Notes From the Upside-Down XVII: 'not for human use' means it's OK to inject billions with potentially carcinogenic and/or genotoxic products, such as Comirnaty

Too bad that no regulator actually required the manufacturer to conduct any such carcinogenicity and/or genotoxicity studies, isn't it?

In one of my comments, with respect to the currently available Covid-19 injections, I alluded to ‘toxic ingredients with unknown carcinogenic potential’ these products may contain.

Please let me fact-check this certainly outrageous statement to provide both context and accountability.

First, Jessica Rose wrote about SM-102, an ‘ionizable amino lipid’, by which is meant a, if not the, crucial component of Moderna’s Covid-19 injection. These particles are what’s called ‘cationic’, positively charged, and are the way-of-entry of the product’s mRNA into your cells, provided you elect to receive these injections.

Here is Dr. Rose on SM-102’s qualities:

This lipid is listed as having the following hazards: flammable in liquid and vapor form, acute toxicity if swallowed or inhaled, hazardous to health, and mutagenic (causes cancer). It is listed as being 90% ethanol and 10% SM-102 and known to cause anemia, cough, CNS depression, drowsiness, headache, heart damage, lassitude (weakness, exhaustion), liver damage, narcosis, reproductive effects and teratogenic effects as per the First-Aid Measures and treatment from potential exposure.

There is more, from her post:

Just how potentially dangerous, you’d might ask?

The answer appears to be: good question, and Dr. Rose then went down the rabbit hole masquerading as the UK government and found out that no such toxicity studies were performed and/or required by the regulator to be performed:

[from the UK gov’t website] ‘in vitro and in vivo genotoxicity studies were conducted with the novel lipid component SM-102 of the “vaccine”. Results suggests the genotoxicity potential to humans is very low. Carcinogenicity studies were not performed.’

[Dr. Rose] Oh. So it’s very low. In in vitro and in vivo models. And how many animals were tested? Ok. Hmm. And no carcinogenicity studies. They aren’t meant to cause cancer. Right. the Mod(e)rna injectable products utilize the LNPs from the LNP-102 kit which in turn utilizes the cationic lipids SM-102 that are highly toxic according to the MSDS. It is also means that a lab-grade LNP product is being used in humans.

Now, being the early-rising data-and-evidence nerd that I am (my wife typically calls me ‘a problematic person’ because I ‘actually read the footnotes and annotations’), I thought about the BioNTech/Pfizer product, which is the one that’s more frequently used here in Europe, specifically both in Austria and Norway.

Dr. Rose also mentioned it, however briefly, in her posting: ‘the cationic lipid for the P-fizer p-f-roducts is ALC-0315’.

So, here’s what I found about ALC-0315

First of all, I checked felleskatalogen.no to obtain the government-and-manufacturer certified product information about ‘Comirnaty’, which has a wealth of interesting information about a great number of things (which will have to wait until another time, though).

Manufactured by Echelon Biosciences Inc., founded by ‘two professors from the University of Utah’ whose primary mission is ‘to be a global leader in supplying biochemical reagents, assays, and screening services to further academic research and pharmaceutical development…We value integrity in business and strive to keep our focus on our customer’s needs’ (emphasis in the original).

Here’s what Echelon says about its product:

The same ‘disclaimer’ as with SM-102 above: ‘not for human use’.

So, integrity, right? Sure, the manufacture cannot really be held liable for what the customer does with any of these products—but that’s what regulators do, isn’t it?

Here’s the EMA’s Product Information

As the above-cited Norwegian website mentioned the European Medicines Agency as the supra-ordinate regulatory body, I then went to their website and looked up the BioNTech/Pfizer product information, conveniently available in 24 languages (your tax euros at work).

It’s a document of 111 pages, and I will not bore you with most of the data contained therein (even though doing so would be quite instructive, as to, e.g., the RT-PCR-tested clinical trial data, even though the testing method had been altered since then, but nevermind the possible alterations to the clinical data). So, I shall highlight a few items here and there, alright?

4.8 Undesirable effects [pp. 6-8]

The most frequent adverse reactions in participants 16 years of age and older that received 2 doses were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia (> 40%), chills (> 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age

There is a tabulated entry of these ‘undesirable effects’, followed by a ‘description of selected adverse reactions’, containing the known knowns of myocarditis (no mention of pericarditis, though), which is classified, in the above-related table, as ‘very rare (< 1/10,000)’, but since there are so many millions, if not billions of individuals who have received this product, there would have to be quite a few people with this condition.

Sidenote: just how many? I don’t know, but at least in the Norwegian case, the authorities declare that out of a total of 11,275,000 injections, 8,852,740 (or c. 78.5%) were with the BioNTech/Pfizer product (data as of 19 April 2022, according to the Norwegian Medicines Agency most recent AE report, pp. 4 and 6). If one now divides the latter number by 10,000, we’d arrive at slightly less than 900 cardiac problems. Yet, the data (ibid., pp. 7-8) contain ‘only’ 293 instances of pericarditis and 148 of myocarditis, for a combined total of 441 such AEs. That means that these severe cardiac AEs are either less widespread than the manufacturer and the regulators admit to (> 1/10,000), or they are under-reported by at least 50% (personally, I think the latter).

Back to the EMA’s report, which also holds a curious item on p. 8. Entitled ‘4.9 Overdose’, it reads:

Overdose data is available from 52 study participants included in the clinical trial that due to an error in dilution received 58 micrograms of Comirnaty. The vaccine recipients did not report an increase in reactogenicity or adverse reactions.

In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.

On the Pharmacokinetics of the BioNTech/Pfizer Product

The most important issue for us, though, is found in section ‘5. Pharmacological Properties’, which begins at p. 9. First up, a reminder about the ‘mechanism of action’ (ibid., my emphasis):

The nucleoside-modified messenger RNA in Comirnaty is formulated in lipid nanoparticles, which enable delivery of the non-replicating RNA into host cells to direct transient expression of the SARS-CoV-2 S antigen.

So, this is why SM-102 and ALC-0315 are important to these products.

Now, please scroll down to p. 15 to learn about ‘Preclinical safety data’, which reads as follows:

I’ve got a handful of questions here:

1. What are these ‘non-clinical data’? Any ideas about ‘special hazard for humans’?

2. How do BioNTech, Pfizer, or the EMA ‘know’ about these hazards if ‘neither genotoxicity nor carcinogenicity studies were performed’? As a follow-up, are regulators and the like currently conducting such studies?

3. As regards reproductive toxicity, there were 5,423 AEs for Babies aged 0-2 in the EudraVigilance database for 2021 alone, including 23 deaths. Jessica Rose has found more than 25K such entries in the US VAERS data.

I suppose we may ask ourselves: at what number would you stop these injections?

If you’d need more information about ALC-0315, here’s a link to the manufacturer’s Safety Data Sheet:

Warnings continue on p. 2.