FDA Approval

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  • Mon, Aug 23, 2021 - 04:43pm

    #21
    Wcave

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    FDA Approval

I was afraid of this. I hope chris reads these threads. My understanding is this is NOT an fda approval but an indefinite extension of the EUA. Last line of the approval is.

On the last page it reads:

This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.

  • Mon, Aug 23, 2021 - 04:46pm

    #22

    Jim H

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    Excellent post by Meryl Nass MD regarding Pfizer

http://anthraxvaccine.blogspot.com/2021/08/are-fda-and-pfizer-biontech-scamming-us.html

Monday, August 23, 2021
Are the FDA and Pfizer-BioNTech scamming us with a license-in-name-only? And WHY do they want us to be vaccinated so badly???
This is a convoluted legal argument, but since it hinges on the potential loss of huge amounts of money, I think there is a good chance my guess is correct.

EUA or “authorized” vaccines and drugs are defined as experimental. Experimental products require informed consent, and there are other restrictions on their use. Most lawyers believe, as I do, that they cannot be legally mandated, because they require you to have the right to refuse. It is written into the EUA statute. There also cannot be approved, licensed drugs that do the same thing as the EUA drug or vaccine, and of course, in this case both HCQ and IVM can prevent as well as treat Covid.

This has troubled the federal government. And so it had the DOJ’s Office of Legal Counsel manufacture a legal opinion in late July that you could be forced to be vaccinated even while the vaccines were only authorized. However, the OLC arguments were ridiculous and therefore ignored.

When that didn’t work, federal threats got heavy. First it was going to be mandates “if you wanted to do business with the government.” Then mandates for the military. Then mandates for healthcare workers, schools, colleges, you name it. And federal workers.

But legally, all these mandate threats hinged on licensure, aka “approval.” No one wanted to go to court defending a mandate under EUA. And the feds probably promised all the employers, schools, states, etc. that a license would be issued before colleges and schools started.

But there is a huge elephant in the room. Under EUAs, the government pays for the product and the manufacturer has NO liability, unless you can prove willful misconduct AND the DHHS Secretary allows you to sue. That has never happened.

But once the product (Pfizer’s vaccine, today) is licensed, the liability shield under EUA disappears. Unless there has a been a secret agreement regarding liability after approval, which is probably not legal, Pfizer will be liable for all injuries sustained by the licensed vacine. And Pfizer’s vaccine seems to be causing a record number of injuries and deaths, based on the VAERS data.

The FDA approval letter, issued today, was unusual. It stated that current bottles of vaccine, which are not branded with the “Cominarty” brand name, are still authorized, not approved. Only newer bottles with “Cominarty” labels will be approved, licensed product.

What that means is that people cannot be mandated to receive vaccine from the old bottles. But if they do accept the non-brand vaccine, they cannot sue if injured.

If they receive the branded vaccine and are injured, they can be mandated to take it, but they can also sue the company for damages.

Here is what might be happening. FDA issued a license, so everyone thinks the mandate is now in effect. But if no “Cominarty” labelled vaccine is being administered, just the old authorized vaccine, there is no licensed product being used, and there is no actual mandate. And no ability to sue if injured.

If you have looked at any of the leaked contract documents between Pfizer and Israel or Albania, or heard about the contract signed in Brazil, you will probably agree with me that Pfizer would not be willing to accept liability for this product.

So: if it does not say “Comirnaty” it cannot be mandated. If it does say “Comirnaty,” it can be mandated. But if it doesn’t say “Comirnaty it is still experimental and you cannot be forced to take it, and if you do get injured, you are out of luck.

Don’t sign a liability waiver for this product! Don’t sign away your rights if you take it.

I am guessing Pfizer will continue to supply the old “authorized” vaccine to avoid liability… and that explains the convolution in FDA’s letter this morning. If I am correct, you won’t have to take it… Anyway, not till Pfizer gets rid of the liability problem…which could happen, as a bill has been introduced in Congress to solve Pfizer’s problem. It’s the Vaccine Injury Modernization Compensation Act of 2021. Will our legislators throw us under the bus again and remove manufacturer liability for the few vaccines that still have it? Be forewarned.

You can track the bill here.

  • Mon, Aug 23, 2021 - 05:21pm

    #23
    Chuck in Belize

    Chuck in Belize

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    Reply To: FDA Approval

Whoa! Hang on!
Wcave just wrote,

On the last page it reads:

This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.

Please let us have the link for this document!
It wasn’t anywhere to be found in the Press Release.
Where did you dig this up?

Or maybe I am just missing something.
Are you saying, the original EUA is still in effect because that’s the last line of the EUA, or that today’s “Final Approval” contains the words “this EUA” in it??
I am a bit confused, I guess.

  • Mon, Aug 23, 2021 - 05:30pm   (Reply to #23)

    #24
    Kathy

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    FDA Approval

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

It is in the FDA letter.

Mike from Jersey asked ,

Is Biden delusional?

No, he’s not delusional.  Biden has never met a lie he didn’t like.  Watch this and see what I mean:

https://youtu.be/_f2Z30j61aw?t=210

Three blatant lies in the span of thirty seconds!  He will say anything that pops into his head, whether he knows it to be true or not, and hopes you will trust the words and fake sincerity.  People who make a habit of lying constantly eventually are unable to discern truth from the lies.

 

  • Mon, Aug 23, 2021 - 05:36pm

    #26
    westcoastjan

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    FDA Approval

https://rumble.com/vll4b9-fda-approval-illegal-doctor-reveals-pfizer-insert-proves-criminal-regulatio.html

BREAKING FINDINGS! FDA Approval may give lawyers MORE AMMUNITION to fight mandates and the Pfizer injections from being pushed onto your KIDS!

The package insert reveals “criminal action”, according to Dr. Jane Ruby, who joins Stew Peters to discuss the unprecedented action taken by the FDA.

Have not watched it so cannot speak to content but looks like it might be something…

  • Mon, Aug 23, 2021 - 05:46pm

    #27
    Karen Torsoe

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    FDA Approval

I recently saw this interview by Karen Kingston on the Stew Peters show.

I would love to know what the community thinks.

https://www.redvoicemedia.com/2021/07/deadly-shots-former-pfizer-employee-confirms-poison-in-covid-vaccine/

I can send a PDF of her proof to anyone that pm’s me. Otherwise, you can also get it by clicking below the video on that link.

Karen from Florida

  • Mon, Aug 23, 2021 - 06:09pm

    #28
    Kat43

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    deleting post that FDA approval was not granted

The link looks legit but maybe there is a glitch somewhere?

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

I have followed Mish (Mike Shedlock) for a long time, but his coverage of vaccines have been very disappointing. He obviously doesn’t bother to look deeper into issues, just scratching the mainstream media surface. His commentary is incoherent and mostly useless.

I wish he stuck with economics. He already lost many readers last year with constant posts about Trump politics. I rarely read his blog these days.

  • Mon, Aug 23, 2021 - 06:37pm   (Reply to #28)

    #30

    Jim H

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    Kat.. did you see the post from Meryl Nass, MD?

I think that the devil is in the details because they are doing two things at once here.. granting approval for the new vials that will be made and named with the updated name (Cominarty?) and yet keeping EUA in place for all existing stock.  Games being played.  Is Meryl’s take on this wrong?  Part of the game has to do with Pfizer’s losing (or not losing as the case may be) their (EUA) liability protection, at least not for now.

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