Pfizer, Moderna, and the Gene Therapy Scandal
.. a significant aside to the contamination issue .. shared with DOGE
good Substack Folk,
this story closes the loop, as it were, on the Gene Therapy story of my last substack
in my last substack i detailed the Citizen Petition we filed with the FDA
the Petition asks RFK Jr as the Secretary of HHS to suspend or revoke the approvals provided to Pfizer and Moderna for their Covid-19 products on the following grounds ..
the first ground - 2(a) - involves some pretty straight forward abuse by the FDA
.. too much abuse to ignore
especially when that abuse
amounts to a fraud on the population of a planet
.. right?
while RFK Jr. has the power to grant the Petition based on the legal reasons sets forth in the Petition, it still leaves the actions of the FDA in 2020 right up to now
unaddressed
and those FDA actions do appear to have involved Pfizer and Moderna committing a fraud to conceal the true nature of their products
- being Gene Therapies -
from not only the American People
.. and in turn, the World ..
but also the President of the United States at the time
.. one Donald J. Trump
yeah .. he was also duped
without going into the resultant harms (and deaths) consequent on the fraud, the US has the issue of approvals fraudulently obtained that resulted in at least $16 Billion being received by Pfizer and Moderna
.. with .. for now
unknown amounts
in kickbacks and payoffs
going to those who helped them
squeeze through an approval process
- they would likely have failed to pass -
had the truth of their products been made public
.. but now we live in the age of DOGE
.. to-date DOGE teams are tunneling through and auditing the internal systems of at least 18 US Federal Government departments, agencies, and administrations
.. including our old pals
at the FDA
.. where at the FDA team DOGE got straight to the point of their visit, asking not FDA staff but the public for ‘the dirt’
what an invitation
so .. in furtherance of getting more eyes on the Citizen Petition, and hopefully getting team DOGE to look at a few Billion in ill-gotten booty earned by Pfizer and Moderna
we thought we would oblige DOGE FDA
and send them some info 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 sending that information to team DOGE FDA via a non-public DM, we thought it proper to also share the the material publicly ..
to ensure the DOGE boss
- Mr Musk -
received our little note directly
as well as
American Folk
who need to know where their bloody money went to
.. the little note is below, in full
it is by no means a short read .. “a bruiser” as one friend described it .. but a note another suggested to others they “read every damn word” of
for now .. we await to see what team MAHA and DOGE will do on the Covid-19 front in the coming days
we know what they can do
.. the question is of course
will they do it?
.. or find themselves caught
.. and compromising “for reasons” we will likely never know about .. ..
.. which would mean ..
compromising every one of us here
who know what the goddamn hell has been going on
these past few years
yeah .. we don’t need another J.F. Kennedy Assassination type file created and buried for Covid-19
.. anyone else up for another six decades of top-secrecy?
.. the irony would disturb the very fabric of the universe with RFK Jr. now in office
so for now ..
let us cross our fingers and toes
and for now .. i leave the note here for posterity and hopefully, your good reading
Note: .. the NIH royalties mentioned below are now up to $1.2 Billion (from $400MM) .. and growing .. (hat/tip KM)
Dear Mr @elonmusk,
This note serves to share with you and the American people information in respect of improper and costly actions by the FDA that have been shared with @DOGE_FDA via DM on X, as requested.
Many thanks
___________________
Good morning/evening team DOGE FDA,
My name is Julian Gillespie and I am a lawyer.
Re: Your request on insights on finding and fixing waste, fraud and abuse related to the U.S. Food and Drug Administration.
Summary: The following details how at least US$ 16 billion dollars 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 mandate and team, led by President Trump, to be spearheaded by RFK Jr.
I am also a former Director of Children’s Health Defense, Australia.
INTRODUCTION
First, some brief facts. Together with Kevin McKernan @Kevin_McKernan, Dr Jessica Rose @JesslovesMJK, Dr David Speicher @DJSpeicher, Maria Gutschi @CanningPharm, and Katie Ashby-Koppens @katiebeenanddid, 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: https://regulations.gov/document/FDA-2025-P-0335-0001
Docket No.: FDA-2025-P-0335-0001
In the first instance RFK Jr. as the new Secretary of HHS @SecKennedy 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 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 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 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.
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 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.
The FDA enabled both Pfizer and Moderna to avoid informing the American public their applications concerned Gene Therapies, and not vaccines.
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.
The FDA enabled both Pfizer and Moderna to have their applications considered, and ultimately approved, by the wrong committee lacking requisite expertise, and lacking legal requirements to have Pfizer and Moderna submit a battery of additional safety studies.
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 NIH and individuals within the NIH, where to-date Moderna has paid those interests US $400MM.
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 individuals 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 / CONSIDERATIONS
Based on the evidence, there are strong grounds to assert that violations of 18 U.S.C. §§ 1001, 371, 1343, and 31 U.S.C. § 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 DOJ intervention and clawback of improperly paid billions under False Claims Act provisions.
18 U.S. Code § 1001 (False Statements to Government Officials) – If Pfizer and Moderna knowingly misrepresented their products to circumvent legal approvals, this statute may apply.
18 U.S. 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 U.S. Code § 3729 (False Claims Act - FCA) – This applies if Pfizer and Moderna knowingly submitted fraudulent claims for payments under Operation Warp Speed.
18 U.S. 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 U.S. 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 $400M 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:
Request a DOJ-led probe into the FDA’s fraudulent approval process.
Formally refer findings to Congress to initiate an oversight investigation into Operation Warp Speed abuses.
Submit a request for Congressional committees to subpoena FDA officials involved in the 2020 approvals process.
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
Please share widely and .. restack if you can
God bless you Julian. I am in UK, and have been waiting, and waiting for you to make an appearance to update us all. Please consider getting back on Dr John Campbell or through Rumble, however, wherever you can. I am a care worker on the lowest level, not in your league, in any respect, and am so very, very thankful that you are their to fight for the general person on the 'shop floor'. I have seen so many deaths, and have been beaten down by so many 'professionals' while defending our vulnerable clients (LD's). I have seen deaths, heart attacks, strokes, cancers in clients/staff, all brushed off as dementia/stress etc. My voice, my lack of qualifications are noted, and understandably ignored. But your voice isn't. Thank you so very much, words will never be enough for to express how important your voice has been for all of us.
the CDC is not what it used to be, I believe it has been taken over. I would love to hear your opinion, I do know 'something' is shifting for sure. My instincts are on fire. I am 65 yrs old, and have seen a lot!!
I love you Julian Gillespie, and all who stand alongside you. I just bloody love you.