mRNA Therapies Classified as Gene Therapy

mRNA Therapies Classified as Gene Therapy

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MB

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mRNA: Fulfilling the Promise of Gene Therapy.

https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(16)30267-2

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@metal-brain said
mRNA: Fulfilling the Promise of Gene Therapy.

https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(16)30267-2
Learn something:

"How does mRNA differ from gene therapy?

Helping the body make its own medicine using mRNA sounds like it might be similar to gene therapy or gene editing. While these treatment approaches seek to treat disease through genetic information, they take fundamentally different approaches. Gene therapy and gene editing alter the original genetic information each cell carries. The goal is to produce a permanent fix to the underlying genetic problem by changing the defective gene. Moderna is taking a different approach to address the underlying cause of MMA and other diseases. mRNA transfers the instructions stored in DNA to make the proteins required in every living cell. Our approach aims to help the body make its own missing or defective protein. Unlike gene editing and gene therapy, mRNA technology does not change the genetic information of the cell, and is intended to be short-acting. It acts like traditional drugs that can be adjusted over time based on the dose and frequency needed. In simple terms, we are working to provide physicians and patients with a “controllable” way to start and manage their therapy over time.

https://www.modernatx.com/about-mrna

If you understand how cells are structured, you'd know that:

"Ribosomes are organelles that process the cell’s genetic instructions to create proteins. These organelles can float freely in the cytoplasm or be connected to the endoplasmic reticulum (see above).

https://medlineplus.gov/genetics/understanding/basics/cell/

The vaccine works on the ribosomes, which are not part of the cell that contains DNA:

"First, COVID-19 mRNA vaccines are given in the upper arm muscle. Once the instructions (mRNA) are inside the immune cells, the cells use them to make the protein piece. After the protein piece is made, the cell breaks down the instructions and gets rid of them.
Next, the cell displays the protein piece on its surface. Our immune systems recognize that the protein doesn’t belong there and begin building an immune response and making antibodies, like what happens in natural infection against COVID-19."

And finally:

"Facts about COVID-19 mRNA Vaccines .....................

They do not affect or interact with our DNA in any way.

mRNA never enters the nucleus of the cell, which is where our DNA (genetic material) is kept.
"

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html

Got it?

Guppy poo

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@metal-brain said
mRNA: Fulfilling the Promise of Gene Therapy.

https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(16)30267-2
You are wrong. Get over it already.

MB

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@no1marauder said
Learn something:

"How does mRNA differ from gene therapy?

Helping the body make its own medicine using mRNA sounds like it might be similar to gene therapy or gene editing. While these treatment approaches seek to treat disease through genetic information, they take fundamentally different approaches. Gene therapy and gene editing alter the original genetic infor ...[text shortened]... ."

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html

Got it?
Here is an excerpt from the BioNTech form 20F filed with the United States Securities and Exchange Commission below from page 16:

"Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and may cause certain side effects, mRNA-based medicines are designed not to irreversibly change cell DNA. Side effects observed in other gene therapies, however, could negatively impact the perception of immunotherapies despite the differences in mechanism. In addition, because no mRNA-based product has been approved, the regulatory pathway in the United States and may other jurisdictions for approval is uncertain. The pathway for an individualized therapy, such as our iNeST mRNA-based immunotherapy where each patient receives a different combination of mRNAs, remains particularly unsettled. The number and design of the clinical and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products or therapies that are not individualized or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and submit an application for marketing approval by a regulatory authority varies significantly from one pharmaceutical product to the next and may be difficult to predict."

https://www.sec.gov/Archives/edgar/data/1776985/000156459020014536/bntx-20f_20191231.htm

This should settle it. mRNA therapy is gene therapy according to BioNTech's own SEC filing.

Okay, simple question. Are you calling the FDA liars?
Also, the claim that mRNA cannot change DNA is disputed.

"A study by MIT and Harvard scientists demonstrates that segments of RNA from SARS-CoV-2 are reverse-transcribing into the human genome, likely becoming a permanent fixture in human DNA. This has been thought impossible for the same reasons used to assure us that vaccine RNA cannot alter DNA"

The FDA CLASSIFIES mRNA as gene therapy so you are wrong about that and you are also wrong about mRNA being able to change DNA. The SARS2 virus can do that and it has been proven. I proved that on this forum before and earl recently posted an article proving the same thing.

You are wrong and you are wrong again!

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@metal-brain said
Here is an excerpt from the BioNTech form 20F filed with the United States Securities and Exchange Commission below from page 16:

"Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and may cause certain side effects, mRNA-based medicines are designed not to irreversibly change cell DNA. Side ...[text shortened]... nd earl recently posted an article proving the same thing.

You are wrong and you are wrong again!
Actually the FDA clearly states that gene therapy "modifies a person's genes." https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/what-gene-therapy

The CDC states that the vaccines cannot because they have no contact with DNA ( whereas a virus could).

So you're wrong.

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@metal-brain said
Here is an excerpt from the BioNTech form 20F filed with the United States Securities and Exchange Commission below from page 16:

"Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and may cause certain side effects, mRNA-based medicines are designed not to irreversibly change cell DNA. Side ...[text shortened]... nd earl recently posted an article proving the same thing.

You are wrong and you are wrong again!
Here's more:

"Unlike DNA vaccines, mRNA vaccines cannot integrate into the genome sequence, thus free of insertional mutagenesis."

https://molecular-cancer.biomedcentral.com/articles/10.1186/s12943-021-01335-5#:~:text=mRNA%20vaccines%20have%20become%20a,and%20innate%2Fadaptive%20immune%20stimulation.

"insertional mutagenesis" are mutations of DNA caused by introduction of base pairs, which is what you were screeching about in the OP. Since this is impossible when mRNA vaccines are used, your whole anti-vaxxer scare tactic crumbles to dust.

Another source:

"as mRNA is a non-infectious, non-integrating platform, there is no potential risk of infection or insertional mutagenesis. "

https://www.nature.com/articles/nrd.2017.243

And another:

"Because the target for mRNA vaccines is the cytoplasm of the cell, they are easier to deliver, and cytosolic mRNA has no interaction with the genome."

https://www.cancernetwork.com/view/messenger-rna-vaccines-beckoning-of-a-new-era-in-cancer-immunotherapy

Getting the point yet?

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@metal-brain said
Here is an excerpt from the BioNTech form 20F filed with the United States Securities and Exchange Commission below from page 16:

"Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and may cause certain side effects, mRNA-based medicines are designed not to irreversibly change cell DNA. Side ...[text shortened]... nd earl recently posted an article proving the same thing.

You are wrong and you are wrong again!
And wherever you got this from:

""A study by MIT and Harvard scientists demonstrates that segments of RNA from SARS-CoV-2 are reverse-transcribing into the human genome, likely becoming a permanent fixture in human DNA. This has been thought impossible for the same reasons used to assure us that vaccine RNA cannot alter DNA"

it is complete and utter BS. In point of fact:

" The work, only reported in a preprint, suggests the pandemic pathogen takes a page from HIV and other retroviruses and integrates its genetic code—but, importantly, just parts of it—into people’s chromosomes. "

"All viruses insert their genetic material into the cells they infect, but it generally remains separate from the cell’s own DNA. "

https://www.sciencemag.org/news/2020/12/coronavirus-may-sometimes-slip-its-genetic-material-human-chromosomes-what-does-mean

So it's well known that some viruses can implant their genetic material into human cells. It is equally well-known that mRNA vaccines can't.

MB

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@no1marauder said
And wherever you got this from:

""A study by MIT and Harvard scientists demonstrates that segments of RNA from SARS-CoV-2 are reverse-transcribing into the human genome, likely becoming a permanent fixture in human DNA. This has been thought impossible for the same reasons used to assure us that vaccine RNA cannot alter DNA"

it is complete and utter BS. In po ...[text shortened]... implant their genetic material into human cells. It is equally well-known that mRNA vaccines can't.
"All viruses insert their genetic material into the cells they infect, but it generally remains separate from the cell’s own DNA. "

That in what mRNA vaccines do as well. That insertion of genetic material is exactly what makes it gene therapy. It does NOT have to alter your DNA.

See the FDA definition of gene therapy. I provided it more than once. Read it for once.

MB

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@no1marauder said
Actually the FDA clearly states that gene therapy "modifies a person's genes." https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/what-gene-therapy

The CDC states that the vaccines cannot because they have no contact with DNA ( whereas a virus could).

So you're wrong.
Nope, you omitted this part:

"to alter the biological properties of living cells for therapeutic use".

That is what mRNA does. It fits the definition provided by the FDA.

Here is another from that link:

"Introducing a new or modified gene into the body to help treat a disease".

That is what mRNA does. You are wrong.

I will repeat this again and again until you understand.

"Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA"

That acknowledges that mRNA therapy is gene therapy. Stop believing fake fact checkers! They are contradicting the FDA!

let me make this very clear. Gene therapy does NOT have to alter your DNA! You think the fact checkers have to be correct. That is your mistake. They are full of crap!

MB

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Here is an excerpt from the FDA website below:

"There are a variety of types of gene therapy products, including:

Plasmid DNA: Circular DNA molecules can be genetically engineered to carry therapeutic genes into human cells.

Viral vectors: Viruses have a natural ability to deliver genetic material into cells, and therefore some gene therapy products are derived from viruses. Once viruses have been modified to remove their ability to cause infectious disease, these modified viruses can be used as vectors (vehicles) to carry therapeutic genes into human cells.

Bacterial vectors: Bacteria can be modified to prevent them from causing infectious disease and then used as vectors (vehicles) to carry therapeutic genes into human tissues.

Human gene editing technology: The goals of gene editing are to disrupt harmful genes or to repair mutated genes.
Patient-derived cellular gene therapy products: Cells are removed from the patient, genetically modified (often using a viral vector) and then returned to the patient."

https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/what-gene-therapy

Here is a CDC link:

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/viralvector.html

no1's position seems to be that viral vectors are not viral vectors.

The FDA is very clear that "viral vectors" are gene therapy. The CDC acknowledges viral vector vaccines.

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Notice that the CDC and other government national health agencies NEVER claim the vaccines authorized for emergency use are not gene therapy. They will say it does not change your DNA, but that is not the criteria as the fake fact checkers claim.

There is a reason no government health official will say they are not gene therapy. THEY ARE!

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@metal-brain said
Nope, you omitted this part:

"to alter the biological properties of living cells for therapeutic use".

That is what mRNA does. It fits the definition provided by the FDA.

Here is another from that link:

"Introducing a new or modified gene into the body to help treat a disease".

That is what mRNA does. You are wrong.

I will repeat this again and again un ...[text shortened]... ur DNA! You think the fact checkers have to be correct. That is your mistake. They are full of crap!
No, it doesn't "Introduc[e] a new or modified gene into the body to help treat a disease" One more time:

""Unlike DNA vaccines, mRNA vaccines cannot integrate into the genome sequence".

The quote you keep using isn't from the FDA but from a private company's year end prospectus meant for stockholders. You keep falsely claiming that their description is from the FDA, but I've already cited from the FDA itself saying the description is wrong.

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@metal-brain said
Here is an excerpt from the FDA website below:

"There are a variety of types of gene therapy products, including:

Plasmid DNA: Circular DNA molecules can be genetically engineered to carry therapeutic genes into human cells.

Viral vectors: Viruses have a natural ability to deliver genetic material into cells, and therefore some gene therapy products are derived f ...[text shortened]... FDA is very clear that "viral vectors" are gene therapy. The CDC acknowledges viral vector vaccines.
The mRNA vaccines don't use "viral vectors"; they don't use any part of the viruses.

You really need to read the cites you quote.

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@metal-brain said
Notice that the CDC and other government national health agencies NEVER claim the vaccines authorized for emergency use are not gene therapy. They will say it does not change your DNA, but that is not the criteria as the fake fact checkers claim.

There is a reason no government health official will say they are not gene therapy. THEY ARE!
Maybe government health officials in the middle of a pandemic have better things to do than run down every pet theory tossed out by internet cranks.

MB

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@no1marauder said
The mRNA vaccines don't use "viral vectors"; they don't use any part of the viruses.

You really need to read the cites you quote.
One more time:

mRNA vaccines do NOT have to integrate into your genome sequence to be gene therapy. You have a leap in faith in the self proclaimed fact checkers. They do NOT represent facts. They are merely opinion pieces.

I can call this a fact check too. Does that make it one?

NO PUBLIC HEALTH OFFICIAL SAYS the mRNA vaccines are not gene therapy. They are not saying that BECAUSE IT WOULD BE A LIE.

"The quote you keep using isn't from the FDA but from a private company's year end prospectus meant for stockholders"

That is a lie. Why would you claim something so stupid? It is the FDA website.