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DWB's avatar

Could you comment on the "bolus theory" proposed by Marc Girardot? He argues that these injections are harmful due to accidentally going into a vein. However, what I read here is that they all end up in the bloodstream anyway, so accidental IV administration wouldn't be the cause of so many adverse events. I may be summarizing these arguments wrong!

PS One of the things that seems to have disappeared from the Internet is health authorities claiming that the shots "stay at the injection site". I can find people saying that other people have said that, but not original sources of people speaking that claim, even though it's something I'm sure I heard being said several years ago.

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Washed Up Pharmacist's avatar

I am not sure what Marc is trying to say with his bolus theory. Much of what he says has been known before, re IV bolus being especially dangerous especially if they are nanoparticles. Aspirating upon IM administration may be helpful, but unlikely to eliminate all or most of the immediate adverse events imho. Proper administration technique (getting the actual deltoid muscle and injecting in the middle) is harder than it looks (big fat arms, skinny little arms, muscular well vascularized arms etc etc). Need to spend more time on understanding his theory.

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Siguna Mueller, Ph.D., Ph.D.'s avatar

Good write-up, as always!

As for "staying in the injection site." I devoted quite some discussions to this in my book. To see where this claim originated, I first identified the following reference:

Lowe D (2021) Spike protein behavior. https://blogs.sciencemag.org/pipeline/archives/2021/

05/04/spike-protein-behavior--

But when I tried to open it, it did not come up. No idea where it is hiding. I tried the Wayback machine and no success there either.

Another source is: https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf

They did not state this explicitly, but it comes close, e.g.

"Over 48 hours, distribution from the injection site to most tissues occurred, with the

majority of tissues exhibiting low levels of radioactivity." Then, the rest of the EMA report focuses on the injection site.

And then, as Maria Gutschi said somewhere below, much seems to have come from the Moderna trials. See e.g.

"the mRNA constructs did not

persist past 1 to 3 days in tissues other than

the injection site, lymph nodes, and spleen

where it persisted in general 5 days"

source:

https://www.ema.europa.eu/en/documents/rmp-summary/spikevax-previously-covid-19-vaccine-moderna-epar-risk-management-plan_en.pdf

I think it again shows how effective MSM has been in promoting a new narrative.

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Peter Ringo's avatar

CDC avoids saying where the covid vaccine goes, leaving it open to the reader to assume it stays where it's injected:

"After vaccination, the mRNA will enter the muscle cells. Once inside, they use the cells’ machinery to produce a harmless piece of what is called the spike protein...."

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html

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Peter Ringo's avatar

Seems to me "stays in the arm" has been a common claim about vaccines for a long time, and has been from health authorities, but I haven't been able to find original sources either. I found a Reuters article from 2021 quoting Meedan Digital Health Services, who said, "Research shows that spike proteins (here) remain stuck to the cell surface around the injection site and do not travel to other parts of the body via the bloodstream," but I didn't find the research they were alluding to. (https://www.reuters.com/article/idUSL2N2NX1J6/)

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Washed Up Pharmacist's avatar

I think a lot of it comes from the Moderna data above on the muscle and draining lymph nodes, since that was the only preauthorization biodistribution study of the lipids in the vaccines. However it isnt the same mRNA and there was distribution to spleen and liver. The data from Onpattro showed mostly distribution to the liver but it was given IV.

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Amat's avatar

"We don't have to be the smartest - we just have to be the fastest" this blurb from Moderna says it all. Horrific.

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Just a Clinician's avatar

Nice rant. Completely understandable, even to one with a superficial understanding of pharmacokinetics.

I look forward to part two.

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Washed Up Pharmacist's avatar

OOOFFF. I apologize. Did not mean to be insulting. Just lots of not so great memories of trying to dose drugs and explaining why I wanted to do something. This biodistribution stuff of the LNPs is also way more complex.

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Just a Clinician's avatar

Fear not. I wasn't offended. I had way less than three years on pharmacokinetics, and I confess I no longer remember how to calculate pKa!

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DrBines verbales Vitriol's avatar

"Finally, fatty acids may directly stimulate inflammatory pathways through peroxisome proliferator-activated receptors (PPARs)." according to the Moderna review in nature. What do you have on Lipids and PPARs?

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Washed Up Pharmacist's avatar

Not much. Just that PPARs regulate lipid metabolism and these synthetic lipids likely affect these receptors. But it is just a general observation.

The chapter by Michael Palmer on kinetics and LNP toxicity in his book is very well done. Lots of ROS produced with these lipids.

https://www.math.uwaterloo.ca/~ervrscay/mRNA-toxicity-1_0.pdf

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DrBines verbales Vitriol's avatar

The role of peroxisome proliferator-activated receptors (PPAR) in immune responses - PubMed https://pubmed.ncbi.nlm.nih.gov/32791172/

There is a connection between lipids - PPAR and the immune system.

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