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2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine
The Defender ^ | 8-24-21 | RFK Jr & Meryl Nass, MD

Posted on 08/24/2021 7:49:16 PM PDT by Meah

Buried in the fine print of Monday’s approval by the U.S. Food and Drug Administration of the Pfizer Comirnaty COVID vaccine are two critical facts that affect whether the vaccine can be mandated, and whether Pfizer can be held liable for injuries.

Monday, the U.S. Food and Drug Administration (FDA) approved a biologics license application for the Pfizer Comirnaty vaccine.

The press reported that vaccine mandates are now legal for military, healthcare workers, college students and employees in many industries. New York City Mayor Bill de Blasio has now required the vaccine for all teachers and school staff. The Pentagon is proceeding with its mandate for all military service members.

But there are several bizarre aspects to the FDA approval that will prove confusing to those not familiar with the pervasiveness of the FDA’s regulatory capture, or the depths of the agency’s cynicism.

First, the FDA acknowledges that while Pfizer has insufficient stocks of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — available for use.

The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product….

(Excerpt) Read more at childrenshealthdefense.org ...


TOPICS: Culture/Society
KEYWORDS: bloggers; fda; pfizer; vaccine; vaccines
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This article is worth a read. It looks like interesting potential liability issues for Pfizer. Similar to the 4 minute Bannon and Malone clip, but includes legal implications.
1 posted on 08/24/2021 7:49:16 PM PDT by Meah
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To: Meah

They should be liable. For everyone else, if you provide something to someone that goes in their body, sell, give away or whatever, and they end up in bad shape or dead due to what you provided them, your azz is going to held responsible.


2 posted on 08/24/2021 8:01:18 PM PDT by dragnet2 (Diversion and evasion are tools of deceit)
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To: Meah

It all seems a bit fishy....

I think the new vax has to go through trials of some sort before actual approval...

Everyone is acting as though the Phizer jab available now has been fully approved.... has it or not?

Everything about covid is so politicized you can’t simply trust anything being claimed on either side.


3 posted on 08/24/2021 8:02:43 PM PDT by Bobalu (The higher the monkey climbs, the more you see his ass.)
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To: Meah
Steve Bannon & Dr. Robert Malone: Vaccine FDA Approved? Really? Not.
4 posted on 08/24/2021 8:03:22 PM PDT by Robert DeLong
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To: Meah

That it will murder you. No biggie


5 posted on 08/24/2021 8:04:01 PM PDT by Truthoverpower (Arizona !!!! Now the TRUMP TRAIN is getting back on TRACK ! TRUTH! FREEDOM ! LIBERTY! )
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To: Bobalu

As I understand it, it is fully approved for those 16 y/o and over.
The EUA is for 12-15 y/o and the booster shot.


6 posted on 08/24/2021 8:06:16 PM PDT by EEGator
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To: dragnet2

Btt.


7 posted on 08/24/2021 8:06:24 PM PDT by RebelTXRose (Our Lady of Fatima, Pray for us! PRAY THE ROSARY!)
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To: Bobalu

president biden today said it was fully approved..do you trust him?


8 posted on 08/24/2021 8:06:48 PM PDT by rolling_stone
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To: Meah
Sounds like Pfizer got the FDA to help them pull a "bait & switch"


9 posted on 08/24/2021 8:09:13 PM PDT by VideoDoctor
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To: Meah

I read somewhere that this approval is for a future drug and does not apply to the various Covid jabs many have taken.

That makes sense as so many vax deaths and injuries are attributed to their vax. They would not survive a process making them financially liable. Big Pharma owns our politicians.


10 posted on 08/24/2021 8:12:27 PM PDT by WWG1WWA (Beware the fury of a patient man. - John Dryden )
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To: Meah

No one can ultimately “force” anyone to be vaccinated. But if someone owns a business, controls military facilities, or runs a school they can legally demand that people entering their facility meet certain health and safety criteria and exclude anyone that doesn’t. People are required to wear hard hats, ear protection, and safety goggles in certain industrial situations for example.

People can refuse to meet the criteria and not enter the facility or they can comply. If an employer can make reasonable accommodations for them they must show evidence of this or face fines.

I can understand the fear and resistance to mass vaccination given the scientist’s conflicting messages and lack of long term studies but unless the majority of people are prepared to change the current laws by electing people sympathetic to
their position they are not going to avoid getting vaccinated at some point. So far the majority is supporting vaccinations. If the medical case deteriorates further this could change.


11 posted on 08/24/2021 8:16:06 PM PDT by Dave Wright
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To: Meah
I don’t believe the FDA approval status of these vaccines has anything to do with the immunity from lawsuits that protects the manufacturers. There have been a number of reports out there in the last 24 hours claiming that Pfizer is now exposed to potential lawsuits because the new FDA license removes the EUA designation and eliminates the protection Pfizer had for its vaccine under the PREP Act of 2005. I’m quite sure these reports are factually incorrect.

While it’s true that a vaccine that is no longer issued to the public under an EUA isn’t covered by the legal protections of the PREP Act, these manufacturers would still be covered under a different Federal law that applies to traditional FDA-approved vaccines: the Public Health Service Act of 1988.

12 posted on 08/24/2021 8:18:31 PM PDT by Alberta's Child ("And once in a night I dreamed you were there; I canceled my flight from going nowhere.")
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To: dragnet2

Double sword. That could go for many things...guns, cars, booze, drugs, etc.


13 posted on 08/24/2021 8:27:05 PM PDT by TribalPrincess2U
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To: TribalPrincess2U

They already do.


14 posted on 08/24/2021 8:35:40 PM PDT by dragnet2 (Diversion and evasion are tools of deceit)
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To: Bobalu

The licensed labelled product....which is not available at present is approved. For now it appears that the only products available are j and j, moderna, and pfizer eua product.
Maybe the pandemic will ease or the virus will mutate far enough that the vaccine won’t work very well, before all stocks are used up...and it will be a moot point.
And I completely agree that one cannot trust much of the “information” out there. Both sidex.


15 posted on 08/24/2021 8:49:44 PM PDT by Getready (Wisdom is more valuable than gold and diamonds, and harder to find.)
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To: Meah

bkmk


16 posted on 08/24/2021 8:55:27 PM PDT by sauropod (Time is like quicksilver, smearing the years... - Bill Nelson)
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To: Meah
In my opinion anyone who does not want to get this vaccine should not do so under any circumstances, zero, none, nada.

If enough people leave these industries be they government agencies or private employers, it will crush that industry. There will be plenty of other places to work. That's easier said than done I know but remember you can't get get unvaxed. Lastly if you don't want to get this vaccine you probably already know this is just the start of this medical experimentation tyranny. Make a stand now while the numbers are on your side.

Take a look at the video of Nancy Piglosi at her fund raiser event. Dozens of millionaires and billionaires sitting right on top of each other drinking and eating and not one of them wearing a mask. Many of them are advanced age also which puts them in the supposed higher risk category yet none of them wearing a mask. At the same time the wait staff are all waiting on them hand and foot and all are forced to wear a mask. It's a literally grotesque display of arrogance. Do you think ANY of these people have been vaxed like they are telling you to do? Since when do disgusting leftists do ANYTHING they force on others?

You can take it to the bank these arrogant commie pigs are not getting this vaccine and that should tell you something. What do they know that you don't?

17 posted on 08/24/2021 9:04:04 PM PDT by precisionshootist
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To: Meah

The name of their vaccine sounds suspiciously like commie n ratty.


18 posted on 08/24/2021 9:06:57 PM PDT by Hell to pay
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To: EEGator

There is more to it than that

The brand name vax, Comirnaty is FDA licensed and approved, and mandates are being written based on this, but there is little to no supply (and this article speculates it will not generally be available in America until Pfizer can take care of the associated liability that approval brings)

There is, however, plenty of the “old” vaccine stock that is still only authorized for emergency use. And Pfizer is protected from liability on the EUA product

It’s a bait and switch. They want to use the power of force of the licensed product to trick you into thinking you have no right of refusal while they give you the product which by law you have a right to refuse


19 posted on 08/24/2021 9:17:15 PM PDT by Mygirlsmom (Back after a long hiatus. Now mygrandkidsgrandma)
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To: Mygirlsmom

I believe they authorized extending the shelf life of existing product as well.


20 posted on 08/24/2021 9:34:04 PM PDT by smokingfrog ( sleep with one eye open (<o> --- )
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