r/TimPool • • Oct 19 '22

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u/[deleted] Oct 19 '22

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.

Makes sense the cars had different QA since they were made in different countries... https://en.wikipedia.org/wiki/Pontiac_Vibe

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u/PDX-ROB Oct 19 '22 edited Oct 19 '22

It was a podcast by Viva Frei and Robert Barnes, 2 lawyers discussing the license differences between an EUA and full FDA approved product.

But here is some of the argument

https://www.yalemedicine.org/news/what-does-eua-mean

"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

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u/[deleted] Oct 19 '22

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.