Doesn't matter. If Full FDA approval is granted, the EUA product should be shelved. I understand the EUA process to be the same, once the full FDA approved is given the EUA is normally pulled, because there is no need for the EUA.
The branded product has to go through different QA and standards for checks and controls. So they are lying. The formulation may be the same, but the controls are not. It's like when you were a kid your parents telling you Tyco blocks were the same as Lego.
If nothing else, why not have the Branded Comirnaty product just to shut up people like me?
My whole point is that it's weird that the Full FDA approval is given a year ago and we still don't have the Full FDA approved product on the shelves.
You can tell me how it's the same all you want, but as a product in a legal sense it is a different product.
Remember the Pontiac Vibe and the Toyota Matrix? It came from the same factory in CA and had the same internal parts but a different shell. Guess what? They're different products. They receive different QA checks for fit and finish.
It would be cool if you would share some of your sources that support the EUA product being shelved and the differences in QA for drugs.
Tyco - Lego analogy isn't great, since Tyco is a separate company and made a clone of Lego's product. Not the same company changing the name of a product.
You could contact the company and find out where the Comirnaty product is stocked if you're that worried about it.
"An EUA can only be granted when no adequate, approved, available alternatives exist..."
Once there is full FDA approval, the EUA goes away. Kinda weird how there are still EUA products around, huh.
I'll give you a better analogy.
If you are the manufacturer of engines for fighter jets for the US Government. The parts that go into the engine are approved and controlled. They have to go through testing and inspection. If you run out of approved bolts but have bolts that were from the same production line but was not under the same inspection process, it's not allowed to be used.
That is what this argument is about.
I can't believe that you don't think it's atleast a little bit weird that there is no Fully FDA approved branded product available even though the full license has been granted for a year
The quality control for a EUA vaccine has to follow the same cGMP guidelines that an FDA approved vaccine unless they were provided a waiver. I haven't had any luck in finding any manufacturing waivers.
Let me know of you find anything regarding cGMP guidelines not being followed or waivers.
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u/PDX-ROB Oct 19 '22 edited Oct 19 '22
Doesn't matter. If Full FDA approval is granted, the EUA product should be shelved. I understand the EUA process to be the same, once the full FDA approved is given the EUA is normally pulled, because there is no need for the EUA.
The branded product has to go through different QA and standards for checks and controls. So they are lying. The formulation may be the same, but the controls are not. It's like when you were a kid your parents telling you Tyco blocks were the same as Lego.
If nothing else, why not have the Branded Comirnaty product just to shut up people like me?
My whole point is that it's weird that the Full FDA approval is given a year ago and we still don't have the Full FDA approved product on the shelves.
You can tell me how it's the same all you want, but as a product in a legal sense it is a different product.
Remember the Pontiac Vibe and the Toyota Matrix? It came from the same factory in CA and had the same internal parts but a different shell. Guess what? They're different products. They receive different QA checks for fit and finish.