By Maryanne Demasi PhD Maryannedemasi@substack.com
The US regulator quietly delays action on a petition calling for the suspension of mRNA injections—despite evidence of regulatory failure, DNA contamination, and a surge in cancers among young people.
The U.S. Food and Drug Administration (FDA) has delayed its response to a formal petition demanding the suspension of the mRNA Covid-19 injections, citing “the existence of other FDA priorities.”
In a letter dated 17 July 2025, Dr Vinay Prasad—recently appointed Director of the FDA’s Center for Biologics Evaluation and Research (CBER)—acknowledged that the agency had “not yet reached resolution of the issues raised” in the petition.
Filed on 20 January 2025, the petition alleges that Pfizer’s Comirnaty and Moderna’s Spikevax were “unlawfully approved” in violation of federal regulatory requirements.
It calls for an immediate halt to the injections, independent testing of retained vials, and a full investigation into the approval process.
Fatal flaws in licensing mRNA products
Submitted by lawyer Katie Ashby-Koppens of PJ O’Brien & Associates, and spearheaded by former barrister Julian Gillespie, the petition argues that the mRNA injections were misclassified from the outset.
Although the products meet the FDA’s own definition of gene therapy, they were not regulated as such—sidestepping the heightened oversight normally required for gene-based interventions.
Under U.S. law, gene therapies must undergo ‘Environmental Assessments,’ be reviewed by specialised advisory committees, and face a more rigorous public transparency process.
But by labelling the mRNA injections as conventional ‘vaccines,’ regulators were able to fast-track their approval through a separate, less stringent pathway—bypassing critical safeguards.
The petition also raises alarm over synthetic DNA fragments found in the final products. Independent testing by multiple laboratories—including the FDA’s own facility—revealed DNA contamination far exceeding the safety limits.
Because the DNA is encapsulated in lipid nanoparticles, it can bypass normal immune defences, enter human cells, and in some cases integrate into the genome. The potential consequences, the petition warns, include genomic instability, cancer, and heritable genetic damage.
One of the most serious findings is the presence of SV40 promoter sequences in Pfizer’s injection—elements known to interfere with tumour-suppressing pathways such as p53.
The petition accuses Pfizer of withholding this information from the FDA in breach of disclosure laws.
Interim letter, no timeline
Under federal law, the FDA was required to respond to the petition within 180 days.
Just before the deadline, it issued a standard interim letter—acknowledging the petitioners’ main concerns but offering no timeline for a final decision.
Nor did the agency indicate that any investigation had begun. “We will respond to your petition as soon as we have reached a decision on your request,” wrote Prasad.
The agency’s delay is not uncommon—but critics say it reflects a deeper reluctance to confront the scientific and regulatory implications head-on.
Fully addressing the petition would require a sweeping and uncomfortable re-evaluation of how mRNA technologies were developed, approved, and marketed under the guise of conventional ‘vaccines.’
If the products were unlawfully licensed—mislabelled as vaccines to circumvent gene therapy regulations—the fallout would be unprecedented.
The admission alone could expose governments to extraordinary legal and financial liability—including product withdrawals, class actions, long-term health monitoring, injury compensation, and potential criminal investigations.
Petitioners speak out
Gillespie said the FDA is caught “between a rock and a hard place”—but that doesn’t excuse inaction. He believes the recent surge in cancers among young people demands urgent scrutiny.
“There’s been a tremendous and continuing rise in cancers across the United States commensurate with the rollout of these products,” he said. “Government officials have seen the data… and are refusing to address the elephant in the room.”
Dr Jessica Rose, a computational biologist and co-author of the petition, said the public was never given accurate information about the nature of the products.
“The public was not told what they were being injected with,” she said. “And still to this day, they are not.”
She described the failure to distinguish gene-based therapies from traditional vaccines as “an existential crisis,” warning that “more and more people—including children and infants—are being exposed to the harms of foreign DNA.”
Dr David Speicher, a virologist and co-signatory on the petition, said the FDA’s letter amounts to bureaucratic minimisation.
“The number of vaccine-injured people continues to grow, and we do not all know the long-term harms caused by these genetic products,” he said. “Yet the FDA states that ‘other priorities’ are more important.”
He called for “an independent scientific team to examine the regulatory process, as well as to provide funding to researchers to explore biological mechanisms such as genomic integration.”
Pharmacy consultant and petitioner Maria Gutschi said the mRNA products represent a new therapeutic category “with no previous knowledge to leverage in assessing safety and efficacy.”
She argued that, given the novelty and risks, “the bar to suspend and/or mandate ‘black box’ warnings must be higher than for any previous therapeutic agent.” Gutschi urged the FDA to treat this as “THE priority” going forward.
