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By Interest of Justice
The FDA is experiencing a crisis of credibility so profound it would be comedic if the stakes weren’t life and death.
In the span of just months, the same agency has:
Demanded pharmaceutical companies prove flu vaccines actually work—despite 80+ years of use
Slashed childhood vaccine recommendations claiming the science isn’t rigorous enough
Issued comprehensive “regulatory flexibility” guidance for cell and gene therapy products
Refused to answer whether mRNA COVID products are gene therapies under FDA’s own definitions
Told us they need “more time” and “additional agency review” for a yes-or-no classification question
Let’s break down this spectacular display of selective scientific rigor.
FDA to Pharma.. “Prove It Works”
In May 2025, HHS announced a policy shift that sent shockwaves through the vaccine industry:
“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure—a radical departure from past practices.”
FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an editorial in the New England Journal of Medicine rejecting the existing vaccine approval framework as the world’s “most aggressive” and demanding “gold standard science” before approving vaccines for healthy people.
Prasad went further, calling the current flu vaccine system an “evidence-based catastrophe.”
Read that again. The FDA’s top vaccine official called flu vaccines—which have been administered to hundreds of millions of Americans—an “evidence-based catastrophe.”
The Høeg-Kulldorff assessment that justified slashing childhood vaccine recommendations demanded:
Placebo-controlled randomized trials
Long-term observational studies
Proof of reduction in hospitalizations and deaths
Testing of vaccines given in combination
Vaccine experts called these requirements “impossible” and “unethical.”
Dr. Jesse Goodman, former FDA vaccine official: “It would be unethical to use placebos and let people get pneumococcal pneumonia.”
Former FDA Commissioner Robert Califf warned: “The goal of RFK seems to be to make it impossible for vaccines to be available in the U.S. If the proposals advance, it won’t be a viable business.”
Yes..Thats right, you read that correctly “it won’t be a viable business.”!! The Big Pharma Big Business.
Meanwhile, on Gene Therapy...
While FDA demands pharma companies run years-long placebo-controlled trials to prove flu vaccines work, here’s what happened with our citizen petition asking a simple question:
“Are mRNA COVID-19 products gene therapies under FDA’s own binding definitions?”
FDA’s response on July 17, 2025:
“Not yet reached resolution... additional agencies needed more time to review.”
No deadline provided. No substantive answer. No denial we could appeal.
Just silence on a yes-or-no question that FDA’s own guidance documents already answer.
Then, 30 days later, FDA issued comprehensive regulatory flexibility guidance for cell and gene therapy products—demonstrating they know exactly what gene therapy is, how to regulate it, and how to apply flexible standards within that framework.
The Double Standard, Exposed
Let’s put this in a table so the absurdity is crystal clear
What FDA Demands for Flu/Childhood Vaccines What FDA Does for mRNA COVID Products “Gold standard” placebo-controlled trials “Regulatory flexibility” Calls current testing an “evidence-based catastrophe” Claims they need “more time” to apply definitions 80+ years of data not rigorous enough 4+ years and can’t answer classification question Demands Pharma prove efficacy against hospitalization/death Won’t determine if products meet gene therapy definition Slashes recommendations without ACIP input Ignores statutory deadline for petition response Publishes 34-page assessment in 30 days Can’t provide response deadline as law requires
The same FDA that calls flu vaccine testing “catastrophic” just issued gene therapy regulatory flexibility guidance while claiming they can’t determine what gene therapy is.
What FDA Says About Gene Therapy (When It’s Not mRNA)
The January 11, 2026 regulatory flexibility announcement reveals FDA’s deep institutional expertise:
Commissioner Makary:
“Regulatory flexibility must be tailored for cell and gene therapies. These are common-sense reforms that will address the unique characteristics of cell and gene therapies and foster more innovation.”
Prasad:
“There has been tremendous enthusiasm amongst product developers resulting in an explosive growth of cell and gene therapy submissions.”
FDA has approved “close to 50” cell and gene therapies over the last decade. They have “growing experience” with these products. They understand the “unique characteristics” of genetic interventions.
But ask them whether mRNA products—which deliver synthetic genetic material that human cells transcribe and translate to produce foreign proteins—meet their own definition of gene therapy?
“We need more time.”
FDA’s Own Definition (That They Apparently Forgot)
Let’s review what FDA says gene therapy products are:
“Products that mediate their effects by transcription and/or translation of transferred genetic material”
And:
“Modify or manipulate the expression of a gene or alter the biological properties of living cells for therapeutic use”
mRNA COVID-19 products
✓ Deliver transferred genetic material (synthetic mRNA)
✓ Mediate effects through translation of that material
✓ Alter the biological properties of living cells (to produce spike protein)
Moderna itself stated in its 2020 SEC filing: “Currently, mRNA is considered a gene therapy product by the FDA.”
But FDA needs more time to figure this out?
The “Gold Standard” They Don’t Want to Apply
Here’s the ultimate irony:
FDA is demanding “gold standard science” for vaccines that have been used safely for decades. They want:
Placebo-controlled trials
Long-term safety monitoring
Proof of clinical outcomes
Transparent review processes
These are exactly the standards that would have applied to mRNA products if they had been properly classified as gene therapies.
Gene therapy products require:
Environmental Assessments
Review by the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC)
Enhanced safety monitoring
Specific informed consent requirements
By misclassifying mRNA products as “vaccines,” FDA allowed them to bypass every single one of these requirements—the very “gold standard” protections FDA now claims to champion.
The “gold standard” is only for products FDA wants to scrutinize. For mRNA products, it’s “regulatory flexibility” all the way down.
They authorized mass human experimentation on the entire planet without informed consent — in direct violation of the Nuremberg Code, ICCPR Article 7, and the Declaration of Helsinki!IoJ Needs your help to sustain Legal actions in the courts! We’re actively suing the FDA, HHS, DoD and also the WHO For COVID-19 abomination! Can you help Sponsor the cases or know someone who can? Support our legal work. IoJ’s suing in US federal court right now! If you are in the position to sponsor these cases, please make a donation today! We need your help! Call me (+1 323-244-2960) Dustin if you have any questions! Contact@interestofjustice.org
The Childhood Vaccine Schedule: A Case Study in Selective Rigor
On January 5, 2026, CDC slashed childhood vaccine recommendations from 17 to 11 diseases. The justification? A 34-page assessment claiming:
Vaccines lack sufficient placebo-controlled trial data
The U.S. is a “global outlier” in vaccine recommendations
Public trust has declined and the schedule needs to be “more focused”
The assessment was written by Tracy Beth Høeg (FDA) and Martin Kulldorff (HHS)—both of whom had publicly advocated for reducing vaccine schedules before their government appointments.
The changes bypassed the Advisory Committee on Immunization Practices (ACIP). No public comment period. No input from vaccine manufacturers or medical societies.
When it comes to reducing childhood vaccine recommendations, FDA can:
Produce a comprehensive assessment in 30 days
Make sweeping policy changes without ACIP
Demand “gold standard” evidence that experts call “impossible”
When it comes to classifying mRNA products as gene therapy, FDA:
Cannot answer a yes-or-no question in nearly a year
Cannot provide a deadline for response
Cannot apply its own published definitions
The Ethics Argument They Use Against Themselves
FDA’s justification for demanding placebo-controlled trials is that Americans deserve to know vaccines are safe and effective. Dr. Makary says:
“Public health works only when people trust it. That trust depends on transparency, rigorous science, and respect for families.”
We agree completely.
So why doesn’t that standard apply to mRNA products?
Transparency? Americans were told they were getting “vaccines”—not gene therapy products.
Rigorous science? FDA won’t even apply its own definitions.
Respect for families? You cannot give informed consent to a gene therapy product if you’re told it’s a vaccine.
The bioethicists FDA cites to attack childhood vaccines would be horrified by the mRNA classification evasion. Arthur Caplan and colleagues wrote that participants in medical research must not be “disadvantaged or exploited by being denied known effective or partially effective treatments.”
What about being denied the right to know what you’re actually receiving?
That’s not disadvantage. That’s deception.
What This Reveals
FDA’s simultaneous demands for “gold standard science” on some products and “regulatory flexibility” on others reveals a simple truth:
The standard isn’t scientific. It’s political.
Products FDA wants to scrutinize get impossible evidentiary demands. Products FDA wants to protect get definitional evasion and regulatory flexibility.
The same Vinay Prasad who:
Calls flu vaccine testing an “evidence-based catastrophe”
Demands placebo-controlled trials for childhood vaccines
Says FDA needs “gold standard science”
Also:
Told us FDA needs “more time” to determine if mRNA is gene therapy
Issued regulatory flexibility guidance for gene therapy products
Cannot provide a deadline for answering our petition
This is not science. This is selective enforcement masquerading as rigor.
We’re Taking Them to Court
FDA broke the rules. They responded to our citizen petition with a vague delay, no deadline, and a claim that unnamed “agencies” needed more time—all while demonstrating comprehensive gene therapy expertise.
Our petition documented how FDA and DOD violated 50 U.S.C. § 1520a—Congress’s explicit prohibition on experimenting on Americans without informed consent. The misclassification of gene therapy products as “vaccines” was the mechanism that enabled this violation.
These products are void. Void products must be stopped.
We are filing in Federal District Court NOW.
The agency that demands pharma prove flu vaccines work—despite 80 years of data—cannot credibly claim it needs more time to apply its own gene therapy definitions.
The agency that issues comprehensive gene therapy regulatory flexibility guidance cannot claim it doesn’t know what gene therapy is.
The agency that slashed childhood vaccine recommendations in 30 days cannot claim it needs years to answer a yes-or-no question.
They know. They’ve always known.
And now a federal court will decide.
The Questions FDA Must Answer
Why does FDA demand “gold standard” placebo-controlled trials for flu vaccines but not for mRNA products?
Why can FDA issue gene therapy regulatory flexibility guidance but not determine if mRNA products are gene therapies?
Why can FDA produce a 34-page vaccine assessment in 30 days but not answer a classification question in a year?
Why does FDA claim “public trust depends on transparency” while evading basic definitional questions?
Why does “regulatory flexibility” apply to gene therapy generally but not to mRNA products specifically?
How can FDA demand Pharma prove vaccines prevent hospitalization and death while refusing to classify products that bypassed all gene therapy safety requirements?
The answer to all these questions is the same!! Because the classification would expose that mRNA products have been illegally on the market since day one.
Stay Tuned!
Void means void. And “gold standard science” means applying your own definitions
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Interest of Justice is a 501(c)(3) nonprofit organization focused on legal accountability and transparency in global health governance. Support our work at interestofjustice.org.
THE FDA HAS NO SCIENCE…PAY TO PLAY …HOLOCAUST ONGOING AIDS VACCINE…FFS SHUT THEM DOWN!!!!!!
Excellent reporting. Thank you for keeping the pressure on the FDA. That said with all the info that you've provided it sounds like to me they needed to define terms for conduct of Use of gene therapy THEN they can re-classify mrna Covid shot as gene therapy and it will have to be withdrawn as a vaccine.