Pfizer Just Got ‘Full FDA Approval’ For Its COVID Vaccine. There’s Just One Thing…

Authored by ‘Sundance’ via TheConservativeTreehouse.com,

Pfizer got full FDA approval yesterday.

“The move would make it the first Covid vaccine to go from emergency use authorization to full FDA approval.”

(read more

With that in mind, it is worth a reminder that both Pfizer and Moderna stopped the clinical trials the FDA was using in their review:

The Moderna and Pfizer vaccine tests were conducted, as customary, with a control group; a group within the trial who were given a placebo and not the test vaccine.  However, during the trial -and after the untested vaccines were given emergency use authorization- the vaccine companies conducting the trial decided to break protocol and notify the control group they were not vaccinated.  Almost all the control group were then given the vaccine.

Purposefully dissolving the placebo group violates the scientific purpose to test whether the vaccine has any efficacy; any actual benefit and/or safety issues.  Without a control group there is nothing to compare the vaccinated group against.  According to NPR, the doctors lost the control group in the Johnson County Clinicial Trial (Lexena, Kansas) on purpose:

(Via NPR)

[…] “Dr. Carlos Fierro, who runs the study there, says every participant was called back after the Food and Drug Administration authorized the vaccine.

“During that visit we discussed the options, which included staying in the study without the vaccine,” he says, “and amazingly there were people — a couple of people — who chose that.”

He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study.  “It’s a loss from a scientific standpoint, but given the circumstances I think it’s the right thing to do,” he says.

People signing up for these studies were not promised special treatment, but once the FDA authorized the vaccines, their developers decided to offer the shots.

(read more)

Just so we are clear, the final FDA authorization and approval for the vaccines are based on the outcome of these trials.  As noted in the example above, the control group was intentionally lost under the auspices of  “the right thing to do”, so there is no way for the efficacy, effectiveness or safety of the vaccine itself to be measured.

There’s no one left within the control group, of a statistically valid value, to give an adequate comparison of outcomes for vaxxed -vs- non-vaxxed.  This is nuts. That NPR article is one to bookmark when people start claiming the vaccination is effective.

How can the vaccine not be considered effective when there is no group of non-vaccinated people to compare the results to?

Good grief, the entire healthcare system is operating on a massive hive mindset where science, and the scientific method, is thrown out the window in favor of ideological outcomes and self-fulfilling prophecies.  

The fact that the researchers and doctors, apparently under the payroll of the pharmaceutical companies that have a vested financial interest in the vaccine outcome, lost the control group on purpose is alarming.

Of course, Big Pharma will promote the vaccine as beneficial, and the controlled media will promote that message with a complete disconnect from the clinical trial details, and the FDA will grant approval on results that were intentionally constructed to produce only one outcome.

As noted by Dr. Malone, the commonsense therapeutic approach should be the primary focus, not vaccination, for ongoing healthcare systems as the COVID-19 variants will continue to evolve.  Ultimately,  the natural immunity process will be of greater overall benefit than vaccinations which will require continual boosters to deal with the ever-evolving variants (a similar approach to dealing with reoccurring and evolving flu strains).   Dr. Malone provided support for his position with concurrence from the leading U.K. Vaccinologist in Great Britain, Sir Andrew Pollard (SHORT VIDEO):

In essence, both Dr. Andrew Pollard (Director of the U.K. Oxford Vaccine Group), and Dr. Malone state that variants of the COVID-19 virus will continue to spread throughout the population regardless of vaccine status; and the virus will continue to evolve into more infectious but less deadly or pathogenic strains.

There simply is no way to vaccinate the population and stop the spread of COVID variants, because the vaccinated will contract and spread the virus just like the non-vaccinated.  The vaccine approach should be targeted to the elderly and those most at risk.

Specific to the position of Dr. Malone – given the untested nature of the vaccine itself; no one knows the long-term side-effects; the benefit of the vaccine should be weighed against the individual’s current health status.  Elderly populations with lower immune responses should be the target for vaccination; they are the most at risk.  However, younger -less at risk- individuals will likely benefit more from therapeutic treatment after exposure *if* they experience any symptoms at all.

The problem is…. this commonsense approach is less favorable to the interests of the pharmaceutical industry and the healthcare systems that are controlled by the financial mechanisms inside the business of healthcare.  Big Pharma would obviously make less money from a smaller target population for vaccination; ergo the therapeutic approach is a threat to the preferred approach of those who operate the business model.  This is the overarching political battle.

The influence of the massive pharmaceutical corporations, inside the institutions of government controlled healthcare on a global basis, is massive.  This outlook is the origin of the vaccinate push and vaccine narrative as the *only* and *best* solution.   Anyone who raises a point, any point, in opposition to the mandated mass vaccine approach then becomes a target to be isolated, marginalized, ridiculed and removed.

Madness…. All of it.

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25 Comments
B_MC
B_MC
August 24, 2021 2:26 pm

There may be something else going on. I’m going to re-post a comment I made earlier…

Dr. Malone was interesting on the War Room this AM. He says there are two products; the original vaxx still under the EUA, and the new “approved” Pfizer/BioNTech Comirnaty vaccine which is not available or even in production yet.

Bait and switch?

Elder Son
Elder Son
August 24, 2021 2:30 pm

The Devils At The FDA & In The Mockingbird Media Pulled A Fast One On Us! The Pfizer Shot IS NOT FULLY APPROVED! (Video)

This will be short and sweet, but pay attention as to how they use the language to make you think they mean they are providing full approval for the “first COVID vaccine.”

For God’s sake! The American people are just so damn gullible and stupid. The FDA did not “approve” the “vaccine”. Pfizer changed the name of the “vaccine” to “COMIRNATY” and then the FDA extended the EUA.

The very first thing I did when I heard the “vaccine” was “fully licensed and approved” was go to the FDA website, find the “Letter of Authorization” letter from the FDA to Pfizer, and read the damn thing. How many people do you think did that? But… but… the Tele-Vision people said so, and so did Dementia Joe! They have Boobus AmeriKanus so crapping their pants over this fake “pandemic”, they’ll believe everything they are told.

And after reading the damn thing, right at the bottom of the page, it states…

This EUA… This EUA… This EUA… This EUA… REPEAT… 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.

I posted a link to the “Letter of Authorization” on another website in the comments yesterday. What I got was, “I believe you are looking at the wrong document.” Later, someone else posted a few paragraphs of the “Letter of Authorization” in the comments, and the response was… oh, “I saw that afterward.” Afterward what? After you finally broke down and read the damn LoA for EUA? People are so easily manipulated, even those who you thought would know better. Everyone just jumps on the OMG! OMG! OMG! because it brings in panty-twisted readership.

The Fake News that FDA Approved the Vaccines is Made Clear in the Letter

FDA PFizer vaccine RELEASE TODAY PG 12: “THIS PRODUCT IS NOT APPROVED”. Instructions for promotional materials… Simple EUA Is Extended

Turn off the damn Boob-Tube people. And turn off Dementia Joe and Fraud Fauci. They are still gaslighting you. Playing on Boobus AmeriKanus penchant for emotionalism. And they won’t stop until you are jabbed, or dead, or jabbed and dead.

Anonymous
Anonymous
  Elder Son
August 24, 2021 6:45 pm

The only one pulling a fast one is Armstrong … on you.

Here’s the APPROVAL (not authorization) Letter:
https://www.fda.gov/media/151710/download

It IS approved. Fully approved. You had to know they were going to short circuit the standard approval process, say “fuck it” to safety or efficacy, and ram this thing through as fast as they could. How could you not know it was coming?

This is to take that last bit of hesitancy away from employers by removing the possibility that employers could be liable for vaccine injuries. Now, they can’t. Expect more employers to require the “vaccine”.

The beatings will continue until morale improves.

===============================

FDA main page https://www.fda.gov/

FEATURED
FDA Approves First COVID-19 Vaccine
On August 23, 2021, the FDA approved Comirnaty (COVID-19 Vaccine, mRNA), previously known as Pfizer-BioNTech COVID-19 Vaccine, for the prevention of COVID-19 disease in individuals 16 years of age and older.

================================

https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states

It’s the sixth one down.

Anonymous
Anonymous
  Elder Son
August 25, 2021 9:31 am

I don’t know how it works. They authorized the manufacture, while at the same time still using EAU language for the dispensing of it. I don’t think they are following any of their own rules, but how would I know for sure?

Nothing but the truth.
Nothing but the truth.
August 24, 2021 2:35 pm

It’s not been approved , it is merely an extension of the emergency use authorisation. More lies and deceit.

Anonymous
Anonymous
  Nothing but the truth.
August 24, 2021 6:48 pm
Anonymous
Anonymous
  Nothing but the truth.
August 25, 2021 7:05 am

the confusion comes from two different documents being released right next to each other: one of them is the approval (nevermind that it was given without going through the legal procedure for approving such things, the document does say approval on it) and the other extends the EUA for ‘uses other than the ones in the approval’ or something to that effect. that they were released on the same day has confused the matter.
it’s just as real as anything else is in this fake administration. in an empire of lies more lies are .. what exactly?

Anonymous
Anonymous
  Anonymous
August 25, 2021 7:35 am

EUA is continued for 12 to 15 year olds.
Full approval is for ages 16 and up.

Anonymous
Anonymous
  Anonymous
August 25, 2021 9:33 am

That is extremely unusual in itself.

Anonymous
Anonymous
  Anonymous
August 25, 2021 9:32 am

Is approval for manufacture the same as safety approval for use?

TheAssegai
TheAssegai
August 24, 2021 2:38 pm

It appears to be a complete lie. Kabul will not fall, or I mean the injections are fully approved.

There is no FDA approval at all, just an extension of the EUA with some clarifications.

https://www.investmentwatchblog.com/wait-uncle-joe-what-fda-approval/

Anonymous
Anonymous
  TheAssegai
August 24, 2021 6:50 pm

oops

page you linked to vanished.

Why does everyone care? They intended to get this approved come hell or high water and they did.

Is someone here going to take the shot because it’s now approved?

Behind Enemy Lines
Behind Enemy Lines
  Anonymous
August 24, 2021 10:42 pm

Some contrarian/libertarian hosts out there (tim pool, for example) are taking the bait and saying the approval has value. Idiots.

Anonymous
Anonymous
  Behind Enemy Lines
August 25, 2021 7:37 am

Yes. Idiots.

mileytheduchess
mileytheduchess
August 24, 2021 2:43 pm

Why target the elderly? Even the normal fall flu shots do little to impact hospitalization for this group. I don’t think anyone should get the death shot.

KaD
KaD
  mileytheduchess
August 24, 2021 5:49 pm

Our malignant overlords consider the elderly to be useless eaters.

Cleveland
Cleveland
August 24, 2021 2:54 pm

The vaccines encourage the proliferation of new variants, blood clotting, and mass injuries and deaths within 3 years. They’ve opened up Pandoras Box with these vaccines.

B.S. in V.C.
B.S. in V.C.
August 24, 2021 3:46 pm

This is true but you know these evil S.O.Bs are going to get FDA approval. They didn’t waste all that money on thier fear campaign for nothing. It was never about some bullshit flu it’s about absolute control over your life.

Rife
Rife
August 24, 2021 3:51 pm

Is it true that the “placebo” is a meningitis vaccine? Or, what is it?

Anonymous
Anonymous
August 24, 2021 3:55 pm

Gives the rank and file military men a way out.

The General of the Marines should say fuck you!

KaD
KaD
August 24, 2021 5:46 pm

It’s a full approval to extend the emergency use authorization. Check out the top of page 2.
https://www.fda.gov/media/150386/download

Anonymous
Anonymous
  KaD
August 24, 2021 6:58 pm

Don’t know what’s up with that letter, but here’s the one they have up now
https://www.fda.gov/media/151710/download

Note the letter number 151710 and not 150386

We are issuing Department of Health and Human Services U.S. License No. 2229 to
BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section
351(a) of the PHS Act controlling the manufacture and sale of biological products. The
license authorizes you to introduce or deliver for introduction into interstate commerce,
those products for which your company has demonstrated compliance with
establishment and product standards.
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.

PB
PB
August 24, 2021 6:24 pm

Does this mean that Pfizer (or, more correctly, (((Pfizer))) ) shouldn’t need their blanket indemnity anymore?

DFJ150
DFJ150
August 25, 2021 8:38 am

ALL vaccines will now be suspect. Bill Gates and his NWO buddies are so determined to get his depopulating serum, oops, “vaccine”, into the everyone on the globe, it is highly likely they will incorporate this poison into every other previously useful vaccine. This will allow them to surreptitiously introduce their killer covid concoction into all age groups by combining it with DTP, HIB, meningococcal, Gardasil, and all the others required for kids, health care workers, etc. The rapid and illegal “approval” of this genetic manipulation nightmare proves the FDA is not only a propaganda arm of the liberals, but also promoting the goals and tenets of the great reset. Compliance with, and submission to, this nefarious plan will result in untold suffering and death from conditions and diseases which will be deemed “unrelated” to the jab by our esteemed medical experts. Many more will be rendered sterile by the toxic spike protein. Penultimately, the worlds population will be drastically reduce, allowing the Davos bunch, the Bilderbergs, and other elite groups to enjoy nearly unlimited power, wealth, and control. Just say no (to the jab).

Tom
Tom
August 25, 2021 9:19 am

Full approval was not given. The Emergency Use Authorization was extended Please watch https://clicks.aweber.com/y/ct/?l=L.Soi&m=3euDkmDTNA6cBfA&b=p5oqg5sviMxWN7bVhM4U0w