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Started By
Message
FDA must be under EXTREME pressure to remove the “emergency authorization” label.
Posted on 8/3/21 at 11:43 am
Posted on 8/3/21 at 11:43 am
I’m actually shocked the emergency authorization label has not been removed yet.
11
Posted on 8/3/21 at 11:44 am to GumboPot
Doing so would discredit the FDA for a long time and cause incomprehensible damage to them. They are not stupid.
Posted on 8/3/21 at 11:45 am to GumboPot
quote:
I’m actually shocked the emergency authorization label has not been removed yet.
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 11:48 am to Revelator
quote:
How will an FDA approval in any way, shape or form change the makeup of the vaccine and any potential future side effects?
The PR battle has very little to do with facts.
Posted on 8/3/21 at 11:49 am to GumboPot
Posted on 8/3/21 at 11:49 am to GumboPot
The head of the FDA will do it, or he will be replaced by someone who will.
And just like that, what little good faith and credit the FDA has earned since they delayed approval of Thalidomide back in the late 50's goes :poof:.
And just like that, what little good faith and credit the FDA has earned since they delayed approval of Thalidomide back in the late 50's goes :poof:.
Posted on 8/3/21 at 11:51 am to SixthAndBarone
quote:What steps have to be taken in order for it to go from EUA to FDA approved? They would have to be done one vaccine at a time, I would presume? Being honest with the data would be quite helpful but I am seriously asking but I don't know.
Doing so would discredit the FDA for a long time and cause incomprehensible damage to them. They are not stupid.
Posted on 8/3/21 at 11:52 am to SixthAndBarone
quote:That ship has sailed
Doing so would discredit the FDA for a long time and cause incomprehensible damage to them
Posted on 8/3/21 at 11:52 am to Unobtanium
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.
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.
Posted on 8/3/21 at 11:57 am to BuckyCheese
quote:
So when it is approved does the "no liability" part of the emergency authorization go away?
It should you'd think. Might also mean that the drug will have to be advertised with possible side effects warnings like all the new drugs on tv have to do. We have seen no such thing concerning the covid shots which gives me great pause in not getting one.
Posted on 8/3/21 at 12:00 pm to BuckyCheese
Drs. on the PT board assured us it was not gene therapy.
Posted on 8/3/21 at 12:10 pm to Revelator
quote:
How will an FDA approval in any way, shape or form change the makeup of the vaccine and any potential future side effects?
It won’t do any of that…..but it will be the final justification for requiring the vaccine.
Posted on 8/3/21 at 12:16 pm to GoAwayImBaitn
quote:
It's not a vaccine. It's a "gene therapy"
Moderna's words, not mine.
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.
From Moderna's website:
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.
Posted on 8/3/21 at 12:20 pm to LSU316
Bingo. As of now, the military is really pushing the vax, but can't mandate it. The second it receives FDA Approval, it will be a mandatory injection for the DoD.
Posted on 8/3/21 at 12:20 pm to BuckyCheese
I would assume formal approval would remove the liability shields, but I'm just a dumb poster on a sports message board. 
Posted on 8/3/21 at 12:23 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.
it is interesting that some folks still dont know this....
In this country, Pharma companies are NOT liable for any damages caused by their vaccines. They are given complete immunity. You cannot sue pharma. All you can do is take your injury case to the national court of vaccine injuries. this court does everything it can to prevent any blame from being placed on vaccines. Despite that, that court has indeed ruled on $6billion in awarded damages to victims. But pharma doesn't pay for that. The tax payer does.
Posted on 8/3/21 at 12:24 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.
Exactly.
It is the same as marijuana being a Schedule 1 drug. The government says it is, therefor it is.
Also, even if you want to call it "gene therapy," it can still be a vaccine. They are note mutually exclusive.
Posted on 8/3/21 at 12:26 pm to Mickey Goldmill
(no message)
This post was edited on 11/8/23 at 2:01 am
Posted on 8/3/21 at 12:27 pm to Mickey Goldmill
quote:
Moderna isn't saying it's "gene therapy."
It is not gene therapy by the strict definition of gene therapy but that isn't the issue.
Moderna is trying to reframe the issue w/out addressing the actual reason. The actual reason it isn't a vaccine is because it does not meet the definition requirements for being a vaccine.
Moderna can call it whatever they want but they cannot call it a vaccine.
Posted on 8/3/21 at 12:28 pm to GumboPot
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
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.
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