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.
Nothing will change until there is a critical mass of peeples willing to stand up and be counted. But first there need to be enough peeples who care enuff for what they’re prepared to stand up and be counted for.
And that’s going to need some imagination and excitation.
Sure, Pat, but the Notices, which bill the recipient-as in Dan Andrews, Tim Pallas, and others who have received them, follow them around, and there is no escape, as they were issued when these people were in office, and that is it.
If you want t draw actual blood then you will have to do it yourself, and face the consequences for it, if you actually do anything like that.
So for now, you are just being a serial whinger, with no solutions to offer other than capital punishment, which you are not going to get.
So spend your $22:00 and have a look at InPower, and you might just get some inspiration, when you find out that they made the Queen of Denmark, who said she would never abdicate, actually stand down.
Just whingeing will get you nowhere, Pat.
Email I sent to one of our esteemed Pollies
Dear Member,
I have just read your reply to Dianedraytonbuckland and I am trying to figure out what pandemics are you so worried about.
It is a known fact that there was no such thing as a Covid-19 virus or pandemic. It was a lie made up by psychopaths to panic the public into taking a killer “vaccine”. It was all about taking full control of World politics and also creating a reason for the population to take a “vaccine” deliberately created to reduce the population as Bill Gates has suggested numerous time.
I am 80 years of age and cannot remember a real pandemic in my lifetime, so why all of sudden are the politicians of the World so nervous about “another” pandemic. The World Health Organisation through the United Nations Organisation has been chosen to be the tool for this depopulating idiocy.
Perhaps after reading my comment in relation to an article at cairnsnews.org you may gain some realistic view of the World in which we live.
https://gumshoenews.com/japans-nuclear-boom-vax-is-deadly-effective/
It amazes me that most readers seem to be obsessed with Trump’s alleged and probable sex escapades rather than mass murder charges against the World’s population. He flagrantly admits to pushing the pharmaceutical industry into “operation warp speed” to release a “vaccine” as quickly as possible even though there was not the usual testing requirements done. This was even though by the time the “vaccine” was supposedly ready for release it was known that there had not been a pandemic, except in the minds of the World’s psychopathic population.
I myself had confirmed the lack of a pandemic by June 2020 using the government death statistics against the previous 10 years. Dr Robert O. Young of US had broadcast that the death figures for 2020 were less than each of the previous 3 years. These facts were released 7 months before the lethal “vaccine” was placed into the arms of the unsuspecting and panicked population.
If the President of the US along with his medical advisers were not informed of this situation they had no right to hold their respective positions. There was ample time for the pulling of “operation warp speed” when the lack of a pandemic was known.
This man, Trump, should in my opinion, be prosecuted for mass murder as many would have charged Adolf Hilter after World War ll. It looks like his victims way out number Hilter’s real death numbers in time of war.
While his alleged romps with Epstein need attention it is far more important that the charges I bring into focus against him be of concern.
If the push by Australia’s politicians to go along with the attempt by the WHO director to take over our health system ( just a foot in the door) those politicians should be charged with TREASON.
I am not new to this subject as I wrote several articles for the internet site https://gumshoenews.com during the so-called pandemic and the after effects of death and health injury to many in our Australian population. I have also witnessed the death and illness of people known to me or my acquaintances caused by the Covid-19 “vaccine”.
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.”
There is no higher priority. People are dying daily and more are being injected with this killer technology because the FDA do not want to face facts. It is their fault for these deaths for not doing their job before the “vaccines” were allowed and they know it.
obvious_bob said – “… Daniel Andrews… quit fifteen minutes after he received his NoL… WA’s Mark KcGownan bailed, allegedly because he was “burnt out” but found corporate board work a few weeks after he quit as WA Premier…”
Well, the approach has some merit in displacing entrenched arseholes from shoveling shit down our throats.
But there REMAINS a teensy weensy problem, inasmuch as all the machinery to keep right on pumping shit down our throats is still there, fully serviceable and revving for action with all hands on deck, with no shortage of REPLACEMENT sold-out paid-off baby-eating mongrel arsehole bastards all lined up in a queue waiting for THEIR turn to get their snouts in the troph and grind us all down into the dirt.
Victoria stands as a case in point right now.
And obvious bob said – “… it works extremely well and has its intended effect…”
Does it. I mean, does it REALLY?
Dictator Dan is still alive, and so is that mongrel piece of shit McGowan and ALL THE REST, even though all their victims are pushing up daisies in cemetries all across the continent right now.
And just to rub salt into the wound, as you yourself observed, these walking EXCREMENTS simply step sideways OUT of their murder campaigns to go on and live unfettered lives of wealth and luxury on the first-class carriages of their NEXT gravy train.
So by all means, folks, give those Notices of Liability a right flogging, careful targeting might give you some respite and relief from the relentless insufferable draconian corporate BS you otherwise have to tolerate.
But let’s be clear, real justice and real change and enduring liberation from these mass-murdering Luciferian PSYCHOPATHS is unlikely to arrive before sturdy ropes and lamp posts.
“Gene therapy – the ability to make precise changes to the human genome – offers a chance to address the root cause of man diseases.”
– Quote from page 1
Transhumanism anyone?
https://www.weforum.org/stories/2022/10/gene-therapy-why-we-need-to-accelerate-global-access/
I would not go very far with Julian Gillespie, as I will have nothing to do with with lawyers whatsoever.
Gillespie is steeped in the LEGAL BS, not the Lawful truth, and needs to-and everyone should-use the commercial liability approach , rather than legal approaches, because the courts are as corrupt as, and will do no-one any good.
The InPower movement have, in Australia alone, used their Notices of Liability method to rid us of a number of Premiers: Daniel Andrews, says InPower founder Cal Washington, quit fifteen minutes after he received his NoL. Not bad.
WA’s Mark KcGownan bailed, allegedly because he was “burnt out” but found corporate board work a few weeks after he quit as WA Premier.
If peopel here are serious, it would do them well to get a sub to InPower and have a look,as it works extremely well and has its intended effect.
And a sub is only $22:00 AUD per month.
Even I can afford that on my aged pension!
Well folks,
“The Science” Fauci is still on the loose, as free as a Magpie in mating season.
And so is creepy Bill.
And so is Baby-Eating Hillary (yeah, that’s right, folks, she really does butcher children alive and eat them, go find Frazzle Drip if you dare, otherwise shut the Hell up).
And so is “Safe & Effective” Bourla.
And so is zee Cabinet Penetrating Klaus and all his friends.
And just BTW, everyone’s BFF and bestest little ally in the whole wide world, Master Race Polish Benny is STILL slaughtering millions of innocents across the Middle East with the warm and unconditional approval and support and financing and assistance and weaponry of the emphatically Zionist Trump administration.
So seriously, folks, are any of us surprised? If you are, then you need a reality check, because unremitting loyalty to an unaccountable “leader” is the foundation of a CULT. And just BTW, the so-called “politicians” are supposed to be loyal to US, not the other way around. Which is probably moot, because we definitely don’t have any genuine politicians here in Australia, all we have are sold-out paid-off CORPORATE STOOGES who MASQUERADE as “politicians” in our fake corporate foreign-owned “government” PUPPET SHOW. And it seems the Americans are no better off.
Altogether now, folks – Yay MAGA! YayTrump!
Tony:
“If the FDA attempts to block the petition to cease use of these deadly mRNA vaccines, then all those involved are complicit and must face the fuill force of the law for murder.”
In a pre-covid normal world that would apply, but since the cabal (made up of mainly the WHO, UN, WEF, billionaires such as Bill Gates et al), launched their global depopulation project in March 2020: they’re all exempt from the law, particularly the laws governing murder, genocide, infanticide, ethnic cleansing, crime against humanity, etc.. They are required to serve and obey the cabal and their commands, which means they have to help them reduce the global human population by 90%, so the first step in the diabolical process is to exempt all those involved in the global genocide from the any law that forbids / prohibits murder.
They are paid quite generously for their ‘good work’ of course.
This is what most of the ‘normies’ and many so-called truthers, after more than 5 years of this covid based tyranny, don’t seem to understand.
Those involved and complicit have been given ‘permission’ thus are exempted from the normal law (that covers murder) and are allowed to and actually ORDERED to commit mass murder by the cabal and obviously, are all more than willing and eager to carry out their diabolical orders.
On that note, be ready for Operation Warp Speed 2.0 another mass depopulation event, endorsed by none other than its founder: Donald Trump.
So the Sheriff is corrupt or mindfully looking the other way? And there’s no law agency which can force him to do his job properly and honestly?
And we the timid townfolk will huddle and tsk tsk in the background, right?
The grubbernments that create regulatory agencies such as the FDA are not interested in providing them with legal obligations and duties of care.
And the politicians sitting on hefty parliamentary salaries are not TRULY and genuinely interested in holding any of the grubbernments and regulatory agencies to account.
And it seems that we the peeps are also not much interested in holding anyone to account.
So that leaves us with a Wild West landscape where the robber barons, the bandits and the rule of the $$$ prevail with impunity, xcepting any boat rockers and noise makers.
The whole corrupt Vax industry are now working around HHS and ACIP
“” was made public by Moderna when both the Secretary of HHS (JFKjr) and his trusted deputy Chief of Staff Stefanie Spears were on vacation.””
and raking it in at the same time
“”Their stock value and market capitalization surged, with the climb beginning four days before the announcement””
From Robert Malone
What happened on July 10?
I have had many requests to clarify what happened with the recent July 10, 2025 FDA general (non-EUA) marketing authorization of Moderna’s SpikeVax for children. The truth of the matter is that I do not really know what happened at FDA to lead to this outcome. Like many, I was shocked and disappointed. Moderna was overjoyed. Their stock value and market capitalization surged, with the climb beginning four days before the announcement, suggesting that someone had insider knowledge. If true, that would likely constitute insider trading. This would precisely be the type of rule-breaking that many have come to expect from this company and sector. You can consider that a hypothesis, for purposes of this discussion.
Who knew, What and When, and were there larger strategic and tactical considerations
I have limited visibility into these questions. The unfortunate facts are that this decision about FDA/CBER Spikevax authorization “for children aged 6 months through 11 years who are at increased risk for severe COVID-19 disease” was made public by Moderna when both the Secretary of HHS (JFKjr) and his trusted deputy Chief of Staff Stefanie Spears were on vacation. And Moderna certainly made hay while the sun was shining on them.
Australia will just switch to following the UK, the plot is simple, remove useless eaters, the various details don’t amount to anything much. Australian data is converging towards a nation of brown slaves who are on a global equivalent of $2/hour. Cultural icons all contribute, such as “the long commute”, the 40+ hour week, “childcare”, football, university, an excess of socialism, ABC-TV etc. We have been dumbed down beyond belief.
If the FDA attempts to block the petition to cease use of these deadly mRNA vaccines, then all those involved are complicit and must face the fuill force of the law for murder.
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