Part 2 of 7 — Why FDA Will Lose - mRNA and adenoviral vector COVID products are gene therapy under FDA’s own definition, and what the classification actually requires - STOP THE SHOTS!

THE GENE THERAPY PROBLEM MODERNA NAMED FIRST & WHY A NEW MANDAMUS IS OUR REAL SOLUTION TO FORCE THE SHOTS OFF MARKET

THE GENE THERAPY PROBLEM MODERNA NAMED FIRST

Interest of Justice — April 17, 2026 — Citizen Petition Series, Part 2 of 7 — Docket FDA-2025-P-1807 (click to open the public docket)

THIS IS PART 2 OF 7. The full series walks through Citizen Petition FDA-2025-P-1807 section by section. Part 1 — Minimal Risk. Part 2 — Gene Therapy. Part 3 — DoD § 1520a. Part 4 — Warp Speed. Part 5 — Adulteration and SV40. Part 6 — International Law. Part 7 — The Remedy. FDA has been silent on the petition for 305 days — 125 days past the statutory response deadline under 21 CFR § 10.30(e)(2).

Citizen Petition Pending That Could Actually Work To Stop The Shots - LETS EXPLAIN:

Before the analysis begins — a note on what the petition itself actually is.

Skip to the red arrow below if you read yesterdays post and already know about this Petition!!!

Citizen Petition FDA-2025-P-1807 is not a normal citizen petition. Nine months of sixteen-hour days, reading regulations, tracing statutes, mapping case law, pulling FOIA responses, assembling exhibits, drafting and revising until the whole structure stood up on the record. FDA itself instructed petitioners to consolidate every concern into a single filing rather than separate them across multiple dockets — so the scope of the final document reflects what the agency asked for. The result is a filing of a density this agency has, to our knowledge, never had to answer in one response.

Here is the scale, in numbers. Most citizen petitions at FDA run five to fifteen pages. This one runs well over one hundred and thirty pages of primary filing. Add the supporting exhibits, the FOIA-sourced evidence appendices, the expert declarations from Dr. Michael Yeadon and Dr. Janci Lindsay, the statutory and regulatory text references, and the Department of Defense compliance record, and the full administrative submission reaches several hundred pages. It is not a letter. It is not a complaint. It is a full regulatory reclassification filing pushed to the scope the agency itself asked for. Any FDA response has to engage the whole record — which is part of why, 305 days in, there has not been one.

We genuinely believe it is one of the most consequential Citizen Petitions currently pending at FDA. Reclassification of mRNA and adenoviral vector products as gene therapy. The 15-year safety follow-up the regulation was written to require. Clinical hold authority under 21 CFR § 312.42. Honest labeling. Correction of the FOIA-confirmed Department of Defense predicate that was never lawfully established. The petition does not ask for one fix. It asks for the record to finally match the law.

If the Secretary grants it, the ripple reaches well past COVID-19. The regulatory treatment of novel biological agents gets re-anchored to the framework Congress wrote. The practice of deploying experimental products on civilian populations under emergency color loses its cover. The line this country has needed to draw for decades on medical experimentation without informed consent finally gets drawn. That is what is on FDA’s desk right now. That is what they have been silent on for 305 days.

The petition also puts the Department of Defense in the record for what it did — deploying biological agents on civilian populations under a framework Congress wrote for battlefield emergencies. Products called “vaccines” in press conferences while meeting the gene therapy definition in regulation. Under the operation of the statute, and as Costa Rican government testimony confirmed under oath, these are not vaccines at all.

FDA has a definition of gene therapy. It is written down. It is in the Code of Federal Regulations at 21 CFR § 600.3(h)(5). It has been there for decades. The definition covers products that “mediate their effects by transcription and/or translation of transferred genetic material.” That is not a policy statement. That is a binding regulatory text.

mRNA COVID-19 products mediate their effects by transcription and translation of transferred genetic material. That is the entire stated mechanism. That is what the lipid nanoparticle was designed to do. Adenoviral vector COVID-19 products do the same thing through a different delivery system. Under the plain text of the FDA’s own regulation, both categories are gene therapy products.

The mechanism is not in dispute. The definition is not in dispute. The only thing in dispute is whether FDA is allowed to pretend the two do not meet.

IoJ’s petition put this on the docket on June 17, 2025. FDA-2025-P-1807-0002. It has been sitting there for 305 days. The 180-day statutory response deadline under 21 CFR § 10.30(e)(2) expired 125 days ago. FDA has produced no substantive response.

Part 1 laid out why the minimal risk waiver for invasive shots was ultra vires. Part 2 is about the classification that makes the whole architecture collapse once the text is enforced. If the products are gene therapy — and by FDA’s own definition they are — then the entire safety framework that applies to gene therapy applies here. That is what the agency cannot bring itself to say in writing.

A. WHAT FDA’S RULE ACTUALLY SAYS

Read the regulatory definition out loud —

“Human gene therapy/gene transfer is the administration of nucleic acids, viruses, or genetically engineered microorganisms that mediate their effect by transcription and/or translation of the transferred genetic material, and/or by integrating into the host genome. Cells may be modified in these ways ex vivo for subsequent administration to the recipient, or altered in vivo by gene therapy products administered directly to the recipient.”

Three things you should notice. One — the regulation is written in disjunctive form. “And/or.” A product can be gene therapy if it mediates its effect through transcription or translation or integration. Any of the three triggers the definition. mRNA products do all three. The third — integration — is the one the agency would most like to argue is absent. As Part 5 will lay out in detail, Dr. Janci Lindsay’s peer-reviewed analyses and independent lab replications have identified SV40 promoter sequences in the finished mRNA product. SV40 sequences are specifically used to facilitate integration. The agency has not addressed this evidence on the merits.

Two — the regulation is mechanism-based, not intent-based. It does not say “gene therapy for rare disease.” It does not say “gene therapy for chronic illness.” It says what the product does biologically. FDA’s attempt to carve COVID mRNA products out of the definition rests on something called the “therapeutic intent” argument — essentially, we only mean other gene therapies, not this one. That argument has no support in the text of the rule and no support in the legislative authority the rule was promulgated under.

Three — the rule uses the language transferred genetic material. mRNA is transferred genetic material. That is the literal function of the lipid nanoparticle carrier — to transfer mRNA into cells. The regulation applies. The analysis is that short.

B. MODERNA CALLED IT GENE THERAPY FIRST

This is the part the agency cannot talk its way around. Before COVID-19, Moderna’s own pre-pandemic Securities and Exchange Commission filings — specifically its Form 10-K annual reports — repeatedly described the company’s mRNA platform as gene therapy. These are not activist writings. These are sworn corporate disclosures, filed with the SEC, signed by officers, and reviewed by outside auditors. Making a material misrepresentation in a 10-K is a federal crime under Section 18 of the Securities Exchange Act. Moderna had every incentive to characterize its own platform accurately. It called it gene therapy.

Before the pandemic, the company’s own lawyers wrote “gene therapy.” During the pandemic, suddenly no one at FDA could find the word. Both cannot be true.

The petition attaches the specific 10-K language in its appendices. Any federal judge reading the mandamus record can pull the SEC filings directly from EDGAR. Moderna’s early-stage risk disclosures were explicit — the company warned investors that FDA would regulate its platform under the gene therapy framework, which would require long-term follow-up under the agency’s gene therapy guidance. That is what Moderna told its shareholders. It is what the law required.

When the pandemic hit, the regulatory frame changed without any change in the product’s mechanism. The agency did not explain the shift. The agency did not issue a revised gene therapy definition. The agency simply treated the mRNA product as a “vaccine” for scheduling, approval, and informed consent purposes, while continuing to regulate every other mRNA product as gene therapy. That is not a rational distinction. That is an agency-level exception for one product category under political pressure. Under Motor Vehicle Manufacturers Ass’n v. State Farm, that is the definition of arbitrary and capricious. This is actually a big deal.

C. FDA’S 2020 LONG-TERM FOLLOW-UP GUIDANCE

FDA did not just define gene therapy in the CFR. In January 2020 the agency issued a binding guidance document titled Long Term Follow-Up After Administration of Human Gene Therapy Products. That guidance sets out a 15-year post-administration follow-up protocol for gene therapy recipients. Fifteen years. Per recipient. With specified adverse event monitoring, laboratory parameters, and reporting obligations to the sponsor and to FDA.

The 2020 guidance specifically names in vitro transcribed RNA as one of the product categories within the framework. The document is dated January 2020 — nearly a year before Emergency Use Authorization for the first COVID-19 mRNA product. FDA had, in writing, defined the appropriate follow-up regime for exactly the kind of product it was about to authorize. It then authorized the product under a pathway that required none of that follow-up.

The agency wrote the 15-year rule in January 2020. In December 2020, the agency authorized an mRNA product that should have triggered the 15-year rule. It did not. The rule is binding. The authorization was inconsistent with it. No one at FDA has explained the gap.

This is what the petition asks FDA to address. How does the agency reconcile its 2020 gene therapy guidance — which clearly covers mRNA platforms — with its COVID-19 EUA pathway, which treated the products as conventional vaccines and required none of the 15-year follow-up the 2020 guidance demanded? That is not a rhetorical question. That is a binding administrative law question the agency has a non-discretionary duty to answer on the docket.

D. THE JANUARY 2026 UPDATE THAT SAID THE QUIET PART OUT LOUD

On January 11, 2026, FDA published an update to its gene therapy guidance framework. The update confirmed — again, in the agency’s own document — that in vitro transcribed RNA products fall within the gene therapy regulatory architecture for purposes of long-term follow-up and safety monitoring. The update made explicit what the 2020 guidance had already implied. It was published in the same month FDA sent petitioners a letter saying the agency needed “more time” to reach a decision on our petition.

Think about what that means. In one hand FDA told petitioners the classification question was too complex to decide within the 180-day statutory window. In the other hand the agency was publishing guidance that confirmed the classification. You cannot have it both ways. Either the classification is so unsettled that the agency needs more than 180 days to decide, or the classification is settled enough that the agency publishes guidance confirming it. Once again, both cannot be true at the same moment.

E. THE “THERAPEUTIC INTENT” DODGE AND WHY IT FAILS

When agency officials have been pressed informally on the classification question, the response has been something along the lines of — yes, the mechanism technically fits, but the therapeutic intent of a COVID-19 vaccine is prophylactic immunization, not gene modification, and therefore the gene therapy framework does not apply. This argument has been made in public remarks, in conference panels, and in internal agency communications. It has never been made in a formal rulemaking or guidance document. Because it cannot survive examination.

The regulation defines the product by mechanism, not by intended therapeutic use. A cytotoxic chemotherapy agent administered to prevent recurrence is still a cytotoxic chemotherapy agent. A radiopharmaceutical administered for diagnosis is still a radiopharmaceutical. An injectable biologic that operates by transcription and translation of transferred nucleic acid is a gene therapy product regardless of why you injected it. The regulation does not turn on intent. It turns on what the product does inside the body.

The therapeutic-intent argument also collapses under the post-Loper Bright regulatory framework. Before 2024, a federal court might have deferred to FDA’s interpretation of its own regulation under Auer or Chevron deference. Loper Bright v. Raimondo (2024) overruled Chevron and held that courts must now exercise “independent judgment in deciding whether an agency has acted within its statutory authority.” The agency no longer has the deference shield. A court reading the regulation afresh will read what the regulation says. The regulation says “transcription and/or translation of transferred genetic material.” The mechanism fits. We can finally win this! Stay the course.

F. WHAT CHANGES WHEN THE CLASSIFICATION IS APPLIED

This is the part that makes the agency really, really uncomfortable. If the products are gene therapy — and the plain text says they are — then the following regulatory consequences flow, automatically, under existing law. FDA does not get to debate them once the classification is granted.

• Fifteen-year post-administration follow-up per the 2020 guidance, with specified laboratory parameters and adverse event reporting.

• Pre-market safety review under the gene therapy framework — not the expedited conventional vaccine pathway — for any continued use going forward.

• Clinical hold authority under 21 CFR § 312.42 based on FDA’s own designation of gene therapy administration to large populations as an “unreasonable risk” requiring enhanced monitoring.

• Informed consent disclosure specific to gene therapy products — including the long-term integration risk the regulation itself contemplates.

• Adverse event reporting to the agency’s Center for Biologics Evaluation and Research under the gene therapy reporting channels, not the conventional vaccine channels.

• Registry enrollment and post-market surveillance consistent with gene therapy products of comparable mechanism.

None of these consequences is radical. All of them are standard operating procedure for gene therapy products FDA has already approved — Zolgensma, Luxturna, Casgevy. The framework exists. The framework is mature. The framework is not being applied to the one product category where the agency decided political convenience outweighed regulatory consistency.

G. THE 15-YEAR PROBLEM

The 15-year follow-up is where this argument becomes not just a classification dispute but a public health emergency in its own right. Over 670 million doses were administered in the United States. Under the gene therapy framework, each recipient should have been enrolled in a 15-year post-administration follow-up regime — adverse event monitoring, serum tracking, periodic laboratory analysis, and reporting obligations. None of that happened for the mRNA products. None of the infrastructure was built.

What this means, in practical terms, is that we do not actually know what the 15-year adverse event profile of these products looks like. We do not have the data. We did not collect the data. The agency responsible for requiring the data collection waived the requirement and is now unwilling to answer questions about why. Dr. Michael Yeadon, former Vice President of Pfizer has provided expert declarations stating that the absence of this monitoring is itself a safety signal. His declarations are part of the petition record. FDA has not engaged them.

The 15-year follow-up would have caught what we do not now know. That is not speculation. It is what the regulation was designed to do. The agency chose not to do it.

THE QUESTIONS FDA MUST ANSWER

1. Does 21 CFR § 600.3(h)(5) apply to mRNA and adenoviral vector COVID-19 products by reference to their mechanism of action? If not, why not, in writing, on the docket?

2. How does the agency reconcile its January 2020 gene therapy guidance — which specifies 15-year follow-up for in vitro transcribed RNA products — with its authorization of mRNA COVID-19 products under a pathway requiring none of that follow-up?

3. How does the agency explain the inconsistency between Moderna’s pre-pandemic 10-K characterization of its mRNA platform as gene therapy and the agency’s own treatment of the same platform as conventional vaccine under COVID-19 authorizations?

4. Under what regulatory authority does the agency apply a “therapeutic intent” carve-out that appears nowhere in the text of 21 CFR § 600.3(h)(5)?

5. Does the agency dispute Dr. Janci Lindsay’s SV40 promoter findings, and if so, on what evidentiary basis, given that the findings have been replicated by independent laboratories?

6. What, if any, remedial framework does FDA intend to apply to the approximately 670 million U.S. doses administered to date if the gene therapy classification ultimately controls?

DID YOU KNOW

• FDA has already approved other gene therapy products using the exact framework the petition asks to be applied here. Zolgensma (spinal muscular atrophy) is a gene therapy product subject to 15-year follow-up. Luxturna (inherited blindness) is a gene therapy product subject to 15-year follow-up. The framework is not new. It is being withheld from one product category.

• Dr. Michael Yeadon was Vice President of Pfizer. He spent over three decades in pharmaceutical safety and development. His declarations support the petition. FDA has not engaged them.

• The Supreme Court’s 2024 decision in Loper Bright v. Raimondo overruled Chevron deference. Courts now exercise independent judgment on agency interpretations. The “therapeutic intent” carve-out does not survive independent judicial scrutiny of the regulatory text.

• The 2020 guidance was not a policy paper. It was a binding FDA guidance document published in the Federal Register process. The 15-year follow-up requirement is not optional for products that meet the 21 CFR § 600.3(h)(5) definition.

IoJ Needs YOUR Help To Continue To Finish Line!

We are trying to raise enough funds to support the filing of our federal mandamus petition — the one Lady Xylie will file pro se in the U.S. District Court for D.C. If you can pray on this one, pray. If you can fund it, fund it. If you can share it, share it.

Whatever you can offer, please offer!

Humanity really needs FDA to answer asap, and that will obviously require IoJ to file our hard core Mandamus to force FDA to do their simple duty to respond.

IOJ is excited and ready to file to stop the shots next week at the end of this series and once fundraising ensures we can afford the fight.

(we only raised $15 yesterday - THANK YOU SOLO DONOR - so sorry to keep reminding you readers, but fundraising is still needed for real costs!)

Once FDA does respond to the Petition under oath, the court will see FDA is ILLEGALLY acting & need to ORDER FDA to take the shots off the market.

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Share with a doctor, a lawyer, a member of Congress, a state AG, a reporter. Citizen Petition docket FDA-2025-P-1807. Record public at regulations.gov. Mandamus filing details will follow once the case is on the D.C. District Court docket.

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— Interest of Justice

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The citizen petition itself — what we actually filed

• First Citizen Petition — FDA-2022-P-2411 (September 2022 filing + January 2023 amendment) — the original federal docket. The September 2022 original filing and the January 2023 amendment with Dr. Janci Lindsay’s SV40 findings are both on this docket.

• Consolidated Petition — FDA-2025-P-1807 (June 17, 2025) — the current federal docket. This is the petition FDA has been silent on for 305 days.

Related Reading

• BREAKING!! FDA Issues Gene Therapy Guidance While Refusing to Answer if mRNA is Gene Therapy — the January 2026 guidance update that said the quiet part out loud while the petition sat unanswered.

• FDA Demands Big Pharma Prove Flu Vaccines Work — While Refusing to Answer If mRNA Products Are Gene Therapy — the inconsistency FDA cannot explain.

• Dr. Yeadon Explains For First Time How COVID Tests Cannot Detect Proteins Like WHO Purports — Dr. Michael Yeadon on the underlying science.

The 7-part series to explain why Mandamus is needed!

• Part 1 — The Minimal Risk Misclassification — why FDA’s waiver of informed consent for invasive COVID shots is ultra vires.

• Part 2 — The Gene Therapy Classification Problem — (you are here) why mRNA and adenoviral products are gene therapy under FDA’s own rule.

• Part 3 — The DoD § 1520a Problem — the Congressional reports that were never filed.

• Part 4 — The Warp Speed Authority Problem — military pathway, civilian deployment, and the ultra vires extension.

• Part 5 — The Adulteration and SV40 Problem — Dr. Janci Lindsay’s findings and 21 U.S.C. § 351 adulteration.

• Part 6 — The International Law Dimension — ICCPR Article 7, Nuremberg Code, UNESCO Bioethics, Charming Betsy canon.

• Part 7 — Take Them Off the Market (The Remedy) — the remedial framework the petition proposes.