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There’s Definitely Something Very Wrong with Pfizer-BioNTech’s ‘Full Authorization’ Docs
Kyle Becker ^ | August 25, 2021 | Kyle Becker

Posted on 08/26/2021 11:48:23 AM PDT by NoLibZone

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To: Sacajaweau

Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15, or that are approved to provide an additional dose to the immunocompromised population described in this EUA.

What booster shot? That specifically says no approved additional dose to the immunocompromised - which to me “additional dose” is a booster shot.


41 posted on 08/26/2021 1:11:43 PM PDT by ro_dreaming ("XX = female; XY = male. Who's the science deniers now?" - Me)
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To: Political Junkie Too
Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
They are one in the same. No bait and switch.(The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty)as per above. The FDA approved the Pfizer vax for 16+ and that vax has been given a marketing name, Comirnaty. At the same time, they had to revise and re-authorize the EUA usage for 12-15 year olds.
Page 2 para 1 - 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.
Merely reiterating the above announcement but notice the use of biologics license application (BLA).
Page 2 para 2 - On August 23, 2021, 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 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA. https://www.fda.gov/media/150386/download
Simply states that the EUA is being revised and renewed for certain uses that are not included in the approved BLA

Does that make sense now?
42 posted on 08/26/2021 1:23:32 PM PDT by Pollard (#*&% Communism)
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To: Political Junkie Too

“Isn’t it truly a bait and switch to use the authorization of one vaccine to mandate the use of another one?”

EXACTLY!!!!


43 posted on 08/26/2021 1:25:12 PM PDT by Mygirlsmom (Back after a long hiatus. Now mygrandkidsgrandma)
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To: NoLibZone

NoLibZone wrote:

“Robert Barnes @barnes_law

There is no *available* FDA approved licensed vaccine. Here’s what is happening. If FDA approved & licensed COVID19 vaccine, it would have to revoke the EUA vaccines & subject the vaccine maker to more liability risk. So it only approved a future vaccine that isn’t “available”.

3:01 PM · Aug 25, 2021”

What they did was label some empty vials “Comirnaty” and leave the full ones labelled “Pfizer BioNTech”....

The Comirnaty was OK’d, not available now, but legally actionable, and the BioNTech was still EUA’d, available now, but legally not actionable.

Weasels.....

They need some good lawyers to go after them big league....


44 posted on 08/26/2021 1:28:08 PM PDT by WildHighlander57 ((WildHighlander57 returning after lurking since 2000) )
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To: dadfly

dadfly wrote:

“thanks for the post. i’m still studying this, haven’t made a decision on what this “approval” is. i’ve read enough to conclude that there is an adulteration of the normal timelines and processes, though. there’s apparently a bunch of conditions too. but there is definitely something “rotten” in the FDA concerning this new style “vaccine.”

another apparent thing in the “approval” letter was the vote for approval. that vote wasn’t unanimous. it was apparently 17 votes for out of 22 for license approval (think there was one abstention). that’s a big tell, imo. even their kangaroo court committee didn’t vote unanimously.

also over the last few months. there has been a lot of concern about whether this is a vaccine or something else. i now see why the folks who didn’t want to call it a vaccine were so adamant about it. i wasn’t concerned about this as the drug was ultimately producing antibodies like a vaccine.

but now i see their point, this is probably not legally vaccine but some kind of gene therapy which can function as a vaccine. if it’s a gene therapy, then their immunity from law suits takes a big hit. even if they call it a vaccine.

the laws about vaccines do not give blanket immunity for pfizer or a vaccine either. i’ve found sites for law firms out there that apparently make their living suing for vaccine injuries (like their pneumonia vaccine given to children for which there are many injuries according to the law firms i’ve perused online).

there may be compensation pools out there set up by the gov’t/big pharma for vaccine injuries. if so, then logically, law suits could be filed to drain these pools since we have millions of covid19 vaccine injuries reported now, thus getting to pfizer and their ilk.

anyway that’s what i’ve seen so far, i don’t know much about the law and vaccines, but i’m starting to learn.”

I wonder if the changing of the definition of a ‘vaccine’ from ‘provides immunity’ to ‘provides less severe symptoms’ have any bearing on the potential lawsuits?


45 posted on 08/26/2021 1:32:03 PM PDT by WildHighlander57 ((WildHighlander57 returning after lurking since 2000) )
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To: NoLibZone

And the govt etcetera are mandating based on EUA shots.

I thought anything under EUA couldn’t be mandated.

Has anyone challenged the mandates on that basis?


46 posted on 08/26/2021 1:33:28 PM PDT by WildHighlander57 ((WildHighlander57 returning after lurking since 2000) )
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To: mewzilla
In March 2020, the Secretary published several declarations providing immunity for certain countermeasure activities related to the COVID-19 pandemic. One of these declarations expanded the definition of “covered countermeasures” to include drugs, diagnostics, devices, or vaccines used to treat, diagnose, or mitigate COVID-19 or its transmission, or any device used in the “administration” of one of those products. [3] The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) further expanded this definition by including OSHA-approved respiratory protective devices (i.e., face masks) as a “covered countermeasure.” [4]

That was under Trump's watch. That's also how N95 dust masks suddenly became a virus protection device after decades of not being that. They were the only masks we had a lot of because millions of blue collar workers use one or more per day, as have I, for dust and particles, their sole purpose up to that point. Unfortunately, Trump's main concern at that time was that covid might ruin his chances at re-election, which technically it did. Just not in the way he feared or was concerned about.

47 posted on 08/26/2021 1:34:22 PM PDT by Pollard (#*&% Communism)
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To: Pollard

The part that was giving me cows was the bit about countermeasures.

It sounds like docs are protected if they refuse to prescribe prophylaxes and/or therapeutics...?!


48 posted on 08/26/2021 1:36:47 PM PDT by mewzilla (Those aren't masks. They're muzzles. )
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To: Petrosius; NoLibZone

My reply to No Lib Zone’s comment under the story...

“To tie in with what Barnes Law said, my question is:

If they approved the Pfizer, and not Moderna and J&J, does that mean they can’t use Moderna and J&J?

And does the EUA for Moderna and J&J negate using the Pfizer?”


49 posted on 08/26/2021 1:38:32 PM PDT by WildHighlander57 ((WildHighlander57 returning after lurking since 2000) )
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To: Pollard; NoLibZone

How does my question figure into all this?

“To tie in with what Barnes Law said (see NoLibZone’s post #1), my question is:

If they approved the Pfizer, and not Moderna and J&J, does that mean they can’t use Moderna and J&J?

And does the EUA for Moderna and J&J negate using the Pfizer?”


50 posted on 08/26/2021 1:40:36 PM PDT by WildHighlander57 ((WildHighlander57 returning after lurking since 2000) )
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To: WildHighlander57

yeah. the past documents i’ve read about this vaccine always called out the purpose of preventing infection. now it’s some sort of treatment? if so, it doesn’t have the purpose vaccines use to.

another interesting thing in the document was the apparent extension of the expiration dates on the current EUA drug. they’re trying to use up the existing stuff and obviously take the money and run.


51 posted on 08/26/2021 1:43:19 PM PDT by dadfly
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To: WildHighlander57
If they approved the Pfizer, and not Moderna and J&J, does that mean they can’t use Moderna and J&J?

And does the EUA for Moderna and J&J negate using the Pfizer?”

Well I'm not a lawyer, doctor or a bureaucratic but I'm guessing the EUAs for all still apply but if one prefers an "approved' jab, there is one but more importantly in the eyes of totalitarian types, they can mandate it and people can't make the argument that it's experimental. This is all about politics and control freak communists, not about health.

As far as them choosing Pfizer, it could be for a few different reasons but I doubt it's for any good reason. It seems to be weaker against Delta. On the other hand, Israel is having a helluva time due to that. It's almost like Delta + Pfizer is more deadly then Delta alone. That would mean they prefer Pfizer because it will kill more people.

Another reason could be that with Pfizer, they can call for people to get a jab every 6 months which they're already talking about.

It's hard to make sense of crazy. It's hard to know what's real when we don't get real data or much of any truth.

52 posted on 08/26/2021 2:00:59 PM PDT by Pollard (#*&% Communism)
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To: WildHighlander57

Ask Robert:

https://vivabarneslaw.locals.com/


53 posted on 08/26/2021 2:04:01 PM PDT by NoLibZone (In 2 yrs only living will be conservative Christians Liberal vaxed sheep will be dead.Trust G's plan)
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To: Pollard

“Buried deep within the footnotes of the Pfizer-BioNTech documents is one footnote that puts into rather jolting perspective that the currently labeled vaccines are still under Emergency Use Authorization (EUA).”

Please link to sites that have the COMIRNATY labeled vaccines available.

Anyone.

Thank you.


54 posted on 08/26/2021 2:07:09 PM PDT by NoLibZone (In 2 yrs only living will be conservative Christians Liberal vaxed sheep will be dead.Trust G's plan)
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To: Petrosius

They say they are legally distinct. Okay. But they did not say they were the same product. They said they had the same formulation. They could have said it is the exact same product but will be licensed differently or labelled differently. They did not. Why not?

Formulation?

Where did you get “identical in composition”?

I am not be a contrarian but am looking for blurred references such as formulation.

“EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation” which means what?


55 posted on 08/26/2021 2:11:17 PM PDT by Nogara
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To: NoLibZone

Who would have thought the gubmint would be playing 3-Card Monty with the vaccines?


56 posted on 08/26/2021 2:12:10 PM PDT by Savage Rider
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To: Savage Rider

I called the phone number in the article.
The lady on recording said it was approved.
I am still not getting the shot. Already had the chinese flu.


57 posted on 08/26/2021 2:20:14 PM PDT by Iceclimber58
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To: NoLibZone

bkmk


58 posted on 08/26/2021 2:24:22 PM PDT by Sergio (An object at rest cannot be stopped! - The Evil Midnight Bomber What Bombs at Midnight)
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To: Bob434

Been saying that since 2020.


59 posted on 08/26/2021 2:25:05 PM PDT by Sergio (An object at rest cannot be stopped! - The Evil Midnight Bomber What Bombs at Midnight)
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To: Political Junkie Too

Just getting approval for the massive increase in price.


60 posted on 08/26/2021 2:35:25 PM PDT by Organic Panic (Democrats. Memories as short as Joe Biden's eyes.)
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