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Started By
Message
re: FDA must be under EXTREME pressure to remove the “emergency authorization” label.
Posted on 8/3/21 at 12:28 pm to TomBuchanan
Posted on 8/3/21 at 12:28 pm to TomBuchanan
Big pharma doesn't want to lose it's immunity from lawsuits.
1
Posted on 8/3/21 at 12:29 pm to Shaft Williams
quote:
Big pharma doesn't want to lose it's immunity from lawsuits.
Irrelevant. They already have immunity.
Posted on 8/3/21 at 12:30 pm to Mickey Goldmill
quote:
Moderna isn't saying it's "gene therapy." They are saying it is currently considered a gene therapy product by the FDA. They were seeking to get it reclassified.
So, currently gene therapy, then. Good to know
Posted on 8/3/21 at 12:33 pm to RobbBobb
Sure
Posted on 8/3/21 at 12:34 pm to Mickey Goldmill
quote:
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.
There is a distinction here however nRNA is still a gene. Here is the NIH:
quote:
The mRNA is an RNA version of the gene that leaves the cell nucleus and moves to the cytoplasm where proteins are made.
LINK
mRNA vaccines ARE gene therapy. They are using a gene to assemble amino acids into a COVID spiked proteins.
There are two two types of gene therapy that I know of. Germ line gene therapy and somatic gene therapy. mRNA gene therapy falls more under the somatic gene therapy category, i.e., it is temporary. Whereas germ line gene therapy is permanent and it carried on to subsequent generations. The mRNA vaccine is not germ line gene therapy.
Posted on 8/3/21 at 12:35 pm to notsince98
quote:
Big pharma doesn't want to lose it's immunity from lawsuits.
Irrelevant. They already have immunity.
I believe it can be argued that once fully approved, liability will attach. Those who took the vaccine in experimental stage can't sue, but those getting the fully approved jab should be able to sue, maybe even a class action.
Posted on 8/3/21 at 12:45 pm to SixthAndBarone
quote:
Doing so would discredit the FDA for a long time and cause incomprehensible damage to them. They are not stupid.
We will see.
Posted on 8/3/21 at 12:47 pm to GumboPot
Posted on 8/3/21 at 12:51 pm to Revelator
quote:It won't. Current lack of FDA approval(big govt agency) is just an excuse used by anti-vaccine people. Once it is approved we'll hear how they were coerced into doing so, or some other grand conspiracy. Another set of false info will rise to the fore.
How will an FDA approval in any way, shape or form change the makeup of the vaccine and any potential future side effects?
Posted on 8/3/21 at 1:04 pm to Jake88
quote:
t won't. Current lack of FDA approval(big govt agency) is just an excuse used by anti-vaccine people. Once it is approved we'll hear how they were coerced into doing so, or some other grand conspiracy.
First off, I don’t need an excuse to not get vaccinated any more than you need my permission to eat Twinkies.
Secondly, read what I posted. Having the FDA approval changes nothing as far as the makeup of the vaccine.
Posted on 8/3/21 at 1:06 pm to NC_Tigah
quote:
That ship has sailed
As has "being honest about the data."
If they were honest about their incompetence, that would go a long with with me. I'm not holding my breath (while wearing 3 masks and a face shield), however.
Posted on 8/3/21 at 1:10 pm to GumboPot
Yes they are but money $$$ will win in the end. The FDA will eventually surcom to the $$$$ that's promised in exchange for an approval.
The money will likely come from these enormous spending packages being passed.
The money will likely come from these enormous spending packages being passed.
Posted on 8/3/21 at 1:12 pm to Jake88
quote:
Current lack of FDA approval(big govt agency) is just an excuse used by anti-vaccine people.
You're so upset you can't change people's minds with your bullshite.
Posted on 8/3/21 at 1:14 pm to Outside looking in
quote:
I believe it can be argued that once fully approved, liability will attach. Those who took the vaccine in experimental stage can't sue, but those getting the fully approved jab should be able to sue, maybe even a class action.
He claims pharma is not liable for vaccines approved by the FDA.
Posted on 8/3/21 at 1:21 pm to Outside looking in
quote:
I believe it can be argued that once fully approved, liability will attach.
Not in this country. See previous post about the national court of vaccine injuries. You cannot hold any vaccine maker liable in this country.
Posted on 8/3/21 at 1:21 pm to Outside looking in
quote:
I believe it can be argued that once fully approved, liability will attach.
It cannot. There is no liability for pharma in the vaccines.
Posted on 8/3/21 at 1:29 pm to BuckyCheese
quote:
So when it is approved does the "no liability" part of the emergency authorization go away?
If so, pharma may not want it to go away. They're moving plenty of it with the government attempting to force it upon the unwilling.
Bing-MOTHERF*CKING-O!!!
How in the ever living f*ck are they going to remove the "emergency authorization" label and declare that these [non-vaccine] "vaccines" are perfectly safe WITHOUT lifting the unlimited f*cking IMMUNITY for both the makers and the politicians.
By retaining the unlimited immunity, they are all but admitting that they do not know the effects of taking this experimental drug. WHY? Because, unlike all other drugs on the market, they can't even begin to tell you what the short-term side effects are MUCH LESS the long-term side effects.
And, how in the ever living f*ck are employers going to force this on their employees without full FDA approval without incurring and accepting the liability of these experimental drugs?
If my employer ever attempts to force me to take this poison, I will immediately file an OSHA complaint.
Compare this with a cancer drug (see, e.g., Steve McQueen). McQueen had to go to Mexico to try to get an experimental surgery because the FDA would not approve it here. However, there was nothing else that could be done for McQueen in the United States. So, as a last resort he went to Mexico.
In the case of these experimental drugs, you are not going to die if you don't take it. In fact, even if you get Covid (of any known varient), you will still have a 99.99% chance of living.
But, there are people think that the FDA should be able to force individuals to take this EXPERIMENTAL drug anyway while the FDA can also deny EXPERIMENTAL drugs where you will die ANYWAY if you don't try it???
The Media and their Comrades in Congress has politicized this disease so badly that people have literally gone completely f*cking NUTS and have lost every f*cking ounce of just plain common f*cking sense they've ever had.
This post was edited on 8/3/21 at 1:41 pm
Posted on 8/3/21 at 1:29 pm to BuckyCheese
quote:Really don't care. But I will point out falsehoods about the vaccine.
You're so upset you can't change people's minds with your bullshite
Posted on 8/3/21 at 2:08 pm to GumboPot
The head of UL School System, Jim Henderson, send out an email yesterday saying they expected FDA approval “in the coming weeks.”
Posted on 8/3/21 at 2:22 pm to RobbBobb
quote:
Nope. Paperwork has already been filed. No one can cheat the 2-year follow up plan for phase III trials. The phase III trials 2-year window is when ADE is detected, and would require the scrapping of the vaccine entirely.
This is when the FDA will pull the EUA
quote:
the Pfizer-BioNTech coronavirus vaccine has been given an estimated study completion date of Jan. 31, 2023. For the COVID-19 vaccine created by Moderna, studies are expected to end on Oct. 27, 2022.
Actually RobbBobb, Pfizer has already filed for the BLA for >16yr olds; the filing has been accepted and is under FDA review. Technically the planned decision date (the PDUFA date) is January 2022, but due to the rolling provision of data from Pfizer to FDA, and the high priority within the division, we expect a decision much sooner than that.
While the clinical trial protocols do include a 2 year followup, FDA guidance for vaccines (all vaccines, not just COVID) only require a mean 6 month follow-up period.
Also, the reason the Pfizer/BioNTech study completion date is now 2023 is that it is an adaptive study design. Meaning, they continue to amend to add study cohorts (younger age groups, boosters, etc) instead of starting over with separate protocols for each (which is Moderna's strategy.)
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