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Nzoner's Game Room>***NON-POLITICAL COVID-19 Discussion Thread***
JakeF 10:28 PM 02-26-2020
A couple of reminders...

Originally Posted by Bwana:
Once again, don't come in this thread with some kind of political agenda, or you will be shown the door. If you want to go that route, there is a thread about this in DC.
Originally Posted by Dartgod:
People, there is a lot of good information in this thread, let's try to keep the petty bickering to a minimum.

We all have varying opinions about the impact of this, the numbers, etc. We will all never agree with each other. But we can all keep it civil.

Thanks!

Click here for the original OP:

Spoiler!

[Reply]
ChiliConCarnage 07:52 AM 08-08-2021
Originally Posted by Nickhead:
honest question:

i was of the impression vaccines like flu, small pox, etc. were meant to suppress the virus and therefore pass on so called antibodies (sorry if using wrong term). isn't that what helped tamp down previous virus'?

where as this current covid delta is supposedly making the vaccinated a host and not killing the virus, only making it more transmissible to those around them?

im all for taking a covid vaccine but if what i have read is true, mRNA is not a 'vaccine' by definition?
I mean, yeah, in general the idea is to teach your immune system to fight back. I think we've eliminated very few things, most were just making safer/more liveable. We deal with the flu every year, most of us had variants as a kid which helps

I don't know why mRNA would not be considered a vaccine. I think both the Johnson & Johnson and Astrazeneca vaccines are live virus DNA type vaccines if you'd prefer.
[Reply]
TLO 07:54 AM 08-08-2021

I don't like tweets about 'Bob the antivaxxer' or 'Jane the denialist' who died in pain and in a last gasp, cried about their choices. I find it manipulative and disrespectful and equivalent to antivax propaganda. We should fight vaccine hesitancy with facts and appeal to reason.

— Prof Francois Balloux (@BallouxFrancois) August 7, 2021

[Reply]
TLO 07:55 AM 08-08-2021

Yes, the vaccines ARE effective against the Delta variant. Yes, you will need both doses for maximum protection. Yes, they’re effective against preventing symptomatic infection, severe disease, AND hospitalization. Several studies have proven this now. Stop the misinformation.

— Chise �������� (@sailorrooscout) August 8, 2021

[Reply]
MahomesMagic 07:56 AM 08-08-2021
Originally Posted by SupDock:
I’m not sure what you mean.
Both Pfizer and Moderna stated the FDA position in their SEC filings:

"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,...

https://www.sec.gov/Archives/edgar/d...a-20200630.htm
[Reply]
TLO 07:56 AM 08-08-2021
Originally Posted by SupDock:
I feel like I left the thread for months and nothing changed
Things just recently took a turn in here. The conversation had been much better up until recently.
[Reply]
BigBeauford 08:08 AM 08-08-2021
Originally Posted by TLO:
Things just recently took a turn in here. The conversation had been much better up until recently.
I'll admit I am very frustrated at this point and prone to lashing out. I know I am not helping, but damn I can't help replay in my head how this should be done and buried, but a lot of Americans of different stripes aren't doing what it takes.
[Reply]
SupDock 08:09 AM 08-08-2021
Originally Posted by MahomesMagic:
Both Pfizer and Moderna stated the FDA position in their SEC filings:

"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,...

https://www.sec.gov/Archives/edgar/d...a-20200630.htm
https://sciencebasedmedicine.org/ant...tware-of-life/


Gene therapy product. Not gene therapy. I don’t really like the confusing language of this claim by Moderna.

Gene therapy alters dna in the cell nucleus. The vaccine does not. Gene therapy can create mRNA, but an mRNA vaccine isn’t gene therapy. The product does not even enter the nucleus of the cell.
[Reply]
MahomesMagic 08:12 AM 08-08-2021
Originally Posted by SupDock:
https://sciencebasedmedicine.org/ant...tware-of-life/


Gene therapy product. Not gene therapy. I don’t really like the confusing language of this claim by Moderna.

Gene therapy alters dna in the cell nucleus. The vaccine does not. Gene therapy can create mRNA, but an mRNA vaccine isn’t gene therapy. The product does not even enter the nucleus of the cell.
They may well want a different definition but they are required to disclose regulatory issues (FDA) with investors.

More in document:

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 are 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 European Union, 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 Pharmaceuticals and Medical Devices Agency 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 European Union, and potentially other countries 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.
Adverse events reported with respect to gene therapies or genome editing therapies could adversely impact one or more of our programs. Although our mRNA development candidates and investigational medicines are designed not to make any permanent changes to cell DNA, regulatory agencies or others could believe that adverse effects of gene therapies products caused by introducing new DNA and irreversibly changing the DNA in a cell could also be a risk for our mRNA investigational therapies, and as a result may delay one or more of our trials or impose additional testing for long-term side effects. Any new requirements and guidelines promulgated by regulatory review agencies may have a negative effect on our business by lengthening the regulatory review process

[Reply]
KCUnited 08:17 AM 08-08-2021
Here in Chicago we went from a high average of 30K shots per day in late April to around 4K per day steady in July into August, sitting close to 60% fully vaxxed citywide.

It just seems like its a slow trickle, is what it is type of situation here until something happens to generate more motivation.
[Reply]
SupDock 08:17 AM 08-08-2021
Originally Posted by MahomesMagic:
They may well want a different definition but they are required to disclose regulatory issues (FDA) with investors.

More in document:

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 are 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 European Union, 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 Pharmaceuticals and Medical Devices Agency 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 European Union, and potentially other countries 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.
Adverse events reported with respect to gene therapies or genome editing therapies could adversely impact one or more of our programs. Although our mRNA development candidates and investigational medicines are designed not to make any permanent changes to cell DNA, regulatory agencies or others could believe that adverse effects of gene therapies products caused by introducing new DNA and irreversibly changing the DNA in a cell could also be a risk for our mRNA investigational therapies, and as a result may delay one or more of our trials or impose additional testing for long-term side effects. Any new requirements and guidelines promulgated by regulatory review agencies may have a negative effect on our business by lengthening the regulatory review process
This is all addressed in the link I provided. I’m not engaging in this discussion any more. mRNA vaccines are not gene therapy. There are multiple sources available to you in order to educate yourself.

Heck. Continue reading what you posted

******************

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.
[Reply]
MahomesMagic 08:20 AM 08-08-2021
Originally Posted by SupDock:
This is all addressed in the link I provided. I’m not engaging in this discussion any more. mRNA vaccines are not gene therapy. There are multiple sources available to you in order to educate yourself.

Heck. Continue reading what you posted

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.
The regulatory agencies in the US and Europe see it differently than you doc.
[Reply]
SupDock 08:30 AM 08-08-2021
Originally Posted by MahomesMagic:
The regulatory agencies in the US and Europe see it differently than you doc.
Once again we’ve reached a point where I no longer understand what you are trying to say.

It is a vaccine. It doesn’t alter your genetics or DNA. Any claim you make that tries to negate these truths is subterfuge.
[Reply]
Sure-Oz 08:35 AM 08-08-2021
I'm not liking more and more news of kids getting really sick now and being hospitalized.
[Reply]
loochy 08:39 AM 08-08-2021
Originally Posted by Sure-Oz:
I'm not liking more and more news of kids getting really sick now and being hospitalized.
Well if more kids are out and about (school starting)
Then more kids will get sick
And more will be hospitalized

Get used to it, because you can't do anything about it other than hide in a hole and not send kids to school
[Reply]
MahomesMagic 08:43 AM 08-08-2021
Originally Posted by SupDock:
Once again we’ve reached a point where I no longer understand what you are trying to say.

It is a vaccine. It doesn’t alter your genetics or DNA. Any claim you make that tries to negate these truth is subterfuge.
It doesn't have to alter your DNA to be classified as a "gene therapy product" by the FDA or the European Union.


Truth can be changed with $$$$, see the change in the definition of the scientific term "herd immunity" that took place at the World Health Organization where people who had Covid, recovered, and were now immune are not counted as immune.

Don't worry, if these companies want to get their products labeled a certain way, they will get their way.
[Reply]
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