With a new administration, will yet another Citizen Petition to FDA finally lead to revocation of the mRNA licenses and EUAs?/ Maryanne Demasi

The Citizen Petition, used by Pharma primarily to require FDA address a licensing question, was tried by RFK, Jr, Children's Health Defense and me in 2021 to stop the shots, but we were brushed off

A Citizen Petition submitted to the US Food and Drug Administration (FDA) on 20 January 2025 is calling for the suspension or outright revocation
of Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax Covid-19 vaccines.The petition alleges violations of regulatory processes, raises serious
safety concerns, and ultimately concludes that the vaccines were
“unlawfully approved.”Filed by lawyer Katie Ashby-Koppens of PJ O’Brien & Associates, the petition is spearheaded by former barrister Julian Gillespie, alongside Chief Scientific Officer and Founder of Medicinal Genomics Kevin McKernan, computational biologist Dr Jessica Rose, virologist Dr David Speicher, and pharmacy consultant Maria Gutschi.

At the heart of the petition is the claim that the FDA “wrongfully and
illegally” permitted Pfizer and Moderna to bypass legally required
Environmental Assessments (EAs) under 21 CFR Part 25—a crucial regulatory step for biologics.EAs
evaluate potential risks to human health and the environment,
particularly for products classified as “gene therapies.” The petition
contends that mRNA vaccines fit the FDA’s definition of gene therapy
products, given their use of synthetic genetic material to induce
therapeutic effects.By treating these vaccines as
conventional biologics rather than gene therapies, the petition argues,
the FDA sidestepped stricter evaluation processes and denied public
transparency by bypassing a required comment period. Under Section
25.15(a), the absence of a proper EA alone is grounds to reject an application.Additionally, the petition asserts that the vaccines were improperly reviewed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) instead of the more appropriate Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC), which specialises in gene therapy evaluations.Notably,
Moderna itself acknowledged that its mRNA technology falls within the
scope of gene therapy regulation. In a 2020 Securities and Exchange
Commission (SEC) filing, the company stated, “Currently, mRNA is considered a gene therapy product by the FDA.”Even
the FDA’s own definition of human gene therapy—“to modify or manipulate
the expression of a gene or alter the biological properties of living
cells for therapeutic use”—mirrors the function of mRNA vaccines, the
petition contends.

DNA contamination as a safety concern

The petition highlights serious safety concerns regarding DNA contamination in the Pfizer and Moderna mRNA vaccines.Multiple studies are cited, including one conducted at the FDA’s own White Oak lab, reporting residual DNA levels between 6 and 470 times above the regulatory limit of 10 nanograms per dose.The
petition notes that the DNA fragments are encapsulated in lipid
nanoparticles (along with mRNA), shielding them from immune detection,
and allowing foreign DNA to enter human cells, including their nuclei.This
process risks genomic integration, self-replication, potentially
leading to cancers such as leukaemia and heritable genetic alterations.Further
concerns revolve around the presence of Simian Virus 40 (SV40) promoter
sequences found in vaccine vials, which may bind to tumour-suppressing
proteins like p53, neutralising the body’s ability to prevent cancerous
growths.The risks extend to transgenerational harm, with
synthetic DNA potentially affecting germline cells, causing
developmental disruptions, miscarriages, or malformations.

Withholding data

Pfizer
is accused of withholding information about SV40 promoter sequences in
their plasmid DNA maps – information which is required for FDA
evaluation under 21 CFR 601.2.Omitting this information, the petition alleges, compromised the FDA’s ability to fully assess the safety of the vaccines.Further,
in failing to classify the products as “gene therapies,” the FDA is
alleged to have violated public trust, bypassing transparency laws and
depriving individuals of the opportunity to make informed decisions.

Previous efforts

This is not the first time regulatory decisions regarding Covid-19 vaccines have been challenged.In May 2021, Robert Kennedy Jr. and Meryl Nass petitioned
to revoke Emergency Use Authorisations (EUAs) for Covid-19 vaccines,
citing safety concerns. The FDA denied the request, stating there was
“no basis” for revocation.In July 2021, BMJ senior editor Peter Doshi and colleagues petitioned
to delay full approval of any Covid-19 vaccine, emphasising the need
for more long-term safety data. This petition was also denied by the
FDA.Attorney Aaron Siri, representing the Informed Consent Action Network (ICAN), later filed
a petition to revoke EUAs for Covid-19 vaccines in young children,
raising similar safety concerns. This attempt, too, was rejected.

What next?

The petitioners demand the FDA immediately
suspend vaccine approvals, conduct independent testing of retained
vaccine stocks, and revise safety thresholds for synthetic DNA
contaminants.“The continued administration
of these products without addressing their synthetic DNA contamination
exposes millions to avoidable health risks, including cancer, genomic
instability, and transgenerational genetic harm,” the petition
concludes.Under US federal law, the FDA must respond to the petition within 180 days.Filed under Docket ID: FDA-2025-P-0335 at regulations.gov, the petition is open for public comments, with the FDA’s official response pending.The
outcome of this petition will serve as a crucial test of the FDA’s
willingness to reassess its approach to vaccine oversight amid mounting
scrutiny—especially with new leadership on the horizon.Click HERE to make a public comment about the petition.