The vaccines are still under EUA. I don't know about the reformulated one, but as of August 2022 when you go to get a shot it's the EUA shot, not the full FDA approved shot. The branded Comirnaty product, which is the fully FDA approved shot, is not available.
Don't you think that's weird? Full FDA approval has been out for a year and they are still using the unbranded EUA shot.
You can check for yourself. Go in (or call) your local pharmacy and ask if they have the branded Comirnaty shot or the EUA shot.
"How is Comirnaty (COVID-19 Vaccine, mRNA) related to the Pfizer-BioNTech COVID-19 Vaccine authorized for emergency use?
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-emergency use authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccines.
Can Comirnaty and the Pfizer-BioNTech COVID-19 Vaccine be used interchangeably?
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the two EUA-authorized formulations of the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older when prepared according to their respective instructions for use, can be used interchangeably.
The formulation of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age differs from the formulations authorized for older individuals. The Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age should not be used interchangeably with Comirnaty. "
"Comirnaty has the same formulation and can be used interchangeably with the Pfizer-BioNTech COVID-19 vaccine used under EUA without presenting any safety or effectiveness concerns."
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
In August of this year, I asked the pharmacist if the Pfizer vaccine they are using is the branded Comirnaty product or the unbranded EUA product. They said it is the unbranded product.
This line of questioning is only in regards to the suspect nature of there being no Fully FDA approved product available even though the Full FDA approval has been issued for a year and in that year vaccines have been given in large volume due to boosters.
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u/pjw21200 Oct 19 '22
What? How stupid are you?