Great breakdown of the FDA Approval letter for the clot shot
(vivabarneslaw.locals.com)
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Great Analysis by lawyer and a champion of populists, Robert Barnes of the BLA issued by the FDA. If you're not on locals, here's a rundown:
Pfizer jab IS approved as COMIRNATY
Simultaneously, EUA was extended for the Pfizer jab
Current batches are NOT COMINARTY and NOT approved by FDA and still fall under EUA. The BLA ONLY APPLIES TO COMINARTY!
The provision for the BLA is for future production of COMINARTY, which may not even get produced anytime soon.
The FDA insisted that there be more testing, with a schedule of reports in the 2023-2025 timeline.
In the rush to approval, the FDA bypassed its own vaccine advisory board and declared the vax safe.
Pfizer only filed for COMINARTY's BLA around May. With approval in August, that makes a 3 month (!) approval process. Ridiculously short.
Until COMINARTY actually hits the shelves, all of Pfizers vaccines are EUA-only. This includes any batch that ISNT properly labelled as COMINARTY and following the labelling they put up in the BLA (includes ingredient list, dosage, etc.)
Barnes has a follow-up video on why the FDA-approved vax may not even get produced anytime soon. Reason being that they probably want full immunity, which they lose by producing COMINARTY. Link: https://vivabarneslaw.locals.com/post/992345/why-that-fda-approved-vaccine-aint-coming-anytime-soon
The FDA was extremely scummy with the language used. The EUA extension is equivocated several times. Legally, they extended the EUA to cover the vax as a whole. They obfuscated this by adding in the language of Under-12's into it. The EUA is extended for all uses for COVID for the Pfizer jab.
It looks like the reason for extending the EUA for the Pfizer shot, is to cover Pfizer, as they might not actually produce COMINARTY anytime soon. (See point #9)
The FDA was extremely scummy. The same person that wrote this memo wrote the response to the Children's Health Defense lawsuit put forth by Robert F. Kennedy & Barnes. Its like they tried to respond and pre-empt that suit over an EUA mandate.
So in short, the FDA went through extremely sketchy measures to override their own protocols in BOTH extending the EUA AND approving the BLA for the Pfizer vax. Only COMINARTY is FDA-approved, and it this does NOT apply retroactively to current batches of the vax. Also, Pfizer may not even produce COMINARTY for a while, meaning current vax's are all EUA.
This is pretty much a sham cover for vax mandates by the Administration of Resident Zhou Bi-Deng under the pretext of having an FDA-approved vax, without actually even producing said vax. Rather sneaky.
Hope this helps clear up all the confusing language over the Pfizer approval letter.
This is a great synopsis. I'm trying to figure out how to explain this to friends that believe that the Coronavirus vaccine now has FDA approval.
What they've done is purposefully muddied the waters so that journalists can now make Fake News stories about how the vaccine now has full FDA approval.
Some reporters understand it and will smirk while they write purposefully misleading stories. Most don't understand and don't care and will just write stories based on their twitter feed.
I'm not going to upvote this because the video will not play unless I create an account.
Here's a rundown fren. Similar arguments, just in written form. No account or paywall either.
https://childrenshealthdefense.org/defender/mainstream-media-fda-approval-pfizer-vaccine/
Hah I had already liked your excellent comment and replied!
Incidently, I know what a EUA is, but what is a BLA?
Biologics License Application. Fancy form filled out by pharma to request permission to sell their drug. Upon approving, the FDA formally grants FDA-approval and the drug is now an FDA-approved drug.
Thanks for posting that. I was still confused as to what FDA approval meant.
Approval has zero relevance to me.