Bacterial DNA a major worry in Jabs

Forget nanograms Synthetic GMO Plasmid DNA in mRNA Jabs, the E. Coli Genomic DNA has a limit of 100 picogram per dose imposed by the FDA because it is considered extremely dangerous. That is too high.

Thanks to one of my very generous supporters, Damon Mcclure for prompting me to look at the work of Maurice Ralph Hilleman by pointing out a video on X.¹

It could not have come at a more useful time as I help write a major submission with eminent scientist Jonathan Gilthorpe.

We know about the species of Bacteria used in filthy toxic soups in the production mRNA Jabs, but it appears some people are confused about the extremely high risk of Bacterial DNA contamination in the vile vials and how that varies Lot to Lot.²

Imagine you are swimming inside a vat when they add Sodium Hydroxide to make the live bacteria spill their guts to yield the desired circular Plasmid double stranded DNA. You need to think of the Bacterial DNA which is rolled up into a tight little Nucleoid ball creating delight for topologists plus all the other toxins liberated.³

How effective is the filtration? We know Bacterial DNA is “nicked” by the alkali and even mechanical handling. What tests have been done by Regulatory Authorities.

Have all test results been redacted?

How much Bacterial DNA has been found by indepedent labs?

Artwork reference, thanks to Moriarty for finding it.⁴

EMA fully aware in 2020

When BioNTech applied for Emergency Use Authorization in 2020, the scientists assessing the Process 2 Poojabs⁵ were clearly aware of the risk from Bacterial Host Cell Genomic DNA “impurities”.

Maurice Hilleman, Chief of Merck Pharmaceuticals Division⁶, who was working on E. coli Supertoxin Lipid A (Pfizer/BioNTech preferred “adjuvant”) in 1962⁷, was also very worried about the foreign DNA influence on the Human Genome in relation to Cancer induction at the cellular level as he was the one who found SV40 contamination in Polio vaccines.⁸

He stated:

The principal concern for safety lies with retention of residual DNA in the vaccine, especially since induction of cancer is a single-cell phenomenon, and a single functional unit of foreign DNA integrated into the host cell genome might serve to induce cell transformation as a single event or part of a series of multifactorial events.

Current proposed standards for vaccines would permit contamination with up to 100 pg of heterologous DNA per dose. This is equivalent to about 100 million ”functional lengths“ of DNA. Total safety would seem to require complete absence of DNA from the product.

At the time Hilleman thought that vaccines produced in bacterial cells or in yeast might be safer than those produced in mammalian cells. However more recent research has shown that is not the case.

I will add more references later, but we are in a hurry.

Assays for Bacterial DNA Contamination

In 1997, researchers at Biopharmaceutical Product Development, Lilly Research Laboratories, reported a sensitive assay for this dangerous contaminant.⁹

In 2006 researchers at the Department of Medical Genetics, Second Military Medical University, Shanghai, China pushed the limit for Bacterial DNA contamination to new limit of detection to 10 picogram through use of dot-blot hybridization assay with E. coli 16S rRNA gene probe.¹⁰

However this detection limit was not considered adequate.

In 2016, clever scientists in Iran, aware of the danger of Bacterial Host Cell DNA, were able to detect as low as 0.0002 picogram in recombinant protein-based drugs.¹¹ They devised a specific primer pair designed to amplify a sequence inside the E. coli 16S rRNA gene using RT-PCR. Their experiments used E. coli W3110 strain.

Those who want to use the toxic shells of lysed Bacteria (called Bacterial Ghosts) try to eliminate the Bacterial DNA by use of Staphylococcal Nuclease A and/or the treatment with β-propiolactone.¹²

Recently I pointed out that 100 Attograms of foreign DNA are recognized as dangerous.¹³

A recent paper from China shows that despite elaborate attempts, the residual content was only reduced to 1 nanogram/ml.¹⁴

Many people are interested in the size distribution of the residual Host Cell DNA and this can be measured by Capillary Gel Electrophoresis with Laser-Induced Fluorescence detector (CGE-LIF).¹⁵ The Limit Of Detection and Limit Of Quantitation of a 200 bp DNA marker were 2.59 pg/ml and 8.64 pg/mL, respectively.

Droplet Digital PCR (ddPCR) is becoming popular for measuring Host Cell DNA.¹⁶

Researchers in China found Residual Bacterial Host Cell DNA (rcDNA) in recombinant biological preparations could be “absolutely quantitated” by ddPCR, and the copies of rcDNA in three multiple diluted samples showed a reduced gradient. The copies of rcDNA in three multiple diluted samples could not be distinguished by the qPCR.¹⁷

Species specificity is a major consideration and researchers in China detected Residual E. coli Host Cell DNA by 23S ribosomal RNA gene-targeted qPCR.¹⁸

Thanks to Maria Gutschi who sent me a link to the latest USP test method that measures Bacterial Host Cell Genomic DNA described in detail and validated for starting DNA concentrations ranging from 0.01 to 50 pg/μL.¹⁹

While I was catching up on sleep, our friend Patent Sun posted on the scandalous change to Host Cell DNA limit INCREASE in 1997 because manufacturers complained they could not cost effectively achieve a safer level of contamination.²⁰

Please forward further references if you have looked at this dangerous residue in jabs.

1. https://x.com/toobaffled/status/1857221502321795557

2.

3. Subhash C Verma, Zhong Qian, Sankar L Adhya. 2019. Architecture of the Escherichia coli nucleoid. https://journals.plos.org/plosgenetics/article?id=10.1371/journal.pgen.1008456

4. Raphael Hans. 2024. The Battle Within: How Phages Trigger Bacterial Cell Lysis. https://www.thephage.xyz/2024/10/03/the-battle-within-how-phages-trigger-bacterial-cell-lysis/

5. European Medicines Agency. Amsterdam, 30 November 2020. EMA/CHMP/641856/2020 Committee for Medicinal Products for Human Use (CHMP). Quality rolling review CHMP overview and list of questions COVID-19 mRNA Vaccine BioNTech BNT162b2, 5’capped mRNA encoding full length SARS-CoV-2 Spike protein Procedure No. EMEA/H/C/005735/RR/02 Applicant: BioNTech Manufacturing GmbH

6. https://en.wikipedia.org/wiki/Maurice_Hilleman

7. Marjorie M. Nemes and M. R. Hilleman. 1962. Effect of Westphal Lipid A on Viral Activities in Mice and Hamsters. https://journals.sagepub.com/doi/abs/10.3181/00379727-110-27563

8. Maurice R. Hilleman. 1990. History, Precedent, and Progress in the Development of Mammalian Cell Culture Systems for Preparing Vaccines: Safety Considerations Revisited. https://onlinelibrary.wiley.com/doi/abs/10.1002/jmv.1890310104

9. A Riggin, V.T Luu, J.K Lobdell, M.K Wind. 1997. A non-isotopic probe-hybridization assay for residual DNA in biopharmaceuticals. https://www.sciencedirect.com/science/article/abs/pii/S0731708597001520

10. Kai-Yu Wang, Ying-Jun Guo, Shu-Han Sun, Ke Shi, Shu Zhang, Kai-Hui Wang, Yi-Zhang, Zu-Huan Chen. 2006. 16S rRNA gene probe quantitates residual host cell DNA in pharmaceutical-grade plasmid DNA. https://www.sciencedirect.com/science/article/abs/pii/S0264410X05012454

11. Babak Mamnoon, Taghi Naserpour Farivar, Ahmad Reza Kamyab, Dariush Ilghari, Ali Khamesipour, Mohsen Karimi Arzenani. 2016. Quality Control of Widely Used Therapeutic Recombinant Proteins by a Novel Real-Time PCR Approach. https://pmc.ncbi.nlm.nih.gov/articles/PMC4689282/

12. Timo Langemann, Verena Juliana Koller, Abbas Muhammad, Pavol Kudela, Ulrike Beate Mayr, Werner Lubitz. 2010. The bacterial ghost platform system Production and applications. https://pmc.ncbi.nlm.nih.gov/articles/PMC3037582/

13.

14. Li Guang, Li jing, Zou Zhenxing, Liu Bo, Li Weiping, Ding Yang, Song Xuri, Fang Xiaolan, Hu Daoqi. 2024. Removal of Residual DNA and Host Cell Proteins for the Purification of Recombinant Staphylokinase Expressed in Escherichia coli. https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/sscp.202300214

15. Wentao Wang, Tie Gao, Ji Luo, Lihai Guo, Xiang Li, Yan Li, Hongxu Chen. 2022. Size distribution analysis of residual host cell DNA fragments in lentivirus by CGE-LIF. https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/elps.202200218

16. Kiyoko Higashiyama, Yuzhe Yuan, Noriko Hashiba, Kyoko Masumi-Koizumi, Keisuke Yusa, and Kazuhisa Uchida. 2023. Quantitation of Residual Host Cell DNA in Recombinant Adeno-Associated Virus Using Droplet Digital Polymerase Chain Reaction. https://www.liebertpub.com/doi/10.1089/hum.2023.006

17. Yixiao Tian, Xinyue Wang, Dongyan Shao, Wen Zhao, Renan Chen, Qingsheng Huang. 2024. Establishment and evaluation of detection methods for process-specific residual host cell protein and residual host cell DNA in biological preparation. https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/cbf.3986

18. Dehua Li, Qian Zhang, Guodi Liu, Linsong Zhang, Zhangjie Gu, Yingjiao Pan, Xingbing Cui, Peizi He, Xiang Li, Jibin Liu, Guoping Liu, Mu Yang, Xiaoli Tian. 2021. Detection of residual E. coli host cell DNA by 23S ribosomal RNA gene-targeted quantitative polymerase chain reactions. https://www.sciencedirect.com/science/article/abs/pii/S0731708521001126

19. https://www.uspnf.com/notices/analytical-procedures-mrna-vaccines-20240802

20. MANUFACTURER’S CONVENIENCE FOR RESIDUAL DNA