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There are no FDA-Approved Wuhan Virus Shots Available


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2021 Oct 9, 6:33pm   769 views  24 comments

by Patrick   ➕follow (55)   💰tip   ignore  

https://lc.org/newsroom/details/100821-no-fda-approved-covid19-shots-available


Oct 8, 2021

WASHINGTON, D.C. – There are currently no fully FDA-approved licensed COVID shots available. All COVID shots remain under federal Emergency Use Authorization, meaning individuals have the “option to accept or refuse” the product.

On September 22, 2021, the Food and Drug Administration (FDA) sent a follow-up letter to the original approval to Pfizer pharmaceutical company that stated, “having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 23, 2021 letter of authorization in its entirety with revisions incorporated to authorize for emergency use the administration of a single booster dose of COMIRNATY.”

On page 6, footnote 12 of that letter the FDA clearly states, “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 to provide: an additional dose to the immunocompromised population, or a booster dose to the authorized population described in this EUA” (emphasis added).

On August 23, 2021, the FDA sent an approval letter to Pfizer regarding the BioNTech injection, Comirnaty. The letter states: “Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA, which is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.”



The FDA did a bait and switch by announcing it approved its “first COVID-19 vaccine” in order to push the “vaccine” mandates and protect the Pfizer pharmaceutical company from legal liability. The Pfizer injection, on the other hand, is still considered experimental under U.S. law.

There is a legal difference between products approved under authorization of emergency use (EUA) compared with those the FDA has fully licensed. The FDA issued another letter for the existing Pfizer shots which confirms they are still under EUA, are not fully approved, and has a liability shield. That means people must be told the risks and benefits, and they have the “option to accept or refuse” the product. The federal Emergency Use Authorization law and the FDA, including the FDA Fact Sheet, state unequivocally that each person has the “option to accept or refuse” the shots.

Therefore:

All existing Pfizer vials (in the hundreds of millions), remain under the federal Emergency Use Authorization (EUA) (meaning people have the “option to accept or refuse”);
The third or “booster” Pfizer shot is identical to the above and remains under the EUA with limited use to certain categories of people;
BioNTech received FDA approval for people ages 16 and above under the name Comirnaty, but there are no Comirnaty doses available in the United States;
In other words, there is currently NO FDA-approved COVID-19 injection available anywhere in the United States. Every COVID shot in America remains under the EUA law and thus people have the “option to accept or refuse” them; and
Even when an FDA-approved COVID shot becomes available, individuals are protected by federal law and many state laws from being forced to get these shots based on their sincere religious beliefs or conscience rights.
Liberty Counsel Founder and Chairman Mat Staver said, “The FDA has clearly stated there is currently no fully FDA-approved licensed COVID shot available to the population. The Pfizer injection that is currently available in the U.S. is not FDA approved and remains under emergency use authorization only. That means that people have the option to accept or refuse the shots.”

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2   WookieMan   2021 Oct 11, 4:43am  

porkchopexpress says
Pfizer admits that there are NO FDA-approved vaccines at all...even Comirnaty.

Not that the FDA is to be trusted anyway. Even the EUA shouldn't be trusted not following the typical path of vaccine testing.

Still pissed the wife got vaccinated. Pfizer too. Fucking got the jabs because she was getting shamed by clients/work. She doesn't lie well or feel good about lying, so she just got it. I would have just said "yes, I got the two jabs a couple months back." Who would ever know you're lying? She still needs to get tested to get in PR and St. Thomas in 6 days. So much for a vaccine that works so well that US territories still make you get tested to enter. Lots of trust in the vaccine and those silly CDC cards, lol.
3   porkchopXpress   2021 Oct 11, 7:14am  

Same. My wife got it secretly even after everything I told her.
4   WookieMan   2021 Oct 11, 7:28am  

porkchopexpress says
Same. My wife got it secretly even after everything I told her.

I'm gonna be sexist here, but women are easily manipulated. I've preached all the anti-vax points that are 100% valid. She still did it. I'm not mad, just disappointed. There was no reason for her to get it. She got dose 2 last week. I'm legit keeping an eye on her behavior and checking in on how she's feeling discreetly. Haven't noticed a change, but who the fuck knows. Maybe it takes months. Maybe it's fine. There was no point in her taking it as a healthy 38 year old woman though.
5   porkchopXpress   2021 Oct 11, 7:35am  

The ones who cave are submissive in nature or “followers”. This means a lot of women and beta males. They’re more concerned about what people will think vs doing what’s right.
6   Onvacation   2021 Oct 11, 7:36am  

WookieMan says
There was no point in her taking it as a healthy 38 year old woman though.

Rare death vs Covid 35-44
7   Onvacation   2021 Oct 11, 7:37am  

It's the vax that is the killer, not the Wuhan.
8   porkchopXpress   2021 Oct 11, 8:44am  

Onvacation says
It's the vax that is the killer, not the Wuhan.
Those are CDC numbers?
9   Onvacation   2021 Oct 11, 9:31am  

porkchopexpress says
Those are CDC numbers?


Yup.
The average number of rare deaths for 35 to 44 year old's until October of 2020 had been well under 150. In November it went to 165, December 204, January 293, February 308, March 453... In July of 2021 2,611 people aged 35 to 44 years old died of diseases that used to be rare.
https://data.cdc.gov/NCHS/Monthly-Provisional-Counts-of-Deaths-by-Select-Cau/9dzk-mvmi
11   Patrick   2021 Oct 22, 10:52am  

https://nitter.pussthecat.org/RWMaloneMD/status/1451249921386967041#m


Robert W Malone, MD
@RWMaloneMD
23h
I have been told my DoD medical personnel on Oahu that DoD is relabeling the Pfizer EUA product as "Comirnaty" to get around USG law that .mil cannot be forced to take unlicensed vaccines. If true, this is yet more illegal fraud by the "Brandon" team which should be prosecuted.
12   Patrick   2021 Nov 30, 8:51pm  

https://childrenshealthdefense.org/defender/judge-allen-winsor-pfizer-eua-comirnaty-vaccines-interchangeable/


11/30/21

COVID › VIEWS

Federal Judge Rejects DOD Claim That Pfizer EUA and Comirnaty Vaccines Are ‘Interchangeable’
A federal district court judge rejected a claim by the U.S. Department of Defense that the Pfizer-BioNTech COVID-19 vaccine being administered under Emergency Use Authorization is interchangeable with Pfizer’s fully licensed Comirnaty vaccine.


There are STILL no FDA-approved Wuhan Virus vaxxes available. Not that I'd want one, but it is clearly criminal to demand the injection of still EXPERIMENTAL gene therapy.
13   HeadSet   2021 Nov 30, 10:20pm  

Patrick says
I have been told my DoD medical personnel on Oahu that DoD is relabeling the Pfizer EUA product as "Comirnaty" to get around USG law that .mil cannot be forced to take unlicensed vaccines. If true, this is yet more illegal fraud by the "Brandon" team which should be prosecuted.

That should mean that these college presidents who forced the students to take the jab or be disenrolled are now liable for any vax injuries.
14   Misc   2021 Dec 1, 9:54pm  

HeadSet says
Patrick says
I have been told my DoD medical personnel on Oahu that DoD is relabeling the Pfizer EUA product as "Comirnaty" to get around USG law that .mil cannot be forced to take unlicensed vaccines. If true, this is yet more illegal fraud by the "Brandon" team which should be prosecuted.

That should mean that these college presidents who forced the students to take the jab or be disenrolled are now liable for any vax injuries.


If anyone has any faith in our justice system, they are in a sorry state.
15   Patrick   2021 Dec 2, 9:47am  

https://childrenshealthdefense.org/defender/under-federal-law-can-your-employer-make-you-get-covid-vaccine/

States and employers, under federal law, can’t mandate emergency use products such as the Pfizer and Moderna COVID vaccines. But that doesn’t mean some won’t try.
16   Patrick   2021 Dec 18, 5:55pm  

6th Circuit Ruling Restoring Employer Vaccine Mandate Falsely Claims ‘Options Available to Combat COVID-19 Changed Significantly’ When ‘FDA Granted Approval to One Vaccine on August 23, 2021’

https://theohiostar.com/2021/12/18/6th-circuit-ruling-restoring-employer-vaccine-mandate-falsely-claims-options-available-to-combat-covid-19-changed-significantly-when-fda-granted-approval-to-one-vaccine-on-august-23-2021/?source=patrick.net
17   Patrick   2022 Mar 19, 7:28pm  

There is still no FDA-approved Wuhan Virus vaxx available in the US.

So why does the Wikipedia page say that there is? And why is that page locked against edits?

18   Patrick   2022 Jun 3, 1:39pm  

https://dossier.substack.com/p/ghost-shot-pfizer-quietly-admits


It was celebrated as a cause for national relief, and many Americans arrived at their local pharmacies under the impression, via government and pharmaceutical propaganda, that they were receiving an FDA-approved COVID vaccine. Yet that legally distinct product, as we know it, never existed. And now we know, via Pfizer, that it will never exist.

For the uninitiated:

Comirnaty is a legally distinct product from the emergency use authorization (EUA) shots, and It has never made its way to market. For months on end, no such vaccine has ever become available. Those who received the “Pfizer shot(s)” have been injected with the emergency use authorization (EUA) version of the shots.
19   richwicks   2022 Jun 3, 1:48pm  

Patrick says
So why does the Wikipedia page say that there is? And why is that page locked against edits?


I think the time for rhetorical questions is over. Just state the obvious for people that don't get it yet - Wikipedia is propaganda now.
20   Undoctored   2022 Jun 5, 11:41am  

The formulation was approved for distribution under license for the first two doses only, ages 16 and up, but it’s being distributed as an EUA product. Got that? The substance, its storage, preparation and administration are the same between the EUA and licensed versions. The main difference is the packaging. Also the licensed stuff doesn’t need the emergency declaration to be in effect to be distributed.

They’re not withholding some safer, more effective vaccine. The PREP act would shield the manufacturer against liability for injury even in the case of licensed Comirnaty, so it’s not to avoid liability, or is it?

Pfizer probably risks something by distributing it under license at this time but I’m not sure what. Maybe they’re just protecting themselves in case the emergency declaration gets canceled, PREP act protection disappears and they get sued. Or maybe they could somehow be sued for violating the terms of the license for something that the PREP act doesn’t cover.
21   mell   2022 Jun 5, 11:52am  

Undoctored says

The formulation was approved for distribution under license for the first two doses only, ages 16 and up, but it’s being distributed as an EUA product. Got that? The substance, its storage, preparation and administration are the same between the EUA and licensed versions. The main difference is the packaging. Also the licensed stuff doesn’t need the emergency declaration to be in effect to be distributed.

They’re not withholding some safer, more effective vaccine. The PREP act would shield the manufacturer against liability for injury even in the case of licensed Comirnaty, so it’s not to avoid liability, or is it?

Pfizer probably risks something by distributing it under license at this time but I’m not sure what. Maybe they’re just protecting themselves in case the emergency declaration gets canceled, PREP act protection disappears and they get sued. Or maybe they could somehow be sued for violating the terms of the license for something that the PREP ...

Yeah I think the full approval was given for age 16 and up. Same stuff. Everything below 16 is covered by EUA. Crazy that parents inject their kids with this shit. But the trial data for full approval is fudged anyways, there isn't a single study with reduction of overall deaths as endpoint, neither for infections, because they don't work. All endpoints are antibody based and are useless.
22   Undoctored   2022 Jun 5, 1:31pm  

Another fun fact. Comirnaty (whether or not it exists) has not been approved to stop infection or transmission. So the approval means nothing in the context of a mandate to protect people from asymptomatic (or even symptomatic) carriers.

Straight from the FDA:

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


Does Comirnaty protect against asymptomatic SARS-CoV-2 infection (i.e. the individual is infected with SARS-CoV-2, but does not have signs or symptoms of COVID-19)?

It is not known if Comirnaty protects against asymptomatic SARS-CoV-2 infection.

If a person has received Comirnaty, will the vaccine protect against transmission of SARS-CoV-2 from individuals who are infected despite vaccination?

Most vaccines that protect from viral illnesses also reduce transmission of the virus that causes the disease by those who are vaccinated. While it is hoped this will be the case, the scientific community does not yet know if Comirnaty will reduce such transmission.
24   Patrick   2022 Aug 15, 12:50pm  

https://dossier.substack.com/p/one-year-later-how-the-biden-admin


One year later: How the Biden Admin, Big Tech, and Pfizer fooled Americans into taking "FDA approved" COVID vaccines that never actually existed

The American government engaged in a pharmaceutical sales campaign, based on polling data, to trick its own citizens into taking a shot that they thought was FDA approved. However, everyone in America was being injected with — and continue to take — the legally distinct emergency use authorization (EUA) version of the shot. The FDA approved Comirnaty shot has never become available to the American public in the United States. ...

Finally, in June, as reported in The Dossier, Pfizer acknowledged in quiet filings to the CDC that they would never produce the FDA approved version of Comirnaty that was authorized on August 23, 2021. ...

Now, as the one year anniversary for the FDA approval of Comirnaty approaches, we are left with more questions than answers. The Biden Administration, Big Pharma, and Big Tech teamed up to fool Americans into taking a shot that they thought was FDA approved, but it turns out, that shot never actually existed, and will never exist.

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