FDA stalls decision on petition to suspend mRNA injections, citing ‘other priorities’
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.
A tale of two gene therapies
Critics say the FDA’s handling of mRNA harms stands in stark contrast to its swift response to safety concerns involving other gene therapies.
Yesterday, the agency announced a halt to clinical trials for Sarepta Therapeutics’ investigational gene therapy after the company reported another patient death—bringing the total to three deaths across two separate gene therapy products.
The treatment, developed for limb girdle muscular dystrophy, prompted immediate regulatory action.
“Today, we’ve shown that this FDA takes swift action when patient safety is at risk,” said FDA Commissioner Marty Makary, declaring the agency is “not afraid to take immediate action when a serious safety signal emerges.”
In contrast, the FDA has remained inert on mRNA injections—which also deliver genetic material into human cells but were classified as “vaccines”—despite thousands of reported deaths and serious adverse events following administration.
According to the petitioners, the public was led to believe they were receiving a conventional vaccine—when in fact, they were being administered gene therapy.
By failing to recognise and regulate the products accordingly, the FDA violated public trust—bypassing transparency laws, concealing critical risks, and depriving individuals of the opportunity to make informed medical decisions.
Next steps
People don’t want agencies to stall. They don’t want bureaucratic evasions. They want answers—and they want accountability.
The FDA’s next move won’t simply test regulatory process.
It will test courage—whether anyone inside the system is willing to confront the fallout in what may be the most consequential medical misclassification in modern history.
Maryanne thanks. Your warnings over months are so well researched and reported. This really is another thalidomide !!!
- if young person increased cancer is connected with the “purported” vaccine which is non trialed/assessed gene therapy.
Now for the real questions - which countries relied on Pfizer/FDA allowing millions of gene therapy doses and which countries didn’t
AND when are RWE (real world evidence) studies comparing vaccines (or gene therapy) used by national govts with trajectories of cancers by aged group.
I’m of course very angry (7 vax - 4 mRNA as that was all available)
It’s not only myself but children and grandchildren who were forced to have mRNA. Authorities stopped AZ, they stopped CSL replacing with gene therapy injections that needed repeating every 4 months to even be effective. Questionable if anything needed more frequently than 12 mths can ever be a vaccine?
This vaccine promotion and Pfizer’s antiviral drugs were used to dominate treatment / prevention whilst good simple antiviral nasal sprays were forcibly stopped in 2021 and Australians have to jump through whoops for respiratory virus protection and treatment importation
The WHO secret COLLUDING WITH global govts has impacted us All
Regardless of what the FDA does on this one, at some stage in the next few years we will have a widespread realisation of the catastrophic impact of these terrible shots. The dam will eventually burst....