My information is factual and I give links. The information on the reverse ORF was given to me verbally and is on GitHub. I have a little difficulty with that site to be honest. Not my area of expertise.
Regardless, the issue is well described in the published paper by Beaudoin, which delineates this issue well and has been essentially ignored.
You might like to know Pfizer had a very cheap and effective method of removing the DNA and RNA fragments from the product but of course chose not to. There is a suggestion Moderna used something to make their product a little cleaner in manufacture.
You mean using that cellulose buffer as described in Baiersdörfer? They are using a cellulose buffer, but am unsure if it is exactly as previously described by Baiersdorfer since there is no mention of ethanol per se. So yes, they could do a lot better. Regardless, I believe they have lower dsRNA levels than Moderna, so I cant figure that out.
From the rolling review
The filter membrane chosen for final filtration of drug substance solution is a 30” 0.45/ 0.2 μm cellulose acetate. Data from the filter validation studies will be provided when available.
As for the plasmid itself, purification is standard I think, using anion chromatography.
pST4-1525 is manufactured by a fed-batch fermentation process initiated from the bacterial working cell bank (WCB). Following fermentation, the cells are harvested and chemically lysed to recover the plasmid DNA. After this lysis step, the circular plasmid DNA is purified by ultrafiltration/diafiltration and anion exchange chromatography.
Thank you for raising the issue about adulteration.
My FIRST question concerns Act 30(1) (a): it says, "any food or drug or class of... is adulterated." What is the drug in question? We don't have ONE single predictable/measurable drug. The genetic injections are by their very design pro-drugs. The final drug is in the body and for each individual different. Thanks to manufacturing properties (increased stability and resistance to degradation, inherent contaminants - both Processes 1 and 2) we have the unavoidable reality of some fragmented/aberrant/unwanted species (dsRNAs, pDNA, micro RNAs etc) where some of those can also form in the body and evoke all sorts of terrifying effects (explored more fully in my book - published by Springer). All the ingredients of the mmRNA products resemble activities, and as such the DRUG in question will have "added" or "extracted" activities and properties (clearance, where it goes, how long it stays in body, how it interacts with other drugs or the microbiome or endogenous genetic material, tissue specificity - codon optimization, etc etc). Thus, IMHO it would seem that, as a pro-drug and pharmaceutical agent, the actual DRUG is certainly not single/homogeneous and, ergo, must fall under the "adulteration" category.
My SECOND question concerns Act 9(1): "or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety." The erroneous impression applies to each of those, imho: "character" - people believed it was a vaccine and not gene-therapy; they believed it would stay in the arm, the injected material would quickly get degraded, it would not interact with their genetic material, etc etc; "value/merit:" people were told relative risk reduction measures rather than the absolute; they were not told that within 2 weeks or so post-injection, people were still labeled unvaccinated; they were initially told the injections would prevent infection/transmission.... after constant modifications (again, followed in detail in my book) that got changed to prevention of severe disease among the elderly (only); "quantity" - see above: since the injections resemble activities at numerous levels (mmRNAs, LNPs) there is no clear single quantity of the actual DRUG in question; then add the manufacturing challenges that have been known for decades (difficulty to scale) in addition to the Process 2 dilemma; "composition" - again, since it's a pro-drug, everyone will experience differences of how their body will, in different tissues and cells, modify and process and deal with the mmRNAs and resulting protein(s); "safety" - no further comments needed here!
Excellent questions, thank you. Everything you write, I have been researching and writing as well though not quite as detailed and thorough and so very very true.
Adulteration has more to do with manufacturing than pharmacology. It pertains to what is on the label (ie mislabelling is also possible with the vaccines, since the fact that the mRNA is modified, plus the LNPs etc) should reflect what is inside with respect to active ingredients. Known impurities and contaminants which are part of the manufacturing process are considered controlled since there are specification to keep these at a minimum and are not on the label. If they exceed allowable limits they could be considered contaminated. Adulteration is usually a substance with 'pharmacological' activity that is added to the product during manufacturing that is not part of the specifications. Usually a substance known to have deleterious effects. Like levamisole added to fentanyl by drug dealers. In this case the SV40 sequences and reverse ORF are "added" substances to the plasmid, which is the starting material. In someways the reverse ORF is worse since it is the part of the plasmid that has the "pharmacological" activity. If every piece of SV40 was removed in the final drug product, then there is no adulteration. HOWEVER, it is REQUIRED that the whole plasmid be annotated and each element described in DNA plasmid vaccine guidance. This was not done so they lied to the Minister. Another offence.
The first question is true to a certain extent of many biological drugs and vaccines. In general, biologics are messy drugs and these jabs are pretty well the worst sewer you can imagine.
The second question is a problem with public health and the regulators who acted as agents for the drug companies. Really problematic and with which I agree 100%!
Thank you for the detailed response. I think we should push back on "Adulteration has more to do with manufacturing than pharmacology." And also extend "Adulteration is usually a substance with 'pharmacological' activity that is added ... Usually a substance known to have deleterious effects." I think the point would be that we do NOT know what these untested platforms are/do (I am afraid that whilst we are learning more about them, it's overall a complete and variable mess). We know hardly anything about biologics. We still also do not know what came out of which lots (manufacturing issues). THEREFORE, we cannot make certain assertions.
I would like to turn the proof of burden around, as you also write above. Now, to show there was NO adulteration, all of the above concerns and known disasters should have to be proven to NOT be true. Each and every one of them. As long as it cannot be shown that these issues are not existent, there is lack of proof of demonstration that it works as promised - ergo: if they cannot clearly demonstrate what is what, then everything else is an adulteration of their promises. If they cannot disprove the concerns and issues, then they cannot demonstrate there is no adulteration. I truly hope the courts will see it this way. Thank you again for all your work!
Yes, the burden of proof is on the manufacturer. We are doing their work for them. We really shouldn't and should pressure the regulators to insist on the appropriate analytical methods and studies.
I am not sure that will work either, but it will hopefully wake enough people up regarding the true nature of these jabs.
The manufacturers should show ONE clear spike protein evoked by the injections, and demonstrate that only that one outcome, and nothing else, is possible. Everything else is an adulteration.
BINGO! That IS the crux of the matter. This has not been demonstrated by both Moderna and Pfizer after 3 years, nor insisted upon by the regulators.
Although the SV40 and reverse ORF and impurities and contamination is very important, the end point of the entire mRNA platform has not been proven. Do these jabs make one clear protein?
I'd like opinions on Trumps silence concerning the many thousands of vaccine deaths, and millions of injuries. I'm watching so many of my friends, relatives, and acquaintances being seriously harmed and killed. I want to know why after 3 years he's still silent? My opinion...makes him complicit. Also his executive order in 2019.....
My information is factual and I give links. The information on the reverse ORF was given to me verbally and is on GitHub. I have a little difficulty with that site to be honest. Not my area of expertise.
Regardless, the issue is well described in the published paper by Beaudoin, which delineates this issue well and has been essentially ignored.
You might like to know Pfizer had a very cheap and effective method of removing the DNA and RNA fragments from the product but of course chose not to. There is a suggestion Moderna used something to make their product a little cleaner in manufacture.
https://geoffpain.substack.com/p/pfizer-knew-how-to-remove-double
You mean using that cellulose buffer as described in Baiersdörfer? They are using a cellulose buffer, but am unsure if it is exactly as previously described by Baiersdorfer since there is no mention of ethanol per se. So yes, they could do a lot better. Regardless, I believe they have lower dsRNA levels than Moderna, so I cant figure that out.
From the rolling review
The filter membrane chosen for final filtration of drug substance solution is a 30” 0.45/ 0.2 μm cellulose acetate. Data from the filter validation studies will be provided when available.
As for the plasmid itself, purification is standard I think, using anion chromatography.
pST4-1525 is manufactured by a fed-batch fermentation process initiated from the bacterial working cell bank (WCB). Following fermentation, the cells are harvested and chemically lysed to recover the plasmid DNA. After this lysis step, the circular plasmid DNA is purified by ultrafiltration/diafiltration and anion exchange chromatography.
Pfizer reused their filters after soaking in NaOH to save money.
Yes, they did that. Considering that one drug substance batch can make 300,00 vials (1.8 million doses), it does seem rather, umm, cheap.
Wonder if that explains the stepwise rise in residual DNA we saw with the PPQ lots?
I cannot weigh in on any of this...and am incredibly grateful to those who can.
But that just made me snort laugh - because I don’t want to gag...
“Pfizer reused their filters after soaking in NaOH to save money.”
Poor Pfizer...just trying to make ends meet.
🤮🤮🤮
Found this. Might be useful
http://uu.diva-portal.org/smash/get/diva2:1762077/FULLTEXT01.pdf
Thanks very much indeed.
It’s a red herring intended to divert and distract. From the DODHHS
Sheesh. We didn't learn from the Polio / SV-40 thingie?
Au contraire. I think some people learned quite a lot
(Saluting in your general direction.)
Point taken, Well said!
I can recall reading "Dr. Mary's Monkey." As I was intimately familier with most of the historical events covered, and was a Louisiana native.
Have actually seen, been most places mentioned in the account.
And as wife and i are the last generation to get the school Polio "21 gun salute" scars on our arms... it seemed need to know.
I keep hearing this, but not seeing any actions being taken. Just words. Under the Prep Act, all of this is legal.
Thank you for raising the issue about adulteration.
My FIRST question concerns Act 30(1) (a): it says, "any food or drug or class of... is adulterated." What is the drug in question? We don't have ONE single predictable/measurable drug. The genetic injections are by their very design pro-drugs. The final drug is in the body and for each individual different. Thanks to manufacturing properties (increased stability and resistance to degradation, inherent contaminants - both Processes 1 and 2) we have the unavoidable reality of some fragmented/aberrant/unwanted species (dsRNAs, pDNA, micro RNAs etc) where some of those can also form in the body and evoke all sorts of terrifying effects (explored more fully in my book - published by Springer). All the ingredients of the mmRNA products resemble activities, and as such the DRUG in question will have "added" or "extracted" activities and properties (clearance, where it goes, how long it stays in body, how it interacts with other drugs or the microbiome or endogenous genetic material, tissue specificity - codon optimization, etc etc). Thus, IMHO it would seem that, as a pro-drug and pharmaceutical agent, the actual DRUG is certainly not single/homogeneous and, ergo, must fall under the "adulteration" category.
My SECOND question concerns Act 9(1): "or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety." The erroneous impression applies to each of those, imho: "character" - people believed it was a vaccine and not gene-therapy; they believed it would stay in the arm, the injected material would quickly get degraded, it would not interact with their genetic material, etc etc; "value/merit:" people were told relative risk reduction measures rather than the absolute; they were not told that within 2 weeks or so post-injection, people were still labeled unvaccinated; they were initially told the injections would prevent infection/transmission.... after constant modifications (again, followed in detail in my book) that got changed to prevention of severe disease among the elderly (only); "quantity" - see above: since the injections resemble activities at numerous levels (mmRNAs, LNPs) there is no clear single quantity of the actual DRUG in question; then add the manufacturing challenges that have been known for decades (difficulty to scale) in addition to the Process 2 dilemma; "composition" - again, since it's a pro-drug, everyone will experience differences of how their body will, in different tissues and cells, modify and process and deal with the mmRNAs and resulting protein(s); "safety" - no further comments needed here!
Excellent questions, thank you. Everything you write, I have been researching and writing as well though not quite as detailed and thorough and so very very true.
Adulteration has more to do with manufacturing than pharmacology. It pertains to what is on the label (ie mislabelling is also possible with the vaccines, since the fact that the mRNA is modified, plus the LNPs etc) should reflect what is inside with respect to active ingredients. Known impurities and contaminants which are part of the manufacturing process are considered controlled since there are specification to keep these at a minimum and are not on the label. If they exceed allowable limits they could be considered contaminated. Adulteration is usually a substance with 'pharmacological' activity that is added to the product during manufacturing that is not part of the specifications. Usually a substance known to have deleterious effects. Like levamisole added to fentanyl by drug dealers. In this case the SV40 sequences and reverse ORF are "added" substances to the plasmid, which is the starting material. In someways the reverse ORF is worse since it is the part of the plasmid that has the "pharmacological" activity. If every piece of SV40 was removed in the final drug product, then there is no adulteration. HOWEVER, it is REQUIRED that the whole plasmid be annotated and each element described in DNA plasmid vaccine guidance. This was not done so they lied to the Minister. Another offence.
The first question is true to a certain extent of many biological drugs and vaccines. In general, biologics are messy drugs and these jabs are pretty well the worst sewer you can imagine.
The second question is a problem with public health and the regulators who acted as agents for the drug companies. Really problematic and with which I agree 100%!
Thank you for the detailed response. I think we should push back on "Adulteration has more to do with manufacturing than pharmacology." And also extend "Adulteration is usually a substance with 'pharmacological' activity that is added ... Usually a substance known to have deleterious effects." I think the point would be that we do NOT know what these untested platforms are/do (I am afraid that whilst we are learning more about them, it's overall a complete and variable mess). We know hardly anything about biologics. We still also do not know what came out of which lots (manufacturing issues). THEREFORE, we cannot make certain assertions.
I would like to turn the proof of burden around, as you also write above. Now, to show there was NO adulteration, all of the above concerns and known disasters should have to be proven to NOT be true. Each and every one of them. As long as it cannot be shown that these issues are not existent, there is lack of proof of demonstration that it works as promised - ergo: if they cannot clearly demonstrate what is what, then everything else is an adulteration of their promises. If they cannot disprove the concerns and issues, then they cannot demonstrate there is no adulteration. I truly hope the courts will see it this way. Thank you again for all your work!
Yes, the burden of proof is on the manufacturer. We are doing their work for them. We really shouldn't and should pressure the regulators to insist on the appropriate analytical methods and studies.
I am not sure that will work either, but it will hopefully wake enough people up regarding the true nature of these jabs.
The manufacturers should show ONE clear spike protein evoked by the injections, and demonstrate that only that one outcome, and nothing else, is possible. Everything else is an adulteration.
BINGO! That IS the crux of the matter. This has not been demonstrated by both Moderna and Pfizer after 3 years, nor insisted upon by the regulators.
Although the SV40 and reverse ORF and impurities and contamination is very important, the end point of the entire mRNA platform has not been proven. Do these jabs make one clear protein?
Yes, and if there is no proven singularity like this, by definition, there are undeclared products, i.e. adulterations, imho
I'd like opinions on Trumps silence concerning the many thousands of vaccine deaths, and millions of injuries. I'm watching so many of my friends, relatives, and acquaintances being seriously harmed and killed. I want to know why after 3 years he's still silent? My opinion...makes him complicit. Also his executive order in 2019.....
Moderna still contains plasmid DNA. IMO not sitting pretty at all.
And the T7 ori makes this plasmid replication competent in the human cell.