Update to:
Alert — Pfizer Vaccine receives full FDA approval… Posted by Kane on August 23, 2021 11:35 am

I found reading through the FDA statements confusing referring to 'COVID-19 Vaccine, mRNA', COMIRNATY, Pfizer-BioNTech COVID‑19 Vaccine, COMIRNATY (COVID-19 Vaccine, mRNA) as if they are all one entity.
There are references to Comirnaty applying for a BLA Biologic License Application

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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. ]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.

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FDA/Media Shell Game: Pfizer ‘Vaccine’ Was Not Approved After All
POSTED BY: PATRICK WOOD AUGUST 24, 2021

In just 24 hours, the mainstream media complex has been flooded with the headline “Full Approval!” for the Pfizer gene therapy injection. Let the vaccine mandates begin!

Anthony Fauci is thrilled over this news, stating, “you’re gonna see a lot more [vaccine] mandates because there will be institutions and organizations which previously were reluctant to require vaccinations, which will now feel much more empowered to do that.”

But wait. Something is not adding up with this new stampede to get the needle into your arm.

First, the drug giant Pfizer did not directly develop its mRNA shot: it hired a German company in 2018, BioNTech, to do that for them. They subsequently entered into a joint marketing/manufacturing agreement to deliver the resulting product to the world. Thus BioNTech is not a subsidiary of Pfizer. According to their joint 2018 press release, we learn that:

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“Under the terms of the agreement, BioNTech and Pfizer will jointly conduct research and development activities to help advance mRNA‐based flu vaccines. Pfizer will assume sole responsibility for further clinical development and commercialization of mRNA‐based flu vaccines, following BioNTech’s completion of a first in human clinical study.”

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The latter human clinical study is what was delivered to the FDA for evaluation, on behalf of BioNTech, in order to get FDA “approval”. BioNTech named the shot Comirnaty. Pfizer has not conducted its own trial, much less submitted it to the FDA.

Because of the contractual development agreement between the two companies, it is unclear that the BioNTech shot is identical to whatever Pfizer is distributing in America, or anywhere else, for that matter. Nevertheless, the media and the FDA promote Pfizer/BioNTech without making any distinctions between the two.

What was “approved” by the FDA on Monday (8/23) was Comirnaty, which belongs to the BioNTech side of the Pfizer/BioNTech working agreement.

In other words, Pfizer is not even in the picture for approval and continues to sell its version of the shot under the Emergency Use Authorization. To repeat, Pfizer has no approval for any mRNA vaccine.

Now, there are a boatload of problems with BioNTech’s application and the FDA’s treatment of it. Medical experts who are examining BioNTech’s human clinical study are quite alarmed. I don’t want to address those issues here, but a detailed analysis is forthcoming.

This report will only point out the duplicitous behavior of the FDA and the mainstream media in promoting this falsehood that Pfizer’s shot has full FDA approval.

To that end, I located the FDA’s official press release dated August 23, 2021 that was titled, “FDA Approves First COVID-19 Vaccine.” We can give them credit for getting the title correct, but the rest of the text is convoluted. We only need to look at the first paragraph to see what has happened:

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. [emphasis added]

To say that the “vaccine has been known as” is not a specific name designated by the FDA or anyone else. It should be BioNTech only because they hold the product name Comirnaty. To be clear, Comirnaty has received FDA approval.

In the next sentence, the FDA says “The vaccine also continues to be available under emergency use authorization (EUA)” Do you see that they are talking about two separate products? The second instance belongs to Pfizer and the former to BioNTech. The Pfizer shot is NOT approved and continues as before under EUA.

There is another distinctive that proves this point. Comirnaty is approved for individuals 16 years of age and older. The EUA drug is authorized for individuals 12 through 15.

Lastly, the approval letter sent from the FDA to Pfizer states in footnote 8,

“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.“ [emphasis added]

The “certain differences” are not specified, but it is perfectly clear that the two jabs are legally distinct.

The FDA and Pfizer have just played a shell game that leads the world to think that the Pfizer drug has been approved, but it clearly has not! This obfuscation, if not outright deception, belongs at the feet of the Food & Drug Administration. Nevertheless, the entire nation is swooning over vaccine mandates from every conceivable quarter. Furthermore, the confusion is being reinforced by Dr. Anthony Fauci and his merry band of medical Technocrats who are quite certain that the end justifies the means.

https://www.technocracy.news/fda-media-s...oved-after-all/

Stunner! Expert says 'FDA-approved' Pfizer shot is NOT what people have been getting
Claims feds are playing 'little trick' between 'two separate vaccines'
Bob Unruh By Bob Unruh
Published August 25, 2021 at 1:25pm

In a much-trumpeted announcement this week the Food and Drug Administration said it was approving for general use the Pfizer COVID-19 vaccine.

Americans have been getting Pfizer shots for months already, under an emergency use authorization.

But an expert in the field says what reports have failed to include is that the vaccine approved by the FDA is not the same as the one that's already been in use.

It is Dr. Robert Malone who said during an interview on "The Warroom with Steve Bannon" that the vaccines are similar, but not the same.

Bannon asked, is the "authorized" vaccine now ready to be administered to patients?

"It's absolutely not available," Malone explained. "The little trick that they've done here is that they've issued two letters, separate letters for two separate vaccines. The Pfizer vaccine which is what is currently available, is still under emergency use authorization, and it still has the liability shield."

He said, "The product that's licensed is the BioNTech product which is substantially similar but not necessarily identical. It's called Comirnaty … and it's not yet available. They haven't started manufacturing it or labeling it and that's the one that the liability waiver will no longer apply."

He said. "So the one that's actually licensed is not yet available and when it does become available it will no longer have the liability shield."

Malone is recognized as knowledgeable, as WND reported earlier on his status as inventor of the mRNA technology behind the COVID-19 vaccines.

He previously warned that Americans don't have enough information to decide whether or not the benefits of getting the shots outweigh the risks.

Malone – after YouTube deleted a video interview of him discussing the risks of COVID-19 shots – told Fox News' Tucker Carlson he's concerned that the government is not being transparent.

"I am of the opinion that people have the right to decide whether to accept vaccines or not, especially since these are experimental vaccines," Malone said.

"This is a fundamental right having to do with clinical research ethics," said Malone. "And so, my concern is that I know that there are risks. But we don't have access to the data, and the data haven't been captured rigorously enough so that we can accurately assess those risks.

"And therefore … we don't really have the information that we need to make a reasonable decision."

In the government's announcement this week boasting of the FDA approval of the "first COVID-19 vaccine," it identified that as the "Pfizer-BioNTech COVID-19 Vaccine," which "will now be marketed as Comirnaty."

Acting FDA commissioner Janet Woodcock said the FDA "approval" "may now instill additional confidence to get vaccinated."

The FDA said the vaccine already has been available under the emergency use provisions.

"Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19," the FDA explains. "The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual's genetic material.

"Comirnaty has the same formulation as the EUA vaccine and is administrated as a series of two doses, three weeks apart."

The FDA also warned of side effects such as "fatigue, headache, muscle or joint pain, chills, and fever" as well as "myocarditis and pericarditis" and admitted "information is not yet available about potential long-term health outcomes."

However, a government vaccine information "fact sheet" on the issue specifically lists the shots as two separate objects.

"You are being offered either COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-Co-V-2," the sheet insists.

Multiple times throughout the "fact sheet" the FDA refers to the two separately, despite claims that they have the same formula, and ingredients.

For example, it explains, "This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and also includes information about the FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA)."

It separately identifies "COMIRNATY (COVID-19 Vaccine, mRNA)" as the FDA-approved drug made by Pfizer for BioNTech and then the separate "Pfizer-BioNTech COVID-19 Vaccine that is under emergency use authorization.

The government insists, too, that the "COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine," in fact, "have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series."

They specifically are addressed differently, with one being "authorized" and the other "approved." The FDA repeatedly mixes the two, carefully keeping in place the differences between "authorized" and "approved."

It explains both contain, "mRNA, lipids ((4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose."

Even in its question-and-answer stage on the fact sheet, it explains what happens if people choose not to get "COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine."

https://www.wnd.com/2021/08/stunner-expe...fddd7bd6bd0bea9

Bannons War Room Published August 24, 2021

VIDEO