CORONA FDA NON-approval of Pfizer jab

G

glennb6

Inactive
I just read Martin Armstongs article;
The Fake News that FDA Approved the Vaccines is Made Clear in the Letter
www.armstrongeconomics.com

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

FDA Letter Final_Pfizer LOA to issue with BLA approval 08.23.21_v2 The FDA did not approve the vaccines but extended the Emergency Use of the vaccines. They are also trying very hard to have agencies force employers to compel everyone to vaccinate but at the same time leaving themselves as an...
www.armstrongeconomics.com www.armstrongeconomics.com

I did read through the FDA letter (PDF link in article) and it appears as best as I can interpret that the FDA ONLY extended the Emergency Use Authorization (EUA) and did NOT fully approve the Pfizer jab.

FDA Letter Final_Pfizer LOA to issue with BLA approval 08.23.21_v2


The FDA did not approve the vaccines but extended the Emergency Use of the vaccines. They are also trying very hard to have agencies force employers to compel everyone to vaccinate but at the same time leaving themselves as an escape clause who they can return to claiming they never approved the vaccines beyond emergency use.


This is getting really questionable as to why they are forcing vaccines that clearly do not work and CANNOT work for as long as COVID exists in animals, it will constantly evolve and mutate just like the seasonal flu that sometimes comes from Birds or even Swine. The real question is WHY are we being lied to for what is the real purpose of the vaccines? They obviously do not care about the Great Unwashed, they prefer to thin the herd.

----------------
I saw this on page 12;
Page 12 – Pfizer Inc.


• This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
----------------
Would be grateful if anyone can tolerate and read through the legal mush and confirm or not.
glennb6
 
ShadowMan

ShadowMan

Designated Grumpy Old Fart
Once AGAIN!! Another bald face lie!! Right there in the text on page 12!! NOT APPROVED, but just extended. "THEY" are really pushing this agenda. Hmmmm......why? Why not FULLY approve AND LICENSE it? What are "THEY" hiding? You have to ask the question, you simply have to.

  • This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
  • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Click to expand...

Funny, but that's not what's being said in the Drive By Media and the white House. Hmmmmmmm
 
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Kathy in FL

Kathy in FL

Administrator
_______________
1-12020 said:
wait, what, is this real?
how can Dr. F and MSM say FDA approval?
won't this come out?
what the heck?
I'm really confused.
Click to expand...

That’s on purpose. Only why are you surprised. They lie. They lie all the time. Sorry, it is called “mis-speaking” these days. Wouldn’t want to scare the chattel and make them realize those speaking puppets cannot be trusted.
 
workerbee

workerbee

* Winter is Coming *
Just saw Dr Malone on War Room.

https://twitter.com/i/web/status/1430181458069663749
View: https://twitter.com/RWMaloneMD/status/1430181458069663749?ref_src=twsrc%5Etfw
"


There is something screwed up here.

The MSM, .gov and EVERYONE is reporting "The Pfizer vaccine has FDA approval".

If I recall correctly from the interview [I only saw a few minutes, and have not yet read this article] the vaccine that has FDA approval HAS NOT YET BEEN MANUFACTURED. The current Pfizer 'vaccine ' in use has NOT been FDA approved.

I swear that is exactly what I heard.

I don't claim to understand, or be able to explain, but if this is true, it is a BOMBSHELL.
 
artichoke

artichoke

Greetings from near tropical NYC!
workerbee said:
Just saw Dr Malone on War Room.

https://twitter.com/i/web/status/1430181458069663749
View: https://twitter.com/RWMaloneMD/status/1430181458069663749?ref_src=twsrc%5Etfw
"


There is something screwed up here.

The MSM, .gov and EVERYONE is reporting "The Pfizer vaccine has FDA approval".

If I recall correctly from the interview [I only saw a few minutes, and have not yet read this article] the vaccine that has FDA approval HAS NOT YET BEEN MANUFACTURED. The current Pfizer 'vaccine ' in use has NOT been FDA approved.

I swear that is exactly what I heard.

I don't claim to understand, or be able to explain, but if this is true, it is a BOMBSHELL.
Click to expand...

You can read the actual FDA letter here: https://www.fda.gov/media/151710/download

My summary-of-Malone's-summary:

Yes the Pfizer-BioNTech vax is now fully approved for people 16 and older. The only diff. is that the existing supplies of "Pfizer" out there are still under EUA which fully absolves liability. When more of it is made as "Comirnaty" that won't have such expansive liability protections.

There is now an EUA for use on people 12-16. They can give it to your 12 year old kid now, but someone will have to sign some kind of disclosure first.

And it's funny that the first signer of the letter is named Malarkey. But Mary A. Malarkey is a real long-time employee there in an executive role; she is a real person, and we don't get to say the letter is just malarkey.

By the way they do call it an "mRNA vaccine" i.e. it is considered a vaccine.

Malone raises many strong and in fact overwhelming points about what FDA did here. It should not have happened in a free country with a reasoned, responsible government. I guess someone could sue to force FDA to follow its own procedures. Federal agencies do have to follow their own policies. I don't have much confidence in SCOTUS to rule properly on such a suit but I suppose it couldn't hurt to make a legal fuss and try.
 
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S

SavedByHisGrace

Contributing Member
glennb6 said:
I just read Martin Armstongs article;
The Fake News that FDA Approved the Vaccines is Made Clear in the Letter
www.armstrongeconomics.com

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

FDA Letter Final_Pfizer LOA to issue with BLA approval 08.23.21_v2 The FDA did not approve the vaccines but extended the Emergency Use of the vaccines. They are also trying very hard to have agencies force employers to compel everyone to vaccinate but at the same time leaving themselves as an...
www.armstrongeconomics.com www.armstrongeconomics.com

I did read through the FDA letter (PDF link in article) and it appears as best as I can interpret that the FDA ONLY extended the Emergency Use Authorization (EUA) and did NOT fully approve the Pfizer jab.

FDA Letter Final_Pfizer LOA to issue with BLA approval 08.23.21_v2


The FDA did not approve the vaccines but extended the Emergency Use of the vaccines. They are also trying very hard to have agencies force employers to compel everyone to vaccinate but at the same time leaving themselves as an escape clause who they can return to claiming they never approved the vaccines beyond emergency use.


This is getting really questionable as to why they are forcing vaccines that clearly do not work and CANNOT work for as long as COVID exists in animals, it will constantly evolve and mutate just like the seasonal flu that sometimes comes from Birds or even Swine. The real question is WHY are we being lied to for what is the real purpose of the vaccines? They obviously do not care about the Great Unwashed, they prefer to thin the herd.

----------------
I saw this on page 12;
Page 12 – Pfizer Inc.


• This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
----------------
Would be grateful if anyone can tolerate and read through the legal mush and confirm or not.
glennb6
Click to expand...
Hmm...just went on to FDA site and looked at this letter. If you press "ctrl" "f", then type in "emergency", you can quickly search the entire document to find all the places it talks about the EUA. Maybe I read it wrong, but it sure looks like an approval for emergency use. This is infuriating! Most people will just believe the narrative spewed out by the MSM and our government officials, and believe there is a true stamp of "APPROVAL", and perhaps roll up their sleeves.

My contribution to society ("doing my part") will be to remain a part of the control group, and maintain a simple lifestyle of trusting in the Lord with all my heart, while not leaning on my own understanding.

Let us not fret because of those who bring wicked schemes to pass, for the wicked plots against the just and gnashes at him with is teeth, BUT the Lord laughs at him, for He sees his day coming. He Who sits in the heavens shall laugh; the LORD shall hold them in derision, then He shall speak to them in His wrath, and distress them in His deep displeasure.

Remember, the little that the righteous man has is better than the riches of may wicked, for the arms of the wicked shall be broken, but the LORD upholds the righteous. May the Lord keep us from the snares they have laid for us, and the traps from the workers of inquity. Let the wicked fall into their own nets, while we escape safely.
 
Mark D

Mark D

Now running for Emperor.
I read the FDA's statement a few times; all I come away with is the extension/renewal of the Emergency Use Authorization, and the extension of that EUA to cover the new name for the shot.

Per the FDA's own document, the shot is NOT "Fully Approved." The MSM is flat-out lying.
 
artichoke

artichoke

Greetings from near tropical NYC!
SavedByHisGrace said:
Hmm...just went on to FDA site and looked at this letter. If you press "ctrl" "f", then type in "emergency", you can quickly search the entire document to find all the places it talks about the EUA. Maybe I read it wrong, but it sure looks like an approval for emergency use. This is infuriating! Most people will just believe the narrative spewed out by the MSM and our government officials, and believe there is a true stamp of "APPROVAL", and perhaps roll up their sleeves.

My contribution to society ("doing my part") will be to remain a part of the control group, and maintain a simple lifestyle of trusting in the Lord with all my heart, while not leaning on my own understanding.

Let us not fret because of those who bring wicked schemes to pass, for the wicked plots against the just and gnashes at him with is teeth, BUT the Lord laughs at him, for He sees his day coming. He Who sits in the heavens shall laugh; the LORD shall hold them in derision, then He shall speak to them in His wrath, and distress them in His deep displeasure.

Remember, the little that the righteous man has is better than the riches of may wicked, for the arms of the wicked shall be broken, but the LORD upholds the righteous. May the Lord keep us from the snares they have laid for us, and the traps from the workers of inquity. Let the wicked fall into their own nets, while we escape safely.
Click to expand...
The approval is in the very first section "Licensing". Also the heading which says "BLA Approval".

If you just look for "emergency" you will find the new EUA for ages 12-15. But there's also the full approval for people 16 and over, and it won't appear in your search.
 
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SouthernBreeze

SouthernBreeze

Has No Life - Lives on TB
artichoke said:
The approval is in the very first section "Licensing".

If you just look for "emergency" you will find the new EUA for ages 12-15. But there's also the full approval for people 16 and over, and it won't appear in your search.
Click to expand...

So, you're saying it has been approved?
 
S

SavedByHisGrace

Contributing Member
artichoke said:
The approval is in the very first section "Licensing". Also the heading which says "BLA Approval".

If you just look for "emergency" you will find the new EUA for ages 12-15. But there's also the full approval for people 16 and over, and it won't appear in your search.
Click to expand...

Thank you so much for the insight. I appreciate it : )
 
T

TFergeson

Non Solum Simul Stare
From what I read, the name brand has been approved for use. However, and this is where it gets interesting, the document states that the remaining doses of the Pfizer vax are not approved, just extended under EUA. Another comment on here mentioned that the new name brand is not on the shelves yet, all they are working with right now is the Pfizer vax under the EUA.

So from what I understand from my reading, there's the doublespeak. The new name brand vax has been approved, but what is currently on your store shelves that you will get when the vax mandate comes down, is the old Pfizer vax under EUA.

Therefore, Everybody wins! The media can say the vaccine is approved, because it is! The .gov can mandate the vaccine, because it is! Pfizer is still absolved of all liability! Hooray!

Also, this may present an interesting loophoole. What are you giving me? Pfizer? Nope sorry still under EUA. Corminanunityism or whatever its called? Still no, but thats the FDA approved one.
 
T

TerryK

TB Fanatic
This was covered yesterday in the first thread on Pfizer approval.
The vaccine is no longer called Pfizer. Pfizer is a damn company name. The vaccine is approved and licensed and patented under the name Comirnaty. Pfizer tried to be cute and took the word community and substituted the letters I for immunity and rna for, well rna, in the middle of the word.

But the fact is that it is now approved and Pfizer will soon be starting an ad campaign like you see for many other drugs on TV and online and in print. The vaccines rolling off the production line already have the new label and boxes.
I know this will piss many people off, but expect to see ads showing the advantages of getting the vaccine compared to the disadvantages of not getting it.

The emergency use standard will still apply to those under 16 years old.

I do not know about any changes in the legal liability issues, but expect to see a long disclaimer list on the document you must sign to get the new Comirnaty vaccine at your local drug store. It might make interesting reading to see all the listed possible side effects and cautions. :)

Full Disclosure: My wife and I have both gotten the pfizer shots along with our neighbors and most of the neighborhood. There was even one house in the neighborhood that went to another county and got a unauthorized booster shot early. No one had any side effects beyond a sore arm, fever, and one had a rash.
In our 75 home neighborhood about 3/4 have gotten vaccinated and 1/4 have not. No big deal. For some it's religion(Moslem and Christian). For a few others they just aren't sure about it yet. And finally we have a few "Q" ball nuts, and that's ok.
 
T

TFergeson

Non Solum Simul Stare
TerryK said:
This was covered yesterday in the first thread on Pfizer approval.
The vaccine is no longer called Pfizer. Pfizer is a damn company name. The vaccine is approved and licensed and patented under the name Comirnaty. Pfizer tried to be cute and took the word community and substituted the letters I for immunity and rna for, well rna, in the middle of the word.

But the fact is that it is now approved and Pfizer will soon be starting an ad campaign like you see for many other drugs on TV and online and in print. The vaccines rolling off the production line already have the new label and boxes.
I know this will piss many people off, but expect to see ads showing the advantages of getting the vaccine compared to the disadvantages of not getting it.

The emergency use standard will still apply to those under 16 years old.

I do not know about any changes in the legal liability issues, but expect to see a long disclaimer list on the document you must sign to get the new Comirnaty vaccine at your local drug store. It might make interesting reading to see all the listed possible side effects and cautions. :)

Full Disclosure: My wife and I have both gotten the pfizer shots along with our neighbors and most of the neighborhood. There was even one house in the neighborhood that went to another county and got a unauthorized booster shot early. No one had any side effects beyond a sore arm, fever, and one had a rash.
In our 75 home neighborhood about 3/4 have gotten vaccinated and 1/4 have not. No big deal. For some it's religion(Moslem and Christian). For a few others they just aren't sure about it yet. And finally we have a few "Q" ball nuts, and that's ok.
Click to expand...

Correct. The only remaining confusion is concerning the current vax doses on the store shelves not labeled under the new product name. From what I was reading, it appears they still fall under the old EUA as well
 
subnet

subnet

Boot
Someone correct me if I'm wrong, but having visited the fda site, there looks to be an additional letter at the top of the list that signals approval....
 
T

TerryK

TB Fanatic
TFergeson said:
Correct. The only remaining confusion is concerning the current vax doses on the store shelves not labeled under the new product name. From what I was reading, it appears they still fall under the old EUA as well
Click to expand...
Good point, unless they are going to be slapping Comirnaty stickers on them as well. :lol:
Also no matter the label it still has only emergency use certification for those under 16.
 
Marie

Marie

Veteran Member
The problem is actually the wording of the fda approval letter. Per fda guidelines once a BLA is approved. There can no longer be a product used under EUA. That is the technical fake loophole.
Another words you can't approve brand name B and still use EUA B product.
 
Kris Gandillon

Kris Gandillon

The Other Curmudgeon
_______________
"Per fda guidelines once a BLA is approved. There can no longer be a product used under EUA."

Marie, please provide a link to the FDA Guidelines that documents this claim.

Thanks!
 
J

jaw1969

Senior Member
TerryK said:
This was covered yesterday in the first thread on Pfizer approval.
The vaccine is no longer called Pfizer. Pfizer is a damn company name. The vaccine is approved and licensed and patented under the name Comirnaty. Pfizer tried to be cute and took the word community and substituted the letters I for immunity and rna for, well rna, in the middle of the word.

But the fact is that it is now approved and Pfizer will soon be starting an ad campaign like you see for many other drugs on TV and online and in print. The vaccines rolling off the production line already have the new label and boxes.
I know this will piss many people off, but expect to see ads showing the advantages of getting the vaccine compared to the disadvantages of not getting it.

The emergency use standard will still apply to those under 16 years old.

I do not know about any changes in the legal liability issues, but expect to see a long disclaimer list on the document you must sign to get the new Comirnaty vaccine at your local drug store. It might make interesting reading to see all the listed possible side effects and cautions. :)

Full Disclosure: My wife and I have both gotten the pfizer shots along with our neighbors and most of the neighborhood. There was even one house in the neighborhood that went to another county and got a unauthorized booster shot early. No one had any side effects beyond a sore arm, fever, and one had a rash.
In our 75 home neighborhood about 3/4 have gotten vaccinated and 1/4 have not. No big deal. For some it's religion(Moslem and Christian). For a few others they just aren't sure about it yet. And finally we have a few "Q" ball nuts, and that's ok.
Click to expand...
Did you go to every house and ask the side effects and if they got the gene therapy shot I'm gonna need some proof of that seriously!
 
psychgirl

psychgirl

Has No Life - Lives on TB
And heeeere we go!


Already getting emails from CVS proclaiming with joy the blessed arrival of THE NEW IMPROVED, APPROVED injection of death.
BioNtech is here to save the day”!
 
T

TerryK

TB Fanatic
jaw1969 said:
Did you go to every house and ask the side effects and if they got the gene therapy shot I'm gonna need some proof of that seriously!
Click to expand...
It's a small neighborhood with only one entrance and exit.
No I personally didn't survey everyone. But the HOA did. ;) They mentioned the numbers in the monthly newsletter with info on where to get each kind of test and what places have what brand of vaccine.
I know about half the people here and none of them had any side effects, how about your neighborhood? :lol:

Oh, and you throw around the term gene therapy. Could you please explain in biochemical or even just cellular biology terms exactly how that happens??? Or is that just something you picked up off the interweb?
 
et2

et2

Has No Life - Lives on TB
I have a large client base. I personally know people who died from the jab, those who had blood clots, heavy bleeding, hospitalized, and extremely sick after being jabbed. Many not the same since. Many never went back for the second required jab. A few quit working from bad reactions, as there energy and health declined severely after.

I have broad base of hands on real-time information from people crossing a whole state to base my decisions on, hundreds. Personally I don’t listen to the vaccine preachers. I trust what I see, and what I hear from real people of different backgrounds and ages.

People I’m telling you, there’s a lot of people who will refuse the jab, even if it costs them their jobs. Including me. I’ve been discussing this a lot the last 3 weeks with people.

THEY AREN‘T BEING HONEST WITH US. THEY’RE HIDING A LOT FROM US.
 
T

TerryK

TB Fanatic
naegling62 said:
I can't find it anywhere, does anyone know how many Pfizer staff have taken the vaccine?
Click to expand...
Pfizer CEO got the vaccine in Mar.

HEALTH AND SCIENCE
Pfizer will require U.S. employees to get Covid vaccine or undergo weekly testing
PUBLISHED WED, AUG 4 20213:18 PM EDT

This was before the vaccine received approval. Most places that had the above requirements had them because the vaccine was still classified for emergency use. After the approval most companies are already removing the option for weekly testing.
 
artichoke

artichoke

Greetings from near tropical NYC!
TerryK said:
...
Oh, and you throw around the term gene therapy. Could you please explain in biochemical or even just cellular biology terms exactly how that happens??? Or is that just something you picked up off the interweb?
Click to expand...
Here's an article saying that mRNA might actually translate its instructions into host DNA. That would apply to Pfizer / Comirnaty and to Moderna. This seems to be a new line of research and it may not have been known during vaccine development, but it should still be resolved before providing or continuing to provide these shots to the public. SARS-CoV-2 RNA reverse-transcribed and integrated into the human genome - PubMed

and here is a blog talking about how it could happen: MIT & Harvard Study Suggests mRNA Vaccine Might Permanently Alter DNA After All

J&J contains live adenovirus containing DNA. I'm not sure of the argument by which we are supposed to know that information will not be transcribed to host DNA. Are we sure?
 
G

glennb6

Inactive
1-12020 said:
wait, what, is this real?
how can Dr. F and MSM say FDA approval?
won't this come out?
what the heck?
I'm really confused.
Click to expand...
1. you're confused - that's part of propaganda
2. how can they say...? They can and do say anything. The ends justify the means > remember that axiom of the commies?
say it enough and people will believe, usually
 
J

jaw1969

Senior Member
TerryK said:
It's a small neighborhood with only one entrance and exit.
No I personally didn't survey everyone. But the HOA did. ;) They mentioned the numbers in the monthly newsletter with info on where to get each kind of test and what places have what brand of vaccine.
I know about half the people here and none of them had any side effects, how about your neighborhood? :lol:

Oh, and you throw around the term gene therapy. Could you please explain in biochemical or even just cellular biology terms exactly how that happens??? Or is that just something you picked up off the interweb?
Click to expand...
It is what this vaccine is That is why I used that term. My neighbors have no idea about their vaccination status but I do know about their patriotic status... I have 2 with in two miles of me You must live in a little socialist utopia for everybody to get in everybody else's business like that.
 
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  • LOL
Reactions: et2
G

glennb6

Inactive
SouthernBreeze said:
So, despite what they are telling us on MSM and the White House, this vaccine has NOT met FDA approval? Am I getting that right?!
Click to expand...
some discussions on social media is that the FDA approved the COMIRNATY version from BioNTech, which is not yet (either in official production or distribution). but the EUA for the current in distribution Pfizer jab has been extended.
this is a legal magicians trick - watch this hand not the other hand.
 
Cacheman

Cacheman

Ultra MAGA!
Steve Bannon and Dr Malone RT4:39

Synopsis: There are two letters in one. No full authorization until 2023 or 2024, the way Dr. Malone reads them. The one that has the liability shield is the current one, it's still under EUA. The one that's approved, is still being developed, it doesn't exist yet, and has not liability shield. They acknowledge the cardiomyopathy issues require a 5-year follow-up.

Pfizer Seeking Full Indemnification - Rumble

rumble.com
 
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