Bacterial Endotoxins In mRNA Shots Exceeds FDA Acceptability Criteria | EMA Leaks

Josh Guetzkow spots another failing

Criminologist Josh Guetzkow from Children’s Health Defense remarked that “Pfizer's own reports show endotoxin remains”. Do they?

Surprise Toxicity

What are endotoxins? Science Direct notes endotoxins are "lipopolysaccharides found in the cell wall of Gram-negative bacteria, which can induce inflammation and fever as an immune response in higher organisms". So basically, a toxin produced by bacteria.

Immunologist, molecular biologist and biochemist (besides other things) Jessica Rose challenged Guetzkow for the endotoxin levels, pointing out it was retracted in the Freedom of Information Act requests:

Governments hide evidence of crimes and then try to blame “trade secrets”. How toxic, how deadly a product is, now a “trade secret”. Killing you is de facto part of the trade. So the only source, of course, are the EMA leaks. Huzzah:

In-case anyone reading are unfamiliar, “<” means ‘less than’, and “>” means ‘more than’. For those wanting to read Josh Guetzkow’s original image in full can see here:

Source: Under folder '09. Applicant-Rapps-EMA CMC TC-26.11.2020', in file 'M3 20 Nov 2020 FDA Query Responses.pdf', on PDF page 111

Notice that BioNTech (at the very top) manufacture shots with less endotoxins (“<1”), whilst Pfizer are the ones responsible for awful endotoxin ranges (“<5”).

In terms of endotoxins observations, here are the parts of interest:

Under the “Acceptance Criteria” column, it shows for “Bacterial Endotoxins” that the amount must be lower than <12.5 EU/mL. EU/mL stands for endotoxin units per milliliter. For more technically minded people, one EU equals roughly 0.1 ng endotoxin/mL. The script for converting is 10 EU/mL = 1.0 ng/mL (or roughly 1 EU = 0.1 ng).

Notice that under the “Clinical Range” column is “<1”, but for the results everything else is “< 5.0”, and not “<1”, as Josh Guetzkow highlights. That means there are detectible amounts of bacterial endotoxins in the mRNA shots, implying bacterial contamination.

Violates FDA’s Acceptability Criteria

What Josh Guetzkow may not know is whilst the EU (European Union; not to be confused with Endotoxin Units) are incredibly lax with their Pfizer preferential treatment of granting “<12.5 EU/mL” as the extremely high ceiling on endotoxins, the FDA actually has stricter EU/mL requirements.

For that, we have to turn to documentation on Ophthalmic implants and Ophthalmic
viscosurgical devices, which are medical devices put in the eye. Why this? The FDA are cagey and don’t seem to publish easily accessible endotoxin limits; notice all references are second hand.

Eye implants might not seem relevant until you realise the mRNA shot material can travel the bloodstream, and ergo, will eventually end up in the eyes. Bearing in mind mRNA shots are associated with increased risks of eye injury. So whatever is bad for the eyes, is bad for the shots.

In documentation on compliance with endotoxin standards regarding such devices, the FDA rejects three standards; the EU (<12.5 EU/mL), ISO (<= 5.0) and ANSI (<= 5.0), as being — get this — too high, and prefers a much lower 0.2 EU/mL:

Pfizer are likely aware of the stricter limit by the FDA, and whilst the EMA likely don’t care about your health and are okay with >0.2 EU/mL, for Pfizer anything not less than “<1” is a regulatory death sentence.

So to get around it Pfizer report “<5”, playing fast and loose. It could mean any range between 0 to 5. But we all know it means at least >4, or otherwise Pfizer would have reported ‘<4’, ‘<3’, ‘<2’ and so on if values were lower.

Pfizer have not met the evidential burden of proving their product is “<0.2” per FDA’s acceptability criterion (they haven’t even met the burden of “<1”). The FDA still emergency use authorised it despite knowing this. Both have committed crimes.

Other products relating to DNA brag how they fall under the “<0.25” EU/mL standard set by the FDA, for stark contrast:

Wider Implications

It isn’t the first time shots have been noted to have issues with endotoxins. One study suggested that anything above 0.1 ng (1 EU/mL) indicates the “presence of other bacterial products as well”:

Another study on so-called anti-allergy shots found even more alarming numbers, up to a whopping 34,000 EU/mL:

As another study notes, humans are harmed by endotoxins, and vaccine manufacturers do not publish the endotoxin counts of their shots:

This isn’t a “trade secret”, so much as hiding evidence of harms, and any health regulator employee that redacts such information on toxicity is guilty by association by covering up evidence that would otherwise reveal harms.

Could endotoxins be the cause of breast milk issues as Josh Guetzkow originally suggests? No. As one peer-reviewed study notes, mRNA products were found in the breast milk:

That said, endotoxins and the failure to meet basic standards represent yet another problem with the mRNA shots that should have never been greenlit to begin with.

Josh Guetzkow raises a pertinent point.

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