FDA Approves Vaccine - or - Did They (1 Viewer)

[Linda]

Today the FDA announced a Pfizer covid vaccine was approved. The following is from their website. Have you ever heard of Comirnaty? Me neither.

For Immediate Release:August 23, 2021​

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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.​

FDA Approves First COVID-19 Vaccine

FDA approved the first COVID-19 vaccine, now marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.

www.fda.gov

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I kept looking around and found this bit on the fact sheet - I'm not fluent in medical double-speak, so I'm confused here. Two formulas that are the same but with different names. One is still emergency use and the second is approved. I'll keep trying figure it out, but if anyone else has any ideas, please share.

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS)​

EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)​

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The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 12 years of age and older and to provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.​

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COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a 2-dose series for the prevention of COVID-19 in individuals 16 years of age and older and is also authorized for emergency use in individuals 12 through 15 years and to provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.​

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The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.1​

footnote - 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.​

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https://www.fda.gov/media/144413/download

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[Ascended1]

Note that you can’t MAKE people make a certain choice (for love and not fear); they have to do it themselves. What few realize is that this vaccine — like you personally, your body, and our entire world — is upside-down. EVERYTHING here is upside-down (and it shows). You are attached to SOURCE by a thin cord that terminates at your heart, your “heart chakra” at the end of this connection, a portal if you will (albeit a very small one, big enough for your spirit to pass through in dreams). In comparison, the sky above, when you’re walking around… is DOWN. Pyramids on this planet are upside down. People, societies, institutions… all upside down. You need to go within to right yourself.

 

[Ascended1]

Sharing some love light logic from 777 heaven frequency

 

[Linda]

Have you ever heard of Comirnaty?

Wondering about the source of the name - why something so difficult to say?

In my head, I'm calling it Co-morbidity, which makes sense to me - many people who died had other medical issues and the shot pushed them over the top.

 

[Sinera]

Have you ever heard of Comirnaty?

It was the brand name chosen by Phizer Biontech right from the start. It was/is also listed as this in the databases for the adverse effects.

 

[Linda]

It was the brand name chosen by Phizer Biontech right from the start

Why are two versions identified? Comirnaty is described as interchangeable with the Pfizer vaccine that has the emergency use authorization, but there are slight difference in the formulation.

The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.1​

Here are some clues in the letter from Pfizer to the CDC that discusses the extension of the EUA for the vaccine. Again, where the Comirnaty came from is unclear. However, there are many doses of the EUA vaccine already manufactured and need to be sold.

Conditions With Respect to Use of Licensed Product​

AA. COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individuals 16 years of age and older. There remains, however, a significant amount of Pfizer- BioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization thus remains in place with respect to that product for the previously-authorized indication and uses (i.e., for use to prevent COVID-19 in individuals 12 years of age and older with a two-dose regimen, and to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise).​

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

 

[Sinera]

NN has an article about this confusion, too.

GASLIGHTING AMERICA: Did the FDA actually approve a FUTURE covid “vaccine” from BioNTech that does not exist yet? – NaturalNews.com

There appears to be a whole lot of confusion out there about which “vaccine” for the Wuhan coronavirus (Covid-19) was actually “approved” by the U.S. Food and Drug Administration (FDA) on Aug. 23, 2021. While many mainstream media outlets quickly ran with the story that Pfizer’s existing mRNA...

www.naturalnews.com

 

[Linda]

NN has an article about this confusion, too.

good article - felt better after I read this part because I was pretty sure I read the release docs correctly, but it made no sense.

At this point, it is uncertain exactly what is going on, but we wanted to bring this conflicting information to your attention.​

 

[Linda]

The article on Zerohedge cites a number of mainstream news pieces questioning the vaccine efficacy.

Former Congressman Ron Paul has highlighted this week that a handful of mainstream media articles have actually begun to break ranks in terms of questioning key aspects of vaccine effectiveness and, particularly when it comes to the controversial boosters now being widely proposed.​

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"Even mainstream media is now asking big questions about the vaccines" Wednesday's Liberty Report featured. A couple of recent headlines in Bloomberg and BBC were unexpected in terms the criticism reflected and somewhat skeptical pushback against the 'consensus narrative'. ​

Zerohedge

ZeroHedge - On a long enough timeline, the survival rate for everyone drops to zero

www.zerohedge.com

 

[Linda]

I've been confused about the wording in the FDA letters about the vaccine, as I don't speak FDA or medical double-talk. Found this analysis, which seems to make sense to me. The author makes the distinction of approval for a Biologics License Application and approval of a drug - BIG DIFFERENCE. However, I'm still left with a WTAF sense of the situation.

The FDA sent two letters. The first one was a letter of BLA (Biologics License Application) approval, and the second was a letter of EUA extension to COMIRNATY.​

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The BLA approval letter approves Pfizer's application for a license to label its COVID-19 drug with the brand name COMIRNATY. This letter also spells out the terms and requirements for nine additional clinical trials over five years, and yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis that have followed the administering of the Pfizer shots. This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials.​

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The EUA extension letter extends the term of the EUA for the current drug and authorizes (licenses) the experimental use of the brand-name drug COMIRNATY. In the first paragraph on page 2, this letter references the license approval letter. In the second paragraph on page 2, the August 12 EUA is re-issued to include the name-branded drug in the emergency use authorization, and to add "language regarding warnings and precautions related to myocarditis and pericarditis." In the last paragraph on page 4, the EUA nature of the drugs is re-iterated, and COMIRNATY is additionally authorized for use for individuals aged 12 through 15 years.​

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The mRNA gene therapy shots are still experimental. Mandating them is still wrong — by a wide variety of ethical standards.​

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Dr. Meryl Nass, M.D. found the truths that the FDA buried in the blather of these letters and offers a theory about why it was done this way. The drug-manufacturers were granted immunity from liability for the drugs produced under the EUAs. The granting of the license re-applies the customary liability for injury and death caused by the product. Pfizer, the health officials, and the politicians get to take a fictitious victory lap for the "approval," while Pfizer-BioNTech continues to stealthily enjoy immunity from product liability because there are many millions of the unlicensed doses on the shelves and in the manufacturing pipeline that will be administered first. The licensed version will not arrive on shelves or be jabbed into arms for many months to come.​

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Of great concern, considering the factual content of the FDA EUA letters to Pfizer, is the breezy way the press release on the FDA website repeatedly uses the words "approve" and "approval" in reference to the Pfizer drug. If only there were a word for intentionally saying things to the public that do not match reality...​

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The FDA did NOT grant full approval to the Pfizer shots

You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday. Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remain...

www.americanthinker.com

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