Why Lie About the FDA Approval of PFIZER's COMIRNATY?
Answer: to protect Pfizer from litigation and a national mRNA vaccine recall
Would the deadly mRNA COVID-19 injections have been pulled off the market by now if lawsuits that were filed under the premise that PFIZER was protected under Emergency Use Authorization (EUA) legal immunity had instead been justifiably filed under the laws of an FDA-approved product that underwent the FDA Initial New Drug (IND) and Biological License Application (BLA) processes instead?
On August 25, 2021, I was on the Stew Peters Show confirming that the FDA approved PFIZER’s mRNA COVID-19 vaccines. This confirmation was crucial in our fight against the COVID-19 bioweapon shots being unleashed on our citizens and children. Why? Because the August 23, 2021, FDA APPROVAL BROKE PFIZER’s EUA SHIELD.
This means that attorneys could have begun civil and criminal litigation against PFIZER last year under TITLE 21, Sec 312, Initial New Drug Application, the Federal Trade Commission Act, the Food & Drug Consumer Protection Act, and hundreds of federal and state laws without having to deal with the absurdity of the unconstitutional immunity under EUA designation.
The evidence I presented was not only dismissed, but leaders in our movement against the Tyrannical Medical Industrial Complex claimed that the approval documentation for COMIRNATY didn’t ‘really mean’ that the FDA approved the mRNA vaccines made by both PFIZER and BioNTech .
Ten (10) months later, on June 29, 2022, I appeared on Brannon Howse and confirmed that PFIZER did manufacture COMIRNATY and shipped the FDA approved product to a military base.
The Epoch Times published an article on August 20, 2022, confirming Pfizer’s FDA approved COMIRNATY is available on military bases.
I sent an email to Senators Ron Johnson and Rand Paul on Aug 3, 2022, with the documentation proving that COMIRNATY is available on military bases as early as June of 2022. I sent the same documentation to a former military doctor who was working with the military directly on a COVID-19 Vaccine Mandate Case. I also invested hours at length explaining to her in detail the irrefutable evidence that the FDA approved COMIRNATY was indeed available on a US military base. The above mentioned Epoch Times article credits the discovery of the data and evidence confirming the availability of COMIRNATY on military bases to a law firm.
On August 31, 2022, a FOIA request was submitted to the Department of Defense (DOD), Defense Logistics Agency requesting how much, if any, FDA approved COMIRNATY was shipped to military bases after August 23, 2021.
The DOD logistics agency responded and confirmed that they began shipping FDA approved COMIRNATY to military bases beginning the week of June 13, 2022.
This is irrefutable evidence that there is FDA-approved product of PFIZER’s COMIRNATY COVID-19 vaccine available in the US, thereby confirming that the August 23, 2021 FDA-approval of PFIZER’s COVID-19 mRNA vaccines occurred.
How many lives could have been saved if the TRUTH hadn’t been dismissed for over 10 months because the messenger was not a world-renowned vaccinologist, scientist, lawyer, or doctor?
Why has there been false and misleading information being promoted over the last ten months regarding the FDA’s approval of PFIZER’s COVID-19 mRNA vaccines?
The answer is simple. I was one (1) small voice of TRUTH that was dismissed by the reverberating voices of many influential leaders. The facts were suppressed by many credentialed doctors, scientists, and attorneys who were misled in falsely stating that the FDA APPROVAL:
· Was NOT for a PFIZER vaccine, therefore PFIZER still has immunity under EUA.
· Was for a vaccine manufactured by the German company BioNTech - NOT Pfizer.
· Does not allow for the manufacturing and distribution of FDA approved vaccines until after the postmarketing studies in the FDA-approval are completed in 2023, 2024, or later.
The damage done over the past 10 months has been immeasurably compounded because of the extended timeframe of the laissez-faire legal immunity granted to PFIZER under the EUA as the Big Pharma tyrant continues to unleash these mRNA bioweapons on our families and communities with no fear of liability.
To clarify the title of this article, I do not mean to imply that everyone who misrepresented the FDA approval of the PFIZER COVID-19 mRNA vaccines or their availability did so intentionally. To lie means that a person made false statements with the intention to deceive, and that is certainly not the case here. More than 99% of doctors, scientists, and attorneys, and probably zero senators, know the legal and regulatory process of bringing a product from Phase-3 data submission through to FDA approval. (Note: FDA approval is literally the BLA approval to engage in interstate commerce and commercialization of an FDA approved product.)
I believe most of the experts and our trusted leaders were misled.
Dr. Robert Malone was among the first medical and scientific experts to make the inaccurate statements regarding the ‘false flag’ FDA approval of PFIZER’s COVID-19 mRNA vaccines on Steve Bannon’s WAR ROOM on August 24, 2021. Dr. Malone is highly respected and influential with extensive experience in mRNA technology, as well as vaccine development and commercialization. He has extensive experience with the FDA approval process, being part of the team for the FDA approved Ebola vaccine.
As he has said himself (and I am paraphrasing here), “If I (Dr. Malone), the inventor of mRNA and a vaccinologist don’t have the credibility to speak on matters regarding the COVID-19 mRNA vaccines, then who?” I agree with Dr. Malone. He carries a great deal of credibility and has won the hearts and minds of millions who both believe and trust him.
Following is a synopsis of Dr. Malone’s claims made during the WAR ROOM interview.
This clip of the interview opens with Steve Bannon asking Dr. Malone a straightforward question, “Does the FDA approved vaccine exist?” Dr. Malone responds with, “It’s absolutely NOT available.” This statement was partially correct when it was made on August 24, 2021. (I’ll explain the discrepancy later in this article.)
Dr. Malone goes on to state that the FDA issued two (2) separate letters; one (1) that is for the PFIZER mRNA vaccine that is still under Emergency Use Authorization (EUA) and still has the liability shield; and one (1) for the BioNTech mRNA vaccine (COMIRNATY) that is licensed (FDA approved) but is not yet available because COMIRNATY has not yet been manufactured or labeled.
These statements are partially true and partially false.
There were two letters issued. TRUE
The FDA approved mRNA vaccine COMIRNATY was not currently manufactured or labeled in the United States (on August 24, 2021). INACCURATE*
* When a Dear HCP letter was issued by CBER identifying BLA compliant lots, per the BLA documentation, PFIZER did engage in interstate commerce of an FDA approved product by defacto.
The BioNTech vaccine is a separate product from the PFIZER vaccine. FALSE
Dr. Malone accurately states that PFIZER is not wanting FDA approval of their mRNA COVID-19 vaccine because PFIZER requires legal immunity from all liability. Dr. Malone falsely claims that the FDA-approved BioNTech vaccine is the one that the liability waiver will no longer be applied to (when it does become available). He goes on to claim that the PFIZER vaccine does have the liability shield. He states that the PFIZER vaccine is currently available and it’s still under emergency use authorization (EUA) and so that’s no change. He even recommends folks wait for the FDA-approved BioNTech vaccine which he claims is not the PFIZER vaccine. These statements are FALSE.
Below is the synopsis of the interview that I copied from the WAR ROOM website.
Per the WAR ROOM’s synopsis of the interview, the takeaway message is, “In other words, if something goes wrong, you cannot sue PFIZER if you use that company’s vaccine, but you will be able to sue BioNTech if you use their product.” These statements are FALSE.
I will clearly lay out several government and publicly available documents proving that the COVID-19 mRNA vaccines (BNT162b and COMIRNATY) are CO-SPONSORED, CO-DEVELOPED, and CO-DISTRIBUTED by both PFIZER and BioNTech.
Pfizer’s July 21, 2020, contract with the DOD clearly states BOTH companies are seeking Emergency Use Authorization and/or FDA approval for their CO-DEVELOPED and CO-DISTRIBUTED mRNA vaccine to be administered in the United States.
On July 20, 2018, PFIZER entered in a partnership with BioNTech under the Research Collaboration and Licensing Agreement for an mRNA vaccine. You’ll notice the most critical milestone for the commercial sale of a vaccine in the United States is missing– the FDA approval date.
Why is the most critical milestone for a co-partnership contract for the commercial sale of a vaccine in the United States missing from this agreement? Because PFIZER never intended on getting FDA approval in order to begin selling hundreds of millions of highly-deadly mRNA vaccines to the American people. PFIZER requires full-government immunity from all governments to manufacture and sell its COVID-19 mRNA vaccines and the Big Pharma tyrant needs the EUA status to have that kind of unbridled immunity in the United States.
Per the October 22, 2020 licensing agreement between the NIH and GEOVAX, the designated holding company of all NIH patents and NIH royalty agreements worldwide for COVID-19 vaccines, the intended FDA approval date was June 1, 2025.
(And BTW - This document contains the contact information of David Dodd, CEO of GEOVAX, who has the evidence that NIH employees received royalty payments from sale of the COVID-19 vaccines.)
PFIZER’s EUA shield was further shattered when the FDA’s Center for Biologics Evaluation and Research (CBER) stated in the FDA approval of the Biological License Application (BLA) that they would be sending Dear HCP letters out identifying the lot numbers of EUA vaccines that were COMIRNATY compliant. This meant PFIZER and BioNTech were going to be immediately engaging in interstate commerce and marketing of an FDA approved product by defacto per the Dear HCP letter.
Dr. Malone’s responses to Bannon’s question about the differences between the PFIZER/BioNTech Emergency Use Authorized (EUA) vaccines vs the FDA approved vaccines are inaccurate. Dr. Malone does not allude to, but states that the PFIZER COVID-19 mRNA vaccine continues to have immunity under the EUA because it is not the BioNTech FDA approved vaccine. This is FALSE.
Both companies are CO-SPONSORS of the mRNA vaccines (BNT162b and COMIRNATY) per the FDA Biological License Application (BLA), FDA approval letter, Initial New Drug (IND) Application, and the Department of Defense Operation Warp Speed Contract. One product does not belong to PFIZER with another belonging to BioNTech.
The following FDA documents are further evidence that BNT162b and COMIRNATY were and are developed, researched, manufactured, and distributed under a legal partnership with both companies.
The applicants named on the August 23, 2021 FDA Approval (BLA) for the PFIZER/BioNTech COVID-19 mRNA vaccines are PFIZER and BioNTech.
The August 23, 2021, FDA Approval Letter is addressed to PFIZER’s US Regulatory Director, Amit Patel, and states that the PFIZER/BioNTech BLA has been approved for the manufacturing and sale of their COVID-19 mRNA vaccines in the United States (interstate commerce).
Per the April 2020 Initial New Drug (IND) Application from PFIZER’s Website, PFIZER conducted the Phase 1/2/3 studies under the IND, separate from the Department of Defense Operation Warp Speed Contract, and is subject to criminal and civil charges under TITLE 21, Sec 312, Initial New Drug Application.
In the interview, Bannon goes on to question Dr. Malone, “The EUA as it currently stands for PFIZER does not allow its use for children under 16, is that correct?” Dr. Malone responded that that was correct and that there is no PFIZER EUA product for children under 16 (on August 24, 2021). This statement is FALSE. The PFIZER COVID-19 vaccine was give Emergency Use Authorization (EUA) from the FDA for Children ages 12-15 on May 10, 2021.
Bannon went on to ask, “The overall blanket approval for the other one, for BioNTech, the one that is not done yet, that does not include a full FDA authorization (FDA-approval) until 2023 or 2024, until these other studies are completed, correct?” Dr. Malone responded by stating, “That’s the way I read it. That seems to be the way it is written.”
As Dr. Malone has personally worked with teams that brought FDA approved products to market and is an expert in the FDA approval processes, it is perplexing as to why he is confirming with his expert opinion that the final FDA approval is not given to a product until after the postmarketing studies listed in the FDA approval letter and approved BLA are completed. This is FALSE.
In industry jargon, pre-market means pre- or before FDA approval and postmarket means post- or after FDA approval. So that means the IND applicants (PFIZER and BioNtech) can begin to manufacture, distribute, and market their mRNA COVID-19 vaccine in the United States once they get FDA approval and agree to conduct the postmarket studies, which PFIZER and BioNTech did and continue to do.
Here’s the FDA definition of postmarket studies verbatim from the FDA, “The phrase postmarket requirements and commitments refers to studies and clinical trials that sponsors conduct after approval to gather additional information about a product's safety, efficacy, or optimal use.”
Bannon goes on to ask, “Then the FDA will have to come back and issue an EUA for this 2nd one for children, correct?” Dr. Malone’s. responds claiming that he imagines that is what the FDA will do; issue an EUA for PFIZER (for children under the age of 16) so that will remain PFIZER indemnified because PFIZER is seeking full indemnification in all their worldwide government contracts.
This response is nonsensical because at the time of the interview PFIZER already had the EUA for their COVID-19 vaccine for children aged 12-15. Dr. Malone did emphasize during the interview that PFIZER will not likely seek FDA approval so they can keep their indemnification.
EXCEPT that PFIZER did seek FDA approval per their April 2020 IND filing, the May 2021 BLA submission, and the PDUFA date scheduled for January 18, 2022. THEN PFIZER and BioNTech received an early FDA approval on August 23, 2021 for their COVID-19 mRNA vaccines.
The FDA broke the EUA immunity shield for PFIZER with this approval and subjected PFIZER to all the state, federal and consumer protection laws of an FDA approved product.
This is further proven by the PFIZER/BioNTech COMIRNATY website which promotes COMIRNATY as APPROVED for the prevention of COVID-19 for US residents 12 years of age and older. https://www.comirnaty.com/
These misleading claims about the FDA approval of the PFIZER/BioNTech COVID-19 mRNA vaccines essentially extended PFIZER’s unbridled EUA legal immunity with little to no pushback.
The facts are that on August 23, 2021, the FDA broke the EUA shield for the PFIZER COVID-19 mRNA vaccines. What if attorneys followed the precedent of dozens of FDA approved product recall cases? and hundreds of False and Misleading Claims cases?
Ten months bought PFIZER an invaluable amount of time enabling the Big Pharma Tyrant to capture millions of more lives and gain significant legal ground in the battle against our freedoms, our nation, and our children.
Dr. Malone is well-respected, has the most prestigious credentials as an expert in mRNA vaccines, is experienced in the FDA approval process of vaccines, and is one of the good guys.
If it had been Albert Bourla, CEO of PFIZER, on The WAR ROOM on August 24, 2021, proclaiming that PFIZER still had EUA legal immunity and it is the German company, BioNTech, that Americans would need to sue, would the American people have been so quick to believe these fictitious legal immunity claims that are easily proven to be false?
HONOR, INTEGRITY, and TRUTH are of critical importance moving forward.
In the words of St. Augustine, “The truth is like a lion. You don't have to defend it. Let it loose. It will defend itself.”
- The Kingston Report. TRUTH WINS.
Dr. Malone is going thru a very hard time right now because of people calling him a mass murderer. He has a clip talking about the trolls bashing him, I feel very bad for what he's going thru. If people are questioning him then why not contact him privately and ask him questions, instead of publicly bashing him. I'm not saying you are doing that but I can tell you he's going thru absolute hell right now. I love what you do Karen, I've learned tons from your videos, thank you and God Bless.
I’m a PA, not a doc, and no uber-credentialed alphabet behind my name, but you make a good point here. I believe that in “normal” circumstances that Dr Malone would have been correct in that studies are usually completed before FDA approval is given. By the sheer unprecedented “warp speed” of this contemptuous push, it has defied previously established guidelines.
Can you sue for disability after it has become approved if the shot was given prior? I don’t think so, but let the lawsuits begin.