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sorry the typo: interpretation

Two documents: https://www.fda.gov/media/151710/download https://www.fda.gov/media/150386/download

The FDA Letter: Our STN: BL 125742/0 - BLA APPROVAL BioNTech Manufacturing GmbH August 23, 2021 Attention: Amit Patel
Pfizer Inc.
235 East 42nd Street
New York, NY 10017 Dear Mr. Patel:

It appears that the "BLA APPROVAL" only gives Pfizer an authorization (license) to manufacture the COVID-19 Vaccine and use it in accordance to the guidelines of the EUA.

And this FDA Letter: August 23, 2021
Pfizer Inc. Attention: Ms. Elisa Harkins 500 Arcola Road Collegeville, PA 19426
Dear Ms. Harkins:

Only gives Pfizer the reauthorization of the EUA.

Am I on the right track? Is there another document that clearly spells out everything.

sorry the typo: interpretation Two documents: https://www.fda.gov/media/151710/download https://www.fda.gov/media/150386/download The FDA Letter: Our STN: BL 125742/0 - BLA APPROVAL BioNTech Manufacturing GmbH August 23, 2021 Attention: Amit Patel Pfizer Inc. 235 East 42nd Street New York, NY 10017 Dear Mr. Patel: It appears that the "BLA APPROVAL" only gives Pfizer an authorization (license) to manufacture the COVID-19 Vaccine and use it in accordance to the guidelines of the EUA. And this FDA Letter: August 23, 2021 Pfizer Inc. Attention: Ms. Elisa Harkins 500 Arcola Road Collegeville, PA 19426 Dear Ms. Harkins: Only gives Pfizer the reauthorization of the EUA. Am I on the right track? Is there another document that clearly spells out everything.

(post is archived)

[–] • 9 pts (edited )

This is clearly being done on purpose to cause legalese confusion and bog everyone down in debates about approval status when the approval status is and should be 100% irrelevant and the only correct position is to deny and refuse to allow any medical procedure to be mandated whether it's an approved procedure or not.

[–] • 4 pts

How quick some forget "my body my choice"

[–] [deleted] • 3 pts

The new drug, filed by BioNTech, named COMIRNATY, has full approval for people 16+. Only BioNTech is authorized to produce that drug, and only that specific drug, COMIRNATY, is able to be prescribed outside of the EUA.

The Pfizer mRNA Covid vaccine is "technically" a different drug, even if it is physically identical. It is still only authorized under the EUA, and is available for people 12+.

So it's legalese confusion. BioNTech's "Comirnaty" is fully approved for normal use, and everything else is still only authorized under the EUA, including Pfizer's mRNA Covid vaccine.

[–] • 1 pt

First I thought the same, but Footnote 9 "described in this EUA": 9 Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15, or that are approved to provide an additional dose to the immunocompromised population described in this EUA.

[–] [deleted] • 0 pt (edited )

It's confusing, but what I'm sussing out is that, COMIRNATY is fully approved, but there isn't a lot of the drug produced by BioNTech under the name COMIRNATY to fully vaccinate the population.

Since they don't have enough of COMIRNATY, they still need to re-authorize Pfizer's mRNA Covid Vaccine under the EUA. In addition, COMIRNATY isn't authorized for ages 12-15, only the Pfizer mRNA Covid Vaccine is, so the only way to vaccinate everyone down to age 12 is to keep the EUA-only version. That's what I'm getting out of it.

I'm not really sure why it's being said in the way that it is...but my suspicion is they know they're rushing approval, and that even with approval they can't get everyone vaccinated that they want, which is everybody. They're treating the two drugs as if they are different drugs, based on who filed for what, while being able to talk about them as if they're identical. Perhaps this is Pfizer's way of avoiding responsibility. You can now sue BioNTech if COMIRNATY harms you. You still can't sue Pfizer for the EUA vaccine, because of the EUA.

So the point of rushed approval is to get the hesitant to take their shots. They think 30% of us were just waiting for approval. Maybe so, but rushed approval is just as bad as no approval to me. Maybe they're also hoping that the confusion in the names will get people to trust the EUA vaccine in addition to COMIRNATY. And, of course, now they can market COMIRNATY, with TV ads and such. Being that COMIRNATY is the same as Pfizers EUA vaccine, they're technically getting to market their still experimental vaccine.

[–] • 1 pt

thanks for making my head spinnnnnnnnnnnnnnnnnnnnnnnnnnn

[–] [deleted] • 1 pt (edited )

Never accept your opponent's premise.

In this case, it goes something like this:

It's FDA approved, now out and get the vaccine!

The last thing you'd want to do is haggle over the approval. This follows the assumption that as long as it's FDA approved, it must be "safe and effective".

If it isn't 100% approved now, they can make it happen next week and you're left with no leg to stand on. It goes a little more like this:

Fuck you, communist pig. Your son is a degenerate, crackhead, whore hopping traitor and you've footed the bill for his escapades more than once. Where's the laptop, Joe? lol

Then every time he tries to make a point you refuse to let it go "where is the laptop" and "we have the evidence" and demand to see his banking records. You just keep mocking the fuck, that's how you destroy someone publicly.

Sometimes I wish we could get back to that old and effective way of dealing with known enemies instead of having to pretend that they're acting in good faith.

Just once, I'd like one of these milquetoast Republicans to go on CNN and say:

Oh you know what? Screw you, Ted. You lying, thieving, baby fucking chi com whore. You don't like that? Maybe you should sue, I can make things very interesting for you. That's what I thought, you little weasel.

Or whatever, assume the fuck's name is Ted. lol

[–] • 1 pt

> Is there another document that clearly spells out everything.

Agree, would like to use something for ammunition.

[–] • 0 pt

It’s approved, but just under a different name than the original. For “logistical purposes” the vaccine previously manufactured under a different name will still be EUA. Same vaccine, same formula, just different name and manufacturing date. I think they reaffirmed the EUA for the existing vaccine because there are still a lot of doses sitting around that need to be used up. You can read this Q&A from the FDA regarding the vaccine to confirm:

https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna

[–] • 0 pt

thanks. this is the best read explaining it.

[–] • 0 pt

Nothing more then a distraction so Nancy Drunklosi could vote on her Loco Cortez Green Deal BS Bill.