Law This FDA approval document is strangely worded.

Cover your ass (British: cover your arse), abbreviated CYA, is an activity done by an individual to protect themselves from possible subsequent criticism, legal penalties, or other repercussions, usually in a work-related or bureaucratic context.
 
How is that strange? it looks like it’s saying that any existing manufactured stock has to say that it was made under the emergency approval, and only the new stuff can say it’s the full approval

On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.
 
Last edited:
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
 
You're misinterpretting what is being said.

It's saying that anything identifying the Pfizer-BioNTech COVID-19 Vaccine (ie the one that received EUA) shall clearly be identified as that version of the vaccine (and not reported as authorized or licensed by the FDA). Immediately under that section is where it gives approval and licensing allowances to the BRAND NAME of COMIRNATY (LOL, what an embarrasingly low-brow name for something so important).

Nothing really odd about the release, I've read it over twice.
 
Nothing about OP point/question has anything to do with the age ranges of anything.

It's a simple declaration that the vaccine authorized for emergency use is not labeled as approved by the FDA, only the branded version moving forward is. They're treating them as two entities with two separate approval processes for two different things and want to ensure that information is clear on any packaging, advertising, etc.
 
second sight said:
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Click to expand...
You thought that pictures of a porn actor were evidence of a crisis actor during the bomb threat the other day. You should probably take some time off from conspiracy theories.
 
Too many people think that the lack of FDA approval means there is something suspect in how these drugs have performed in trials, it does not.

The FDA has rules in place that require greater time to pass before approval, that is all. The vaccines performed beyond expectations and showed lower risk than most other approved vaccines... this is why they authorized their use before complete approval was reached.
 
Remember the push come school time. Document may help your children avoid forced requirement.

Cheers.
 
In other words, if this virus fucks you up..... you are not suing Pfizer... be wrecked and stay wrecked suckers.
 
Biontec wasn't actually approved, it just had it's EUA extended.

So yeah, Reuters and the Associated Press both printed a fake story. Unbelievable times we are living in.

Who ever is behind all of this will stop at nothing to inject everyone with this shit.

This is a bombshell story. People need to wake the fuck up and watch what is happening.
 
Pinyin said:
Biontec wasn't actually approved, it just had it's EUA extended.

So yeah, Reuters and the Associated Press both printed a fake story. Unbelievable times we are living in.

Who ever is behind all of this will stop at nothing to inject everyone with this shit.

This is a bombshell story. People need to wake the fuck up and watch what is happening.
Click to expand...

Please expound, links if you have them. I do not doubt your post, but for me to be swayed I need more.

Thanks.
 
Whippy McGee said:
Please expound, links if you have them. I do not doubt your post, but for me to be swayed I need more.

Thanks.
Click to expand...

The FDA has not approved Biontech. It only issued a new EUA (emergency use authorization).

Typically FDA approval takes 7-9 years.

https://www.fda.gov/media/150386/download

straight from the horses mouth.

Conditions Related to Printed Matter, Advertising, and Promotion

Y. All descriptive printed matter, advertising, and promotional material relating to the
use of the Pfizer-BioNTech COVID‑19 Vaccine clearly and conspicuously shall state
that:

Page 12 – Pfizer Inc.
• This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
 
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