On Thursday, January 4, 2024 at 7:22:29 PM UTC-5, *Hemidactylus* wrote:
I guess the Florida surgeon general goofball appointed by Desantis is in
the news for scare mongering about mRNA vaccines again. This is a bit
outside my wheelhouse but I’ll try to deal with it. My incoherence follows…
Here’s FL Department of Health’s proclamation about the dangers of mRNA >> vaccines:
https://www.floridahealth.gov/newsroom/2024/01/20240103-halt-use-covid19-mrna-vaccines.pr.html
“The Surgeon General outlined concerns regarding nucleic acid contaminants >> in the approved Pfizer and Moderna COVID-19 mRNA vaccines, particularly in >> the presence of lipid nanoparticle complexes, and Simian Virus 40 (SV40)
promoter/enhancer DNA. Lipid nanoparticles are an efficient vehicle for
delivery of the mRNA in the COVID-19 vaccines into human cells and may
therefore be an equally efficient vehicle for delivering contaminant DNA
into human cells. The presence of SV40 promoter/enhancer DNA may also pose >> a unique and heightened risk of DNA integration into human cells.”
Quoting Ladapo: “The FDA’s response does not provide data or evidence that
the DNA integration assessments they recommended themselves have been
performed. Instead, they pointed to genotoxicity studies – which are
inadequate assessments for DNA integration risk. In addition, they
obfuscated the difference between the SV40 promoter/enhancer and SV40
proteins, two elements that are distinct.”
Here’s what he’s apparently talking about:
https://www.fda.gov/media/174875/download
“No SV40
proteins are encoded for or are present in the vaccines…No SV40 proteins >> are encoded by the nucleotide sequences present in the mRNA vaccines. The
treatment of the
products with DNAase also fragments any residual DNA template that might be >> present after other manufacturing
steps. Thus, as noted above, following manufacture of the mRNA COVID-19
vaccines, no DNA encoding SV40
proteins is present in the residual DNA remaining in the products.”
Are they talking past each other? The SV40 proteins would be encoded for by >> the associated viral sequences, which wouldn’t be involved in the mRNA
vaccine manufacture process as the SV40 promoter/enhancer merely regulates >> expression of a downstream genetic sequence right? It is good to know the
SV40 products themselves don’t appear. But what importance is the promoter >> enhancer outside the viral context except as a tool, from what I think is
going on, to express some associated resistance marker gene? Isn’t this
early on in manufacture to indicate successful cell transfection (or
bacterial transformation) with an associated (or linked?) spike protein
encoding sequence? I’m totally going on guesswork based on what little I >> could gather after this new news cycle erupted.
I wasn’t previously aware of the SV40 component used in manufacture, but >> it’s not the virus itself. Whew!
This is superficial:
https://apnews.com/article/853343189368
“The European Medicines Agency, which regulates vaccines in European Union >> nations, explained that “non-functional” fragments of SV40’s DNA sequence
are used as “starting material” in producing the vaccine.
But those materials are broken down and removed in the manufacturing
process. Trace amounts might still remain at “very low levels” in the final
product, the agency and others acknowledged, but they are well within
established safety guidelines.”
So the SV40 promoter/enhancer thingy is in the vaccine starter kit which is >> latter mangled or shredded by DNAases?
And on elusive integration Paul Offit was quoted: “One, it’s very hard for
a DNA fragment to enter a cell, specifically its nucleus, where the DNA
resides,” Offit explained in a phone interview Monday. “Your cytoplasm --
the white egg part of your cell -- doesn’t like DNA and has a variety of >> mechanisms to rid itself of DNA.”
“Two, for that fragment of DNA to be integrated into your DNA, you also
have to have enzymes that disrupt the DNA and allow you to insert that
fragment,” he continued. “That’s what gene therapy is all about, and that’s
what makes gene therapy so hard to do.”
One would need an integrase?
Not sure about the reputability of this site but it seems OK:
https://www.techarp.com/science/mrna-vaccines-contaminated-sv40/
“The SV40 promoter is a DNA sequence that was derived from the SV40 (Simian
Virus 40) virus, and is not the same thing as the SV40 virus DNA. Think of >> it as a genetic tool obtained from the SV40 virus, just like how botulinum >> toxin is a treatment derived from the bacteria, Clostridium botulinum.”
That seems an ok analogy.
“Michael Imperiale, a molecular biologist at the University of Michigan
Medical School, explained that the SV40 promoter, on its own, can’t cause >> cancer. The part of SV40 that’s potentially cancer-causing, known as the >> T-antigen, isn’t present in the vaccine”
That’s reassuring. Phillip Buckhaults is quoted: “It’s [SV promoter] just
the volume knob that drives high level expression of anything put under its >> control, which in this case is just an antibiotic resistance marker.”
So part of selecting cells/bacteria that were successfully
transfected/transformed?
Quoting Health Canada:
“Plasmids are an essential starting material for the production of mRNA
vaccines. During the downstream process in mRNA vaccine manufacturing, the >> plasmid DNA is digested with enzymes to small fragments, and further
removed to a level of not more than 10 ng/human dose, which is in line with >> the World Health Organization’s recommendation concerning residual DNA in >> biological drugs. The DNA is digested with enzymes post-transcription.”
Also from the website: “The presence of residual DNA itself does not mean >> that they will integrate into our genome. For one thing – these are DNA
fragments that have been broken down by the DNase enzyme.”
Here’s more on the manufacturing process:
https://www.scientificamerican.com/article/no-covid-mrna-vaccines-wont-damage-your-dna/
“To make an mRNA vaccine against COVID, scientists start with circular
pieces of DNA called plasmids that contain a gene for the spike protein of >> SARS-CoV-2, the virus that causes the disease. The plasmids are amplified
into billions of copies inside of bacteria, and chemicals are then added to >> release them from the bacteria. Enzymes are used to cut the plasmids into
linear pieces of DNA that encode the spike protein, and a different enzyme >> converts that DNA into mRNA. Another enzyme is added to chop any remaining >> DNA into tiny harmless fragments.”
So if bacteria are used the process is called transformation instead of
transfection according to my molecular biology text? Still the scary SV40
promoter is there for the antibiotic resistance marker to cull the bacteria >> lacking the means to be productive?
There’s more going on than the SV40 but that’s what interested me today. >>
I also found this tangentially related patent:
https://patents.google.com/patent/US20050064547A1/en
You seem to have it.
A plasmid is constructed containing a sequence that will ultimately be transcribed in vitro
to manufacture the mRNA used in the vaccine.
The plasmid is transfected into bacteria, the bacteria is cultured to a reasonable
number of cells and then induced to make lots of copies of the plasmid.
Bacteria are lysed, killing the bacteria, and the plasmids are isolated
from cellular debris.
Circular plasmids are linearized, which makes them incompetent to
reproduce viable plasmids.
The plasmid templates are used for in vitro
transcription to produce mRNA from plasmid DNA.
DNase is added to chop up the plasmid DNA templates. Most of the DNA fragments are
washed away as the mRNA is purified from that reaction mixture.
The purified mRNA is formulated into the final vaccine formulation which is mostly a matter
of encapsulating the mRNA inside lipid nanoparticles.
All along the process, analytical samples are taken and the materials are subject to multiple
forms of biochemical characterization along with being subjected to microbiological
assays looking to assay for any culturable contaminants. Safety criteria for batch
analytics are developed collaboratively with the FDA with a history that runs back to
the initial development of the manufacturing process. This is hard to trivially capture
but it initially involves doing deep dive explorations when ever a problem is discovered
as methods to readily detect and hopefully prevent such problems are developed.
Per your cites, they assay for residual levels of DNA contamination in the final product.
And I should point out that the quality control/quality assurance assays leverage lessons
the FDA learns from other manufacturers when they screw things up. This is an under-appreciated role of the FDA as a clearinghouse that develops institutional
knowledge from fingers burnt in each process but fingers burnt elsewhere. It's good
to learn from your mistakes, even better to learn from the mistakes of others so that
you can proceed to make your own mistakes instead of repeating the easy mistakes.
On 1/4/24 4:20 PM, *Hemidactylus* wrote:
I guess the Florida surgeon general goofball appointed by Desantis is inHey, it's Florida.
the news for scare mongering about mRNA vaccines again. This is a bit
outside my wheelhouse but I’ll try to deal with it. My incoherence follows…
Here’s FL Department of Health’s proclamation about the dangers of mRNA >> vaccines:
https://www.floridahealth.gov/newsroom/2024/01/20240103-halt-use-covid19-mrna-vaccines.pr.html
“The Surgeon General outlined concerns regarding nucleic acid contaminants >> in the approved Pfizer and Moderna COVID-19 mRNA vaccines, particularly in >> the presence of lipid nanoparticle complexes, and Simian Virus 40 (SV40)
promoter/enhancer DNA. Lipid nanoparticles are an efficient vehicle for
delivery of the mRNA in the COVID-19 vaccines into human cells and may
therefore be an equally efficient vehicle for delivering contaminant DNA
into human cells. The presence of SV40 promoter/enhancer DNA may also pose >> a unique and heightened risk of DNA integration into human cells.”
Quoting Ladapo: “The FDA’s response does not provide data or evidence that
the DNA integration assessments they recommended themselves have been
performed. Instead, they pointed to genotoxicity studies – which are
inadequate assessments for DNA integration risk. In addition, they
obfuscated the difference between the SV40 promoter/enhancer and SV40
proteins, two elements that are distinct.”
Here’s what he’s apparently talking about:
https://www.fda.gov/media/174875/download
“No SV40
proteins are encoded for or are present in the vaccines…No SV40 proteins >> are encoded by the nucleotide sequences present in the mRNA vaccines. The
treatment of the
products with DNAase also fragments any residual DNA template that might be >> present after other manufacturing
steps. Thus, as noted above, following manufacture of the mRNA COVID-19
vaccines, no DNA encoding SV40
proteins is present in the residual DNA remaining in the products.”
Are they talking past each other? The SV40 proteins would be encoded for by >> the associated viral sequences, which wouldn’t be involved in the mRNA
vaccine manufacture process as the SV40 promoter/enhancer merely regulates >> expression of a downstream genetic sequence right? It is good to know the
SV40 products themselves don’t appear. But what importance is the promoter >> enhancer outside the viral context except as a tool, from what I think is
going on, to express some associated resistance marker gene? Isn’t this
early on in manufacture to indicate successful cell transfection (or
bacterial transformation) with an associated (or linked?) spike protein
encoding sequence? I’m totally going on guesswork based on what little I >> could gather after this new news cycle erupted.
I wasn’t previously aware of the SV40 component used in manufacture, but >> it’s not the virus itself. Whew!
This is superficial:
https://apnews.com/article/853343189368
“The European Medicines Agency, which regulates vaccines in European Union >> nations, explained that “non-functional” fragments of SV40’s DNA sequence
are used as “starting material” in producing the vaccine.
But those materials are broken down and removed in the manufacturing
process. Trace amounts might still remain at “very low levels” in the final
product, the agency and others acknowledged, but they are well within
established safety guidelines.”
So the SV40 promoter/enhancer thingy is in the vaccine starter kit which is >> latter mangled or shredded by DNAases?
And on elusive integration Paul Offit was quoted: “One, it’s very hard for
a DNA fragment to enter a cell, specifically its nucleus, where the DNA
resides,” Offit explained in a phone interview Monday. “Your cytoplasm --
the white egg part of your cell -- doesn’t like DNA and has a variety of >> mechanisms to rid itself of DNA.”
“Two, for that fragment of DNA to be integrated into your DNA, you also
have to have enzymes that disrupt the DNA and allow you to insert that
fragment,” he continued. “That’s what gene therapy is all about, and that’s
what makes gene therapy so hard to do.”
One would need an integrase?
Not sure about the reputability of this site but it seems OK:
https://www.techarp.com/science/mrna-vaccines-contaminated-sv40/
“The SV40 promoter is a DNA sequence that was derived from the SV40 (Simian
Virus 40) virus, and is not the same thing as the SV40 virus DNA. Think of >> it as a genetic tool obtained from the SV40 virus, just like how botulinum >> toxin is a treatment derived from the bacteria, Clostridium botulinum.”
That seems an ok analogy.
“Michael Imperiale, a molecular biologist at the University of Michigan
Medical School, explained that the SV40 promoter, on its own, can’t cause >> cancer. The part of SV40 that’s potentially cancer-causing, known as the >> T-antigen, isn’t present in the vaccine”
That’s reassuring. Phillip Buckhaults is quoted: “It’s [SV promoter] just
the volume knob that drives high level expression of anything put under its >> control, which in this case is just an antibiotic resistance marker.”
So part of selecting cells/bacteria that were successfully
transfected/transformed?
Quoting Health Canada:
“Plasmids are an essential starting material for the production of mRNA
vaccines. During the downstream process in mRNA vaccine manufacturing, the >> plasmid DNA is digested with enzymes to small fragments, and further
removed to a level of not more than 10 ng/human dose, which is in line with >> the World Health Organization’s recommendation concerning residual DNA in >> biological drugs. The DNA is digested with enzymes post-transcription.”
Also from the website: “The presence of residual DNA itself does not mean >> that they will integrate into our genome. For one thing – these are DNA
fragments that have been broken down by the DNase enzyme.”
Here’s more on the manufacturing process:
https://www.scientificamerican.com/article/no-covid-mrna-vaccines-wont-damage-your-dna/
“To make an mRNA vaccine against COVID, scientists start with circular
pieces of DNA called plasmids that contain a gene for the spike protein of >> SARS-CoV-2, the virus that causes the disease. The plasmids are amplified
into billions of copies inside of bacteria, and chemicals are then added to >> release them from the bacteria. Enzymes are used to cut the plasmids into
linear pieces of DNA that encode the spike protein, and a different enzyme >> converts that DNA into mRNA. Another enzyme is added to chop any remaining >> DNA into tiny harmless fragments.”
So if bacteria are used the process is called transformation instead of
transfection according to my molecular biology text? Still the scary SV40
promoter is there for the antibiotic resistance marker to cull the bacteria >> lacking the means to be productive?
There’s more going on than the SV40 but that’s what interested me today. >>
I also found this tangentially related patent:
https://patents.google.com/patent/US20050064547A1/en
AFAIK an ideal vaccine stays at the injection site, and is gone in a short time.
You have no control of the dosage with the mrna vaccins, because the body produces spikes according to the mrna instructions.
The body may produce spikes for a very long time, weeks and months,
although I guess it is highly variable per individual.
The mrna goes throughout the body, because it is packaged in these
lipids, which lipids were originally designed to even cross over into the brain.
Which then results in immune dysfunction, that the body will attack the
cells that produce the spikes. And also that the immune system will
tolerate the spikes, because of it coming from the body itself, leading to immune escape.
And now you also have a lot of contamination of DNA in the vaccins,
because of it's production process. Which means mrna vaccins are total rubbish.
Maybe mrna technology can be used for cells to deliver some medicine in
the body, it is certainly not suited for vaccination.
You lack any kind of common sense, and you are just irrationally fighting
for mrna technology, in a biased way. Like it is a debating game, where
you will just say anything to win the argument for mrna.
You're a complete moron, and your reference is obviously a complete
moron. Lacking any kind of judgment. And it is no use to argue with you, except for you to learn how to make a personal judgment.
Op zaterdag 6 januari 2024 om 05:12:30 UTC+1 schreef *Hemidactylus*:
mohammad...@gmail.com <mohammad...@gmail.com> wrote:
AFAIK an ideal vaccine stays at the injection site, and is gone in a short time.If you want to identify an idiot just let them open their mouth. Ladapo is >> an idiot effectively debunked by Dr. Wilson:
You have no control of the dosage with the mrna vaccins, because the body >>> produces spikes according to the mrna instructions.
The body may produce spikes for a very long time, weeks and months,
although I guess it is highly variable per individual.
The mrna goes throughout the body, because it is packaged in these
lipids, which lipids were originally designed to even cross over into the brain.
Which then results in immune dysfunction, that the body will attack the
cells that produce the spikes. And also that the immune system will
tolerate the spikes, because of it coming from the body itself, leading
to immune escape.
And now you also have a lot of contamination of DNA in the vaccins,
because of it's production process. Which means mrna vaccins are total rubbish.
Maybe mrna technology can be used for cells to deliver some medicine in
the body, it is certainly not suited for vaccination.
You lack any kind of common sense, and you are just irrationally fighting >>> for mrna technology, in a biased way. Like it is a debating game, where
you will just say anything to win the argument for mrna.
https://youtu.be/Y8DXnoVH9Bo?si=1UgPSatjP_7XEOxa
I should have posted that instead of my convoluted wordy OP. SV40 happened >> to fascinate me.
| Sysop: | Keyop |
|---|---|
| Location: | Huddersfield, West Yorkshire, UK |
| Users: | 546 |
| Nodes: | 16 (2 / 14) |
| Uptime: | 04:53:35 |
| Calls: | 10,387 |
| Calls today: | 2 |
| Files: | 14,061 |
| Messages: | 6,416,796 |