribution. This should have included the lymph nodes draining the injection site, white blood cells, red blood cells, platelets, etc.
5. Tissues should have been assessed for the presence of LNPs, plus the mRNA, plus the protein product; not just the LNPs. It would be helpful to know how long the mRNA remains intact versus how long the protein product and LNPs can be detected.
6. Samples should have been analyzed to detect potential shedding. These samples should have included saliva, urine, feces and skin swabs.
7. The study should have been run with the same formulation that is being used in people.
8. A small-scale biodistribution study should have been incorporated into a phase I human clinical trial. If nothing else, it would have been very easy to monitor distribution in serial blood samples, as well as shedding samples, since these are all easy to obtain.

Repeated Dosing With Lipid Nanoparticles is Dangerous

Here is some information that is of concern considering that many people have already received three or four doses of an mRNA ‘vaccine’ in less than one year, with the potential for more on the horizon…

This might be news to many members of the public, but it is a long-accepted scientific fact that lipid nanoparticles used to deliver the mRNA in ‘vaccines’ can be toxic. In fact, that is the very reason why some big pharmaceutical companies strategically focused on using them as vaccine technologies instead of for gene therapies and to deliver drugs. A good quality vaccine, such as those used in the mandated childhood series, only require one or two doses for a person’s lifetime. It was assumed the same would hold true for mRNA vaccines. Repeated administration of lipid nanoparticles, especially over a limited period of time, is known to be toxic.

This was openly discussed with the media prior to the declared COVID-19 pandemic, but many people are either unaware of this or have forgotten. This included an interview with the Chief Executive Officer of Moderna and others in the biotechnology industry. Here are quotes from the hyperlinked article:

“In nature, mRNA molecules function like recipe books, directing cellular machinery to make specific proteins. Moderna believes it can play that system to its advantage by using synthetic mRNA to compel cells to produce whichever proteins it chooses. In effect, the mRNA would turn cells into tiny drug factories. It’s highly risky. Big pharma companies had tried similar work and abandoned it because it’s exceedingly hard to get RNA into cells without triggering nasty side effects.”; “Delivery — actually getting RNA into cells — has long bedeviled the whole field. On their own, RNA molecules have a hard time reaching their targets. They work better if they’re wrapped up in a delivery mechanism, such as nanoparticles made of lipids. But those nanoparticles can lead to dangerous side effects, especially if a patient has to take repeated doses over months or years. Novartis abandoned the related realm of RNA interference over concerns about toxicity, as did Merck and Roche”.

Indeed, there are many peer-reviewed scientific publications that have highlighted serious safety issues related to the administration of lipid nanoparticles used to deliver mRNAs. Some examples of toxicities that can be caused by lipid nanoparticles can be found here, here, and here. Remarkably, lipid nanoparticles used to deliver mRNAs have even been shown to be toxic to cells of the immune system that play a critical role in promoting vaccine-mediated immune responses. This would counteract the very immunization effect that is being sought. It could even, in theory, potentially cause counterproductive acute immunosuppression. A key question is to what degree are these toxicities additive? Unless lipid nanoparticles are definitively proven safe in humans, their repeated administration to people should be avoided.

Implications for Blood Donations

Blood donor organizations conduct fabulous, life-saving work. However, they need to take a long look at their policies surrounding mRNA-based vaccines. For example, Canadian Blood Services has the following policy: “Consistent with our eligibility criteria for other non-live vaccines, Canadian Blood Services accepts donations from otherwise eligible donors who have received a Health Canada-authorized COVID-19 vaccine, with no required deferral period following vaccination”. The problem is that mRNA ‘vaccines’ don’t function like traditional non-live vaccines. Pfizer’s own data suggest that their mRNA ‘vaccine’ circulates in the blood (in both the plasma and the cellular fraction) for at least 48 hours post-inoculation. Should blood containing variable quantities of a mRNA ‘vaccine’ that is still in its initial phase 3 human clinical trial be used in patients?

I strongly recommend that a simple time-course study evaluating the duration of circulation of lipid nanoparticles, mRNA, and the spike protein be conducted. This would allow a safe waiting period to be determined prior to accepting donations from individuals who have received a mRNA ‘vaccine’.

Practical Applications

What should be done with all this information? Well, I would suggest that you investigate the myriad of questions raised by Pfizer’s biodistribution study. Ask yourself if you have been presented with sufficient scientific evidence to address your queries. Do not settle for personal opinions, no matter how much of an ‘expert’ the person or organization appears to be. If you are not confident that systemic biodistribution of mRNA vaccines in people is a non-issue, then consider encouraging the promotion of research to provide definitive answers. Expecting public health officials to practice the precautionary principle is reasonable.

Further, encourage uncensored public discussions of the science between experts on both sides of the debate. After all, the full spectrum of scientific information should not be hidden from the public.

Finally, encourage health regulatory agencies to recruit unbiased scientists with pre-clinical research skills to carefully evaluate these early types of studies. It is challenging for a large company that is responsible for vast amounts of investor dollars to change course in the human clinical trial stages of research where massive amounts of money are one the line; much like trying to turn an oil tanker around. In contrast, there is much less invested at the earlier pre-clinical and translational stages due to the much lower cost of that type of research. Changing course at this point is more akin to turning a speedboat around. Pre-clinical studies can be very informative and, if carefully critiqued, can be used to formulate important questions that can be answered with new, relatively inexpensive, easy and rapid experiments. Unfortunately, most regulatory agencies and advisory committees that have been evaluating COVID-19 ‘vaccines’ have focused on the recruitment of clinically focused researchers. The many problems with Pfizer’s biodistribution study should have been obvious to a pre-clinical scientist. Ideally, places like Health Canada should offer their regulatory scientists the equivalent of tenure in academia to ensure that they can maintain job security no matter how unpopular their reviews of submitted data may be.

In my continued effort to correct mis/dis-information, present information with greater transparency, and promote informed decision-making.”