BREAKING: FDA is pushing to "Fully Approve" Pfizer COVID19 "Vaccine" on Monday August 23rd

[TheCalciumCad]

View: https://twitter.com/TanyaRo58329998/status/1430212200065556485

 

[Peatness]

View: https://twitter.com/TanyaRo58329998/status/1430212200065556485

These people are truly evil. This is deliberate deception

 

[tankasnowgod]

View: https://twitter.com/TanyaRo58329998/status/1430212200065556485

What Dr. Malone says makes a lot of sense (and seems to go with the documents that I posted yesterday).

Whenever a government body does anything like this, the effects rarely take effect immediately. Usually, it's 1-3 months out, sometimes even years. The only exception I am aware of is something like a curfew when riots or unrest is going on.

When drugs are usually "approved," they aren't available on the market hours later. And generally, they aren't on the market -8 months prior to approval. So, it makes sense that no "approved COVID Vaccine" is available now, and might not be for a few months still.

 

[achillea]

FDA themselves on May 18 2021, Pfizer and mRNA application "active immunization to prevent the coronavirus disease". The information has changed! Here is the document itself.
View: https://twitter.com/0ctoberReignz/status/1430192681427275782

Also,
View: https://twitter.com/0ctoberReignz/status/1430192681427275782

FDA has the application from Pfizer and in the application it says "the duration of protection against COVID-19 is currently unknown" so the approval process is null and void because of gross misrepresentation. The information has changed! The definition of prevent is "keep something from happening, or arising" A faulty contract between one party and another, Pfizer, a German company (who is not American) with our United States and our administration. We can say, "the Germans are coming, the Germans are coming!". Pfizer is culpable because there is death and injury and people are getting the corona virus from the injection. The "somebodies" have admitted that the injection "does not prevent".
By the way, DeBlosio has changed his name, Polis has changed his name as well. They are German, very interesting.

 

[tankasnowgod]

Here's a great piece by Meryl Nass-

I explain my theory of the COMIRNATY "license" scam by referring to passages in the FDA approval letter

Read the FDA approval letter please. This is how they scam you, by making it nearly impenetrable. Below, I identify the two most relevan...

anthraxvaccine.blogspot.com

The blogpost itself is short and to the point. The key is two phrases in the "Approval" letter.

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

The first is footnote 8 on the bottom of page 2-

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.

Ah. So both products are "Safe and Effective!™" but the EUA version is probably more "Safe and Effective!™" for Pfizer's bottom line, as they will be have total financial and legal immunity on that one (the approved version probably doesn't have protection from the 1986 National Childhood Vaccine Injury Act, at least not yet).

The second is Section AA on page 12-

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 PfizerBioNTech 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).

So, again, we have two different products out there made by the same company with basically the same formula. Anyone even CONSIDERING taking the demonvax should completely avoid the "Pfizer BioNTech Covid 19 Vaccine" and DEMAND that they receive "COMIRNATY." I'm sure as of this writing, "COMIRNATY" is not available, probably won't be for months, and I wouldn't be surprised if it's done in a very limited release, eg, 100 doses of COMIRNATY are disturbed to one or two pharmacies in Kansas City, while the rest of the country continues to get "Pfizer BioNTech Covid 19 Vaccine."

After all.... how long will the EUA remain in effect? (IV on Page 13)

IV. Duration of Authorization
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.

I see. So, 5 months, 10 months, 2 years, 15 years, 17 centuries..... who knows? Basically, that's a long way of saying "TFN."

 

[yerrag]

It's not real approval because they shortcut through the whole process. All this does is underline thst there is no more rule of law. No rule of law in elections. No rule of law in who the justice department prosecutes. No rule of law for rioters. No rule of law for regulatory approval. And they completely ****88 up Afghanistan. There is no more legitimacy to this government and all the FDA ruling does is show the cancer has spread to all branches.

They have crossed the line.

This means their (Zionists and Freemasons masters) conduct from this point on will be based on 'because we said so.'

No need really for the clown show ***t show anymore, folks.

We can have martial law and it would not make a difference.

 

[863127]

FDA themselves on May 18 2021, Pfizer and mRNA application "active immunization to prevent the coronavirus disease". The information has changed! Here is the document itself.
View: https://twitter.com/0ctoberReignz/status/1430192681427275782

Also,
View: https://twitter.com/0ctoberReignz/status/1430192681427275782

FDA has the application from Pfizer and in the application it says "the duration of protection against COVID-19 is currently unknown" so the approval process is null and void because of gross misrepresentation. The information has changed! The definition of prevent is "keep something from happening, or arising" A faulty contract between one party and another, Pfizer, a German company (who is not American) with our United States and our administration. We can say, "the Germans are coming, the Germans are coming!". Pfizer is culpable because there is death and injury and people are getting the corona virus from the injection. The "somebodies" have admitted that the injection "does not prevent".
By the way, DeBlosio has changed his name, Polis has changed his name as well. They are German, very interesting.

Aren't those two tweets the same picture? Did you make a mistake posting the 2nd?

 

[Peatogenic]

How? What does it really change? It doesn't change my opinion at all. I am not lining up to get their dangerous, ineffective drugs just because some corrupt, unelected bureaucrats working at a corrupt agency did something corrupt.

Something so corrupt, I might add, that they did it fully behind closed doors.

Breaking: FDA gives full approval to COVID vaccines; no public hearing; no transparency; no open review of vaccine data « Jon Rappoport's Blog

From what I understand, the approval only applies to those 16 and older. Soooooo...... does that mean Pfizer suddenly has liability for it's demonvax?

The FDA has approved all sorts of horrid, nasty drugs in the past..... from SSRIs, Benzodiazepines, 5 Alpha Reductase Inhibitors, Vioxx, Xarelto, and on and on. It's not like this was a sterling agency agency that suddenly tarnished their image.

This is simply a more public display of that brazen disregard for health. I think it's a sign of desperation. In some ways, I actually think it's a good thing.

Right. Seems like minor news and didn't shake me at all. Though media framed it like most anti-vaccination was because it wasn't FDA approved yet. The sad day was when NYC decided to be first city to require vaccine passports

 

[Zpol]

The old bait and switch. Isn't this exactly what happened in the 70s with the swine flu vaccine!?

Edit .. Maybe not. The cominarty one is available outside the US.
I haven't read what the "certain differences" are. I'll have to look into that.

 

[haidut]

So wait...... did the FDA actually "approve" the Pfizer Vaccine?

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

Here's the BLA-

https://www.fda.gov/media/151710/download

I saw this from something Martin Geddes posted. The quote-



So far, the only things we've heard about "approval" have come from third party journalists. The meeting was held behind "close doors," either out of embarassment, or possibly, to deliberately obfuscate what, exactly, they were doing.

Is all this "Full Approval" talk just a conjob, to mask what is simply an extension of the EUA?

I don't think it has been fully approved. The EUA has simply been extended for the 4th or 5th time. They list all the prior EUA dates in the PDF below. I don't see anywhere in the PDF discussion that the vaccine has full approval for 16+ old individuals while remaining EUA for 12-16 age groups. It seems pretty clear to me that the current "authorization" for 16+ age is still under EUA. The only true "authorization" seems to apply to now allowing the trade name of the vaccine (Comirnaty) to be used in public. One of the giveaways, aside from the direct statements, is the last sentence from the quote below. It continues to talk about lack of alternatives to the vaccine as a reason for the "authorization". This is only applicable under EUA. When it comes to full approval, the lack of alternative treatments would not matter as a reason. If anybody has a different understanding/information please chime in, but it seems to me FDA simply extended the EUA.
@Regina @boris @Giraffe @Zpol @J.R.K @sweetpeat @achillea @DrJ

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

"...Page 1 Paragraph One: On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes Coronavirus Disease 2019 (COVID-19). 1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act (21 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section.2
Page 2 Paragraph Two: 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.

Page 4 Paragraph Four: Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization. Additionally, as specified in subsection III.BB, I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA when used to provide a two-dose regimen for individuals aged 12 through 15 years, or Page 5 – Pfizer Inc. 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.

Page 5 - I. Criteria for Issuance of Authorization I have concluded that the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because: A. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and C. There is no adequate, approved, and available9 alternative to the emergency use of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19."

 

[Mito]

I don't think it has been fully approved. The EUA has simply been extended for the 4th or 5th time. They list all the prior EUA dates in the PDF below. I don't see anywhere in the PDF discussion that the vaccine has full approval for 16+ old individuals while remaining EUA for 12-16 age groups. It seems pretty clear to me that the current "authorization" for 16+ age is still under EUA. The only true "authorization" seems to apply to now allowing the trade name of the vaccine (Comirnaty) to be used in public. One of the giveaways, aside from the direct statements, is the last sentence from the quote below. It continues to talk about lack of alternatives to the vaccine as a reason for the "authorization". This is only applicable under EUA. When it comes to full approval, the lack of alternative treatments would not matter as a reason. If anybody has a different understanding/information please chime in, but it seems to me FDA simply extended the EUA and the media used the trade name approval/authorization as a license to openly lie to the public left and right about the actual vaccine getting fully approved.
@Regina @boris @Giraffe @Zpol

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

"...Page 1 Paragraph One: On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes Coronavirus Disease 2019 (COVID-19). 1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act (21 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section.2
Page 2 Paragraph Two: 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.

Page 4 Paragraph Four: Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization. Additionally, as specified in subsection III.BB, I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA when used to provide a two-dose regimen for individuals aged 12 through 15 years, or Page 5 – Pfizer Inc. 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.

Page 5 - I. Criteria for Issuance of Authorization I have concluded that the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because: A. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and C. There is no adequate, approved, and available9 alternative to the emergency use of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19."

Sounds like legal tap dancing so the other two vaccines can retain their EUA status.

 

[haidut]

Sounds like legal tap dancing so the other two vaccines can retain their EUA status.

As much as I dislike the FDA, they may be clean on this one. The FDA never gave public interviews/statements saying "the vaccine has now been fully approved". Their official document is pretty clear it has NOT been fully approved. All the claims of full approval are coming from mainstream media, not the FDA.

 

[tankasnowgod]

As much as I dislike the FDA, they may be clean on this one. The FDA never gave public interviews/statements saying "the vaccine has now been fully approved". Their official document is pretty clear it has NOT been fully approved. All the claims of full approval are coming from mainstream media, not the FDA.

Well, there is this Press Release from the FDA.gov website-

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

That seems to be what all news outlets are going off of.

NOTE- The Release gives two contact numbers for clarification.

Consumer- 888-INFO-FDA

Media- 301-796-4540

Concerned members may wish to try one (or both) of those numbers to clarify some issues.

Specifically, if anything was fully approved, what the legal difference is between "COMIRNATY" and "Pfizer BioNTech Covid 19 Vaccine," if Pfizer will have liability for either, and clarification of the sections of the order that have been posted and referenced above.

I think it's pretty clear that forums, blogs, podcasts and live streams are "media" at this point.

 

[haidut]

Well, there is this Press Release from the FDA.gov website-

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

That seems to be what all news outlets are going off of.

Thanks, I guess FDA did release a propaganda statement after all. Yet, their PDF does not mention full approval. Whenever it uses the word "authorization" it always clarifies that it is under prior/existing EUA. Considering the EUA comes with legal liability and the full approval does not (yet), I don't see why Pfizer would rush to get its jab approved.

 

[Michael Mohn]

Thanks, I guess FDA did release a propaganda statement after all. Yet, their PDF does not mention full approval. Whenever it uses the word "authorization" it always clarifies that it is under prior/existing EUA. Considering the EUA comes with legal liability and the full approval does not (yet), I don't see why Pfizer would rush to get its jab approved.

How is Bulgaria, Georgi? Can you make a post about your visit there? Nothing too personal, maybe some pics just to cheer us up. Looking for places where I can buy food without the jab.

 

[JmJ]

Thanks, I guess FDA did release a propaganda statement after all. Yet, their PDF does not mention full approval. Whenever it uses the word "authorization" it always clarifies that it is under prior/existing EUA. Considering the EUA comes with legal liability and the full approval does not (yet), I don't see why Pfizer would rush to get its jab approved.

What about this PDF dated Aug 23, 2021? To me it appears the new version (yet to be delivered) has been FDA approved...?

https://www.fda.gov/media/151710/download

 

[haidut]

What about this PDF dated Aug 23, 2021? To me it appears the new version (yet to be delivered) has been FDA approved...?

https://www.fda.gov/media/151710/download

Thanks. Yes, that one does look like the actual full approval. Well, I guess we will now see many more vaccine mandates, even in the US.

 

[Peatness]

Ignore the first 5 mins of this. Karen Kingston is a former Pfizer employee thinks game is up for Pfizer. Includes discussion of shedding/transmission


View: https://www.bitchute.com/video/v4UR2RfaDozA/

 

[Birdie]

Ignore the first 5 mins of this. Karen Kingston is a former Pfizer employee thinks game is up for Pfizer. Includes discussion of shedding/transmission


View: https://www.bitchute.com/video/v4UR2RfaDozA/

Well this is incredible.

 

[Peatness]

Well this is incredible.

It gives me hope. However, I am mindful of the plague vaccine trial by AZ