Live Bacteria in Pfizer Jabs

Manufacturers rely on Probability of E. coli Breakthrough in Filtration of the toxic soups going into the vile vials. Three mysterious Lots not released? Excipients as sources of Live Bacteria?

As I reported in one of my first Substack articles, US FDA was not happy about Pfizer reusing Filters.¹

In March 2021, Pfizer issued a Correction.

"Endotoxin, which was previously inadvertently stated as an IPT-C, is an IPT-M and method verification is not provided."

Note the Bioburden and Pfizer’s arrogant reply, refusing to supply Literature References or Supporting Documentation to justify their saving money by reusing delicate Membrane Filters after soaking in Caustic Soda.

Pfizer Lots used in Bacterial Bioburden test

By looking at FOI documents released by TGA Australia, I found useful subsquent documents, which though heavily redacted, show us more about their concerns over Live Bacteria penetrating their money saving filtration. First look at one discovery.²

Lot EG5447

Lot EH9979

Lot EK2538

These three mysterious Lots were apparently not released because they do not appear in Albert Benavidez’ online VAERS search interface or Craig Paardecooper’s How Bad is My Batch.

Lot GD6794

One of 3 Pfizer lots analyzed by TGA.³

This Lot GD6794 has 4 Deaths with Craig and Albert.

Lot GE1643

If they are confident about the Live Bacterial testing, why not show us the result?

This Lot GE1643 has 2 Deaths with Albert and Craig.

Lot GE8382

This Lot GE8382 had no entries with Albert or Craig.

Crazy Dangerous Risk uses Statistical Sampling

A recent paper⁴ behind an expensive paywall is creating much interest on X and a kind subscriber let me read a copy for review.

Here is the abstract

Authors from

• Novartis

• AstraZeneca

• Amgen

• Eli Lilly

• Pfizer

• Ecolab Life Sciences

• Genentech division of Roche and very aptly named

• Fate Therapeutics

All worried about #Bioburden

Two of the authors published a paper⁵ on the problem in 2013.

To make the story clear without the mathematics, the following Figure from an industry position paper on Live Bacteria Filter Breakthrough makes it quite clear.⁶

Caption reads:

Figure 2:

Performance characteristics of bioburden testing using 100 ml samples and 10 CFU/100 ml acceptance limit, based on negative binomial distribution with a dispersion factor of 2 (6); dotted line: 5% acceptable risk bound.

The Ph.Eur test for bioburden does not have the capability to determine an accurate bioburden count in a solution as detection depends on the volume tested. The probability of passing a batch for bioburden is best determined using a negative binomial distribution to account for the clumping properties of microbes.

Figure 2 illustrates such a probability curve relationship with the actual bioburden level when 100 ml is tested. There is a significant probability of failing and rejecting a ‘good’ batch or passing a ‘bad’ batch on the basis of any single bioburden test when considered in isolation and applying an acceptance criterion of 10 CFU/100 ml. A holistic approach to bioburden risk is recommended that accommodates the sterile filtration process and associated risk.

Note the reference to “clumping properties of microbes” that Kevin McKernan says is not a problem, but is of course a well known absolute fact that worries the Jab Industry.⁷

Tromethamine is a Source of Live Bacteria

Subscribers will recall that I mentioned Endotoxin in Jabs arising from Tromethamine (Tris) Buffer.

Here is one excipient supplier selling contaminated Tromethamine with up to 1000 CFU per gram Total Aerobic Microbial Count (TAMC), 100 CFU total yeast and mold count (TYMC).

This company claims listed Bacteria as Absent in 1 gram, again a statistical sampling approach to risk.

0.2 micron Diameter Filters Doomed to Fail

Interesting coincidence! When I was searching for the role of US Bioweapons Centre in Manassas Virginia ATCC in relation to the infamous “High School Student DNA study” I unearthed a paper by German researchers from Sartorius⁸ who showed much previous research was Fatally Flawed because wrong Bacteria had been used in Challenge Tests.

What they showed in brief is the the 0.2 micron Diameter Filters test results had captured a physically larger pathogen!

They then examined carefully and showed, as you will find obvious that a 0.1 micron Diameter Filter works much better!

Here is their Table III data showing massive contamination as CFU going through various 0.2 micron–rated filters.

Previous publications with the strain ATCC 700892 showed correct results in regard to penetration of 0.2 micron–rated filters and retention of 0.1 micron–rated filters, except the classification of the organism used was incorrect.

The true culprit identified was Curvibacter sp. ATCC 700892.

This test strain seems to have a low relevance within biopharmaceutical production settings; however, it certainly is a 0.2 micron–rated filter risk, as it penetrates such filters at a challenge level of
10 million per square centimetre. Such penetration was determined not only by utilizing flat filter discs but by utilizing 10 pleated devices.

Now we need to delve into the size distribution of the Pfizer E. coli strain compared with the bacteria mentioned in the German blockbuster paper.

1.

2. TGA FOI 3659-02.

3. TGA FOI 4878.

4. Karoline Bechtold-Peters, Stephen Chang, Andrew C. Lennard, Jeanne Mateffy, Marie Murphy, Melvyn Perry, David Roesti, Donald C. Singer, Friedrich von Wintzingerode, Harry Yang. 2024. Risk-based approach to setting sterile filtration microbial bioburden limits – Focus on biotech-derived products. https://www.sciencedirect.com/science/article/abs/pii/S0939641123003053

5. HARRY YANG, NA LI, and STEPHEN CHANG. 2013. A Risk-based Approach to Setting Sterile Filtration Bioburden Limits. PDA Journal of Pharmaceutical Science and Technology. 67(6):601-609.

6. EBE BioManufacturing WG. 13 September 2016. EBE Position Paper A Risk-Based Approach to Setting Sterile Filtration Bioburden Limits.

7.

8. G. HAAKE, I. KAESLER-NEUMANN, H. HENNIG, T. H. MELTZER, and M. W. JORNITZ. 2012. The Importance of Accurate Microorganism Identification in Microbial Challenge Tests of Membrane Filters. Part II. The Comparison of Hydrogenophaga pseudoflava ATTC 33668 and Curvibacter sp. ATCC 700892 by Microbial Challenge Tests with Membrane Filters.