Pfizer Admits It Will Not Gain Regulatory Approval - Wants To Keep Using EUA

In it's own SEC filing, Pfizer admits it doesn't believe it's mRNA Covid "vaccine" will pass safety standards and be approved for normal regulatory use. As we know, there was a bait and switch pulled last year with Pfizer BioNTech and "Corminaty." The elusive Corminaty was approved for specific circumstances, but it was not available. The big difference are the legal implications between the two. Even if they were the exact same formula, you can't sue if something happens to you when you are injected with an EUA drug, but you could if it was the approved version. That version is not available.

The reason this is being disclosed is because investors could sue for them not admitting there will be lower revenue. Paradoxically, if you have an adverse affect from the vaccine itself, you cannot sue. The cherry on top is that even if they obtain regulatory approval it may not gain market acceptance necessary for commercial success. Meaning specifically, that they believe they will have problems even with approval once doctors start seeing the data. As we know any doctor that spoke out lost their jobs at this point, but most doctors haven't even seen the important data, you know the data they wanted to hide for 75 years, and if they did they would stop using it.

I know this is just anecdotal, but I'll relate it anyway. A good friend of mine has a cousin who is 58 years old. I've met the cousin 2-3 times, so I can't really say I know him. I do know he was very, very healthy. He's a professor. He was able to retire recently because he bought several houses years ago and sold them after they appreciated in value. He was most likely under no stress. ( Of course I can't state that for certain) He walked, jogged, or biked daily. He swam, he lifted weights, he ate very healthy. Low body fat percentage. Check off all the good health boxes.

He got the Pfizer double vax early on, and then the booster late fall of last year. Last week, he had a heart attack, literally out of the blue. Three occluded coronary arteries, one of which was total. He is in the hospital now recovering from surgery, with 3 stents now in place. It makes you wonder.

originally posted by: ColeYounger
... It makes you wonder.

Doesn't make me wonder.

Makes me say, "See, I told you so."

originally posted by: ColeYounger
I know this is just anecdotal, but I'll relate it anyway. A good friend of mine has a cousin who is 58 years old. I've met the cousin 2-3 times, so I can't really say I know him. I do know he was very, very healthy. He's a professor. He was able to retire recently because he bought several houses years ago and sold them after they appreciated in value. He was most likely under no stress. ( Of course I can't state that for certain) He walked, jogged, or biked daily. He swam, he lifted weights, he ate very healthy. Low body fat percentage. Check off all the good health boxes.

He got the Pfizer double vax early on, and then the booster late fall of last year. Last week, he had a heart attack, literally out of the blue. Three occluded coronary arteries, one of which was total. He is in the hospital now recovering from surgery, with 3 stents now in place. It makes you wonder.

I'm sure it's just another coincidence.

a reply to: ColeYounger

Similar story here. Relative who worked out regularly. Vax + Booster and is now using a WALKER, due to something going haywire inside his lower spinal column. He still looks muscular, but won't for much longer. I warned him. Did my part.

investors.biontech.de...

Here is where they state what was presented in the OP.

"We may not be able to demonstrate sufficient efficacy or safety of our COVID-19 vaccine and/or variant-specific formulations to obtain permanent regulatory approval in the United States, the United Kingdom, the European Union, or other countries where it has been authorized for emergency use or granted conditional marketing approval."

From the linked document. I know somewhere they also say they are having a problem with internal corruption...

This is so wild.

a reply to: v1rtu0s0

Another misleading video.

Pfizer are not doing the data dumps. They have already submitted hundreds of thousands of documents to the FDA. The delay in releasing them to the public is that of the FDA not being able to keep up.

And, since non-EUA approval has already been granted to the Pfizer vaccine, the whole basis of this video, that of looking at an old document (published 30/3/2021, for fiscal year ended December 31, 2021), is just misrepresenting what the document contains and suggesting it applies to the current financial period.

Link to actual document on the SEC server: Form 20-F Biontech Se 20-F - Annual and transition report of foreign private issuers [Sections 13 or 15(d)] - SEC file

Please also note the differences between the official SEC document, and the document on this page: Previously linked non-SEC site used as source in the video. Specifically the "Risks" section, which appears significantly different.

These vloggers are clearly peddling misinformation, and that is why they are getting banned. Not because their content is controversial, but because it is false, and misrepresented as if it is truth.

originally posted by: chr0naut
a reply to: v1rtu0s0

Another misleading video.

Pfizer are not doing the data dumps. They have already submitted hundreds of thousands of documents to the FDA. The delay in releasing them to the public is that of the FDA not being able to keep up.

And, since non-EUA approval has already been granted to the Pfizer vaccine, the whole basis of this video, that of looking at an old document (published 30/3/2021, for fiscal year ended December 31, 2021), is just misrepresenting what the document contains and suggesting it applies to the current financial period.

Link to actual document on the SEC server: Form 20-F Biontech Se 20-F - Annual and transition report of foreign private issuers [Sections 13 or 15(d)] - SEC file

Please also note the differences between the official SEC document, and the document on this page: Previously linked non-SEC site used as source in the video. Specifically the "Risks" section, which appears significantly different.

These vloggers are clearly peddling misinformation, and that is why they are getting banned. Not because their content is controversial, but because it is false, and misrepresented as if it is truth.

Yes they are, Pfizer is in the process of releasing 10's of thousands of documents every month. There is a big one coming out on May 1st. Each one has been enlightening. The first document dump showed they recorded over 1200 deaths from the vaccine early last year. Was that out of their 40 thousand person test pool? Impossible to know since they redacted the denominator. It must be bad if they don't want you to see that number. Normally a drug would get recalled when there are 50 deaths, and the 1200 was from early last year, which means there would have been way more, and out of a much smaller group of people.

We also got to see 10 pages of exotic side effects like the 1p36 deletion issue that will cause your future child to be a vegetable and other fun things like that.

There is no approved Pfizer mRNA drug available in the US. We've been over this before. They "approved" corminaty but it's not available nor will it ever be most likely since by using an EUA they can never be sued.

originally posted by: v1rtu0s0

originally posted by: chr0naut
a reply to: v1rtu0s0

Another misleading video.

Pfizer are not doing the data dumps. They have already submitted hundreds of thousands of documents to the FDA. The delay in releasing them to the public is that of the FDA not being able to keep up.

And, since non-EUA approval has already been granted to the Pfizer vaccine, the whole basis of this video, that of looking at an old document (published 30/3/2021, for fiscal year ended December 31, 2021), is just misrepresenting what the document contains and suggesting it applies to the current financial period.

Link to actual document on the SEC server: Form 20-F Biontech Se 20-F - Annual and transition report of foreign private issuers [Sections 13 or 15(d)] - SEC file

Please also note the differences between the official SEC document, and the document on this page: Previously linked non-SEC site used as source in the video. Specifically the "Risks" section, which appears significantly different.

These vloggers are clearly peddling misinformation, and that is why they are getting banned. Not because their content is controversial, but because it is false, and misrepresented as if it is truth.

Yes they are, Pfizer is in the process of releasing 10's of thousands of documents every month.

Please note in the following articles, who is doing the release, and who was holding up the process (don't just read the headline, read the whole articles):

FDA Begins Releasing Pfizer COVID Vax Documents .

‘Paramount importance’: Judge orders FDA to hasten release of Pfizer vaccine docs

There is a big one coming out on May 1st. Each one has been enlightening. The first document dump showed they recorded over 1200 deaths from the vaccine early last year. Was that out of their 40 thousand person test pool? Impossible to know since they redacted the denominator. It must be bad if they don't want you to see that number. Normally a drug would get recalled when there are 50 deaths, and the 1200 was from early last year, which means there would have been way more, and out of a much smaller group of people.

Anti-vaxxers misrepresent Pfizer report to say 1200 died in the first months of rollout

We also got to see 10 pages of exotic side effects like the 1p36 deletion issue that will cause your future child to be a vegetable and other fun things like that.

These 'exotic side effects' were not observed adverse reactions, but rather a list of things to watch for as indicative of adverse reactions. As previously pointed out, one of these 10 pages of "adverse effects" was getting an X-Ray.

1p36 deletion syndrome From Wikipedia, the free encyclopedia

The most usual cause of 1p36 deletions appears to be from a balanced translocational abnormality in one of the parents. Such a balanced translocation has no adverse health effect in the parent, however, when passed on to children, can become unbalanced by the loss of genetic material in the 1p36 region of the short arm of chromosome 1 during fusion of the sperm and ova, in a tiny percentage of those affected children.

It is also unclear how an mRNA sequence that does not code for reverse transcriptase could cause a genetic deletion from a DNA genetic sequence, which is what makes up the chromosome. You would need something more likely to be similar to a genetic engineering tool such as CRISPR or Gene Shears - things absent from the mRNA vaccines.

There is no approved Pfizer mRNA drug available in the US. We've been over this before. They "approved" corminaty but it's not available nor will it ever be most likely since by using an EUA they can never be sued.

Comirnat y and Pfizer-BioNTech COVID-19 Vaccine

From the page: "On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older."

The FDA approved the "Pfizer-BioNTech COVID-19 Vaccine", which was then given a trade name. "Comirnaty".

The "Pfizer-BioNTech COVID-19 Vaccine" are the same product, as is clearly explained in the FDA web page.

The revised EUA is also still in place because the full approval was not granted for all groups. Some fall under the full approval. Others (like children) are covered in the revised EUA.

a reply to: chr0naut

As you clearly have so much invested in this can you re-write your last post as it reads like a load of gibberish.

75 years they wanted to hide the data, stop pretending otherwise.

originally posted by: surfer_soul
a reply to: chr0naut

As you clearly have so much invested in this can you re-write your last post as it reads like a load of gibberish.

75 years they wanted to hide the data, stop pretending otherwise.

They didn't want to hide the data for 75 years (although something similar was alleged in court). The issue was that there were already more than 430,000 documents submitted by Pfizer to the FDA, and that the FDA thought that it would take more than 75 years for them to process all the documents into the public domain.

FDA Says It'll Take 75 Years to Fully Release Pfizer Vaccine Data

Wait what? FDA wants 55 years to process FOIA request over vaccine data

Does FDA Want Until 2076 To Release Vaccine Data?

Disclosing Pfizer vaccine data ‘may take until 2096’

a reply to: chr0naut

"The delay in releasing them to the public is that of the FDA not being able to keep up."

On that point, I'm calling BS. They can keep up just fine, they choose not to do their jobs.

Some quick search figures to prove my point:

Today, the U.S. Food and Drug Administration announced it is requesting a total budget of $8.4 billion as part of the President's fiscal year (FY) 2023 budget – a nearly 34% ($2.1 billion) increase over the agency's FY 2022 appropriated funding level for investments in critical public health modernization, core food ...Mar 28, 2022

Food and Drug Administration
Agency overview
Employees 18,000 (2022)
Annual budget US$6.5 billion (2022)

Quick math!

6.5 billion / 18000
361111.11

8.4 billion / 18000
466666.66

So accounting for (a LOT of) overhead, they have 18,000 people paid between 100k and 350k, plus some "leadership" likely getting millions to sit on ass.
If the department as a whole managed to review ONE document per day per person, which is laughable in any public sector job, they'd still get at LEAST 3 million documents a year processed. That's accounting for only half of their staff getting one document a day processed- assuming the other half of the staff has better things to do, assuming this "pandemic" isn't the worlds leading problem right now (it isn't, the reaction to it is)

bunch of hosers at the FDA, most like every other government agency.
Overfunded and overpowered. they should go get real jobs.

originally posted by: chr0naut

originally posted by: surfer_soul
a reply to: chr0naut

As you clearly have so much invested in this can you re-write your last post as it reads like a load of gibberish.

75 years they wanted to hide the data, stop pretending otherwise.

They didn't want to hide the data for 75 years (although something similar was alleged in court). The issue was that there were already more than 430,000 documents submitted by Pfizer to the FDA, and that the FDA thought that it would take more than 75 years for them to process all the documents into the public domain.

FDA Says It'll Take 75 Years to Fully Release Pfizer Vaccine Data

Wait what? FDA wants 55 years to process FOIA request over vaccine data

Does FDA Want Until 2076 To Release Vaccine Data?

Disclosing Pfizer vaccine data ‘may take until 2096’

in non clown world, if it takes 75 years to validate the data, then it should take 75 or more years to approve the drug. Of should we just ASSume it's all good news and go with it like we have been?

Anti-vaxxers misrepresent Pfizer report to say 1200 died in the first months of rollout

Misrepresent? Pfizer even redacted the total number of vaccine recipients so if anyone is "misrepresenting" it would be them. Were there 10,000 total patients? 20,000? 5,000? The 1200 number is definitely worrying when they don't want to give you the total number that received the vaccine. I wonder why? Do you have stock in Pfizer? Or do you just defend big pharma for free? Seems like a waste of time.

originally posted by: chr0naut

originally posted by: surfer_soul
a reply to: chr0naut

As you clearly have so much invested in this can you re-write your last post as it reads like a load of gibberish.

75 years they wanted to hide the data, stop pretending otherwise.

They didn't want to hide the data for 75 years (although something similar was alleged in court). The issue was that there were already more than 430,000 documents submitted by Pfizer to the FDA, and that the FDA thought that it would take more than 75 years for them to process all the documents into the public domain.

FDA Says It'll Take 75 Years to Fully Release Pfizer Vaccine Data

Wait what? FDA wants 55 years to process FOIA request over vaccine data

Does FDA Want Until 2076 To Release Vaccine Data?

Disclosing Pfizer vaccine data ‘may take until 2096’

Why am I not surprised your using big pharma funded fact checkers? One thing you'll notice is they have never reported a single controversial thing about big pharma, the same industry that is known as the worst of the worst. Gee, I wonder why that is?

James Smith sits on the board of Reuters and Pfizer. No conflict of interest there.

Yes, no matter what evidence is presented, fact checkers will always be there to deny it. They get paid good money to do so.

They asked to wait 75 years to release the data. There's no getting out of that one.

a reply to: v1rtu0s0

He defends billion dollar capitalist pharma companies with the tenacity of a staunch republican LOL

The goal of the jab was to be made permanent within the required vaccines in the US specially targeting children.

Sadly once the adult population understood the scam they just gave the finger to the jabs, endless boosters was not the right approach to sell a yearly required vaccine.

I think pharma got greedy with all the billions they made at the expenses of the tax payer.

Nobody wants to be injected every 3 to 4 months with the same old crap that does not work, specially littler children.

Where at we now? 5 boosters?

originally posted by: v1rtu0s0

originally posted by: chr0naut

originally posted by: surfer_soul
a reply to: chr0naut

As you clearly have so much invested in this can you re-write your last post as it reads like a load of gibberish.

75 years they wanted to hide the data, stop pretending otherwise.

They didn't want to hide the data for 75 years (although something similar was alleged in court). The issue was that there were already more than 430,000 documents submitted by Pfizer to the FDA, and that the FDA thought that it would take more than 75 years for them to process all the documents into the public domain.

FDA Says It'll Take 75 Years to Fully Release Pfizer Vaccine Data

Wait what? FDA wants 55 years to process FOIA request over vaccine data

Does FDA Want Until 2076 To Release Vaccine Data?

Disclosing Pfizer vaccine data ‘may take until 2096’

Why am I not surprised your using big pharma funded fact checkers? One thing you'll notice is they have never reported a single controversial thing about big pharma, the same industry that is known as the worst of the worst. Gee, I wonder why that is?

James Smith sits on the board of Reuters and Pfizer. No conflict of interest there.

Yes, no matter what evidence is presented, fact checkers will always be there to deny it. They get paid good money to do so.

They asked to wait 75 years to release the data. There's no getting out of that one.

I even included a link to an RT report of the fact that it was the FDA that said it would take 75 years. The fact checker link was only one of the supplied links, yet you seem to be unwilling to see past that. If you don't like that, ignore it and look at the weight of other evidence.

You are just wrong and in denial of the the truth.

a reply to: v1rtu0s0

Already fully approved here, some time ago in fact.

We simply move faster than you do because we're less political. We followed the science.

You'd probably have approved this too by now if the pandemic hadn't come in an election year and gotten mixed up in your two party system.

originally posted by: chr0naut

originally posted by: v1rtu0s0

originally posted by: chr0naut

originally posted by: surfer_soul
a reply to: chr0naut

As you clearly have so much invested in this can you re-write your last post as it reads like a load of gibberish.

75 years they wanted to hide the data, stop pretending otherwise.

They didn't want to hide the data for 75 years (although something similar was alleged in court). The issue was that there were already more than 430,000 documents submitted by Pfizer to the FDA, and that the FDA thought that it would take more than 75 years for them to process all the documents into the public domain.

FDA Says It'll Take 75 Years to Fully Release Pfizer Vaccine Data

Wait what? FDA wants 55 years to process FOIA request over vaccine data

Does FDA Want Until 2076 To Release Vaccine Data?

Disclosing Pfizer vaccine data ‘may take until 2096’

Why am I not surprised your using big pharma funded fact checkers? One thing you'll notice is they have never reported a single controversial thing about big pharma, the same industry that is known as the worst of the worst. Gee, I wonder why that is?

James Smith sits on the board of Reuters and Pfizer. No conflict of interest there.

Yes, no matter what evidence is presented, fact checkers will always be there to deny it. They get paid good money to do so.

They asked to wait 75 years to release the data. There's no getting out of that one.

I even included a link to an RT report of the fact that it was the FDA that said it would take 75 years. The fact checker link was only one of the supplied links, yet you seem to be unwilling to see past that. If you don't like that, ignore it and look at the weight of other evidence.

You are just wrong and in denial of the the truth.

I would assume that Pfizer submitted these documents to the FDA for a reason.

The one reason that comes to mind is that they were required to be submitted so that the FDA could determine the safety and efficacy of the drug before it was given to the American public.

It sounds like an awful lot of documentation to review in such short time by an understaffed Administration.

I wonder how they did it?