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Pfizer Vaccine: Long Term Side Effects


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Recently there was a freedom of information request for the Japanese government to release data on the Pfizer vaccine.  That request yielded bio-distribution data on the lipid nanoparticles that carry the mRNA in the body.  I will post a chart which summarizes the data from the FOIA request and also the report itself (Japanese and English).  

My question is, looking at this bio-distribution data which shows large concentrations of the lipid nanoparticles collecting in the bone marrow and ovaries post vaccination, what long term potential side effects might be anticipated in individuals who received the Pfizer vaccine?

Summary of bio-distribution of lipid nanoparticles from Pfizer vaccine:

 

 

Ovaries-get-the-mRNA-from-Pfizer-Shot-Graph-2048x1424.webp Pfizer-report_Japanese-government.pdf

Screen Shot 2021-06-20 at 17.55.29.png

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2 hours ago, Alex_Krycek said:

My question is, looking at this bio-distribution data which shows large concentrations of the lipid nanoparticles collecting in the bone marrow and ovaries post vaccination, what long term potential side effects might be anticipated in individuals who received the Pfizer vaccine?

Probably none of consequence.

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23 minutes ago, swansont said:

Also, how many legs did the individuals in the control group have? (and were these in vivo tests?)

This particular study was on mice, rats, monkeys, and human cells.  There were different studies with different delivery methods (In vivo, in vitro, and intramuscular injection.)

The graph above came from a study on Rats (Wistar Han) and the method of administration was intramuscular injection.  

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There has been some concern over this bio distribution recently, potentially as the cause for the fatal blood clots that have, in rare instances, caused the death of recent vaccine recipients.  Scientists are still investigating why these blood clots are happening, but one theory is that the mRNA crosses the blood brain barrier.  

"The surgeon then mentioned cases of immune thrombocytopenia — a life-threatening blood clot or platelet disorder — occurring shortly after mRNA vaccination. While no causative link has been confirmed, he considered that maybe the LNPs had carried the mRNA vaccine into the megakaryocytes (platelet-producing cells) in the bone marrow. The megakaryocytes then express the spike protein, only to be marked for destruction by cytotoxic T-cells. Platelets then become deficient, causing thrombocytopenia. Of course, he emphasized that these are just speculations."

Source:  https://medium.com/microbial-instincts/concerns-of-lipid-nanoparticle-carrying-mrna-vaccine-into-the-brain-what-to-make-of-it-42b1a98dae27

The issue was also raised in the British Medical Journal:  

"In a rapid response posted on bmj.com, JW Ulm, a gene therapy specialist who has published on tissue targeting of therapeutic vectors,13 raised concerns about the biodistribution of LNPs: “At present, relatively little has been reported on the tissue localisation of the LNPs used to encase the SARS-CoV-2 spike protein-encoding messenger RNA, and it is vital to have more specific information on precisely where the liposomal nanoparticles are going after injection.”14

It is an unknown that Ulm worries could have implications for vaccine safety.

Ulm told The BMJ: “Pfizer-BioNTech and Moderna did a remarkable job of rapidly scaling up manufacturing of such a novel system in swift fashion, which is genuinely a landmark technological achievement. However, pharmacokinetic studies, with independent laboratory confirmation, are essential to ascertain potential cytotoxicity and macroscopic toxicity, especially given the likelihood of booster injections over months or years, since the tissue trafficking patterns of the mRNA vaccine payload will determine which cells and tissues are killed by cytotoxic T-cells in each round.” Given the variation in LNP formulations, it is unclear how relevant previous animal experiments are to answering this question.

Regulators and manufacturers contacted by The BMJ for this article did not wish to address any of the questions raised by Ulm’s rapid response."

Source: https://www.bmj.com/content/372/bmj.n627

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This seems to be an area that requires further inquiry to ensure the safety and efficacy of MRNA vaccines moving forward.  

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34 minutes ago, Bufofrog said:

The medical community.  

That's incredibly vague.  Can you cite a precedent, any research, or specific argument why the dispersion of mRNA or lipid nanoparticles into the human body would not be problematic?  This appears to be a novel situation with little precedent to determine either safety or risk.  

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Before I talk a bit more on the study itself I want to take a step back and talk a bit how risks in medical interventions are generally evaluated. The key element here is monitoring certain clinical endpoints, including efficacy of the drugs but also specific indicators of morbidity, for example.

In a more general sense, there are no "no effect" endpoints. If you eat a cheeseburger, for example, I could monitor increases in negative biomarkers in your blood, there could be short term shifts in the gene expression of you gut microbiota and so on. However, that tells us little about the risks. As such it would be better to use endpoints such as heart attack and stroke rates and so on. The big issue with long-term effects is that it becomes very difficult to figure out what the causes for a given hard endpoint are, which is why for example nutritional studies, which often are long-term, often do not have clear outcomes.

Trials are looking at such outcomes and from that viewpoint the current the current vaccines are no different from other vaccines or therapeutics. You look at endpoints within a given time frame for a given sample size. The SARS-CoV-2 vaccines all fulfil pretty much the same requirements as you typically do not monitor individuals indefinitely after taking a medication.

So as such, we can be fairly certain that the the the mRNA vaccines do not seem to have any acute effects and we know roughly as much about long-term issues as for other medication.

So what is new regarding our knowledge about concerns regarding this specific vaccine? One risk that folks were concerned years back is the risk that the LNP could distribute their payload throughout the body and enrich in the liver. If the spike protein is formed there, it could result in local inflammation of the organ and liver damage. However, this does not happen. In fact, the Japanese report indicates why, within a relatively short time frame all the mRNA expression is basically gone. So what about the LNP alone? Again, you get a dose, the lipids move through your body and get metabolized. Typically they accumulate in adipose tissue or liver (which for some reason is not plotted, it is higher there than in ovaries, for example). So does this cause harm?

The cited study on direct injection of pure LNP indicate that yes, if given in high concentrations they can cause inflammatory responses. However, this itself is not an indicator for adverse health effects. In fact, the paper argues that these inflammatory responses might be why the current mRNA vaccines are so effective (which was a big worry before, the fact that mRNAs are generally not very immunogenic). I.e. the local inflammation caused by LNPs could have been beneficial for efficacy reasons. We do see lower efficacy in the other vaccines, for example.

While the study is helpful to highlight the potential to elicit inflammatory responses from LNPs alone,  (and therefore nasal delivery is not a good idea) it does not actually suggest health issues. 

Again, it is about endpoints and what the study measured is not helpful to provide evidence of harm in humans.  First,  mice are not a a great model for immune responses in humans (which is a common issue with animal models) and second, they injected a very high amount- 10 ug, IIRC which is a huge amount compared to their body weight relative to the amount found in vaccines and the body weight in humans (we are talking over a thousand fold at least if I got my numbers right).

Moreover, as you know you only get two injections, so there is no chance for long-term accumulation (as opposed to many of the chemicals we use in personal care products, for example). Thus, if inflammation caused by LNPs resulted in adverse effects  you would expect to see most the effects fairly soon (within days) of injection, as the levels after that will gradually decline (rather than increase). The precise rate is not known as they only monitored for two days, but it won't be years. What we do know and expect are inflammation, which are common with most vaccines (as inflammation is the result of the immune system reacting). Mild myocardial inflammation has also been recorded which could be related to LNPs (or the vaccine in general). But again, the endpoints do not suggest significant adverse health effects. Blood clots do not seem to be different between unvaccinated and Pfizer/Moderna vaccinated folks, but seem elevated in certain population subsets in AstraZeneca vaccines, which is likely to related to the adenovirus used (there have been reports in the past for issues with certain adenovirus-based vaccines, but I am not sure what they were in detail and in any case, they are not related to mRNA-based vaccines such as Pfizer/BioNTech.

Meanwhile, there are studies (e.g. https://s3.amazonaws.com/media2.fairhealth.org/whitepaper/asset/A Detailed Study of Patients with Long-Haul COVID--An Analysis of Private Healthcare Claims--A FAIR Health White Paper.pdf) showing that even asymptomatic patients might be at risk of having long COVID symptoms, though it is still about double as high in symptomatic patients.

So again, we have a vaccine that might cause issues in some folks, but protects them from much bigger harm. And on top, they also protect those that are too stubborn to protect themselves.

 

 

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10 minutes ago, iNow said:

We’ve been studying mRNA vaccines since 1989. The safety and risk is quite well understood, even if not by you personally. 

Studying, perhaps, but mRNA vaccines were only approved by the FDA in 2018, and the long term effects have yet to be documented.  However, I am interested to know if you can confirm the veracity of what I posted above with respect to immune thrombocytopenia.  This seems to be the most plausible explanation for the rare and often fatal blood clot events that have stricken a small minority of vaccine recipients.  But if you have a better explanation I'm all ears.  

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11 minutes ago, Alex_Krycek said:

Studying, perhaps, but mRNA vaccines were only approved by the FDA in 2018, and the long term effects have yet to be documented. 

This is true for most medications that are not taken long-term.

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Even if so, it's moving the goal posts. I was discussing our understanding of safety and risk. Now Alex is referring to date of first government level approval for widespread human use (which itself only comes after many years of data and study).

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12 hours ago, Alex_Krycek said:

This seems to be the most plausible explanation for the rare and often fatal blood clot events that have stricken a small minority of vaccine recipients.

Your opinion on what is plausible is of no interest to me, what the medical community has to say is of interest.  You see I am of the opinion that when you want to have the best most up to date information you should consult the experts in that field.  What a concept, huh? 

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5 minutes ago, Bufofrog said:

Your opinion on what is plausible is of no interest to me, what the medical community has to say is of interest.  You see I am of the opinion that when you want to have the best most up to date information you should consult the experts in that field.  What a concept, huh? 

Actually, we are debating the cause of a novel situation relating to lipid nanoparticles, mRNA, and immune thrombocytopenia about which there isn't much literature.  Pretty important, if you ask me, if we're to ensure the utmost safety and efficacy of the COVID vaccine moving forward.   Perhaps you might offer some meaningful information pertaining to this issue at some point. 

4 hours ago, swansont said:

They were?

Correction: Lipid nano particles were only approved in 2018.  

12 hours ago, CharonY said:

Before I talk a bit more on the study itself I want to take a step back and talk a bit how risks in medical interventions are generally evaluated. The key element here is monitoring certain clinical endpoints, including efficacy of the drugs but also specific indicators of morbidity, for example.

In a more general sense, there are no "no effect" endpoints. If you eat a cheeseburger, for example, I could monitor increases in negative biomarkers in your blood, there could be short term shifts in the gene expression of you gut microbiota and so on. However, that tells us little about the risks. As such it would be better to use endpoints such as heart attack and stroke rates and so on. The big issue with long-term effects is that it becomes very difficult to figure out what the causes for a given hard endpoint are, which is why for example nutritional studies, which often are long-term, often do not have clear outcomes.

Trials are looking at such outcomes and from that viewpoint the current the current vaccines are no different from other vaccines or therapeutics. You look at endpoints within a given time frame for a given sample size. The SARS-CoV-2 vaccines all fulfil pretty much the same requirements as you typically do not monitor individuals indefinitely after taking a medication.

So as such, we can be fairly certain that the the the mRNA vaccines do not seem to have any acute effects and we know roughly as much about long-term issues as for other medication.

So what is new regarding our knowledge about concerns regarding this specific vaccine? One risk that folks were concerned years back is the risk that the LNP could distribute their payload throughout the body and enrich in the liver. If the spike protein is formed there, it could result in local inflammation of the organ and liver damage. However, this does not happen. In fact, the Japanese report indicates why, within a relatively short time frame all the mRNA expression is basically gone. So what about the LNP alone? Again, you get a dose, the lipids move through your body and get metabolized. Typically they accumulate in adipose tissue or liver (which for some reason is not plotted, it is higher there than in ovaries, for example). So does this cause harm?

The cited study on direct injection of pure LNP indicate that yes, if given in high concentrations they can cause inflammatory responses. However, this itself is not an indicator for adverse health effects. In fact, the paper argues that these inflammatory responses might be why the current mRNA vaccines are so effective (which was a big worry before, the fact that mRNAs are generally not very immunogenic). I.e. the local inflammation caused by LNPs could have been beneficial for efficacy reasons. We do see lower efficacy in the other vaccines, for example.

While the study is helpful to highlight the potential to elicit inflammatory responses from LNPs alone,  (and therefore nasal delivery is not a good idea) it does not actually suggest health issues. 

Again, it is about endpoints and what the study measured is not helpful to provide evidence of harm in humans.  First,  mice are not a a great model for immune responses in humans (which is a common issue with animal models) and second, they injected a very high amount- 10 ug, IIRC which is a huge amount compared to their body weight relative to the amount found in vaccines and the body weight in humans (we are talking over a thousand fold at least if I got my numbers right).

Moreover, as you know you only get two injections, so there is no chance for long-term accumulation (as opposed to many of the chemicals we use in personal care products, for example). Thus, if inflammation caused by LNPs resulted in adverse effects  you would expect to see most the effects fairly soon (within days) of injection, as the levels after that will gradually decline (rather than increase). The precise rate is not known as they only monitored for two days, but it won't be years. What we do know and expect are inflammation, which are common with most vaccines (as inflammation is the result of the immune system reacting). Mild myocardial inflammation has also been recorded which could be related to LNPs (or the vaccine in general). But again, the endpoints do not suggest significant adverse health effects. Blood clots do not seem to be different between unvaccinated and Pfizer/Moderna vaccinated folks, but seem elevated in certain population subsets in AstraZeneca vaccines, which is likely to related to the adenovirus used (there have been reports in the past for issues with certain adenovirus-based vaccines, but I am not sure what they were in detail and in any case, they are not related to mRNA-based vaccines such as Pfizer/BioNTech.

Meanwhile, there are studies (e.g. https://s3.amazonaws.com/media2.fairhealth.org/whitepaper/asset/A Detailed Study of Patients with Long-Haul COVID--An Analysis of Private Healthcare Claims--A FAIR Health White Paper.pdf) showing that even asymptomatic patients might be at risk of having long COVID symptoms, though it is still about double as high in symptomatic patients.

So again, we have a vaccine that might cause issues in some folks, but protects them from much bigger harm. And on top, they also protect those that are too stubborn to protect themselves.

 

 

Interesting, thanks.  So as to this point:

Blood clots do not seem to be different between unvaccinated and Pfizer/Moderna vaccinated folks, but seem elevated in certain population subsets in AstraZeneca vaccines, which is likely to related to the adenovirus used (there have been reports in the past for issues with certain adenovirus-based vaccines, but I am not sure what they were in detail and in any case, they are not related to mRNA-based vaccines such as Pfizer/BioNTech.

In your view, what about this adenovirus might be causing the blood clot issue in the AZ vaccine?

Also, I noted that Australia and now the UK have advised young people against getting the AZ vaccine. (I believe under 30s in the UK and under 50s in Australia have been advised against AZ, according to the latest news.  Is that cautionary measure justified, in your opinion?  

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1 hour ago, Alex_Krycek said:

Correction: Lipid nano particles were only approved in 2018. 

This would be your opportunity to provide a link to support your claim.

1 hour ago, Alex_Krycek said:

Actually, we are debating the cause of a novel situation relating to lipid nanoparticles, mRNA, and immune thrombocytopenia about which there isn't much literature.  Pretty important, if you ask me, if we're to ensure the utmost safety and efficacy of the COVID vaccine moving forward.   Perhaps you might offer some meaningful information pertaining to this issue at some point. 

thrombocytopenia is a rare result in 2 of the vaccines

https://www.uptodate.com/contents/covid-19-vaccine-induced-immune-thrombotic-thrombocytopenia-vitt

VITT has not been reported after mRNA-based COVID-19 vaccines such as the BNT162b2 (Pfizer-BioNTech) or the mRNA-1273 (Moderna) vaccines despite administration and safety data collection from hundreds of millions of recipients.

At least one of the available vaccines, (Oxford- AstraZeneca) is not an mRNA vaccine 

https://www.nytimes.com/interactive/2020/health/oxford-astrazeneca-covid-19-vaccine.html

The Oxford-AstraZeneca vaccine is based on the virus’s genetic instructions for building the spike protein. But unlike the Pfizer-BioNTech and Moderna vaccines, which store the instructions in single-stranded RNA, the Oxford vaccine uses double-stranded DNA.

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50 minutes ago, Alex_Krycek said:

In your view, what about this adenovirus might be causing the blood clot issue in the AZ vaccine?

Also, I noted that Australia and now the UK have advised young people against getting the AZ vaccine. (I believe under 30s in the UK and under 50s in Australia have been advised against AZ, according to the latest news.  Is that cautionary measure justified, in your opinion? 

We have to separate the issues. If we talk about the current vaccine, there are two factors that are relevant. The first is the availability of other vaccines and the respective countries seem to have sufficient access to cover their population with these vaccines. And the second is that currently B.1.617.2 (delta) is becoming dominant in many areas and AZ seems to perform worse than the others. Given the overall risk data, if there was no other vaccine, I would still take the AZ, even if I was in a risk group.

Going to adenovirus-based vaccines and therapeutics, I should add that, again, almost everything we put in our bodies does something to it and especially when applied to a large population it is almost inevitable that there will be rare harmful interactions. The goal is therefore not zero events, but to ensure that the overall benefits outweigh the risks for a given population.

Moreover, it is important to note that interactions that can lead to harmful events are not the same thing as the harmful event itself, there are mitigation strategies, dosage effects and so on. For example aspirin, causes blood thinning and in theory that could lead to internal bleeding. However, at recommended dosages it is considered to be safe, except for certain folks. In the past some studies indicate that certain adenovirus-based vectors might bind to circulating platelets and getting sequestered. That actually leads to reduced platelet count but not necessarily to clots alone. For that, it has been suggested that the vaccine might form an antigenic complex with platelet factors, resulting in the formation of antibodies against that complex. These antibodies than activate the platelets and initiate a pro-thrombotic response. It is not really my field so I do not know who would be at higher risk for this event and why.

 

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26 minutes ago, swansont said:

This would be your opportunity to provide a link to support your claim.

According to this article the first FDA approved RNA drug utilizing lipid nanoparticles was Onpattro in 2018.

"In 2018, the biotech Alnylam turned Nobel Prize-winning RNA interference research into the first siRNA drug — Onpattro, for patients with an inherited neurological disorder — by packaging the small interfering RNA in lipid nanoparticles. Now, similar formulations are paving the way for messenger RNA vaccines.

STAT Reports: 

Nanotechnology in Medicine

“In my mind, one of the heroes in this story is the RNA nanoparticle,” said Daniel Anderson, professor of chemical engineering at the Massachusetts Institute of Technology, because “siRNA led to mRNA vaccines.” 

The FDA’s approval of the first RNAi-based drug was “proof these nanoparticles were not just tools we use in the lab to manipulate genes,” Anderson said in a new STAT Report on nanomedicine, “but proof they can be translated into approved medicines.”

https://www.statnews.com/2020/12/01/how-nanotechnology-helps-mrna-covid19-vaccines-work/

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210922s000lbl.pdf

26 minutes ago, swansont said:

thrombocytopenia is a rare result in 2 of the vaccines

https://www.uptodate.com/contents/covid-19-vaccine-induced-immune-thrombotic-thrombocytopenia-vitt

VITT has not been reported after mRNA-based COVID-19 vaccines such as the BNT162b2 (Pfizer-BioNTech) or the mRNA-1273 (Moderna) vaccines despite administration and safety data collection from hundreds of millions of recipients.

At least one of the available vaccines, (Oxford- AstraZeneca) is not an mRNA vaccine 

https://www.nytimes.com/interactive/2020/health/oxford-astrazeneca-covid-19-vaccine.html

The Oxford-AstraZeneca vaccine is based on the virus’s genetic instructions for building the spike protein. But unlike the Pfizer-BioNTech and Moderna vaccines, which store the instructions in single-stranded RNA, the Oxford vaccine uses double-stranded DNA.

Here are the links to the updated health advisories as issued by the UK and Australian governments.

https://www.health.gov.au/news/atagi-statement-on-revised-recommendations-on-the-use-of-covid-19-vaccine-astrazeneca-17-june-2021

https://www.gov.uk/government/news/mhra-issues-new-advice-concluding-a-possible-link-between-covid-19-vaccine-astrazeneca-and-extremely-rare-unlikely-to-occur-blood-clots

https://extra.ie/2021/04/07/news/world-news/ema-reaches-conclusion-astrazeneca

https://www.huffingtonpost.co.uk/entry/oxford-astrazeneca-under-30s-uk-covid-vaccine_uk_606c21cfc5b66c4ab6b6ae80

 

 

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17 minutes ago, Alex_Krycek said:

According to this article the first FDA approved RNA drug utilizing lipid nanoparticles was Onpattro in 2018.

LNPs were in use before that. See Anselmo and Mirtagotri Bioeng Transl Med. 2016 Mar; 1(1): 10–29.

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52 minutes ago, Alex_Krycek said:

You're responding to the part which was not in question and to which I was not objecting, and ignoring the part I was. 

You were lumping all of the vaccines together under one umbrella and ignoring (possibly important) distinctions between them.

Your OP was about Pfizer and lipid nanoparticles, and all of the sudden you're talking about blood clots, which are not associated with the Pfizer vaccine.

 

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Posted (edited)

@swansont

My intent is to investigate the serious side effects related to the covid vaccines and the emerging research which attempts to identify and explain them.  Perhaps the title of the thread should be amended to reflect this.  

@CharonY

I discovered a very interesting hypothesis which claims to explain the clotting issue.   Is this essentially what you were indicating above?

Rolf Marschalek, a professor at Goethe university in Frankfurt who has been leading studies into the rare condition since March, said his research showed the problem sat with the adenovirus vectors that both vaccines use to deliver the genetic instructions for the spike protein of the Sars-Cov-2 virus into the body.

The delivery mechanism means the vaccines send the DNA gene sequences of the spike protein into the cell nucleus rather than the cytosol fluid found inside the cell where the virus normally produces proteins, Prof Marschalek and other scientists said in a preprint paper released on Wednesday.

He says the problem can be fixed:

But Prof Marschalek believes there is a straight forward “way out” if the vaccine developers can modify the gene sequence that codes for the spike protein to prevent it splitting apart.

J&J had already contacted Prof Marschalek’s lab to ask for guidance and was looking at ways to adapt its vaccine to prevent splicing, he said.

Source:  https://www.irishtimes.com/news/world/europe/german-scientists-claim-to-have-solved-covid-vaccine-blood-clot-puzzle-1.4576752

Here is his preliminary research (which has not yet been peer reviewed)  PDF attached below.  

https://www.researchsquare.com/article/rs-558954/v1

ABSTRACT:

During the last months many countries have started the immunization of millions of people by using vector-based vaccines. Unfortunately, severe side effects became overt during these vaccination campaigns: cerebral venous sinus thromboses (CVST), absolutely rare under normal life conditions, were found as a severe side effect that occured 4-14 days after first vaccinations. Besides CVST, Splanchnic Vein Thrombosis (SVT) was also observed. This type of adverse event has not been observed in the clinical studies of AstraZeneca, and therefore led immediately to a halt in vaccinations in several european countries. These events were mostly associated with thrombocytopenia, and thus, similar to the well-known Heparin-induced thrombo­cytopenia (HIT). Meanwhile, scientists have proposed a mechanism to explain this vaccine-induced thrombocytopenia. However, they do not provide a satisfactory explanation for the late thromboembolic events. Here, we present data that may explain these severe side effects which have been attributed to adenoviral vaccines. According to our results, transcription of wildtype and codon-optimized Spike open reading frames enables alternative splice events that lead to C-terminal truncated, soluble Spike protein variants. These soluble Spike variants may initiate severe side effects when binding to ACE2-expressing endothelial cells in blood vessels. In analogy to the thromboembolic events caused by Spike protein encoded by the SARS-CoV-2 virus, we termed the underlying disease mechanism the “Vaccine-Induced Covid-19 Mimicry” syndrome (VIC19M syndrome).

PDF version.pdf

Edited by Alex_Krycek
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1 hour ago, Alex_Krycek said:

I discovered a very interesting hypothesis which claims to explain the clotting issue.   Is this essentially what you were indicating above?

Yes, that is basically the most likely scenario.

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