Covid-19

[GIMMFD]

Actually, Moderna DOES call them a gene therapy product. It's right here in their SEC filing:

"Currently, mRNA is considered a gene therapy product by the FDA."

https://investors.modernatx.com/stat...7-78b32f244125

mRNA medication that treats tumors among other diseases is very different than the vaccine. In your link provided it does not call the influenza vaccine that it is studying “gene therapy,” it calls it a vaccine. The potential medication for tumors are considered gene therapy because they modify the genetic makeup of the cells they enter. The vaccines they are studying do not.

Page 20 - "Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a
source of side effects, mRNA based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could
negatively impact the perception of mRNA medicines despite the differences in mechanism... 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 may require safety testing like gene therapy products.


Page 26 - "Safety or efficacy concerns regarding our investigational medicines may result from any safety or efficacy concerns arising from nonclinical or clinical testing of other therapies targeting a similar disease state or other therapies, such as gene therapy, that are perceived similar to ours."

Page 27 - Gene therapy products have the effect of introducing new DNA and potentially irreversibly changing the DNA in a cell. In contrast, mRNA is highly unlikely to localize to the nucleus, integrate into the DNA, or otherwise make any permanent changes to cell DNA.

Page 28 - Regulatory requirements governing gene and cell therapy products have evolved and may continue to change in the future, and the implications for
mRNA-based therapies is unknown. For example, the FDA has established the Office of Tissues and Advanced Therapies within CBER to consolidate
the review of gene therapy and related products, and convenes the Cellular, Tissue and Gene Therapies Advisory Committee to advise CBER on its
review. In the EU, mRNA has been characterized as a Gene Therapy Medicinal Product. In certain countries, mRNA therapies have not yet been
classified or any such classification is not known to us, specifically, in Japan, the PMDA has not taken a position on the regulatory classification.
Notwithstanding the differences between our mRNA investigational medicines and gene therapies, the classification of some of our mRNA
investigational medicines as gene therapies in the United States, the EU and potentially other counties could adversely impact our ability to develop
our investigational medicines, and could negatively impact our platform and our business. For instance, a clinical hold on gene therapy products
across the field due to risks associated with altering cell DNA irreversibly may apply to our mRNA investigational medicines irrespective of the
mechanistic differences between gene therapies and mRNA.

Page 132 - mRNA allows for transient production of the encoded protein. mRNA therapies should also allow for dose titration and repeat dosing. This
provides several advantages over gene therapy. Gene therapy typically results in a permanent change to cellular DNA that may result in
uncontrolled or constant production of the desired protein in local tissue or in distant sites, which could cause local or systemic side effects.
Further, some gene therapy delivery vehicles are associated with immune responses that limit the ability to repeat dose, preventing dose titration


So no, Moderna doesn't call it a gene therapy product, the FDA does, if anything Moderna hates the gene therapy product label.

[XU_Lou]

mRNA medication that treats tumors among other diseases is very different than the vaccine. In your link provided it does not call the influenza vaccine that it is studying “gene therapy,” it calls it a vaccine. The potential medication for tumors are considered gene therapy because they modify the genetic makeup of the cells they enter. The vaccines they are studying do not.

Okay, you appear to be correct on this. The first mention of “gene therapy” is near the beginning of the document in the Risk Factors section, and seemed to me to be an overarching declarative. But I see the distinction you mentioned now.

[Strange Brew]

I didn’t make a suggestion that the vaccines shouldn’t be “pushed” because they are in experimental phase, you did. Which is a different argument than they shouldn’t be pushed because it’s a personal choice.

And you asked when is a drug no longer experimental. I don't know but you are pushing for people to take a still experimental vaccine.

[Strange Brew]

Page 20 - "Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a
source of side effects, mRNA based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could
negatively impact the perception of mRNA medicines despite the differences in mechanism... 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 may require safety testing like gene therapy products.


Page 26 - "Safety or efficacy concerns regarding our investigational medicines may result from any safety or efficacy concerns arising from nonclinical or clinical testing of other therapies targeting a similar disease state or other therapies, such as gene therapy, that are perceived similar to ours."

Page 27 - Gene therapy products have the effect of introducing new DNA and potentially irreversibly changing the DNA in a cell. In contrast, mRNA is highly unlikely to localize to the nucleus, integrate into the DNA, or otherwise make any permanent changes to cell DNA.

Page 28 - Regulatory requirements governing gene and cell therapy products have evolved and may continue to change in the future, and the implications for
mRNA-based therapies is unknown. For example, the FDA has established the Office of Tissues and Advanced Therapies within CBER to consolidate
the review of gene therapy and related products, and convenes the Cellular, Tissue and Gene Therapies Advisory Committee to advise CBER on its
review. In the EU, mRNA has been characterized as a Gene Therapy Medicinal Product. In certain countries, mRNA therapies have not yet been
classified or any such classification is not known to us, specifically, in Japan, the PMDA has not taken a position on the regulatory classification.
Notwithstanding the differences between our mRNA investigational medicines and gene therapies, the classification of some of our mRNA
investigational medicines as gene therapies in the United States, the EU and potentially other counties could adversely impact our ability to develop
our investigational medicines, and could negatively impact our platform and our business. For instance, a clinical hold on gene therapy products
across the field due to risks associated with altering cell DNA irreversibly may apply to our mRNA investigational medicines irrespective of the
mechanistic differences between gene therapies and mRNA.

Page 132 - mRNA allows for transient production of the encoded protein. mRNA therapies should also allow for dose titration and repeat dosing. This
provides several advantages over gene therapy. Gene therapy typically results in a permanent change to cellular DNA that may result in
uncontrolled or constant production of the desired protein in local tissue or in distant sites, which could cause local or systemic side effects.
Further, some gene therapy delivery vehicles are associated with immune responses that limit the ability to repeat dose, preventing dose titration


So no, Moderna doesn't call it a gene therapy product, the FDA does, if anything Moderna hates the gene therapy product label.

Right, they're having a hard enough time getting everyone to take the vaccine. I'd shy away from that label as well....

[Lloyd Braun]

And you asked when is a drug no longer experimental. I don't know but you are pushing for people to take a still experimental vaccine.

So for you, is it no longer experimental when it has FDA approval? Or is there a timeframe after approval to be no longer experimental?

I could argue, for arguments sake alone, that every medicine/treatment whether artificial or natural is a lifelong experiment. Perhaps natural immunity is experimental?

I just find it odd that there are a lot of people in the same mindset that say this is a lab produced virus and yet won’t take the vaccine. Which experiment are you more comfortable with? (Not directing that last question at you Strange as I don’t know your position on origins of virus, just a rhetorical question ).

I’m not pushing anything, I hold the opinion that the vaccine is not gene therapy, that the overwhelmingly vast majority of the population benefits from the vaccine, and that further delay of mass immunity will be of detriment to everyone long term. It’s frustrating to see this perpetuate due to misinformation. Are there people that haven’t received the vaccine because they believe it to be gene therapy and their DNA is different? Yes apparently. And that is based on misinformation. That’s frustrating to see as I deal with this crap on a daily basis.

It doesn’t change my out of work life other than my small kids are unable to get vaccinated, which makes a lot of activities different. Typically vaccines are less likely to cause long term issues than the disease which it is protective. When it is approved for children, mine will receive the vaccine. If they had covid recently I could see waiting for awhile. Same for adults.

[Strange Brew]

So for you, is it no longer experimental when it has FDA approval? Or is there a timeframe after approval to be no longer experimental?

I could argue, for arguments sake alone, that every medicine/treatment whether artificial or natural is a lifelong experiment. Perhaps natural immunity is experimental?

I just find it odd that there are a lot of people in the same mindset that say this is a lab produced virus and yet won’t take the vaccine. Which experiment are you more comfortable with? (Not directing that last question at you Strange as I don’t know your position on origins of virus, just a rhetorical question ).

I’m not pushing anything, I hold the opinion that the vaccine is not gene therapy, that the overwhelmingly vast majority of the population benefits from the vaccine, and that further delay of mass immunity will be of detriment to everyone long term. It’s frustrating to see this perpetuate due to misinformation. Are there people that haven’t received the vaccine because they believe it to be gene therapy and their DNA is different? Yes apparently. And that is based on misinformation. That’s frustrating to see as I deal with this crap on a daily basis.

It doesn’t change my out of work life other than my small kids are unable to get vaccinated, which makes a lot of activities different. Typically vaccines are less likely to cause long term issues than the disease which it is protective. When it is approved for children, mine will receive the vaccine. If they had covid recently I could see waiting for awhile. Same for adults.

Not comfortable with either hypothetical experiment. Are you?
Calling it gene therapy and not a traditional vax isn’t mis-info. Unless mis-info is whatever doesn’t fit what you believe.
Agree on the kids. Don’t plan on masking them at school. Too much mid-info on masks. :)

[principal]

It is beginning to look like this is not a “pandemic of the unvaccinated”:

https://www.yahoo.com/news/cdc-emerg...170225381.html

“The data bolsters emerging evidence that vaccinated people have high viral loads and may transmit the Delta variant as easily as those who are unvaccinated.”

[Lloyd Braun]

Not comfortable with either hypothetical experiment. Are you?
Calling it gene therapy and not a traditional vax isn’t mis-info. Unless mis-info is whatever doesn’t fit what you believe.
Agree on the kids. Don’t plan on masking them at school. Too much mid-info on masks. :)

We make lesser of two evil choices every day, don’t we?

Calling it gene therapy is misinformation because it isn’t true. Pretty black and white on that one. Does it alter our genes? No. Not gene therapy. It’s not perspective it’s objective, unless you are a conspiracy theorist, in which you can question everything in life as not face value.

[principal]

We make lesser of two evil choices every day, don’t we?

Calling it gene therapy is misinformation because it isn’t true. Pretty black and white on that one. Does it alter our genes? No. Not gene therapy. It’s not perspective it’s objective, unless you are a conspiracy theorist, in which you can question everything in life as not face value.

I don’t know the first thing about gene therapy and whether or not this is gene therapy…but if it is not gene therapy, why does the FDA call it gene therapy?

[XU_Lou]

It is beginning to look like this is not a “pandemic of the unvaccinated”:

https://www.yahoo.com/news/cdc-emerg...170225381.html

“The data bolsters emerging evidence that vaccinated people have high viral loads and may transmit the Delta variant as easily as those who are unvaccinated.”

Additionally, getting the vaccine is risky - latest data from CDC VAERS:

12K deaths
13K permanent disabilities
11K life threatening situations
41K hospitalizations
65K emergency room doctor visits

https://basedunderground.com/2021/07...d-as-unvaxxed/