Message to DOGE: FDA, Pfizer and Moderna Committed Fraud During the Approval Process For the mRNA Covid “Vaccines”
A petition filed by Australian lawyer to the FDA in January, alleges that the FDA’s actions were fraudulent and resulted in Pfizer and Moderna receiving at least $16 billion on in improper payments...
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By Rhoda Wilson February 22, 2025
A petition filed by Australian lawyer Julian Gillespie and others to the FDA in January, alleges that the FDA’s actions were fraudulent and resulted in Pfizer and Moderna receiving at least $16 billion in improper payments for their Covid injections.
The petition was for the FDA to revoke approvals for Pfizer-BioNTech and Moderna’s covid injections, citing two grounds: the FDA’s failure to acquire Environmental Assessments and the products’ excessive synthetic DNA contamination.
Elon Musk’s team, DOGE, called for the public to submit information about Federal Government departments, including the FDA, to help find and fix waste, fraud, and abuse of Government funds. Gillespie shared information about the petition with DOGE and then shared his message to DOGE publicly.
As Gillispie explained to DOGE, the FDA, Pfizer and Moderna committed fraud during the emergency use authorisation approval process for the mRNA covid injections.
The FDA enabled Pfizer and Moderna to avoid expert scrutiny and public scrutiny by not requiring them to inform the public and the US President that their covid injections were gene therapies, not vaccines.
The FDA allowed Pfizer and Moderna to bypass the usual approval process for gene therapies, avoiding the submission of additional safety studies, and instead approved their products through the wrong committee, resulting in illegal and wrongful approvals.
The fraudulent approval process enabled Pfizer and Moderna to receive multi-billion-dollar purchase contracts, with the US government potentially losing billions of dollars, and the companies’ owners and shareholders enjoying significant profits.
Together with Kevin McKernan, Dr. Jessica Rose, Dr. David Speicher and Maria Gutschi, retired Australian lawyer and former barrister Julian Gillespie drafted a Citizen Petition that was filed with the US Food and Drug Administration (“FDA”) on 20 January by Katie Ashby-Koppens of PJ O’Brien & Associates.
The Petition presents just two grounds as the basis for the FDA to suspend or revoke the approvals given to Pfizer-BioNTech and Moderna’s covid injections:
The approvals at all times have been illegally invalid due to the failure of the FDA to acquire Environmental Assessments (“EAs”) from Pfizer and Moderna.
Pfizer and Moderna’s covid injections contain grossly excessive synthetic DNA contamination and genetic sequences known to promote and cause cancers and genetic disease.
The second reason noted above appears to have involved Pfizer and Moderna committing fraud to conceal the true nature of their products, Gillespie said. “Approvals [were] fraudulently obtained that resulted in at least $16 billion being received by Pfizer and Moderna.”
DOGE teams are auditing the internal systems of at least 18 US Federal Government departments, agencies and administrations including the FDA.
Because DOGE is seeking help from the public to find and fix waste, fraud and abuse related to the FDA, Gillespie messaged DOGE on Wednesday with “some information on the dodgy approvals that earned Pfizer and Moderna billions … many many billions from the deaths and injuries, and contamination of billions … billions of People.”
After sharing the information with DOGE through a direct message (“DM”), which is a private messaging function on Twitter (now X), Gillespie published the message on his Substack page. We have reproduced his DM to DOGE below. We have made a few minor edits for readability, largely in the formatting and style.
Pfizer, Moderna and the Gene Therapy Scandal
Dear Mr. Elon Musk,
This note serves to share with you and the American people information in respect of improper and costly actions by the FDA that have been shared with @DOGE_FDA via DM on X, as requested.
Many thanks
Good morning/evening team DOGE FDA,
My name is Julian Gillespie and I am a lawyer.
Re: Your request [for] insights on finding and fixing waste, fraud and abuse related to the US Food and Drug Administration.
Summary: The following details how at least US$16 billion in improper and possibly illegal payments resulted from what appears to be a continuing fraud by the FDA.
About Us
Together with Katie Ashby-Koppens (attorney) we have been initiating covid litigations since 2021 which has caused us to become knowledge experts in the field, particularly as to the nature of the products and approval processes for same in multiple jurisdictions.
The below information came to our attention in late 2023.
The new Trump Administration finally provided a basis for pursuing this information, especially with the advent of the MAHA [Make America Healthy Again] mandate and team, led by President Trump, to be spearheaded by RFK Jr [Robert F. Kennedy Jr.].
I am also a former Director of Children’s Health Defense, Australia.
Introduction
First, some brief facts. Together with Kevin McKernan, Dr Jessica Rose, Dr David Speicher, Maria Gutschi, and Katie Ashby-Koppens, I created and caused to be filed recently a Citizen Petition requesting the revocation of the approvals given to the Pfizer and Moderna covid-19 products.
You can read the Citizen Petition HERE.
In the first instance RFK Jr. as the new Secretary of HHS [Health and Human Services] has primary legal responsibility for determining the Petition, should he choose not to delegate determination of the Petition to the FDA Commissioner, who may soon be Dr. Marty Makary.
I can confirm JFK Jr has personally received the Petition and read it, as too have the members of team MAHA.
Why Doge Intervention?
The defined jurisdiction in RFK Jr would appear to be reason enough for DOGE not to get involved, BUT the actions of the FDA the subject of the Petition appear to involve significant fraud against POTUS [President of the United States] in 2020, and the American People in 2020, resulting in Pfizer and Moderna receiving at least ~$16 billion in payments for vaccines from US Taxpayers that in all likelihood, may never have occurred but for the fraud of the FDA in 2020.
There also exist significant grounds to allege Pfizer and Moderna colluded with the FDA to perfect the fraud on the President, the US People and US Taxpayers.
If collusion is shown then clear legal grounds exist for a return of the billions paid.
If collusion is shown then clear legal grounds exist for halting any future payments to those companies.
Before detailing the fraud further, the scope of the Citizen Petition needs to be understood to see where it leaves off, so DOGE can step in.
As the cover letter accompanying the Petition notes:
The grounds for revoking or suspending the approvals are:
a. The approvals have at all times been legally invalid due to the failure by the FDA to require and receive Environmental Assessments (EAs) from each company, which EAs would have disclosed to the American public in late 2020 the true characterisation of the Pfizer and Moderna covid-19 products as gene therapies requiring, prior to any possible EUA [emergency use authorisation] approval, a public comment period and consideration of public submissions on the gene therapy nature of the products, being legal requirements the FDA circumvented without legal authority; and
b. The covid-19 products of Pfizer and Moderna contain grossly excessive levels of synthetic DNA contamination and genetic sequences known to promote and cause cancers and genetic disease.
Gene Therapies
For the functions, authority and mandate of DOGE, your attention is drawn to (a) above, which the Petition substantiates with legal clarity.
Details not included in the Petition and relevant to DOGE are: Had the FDA not illegally allowed Pfizer and Moderna to avoid submitting Environmental Assessments – which experts within the FDA knew Pfizer and Moderna were required to submit – both companies would have had to disclose in their Environmental Assessments that their covid-19 products properly fall under FDA Guidance for being correctly deemed gene therapies.
That disclosure as to the gene therapy nature of their products would have fundamentally altered the approval dynamics in 2020 and beyond.
To be clear, both companies knew in 2020 that their products were and are gene therapies.
See for instance the 2020 SEC filing by Moderna where they state: “Currently, mRNA is considered a gene therapy product by the FDA.”
Both companies deployed exactly the same covid-19 modRNA* drug platforms, and both knew the nature of the other’s product.
[*Note from the Exposé: modRNA is an abbreviation for modified RNA. It is a synthetic or man-made messenger RNA (mRNA). From the beginning, it has been publicised that modified RNA was pivotal in the development of covid mRNA “vaccines,” such as the Pfizer-BioNTech and Moderna. People involved in biotechnology research would have known about modRNA used in mRNA “vaccines” long before 2020 because the technology was decades in the making.)
Consequences
Disclosure of the gene therapy nature of the products would have caused and required the Pfizer and Moderna products to instead be assessed by the Cellular, Tissue and Gene Therapies Advisory Committee (“CTGTAC”), the appropriate body for evaluating gene therapies.
The CTGTAC is prevented by law from unilaterally considering applications for gene therapies without public consultation.
The disclosure of the products being gene therapies and falling under the jurisdiction of the CTGTAC would have required the CTGTAC to open a period for receiving comments from the public, and especially external scientists, in respect of the gene therapy products of Pfizer and Moderna.
The period for receiving written and verbal comments would have been advertised by the CTGTAC, meaning, the American public would have learned the Pfizer and Moderna covid-19 products to not be vaccines but gene therapies.
Further, and there exists an extraordinary collection of peer-reviewed literature that would have been presented in written and verbal form to the CTGTAC, attesting to the array of dangers and risks “the new” products of Pfizer and Moderna represented to the American People.
In other words team DOGE, word would have gotten out that the products of Pfizer and Moderna carried severe threats of adverse events, including death, such was the known history in 2020 about the development of this drug platform by Moderna – all of their prior efforts to commercialise the same drug platform; lipid nanoparticles (“LNPs”) encapsulating modified genetic cargoes (modRNA) – had met with failure, often at the expense of lab animals or human trial participants who died.
Fraud
The disastrous pre-2020 history of the development of LNP-modRNA platforms and their being properly deemed gene therapies threatened the applications of both Pfizer and Moderna.
By the FDA illegally and wrongfully enabling Pfizer and Moderna to avoid submitting Environmental Assessments, and thereby avoid disclosure of the gene therapy nature of the products, the FDA was able to steer their applications to the Vaccines and Related Biological Products Advisory Committee (“VRBPAC”), a committee whose members have known and acknowledged conflicts of interests, and little expertise with gene therapies.
Yes, the VRBPAC were required to and did receive written and verbal submissions from the public – and especially from external science experts – in respect of the products of Pfizer and Moderna, however the VRBPAC was perfectly positioned to “drown out” and wave off submissions as to the gene therapy characterisation of the products, and instead perpetuate a narrative of the products being just new “vaccines” which did not have to undergo assessments like gene therapies; that is because only the CTGTAC is required to investigate the potential genetic detriments and risks of any new gene therapy applications so the VRBPAC was able to perfectly deflect the issue and avoid all proper conversation on the gene therapy nature of the products.
Thus, by FDA personnel wrongly diverting the products to the wrong committee ensured approval of the products, as by avoiding Environmental Assessments, Pfizer and Moderna also avoided having to submit a battery of additional studies showing they posed no dangers to the human genome nor posed any risk of adverse events (ill health) due to their gene therapy nature.
The VRBPAC was not obliged to call for those many additional safety studies – studies that are required by law for the CTGTAC to review when the CTGTAC is responsible for considering applications.
Consequently, the FDA enabled both Pfizer and Moderna to avoid expert scrutiny by the CTGTAC and focused external public scrutiny of the gene therapy nature of their products:
1. The FDA enabled both Pfizer and Moderna to avoid informing the American public their applications concerned gene therapies, and not vaccines.
2. The FDA enabled both Pfizer and Moderna to avoid informing then President of the United States, Donald Trump, their applications concerned gene therapies and not vaccines.
3. The FDA enabled both Pfizer and Moderna to have their applications considered, and ultimately approved, by the wrong committee lacking the requisite expertise and lacking legal requirements to have Pfizer and Moderna submit a battery of additional safety studies.
4. The FDA enabled by the above process the illegal and wrongful approval of the Pfizer and Moderna covid-19 products, thereby ensuring both companies received multi-billion-dollar purchase contracts amounting to at least $16 billion.
Had the FDA not orchestrated the fraud described above and both companies instead furnished the Environmental Assessments required by law, the ensuing scrutiny by the CTGTAC and public knowledge and criticisms received in the form of comments submitted to the CTGTAC, in all likelihood would have resulted in no approvals being granted to either Pfizer or Moderna.
Had the correct legal process been followed, neither company would have received multi-billion-dollar purchase contracts, nor would owners of equity in each company have enjoyed the extraordinary share prices (and profits) both companies enjoyed as a consequence of the invalid approvals.
Billions Improperly Awarded
And, the American People and taxpayers would not have lost, illegally, billions of dollars under purchase contracts.
But – the American People were lied to and lost, for now, billions of dollars.
The American President was also lied to and hood-winked into supporting these products that were never vaccines but gene therapies with a known lethal history.
The FDA used Operation Warp Speed to commit this fraud, as Operation Warp Speed enabled FDA officials to avoid usual oversights into fundamental decisions, like whether Environmental Assessments were required by law.
The Citizen Petition provides additional details.
Role of DOGE
In light of the significant evidence for firmly alleging the involvement of Pfizer and Moderna in this illegal conduct of the FDA, we have a situation where both companies induced the approvals for their covid-19 products by means of fraud, where without such approvals they would never have been offered purchase contracts.
The purchase contracts are thus ill-gotten gains and can be sued upon for a return of all monies received under them, as the basis for those contracts – legally valid product approvals – never existed, where both companies conspired to, and in fact succeeded in, obtaining legally invalid product approvals obtained through deceptive and illegal means.
Further Considerations
Moderna’s covid-19 drug patent rights are shared with the National Institutes of Health (“NIH”) and people within the NIH, where to date Moderna has paid those interests US $400 [million]. The NIH therefore had significant interests and reasons for seeing the FDA approve the covid-19 product of Moderna.
In respect of Pfizer, I need not recite here the criminal history of Pfizer who will stop at nothing and go to all ends to secure profits by any means.
Both companies had a shared and common interest – they had exactly the same type of drug platform they were seeking to be approved under extraordinary circumstances of limited or no oversight for approvals – Operation Warp Speed.
What aided one company in that approval process aided the other. Both companies shared a drug platform with an utterly flawed history of development.
That history would have only been revealed if they had disclosed their drug platforms to be gene therapies.
Thus, they had means and motive and were in fact seen to engage in a common enterprise – they both improperly, and knowingly, applied for Categorical Exclusions from having to submit Environmental Assessments – in circumstances where both companies knew they could exploit Operation Warp Speed with the assistance of FDA personnel, by having knowledge of those wrongful grants of Categorical Exclusions “buried” and not made known to the public or legal experts, in circumstances where the relevant FDA personnel knew they could avoid oversight of the critical and invalid grants of Categorical Exclusion, due to the “cover” Operation Warp Speed afforded the FDA to bury, in 2020, thousands of pages of the Pfizer and Moderna applications.
Both Pfizer and Moderna also have a history of bestowing lucrative executive roles on former FDA personnel, which should be alleged as further likely inducements offered to FDA personnel responsible for the covid-19 product applications of the companies.
With the patent royalties to be earned by the NIH and people within the NIH, it should be alleged until investigations establish otherwise, that pressure and/or inducements from the NIH also influenced and/or benefited FDA personnel responsible for the covid-19 product applications of both Moderna and Pfizer, as the common enterprise above required participation by Pfizer to aid Moderna, and vice-versus.
Legal Implications and Considerations
Based on the evidence, there are strong grounds to assert that violations of 18 US Code §§ 1001, 371, 1343, and 31 US Code § 3729 may have occurred.
If Pfizer, Moderna, and FDA officials knowingly circumvented legal requirements, their conduct constitutes fraud against the US government and taxpayers.
This provides a clear basis for Department of Justice (“DOJ”) intervention and clawback of improperly paid billions under False Claims Act provisions.
18 US Code § 1001 (False Statements to Government Officials) – If Pfizer and Moderna knowingly misrepresented their products to circumvent legal approvals, this statute may apply.
18 US Code § 371 (Conspiracy to Commit Fraud Against the United States) – If FDA officials acted in concert with Pfizer and Moderna to misclassify their products, there is potential liability.
31 US Code § 3729 (False Claims Act – FCA) – This applies if Pfizer and Moderna knowingly submitted fraudulent claims for payments under Operation Warp Speed.
18 US Code § 1343 (Wire Fraud) – Any electronic communications (emails, SEC filings, FDA submissions) that falsely represented the safety or classification of these products may trigger wire fraud charges.
The fraud enabled Pfizer and Moderna to secure at least $16 billion in improper payments from US taxpayers.
Under the False Claims Act, the government is entitled to triple damages, meaning that up to $48 billion may be recoverable.
Additionally, the NIH’s acceptance of $400 million in Moderna royalties raises ethical and legal concerns about Conflicts of Interest, requiring urgent investigation.
DOGE Next Steps
DOGE has the ability and mandate needed to pursue the following:
1. Request a DOJ-led probe into the FDA’s fraudulent approval process.
2. Formally refer findings to Congress to initiate an oversight investigation into Operation Warp Speed abuses.
3. Submit a request for Congressional committees to subpoena FDA officials involved in the 2020 approvals process.
4. Formally request the DOJ consider clawback litigation under the False Claims Act.
With respect, DOGE should formally refer its findings to the House Oversight Committee, the Senate HELP Committee and the House Judiciary Committee to initiate Congressional oversight hearings on the FDA’s handling of Pfizer and Moderna’s approvals.
Additionally, DOGE should request that these committees subpoena key FDA officials involved in the 2020-2021 EUA and BLA approval processes to obtain testimony and documentation regarding potential fraud and regulatory misconduct.
We thank the DOGE team for taking the time to read this submission.
Yours sincerely, Julian Gillespie, LLB, BJuris
Featured image: Stéphane Bancel, CEO of Moderna, and Albert Bourla, CEO of Pfizer.
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Criminal! They also redefined the definition of a vaccine to complete the deadly hoax!
The work of Katherine Watt as documented on her Substack, 'Bailiwick News' and Sasha Latypova's, 'Art and Due Diligence' assign the actual ownership and distribution of what are referred to as 'Gene Therapies' to actually be 'Military Operations' of the DOD and 'His Majesty's Armed Services.'
The research of both women can be found in Substack and is worth the hours of research into their archives to better understand the labyrinth of this LEGALIZED attack on the world's population.
Glaxoklinesmith's 'Wellcome Trust' under Sir Jeremy Farrar, now at W.H.O, was equally involved with the Research and Development with DARPA and other organizations in academia, etc.
The serums are defined 'Countermeasures' by Militaries owning them which is to classify them as WEAPONS or BIO-NANOWEAPON INJECTIONS. They are also defined, 'EUA Demonstrations as well as other distinctions by BARDA using Big Pharma to market/sell which created the appearance of them being medication instead of BIO-NANOWEAPON INJECTIONS. The same substances of the serums are now being manufactured and 'CROP DUSTED' into our environment as well as placed in food to be consumed around the world.
This is a very complicated issue and larger than this letter defines it to be.