Covid-19 vaccine reform is moving slower than many had hoped
Moderna’s latest mRNA vaccine approval stunned reform advocates—but real change demands persistence, especially when science runs up against powerful industry interests.
Just three weeks after Dr Vinay Prasad assumed oversight of vaccines at the FDA, Moderna’s latest Covid-19 vaccine, mNEXSPIKE®, received full approval.
For those who had hoped the mRNA platform would be shelved, the decision landed like a gut punch.
Approved on 31 May 2025, the next-generation shot is intended for adults over 65, as well as individuals aged 12 to 64 with at least one risk factor for severe illness.
And it came under the watch of a man who had spent years demanding greater scientific rigour from the agency.
Prasad had been among the FDA’s most outspoken critics during the pandemic, repeatedly condemning its reliance on surrogate endpoints—such as antibody levels—rather than hard clinical outcomes like reduced hospitalisation or death.
And he didn’t just say it once. He drove the point home, over and over.
“Showing boosters improve neutralizing antibodies or other laboratory measures is not what we need,” he posted on X in July 2022. “We need randomized control trials powered for clinical endpoints showing boosters improve outcomes that people care about.”
In January 2023, he co-signed a formal Citizen Petition to the FDA stating, “This immunobridging surrogate endpoint has not been validated to predict clinical efficacy.”
Then in March 2023, he made his position even clearer on Substack. “I don’t care about transient antibody titer levels,” he wrote.
But mNEXSPIKE® appears to have been approved primarily using exactly those kinds of data—measures of immune response, not measures of meaningful outcomes.
So how do we square that?
Technically, the approval aligns with the policy Prasad outlined in a recent New England Journal of Medicine article.
There, he proposed a two-track system — no further vaccine approvals for healthy adults without RCTs showing clinical benefit—but for older adults and at-risk individuals, immunobridging data could still be acceptable.
So yes, by that standard, mNEXSPIKE® fits the rules.
But it doesn’t erase the discomfort. Because for years, Prasad insisted those very shortcuts—approving Covid vaccines based on antibody levels instead of clinical outcomes—were scientifically flimsy.
Now, under his watch, those same shortcuts are back in play.
When Robert F. Kennedy Jr. was appointed HHS Secretary, reform didn’t just seem likely—it felt imminent.
Many expected the mRNA shots would be pulled from the market, or at the very least, that new approvals would be frozen until stronger evidence emerged.
Instead, we’ve seen a flood of high-production videos and polished slogans about “restoring public trust.”
To many observers, it looks like transparency on the surface—but business as usual underneath.
Of course, no one said this would be easy.
Having worked in government as a political adviser, I know how hard it is to shift systems that are not only slow and bureaucratic, but deeply enmeshed with commercial interests. And no sector is more heavily invested in mRNA than biotech.
This isn’t just about Covid anymore. The pharmaceutical industry has poured billions into mRNA vaccines for RSV, flu, HIV, cancer, and more. Entire product pipelines are now staked on the assumption that the technology is here to stay.
Pulling the plug wouldn’t just alter public health policy—it would tank portfolios, gut R&D budgets, and unleash a political and financial firestorm from some of the most powerful corporate interests on earth.
That’s the kind of pressure Prasad is under now. That’s the reality Kennedy’s team has stepped into.
This is no longer science versus ideology. It’s science versus entrenched industry power.
And many are beginning to worry we’re watching the same playbook unfold—just with better branding.
That’s not what MAHA supporters or vaccine-injured families were hoping for. They’re not asking for tweaks. They want the shots gone. Not revised. Not updated—just gone.
But political reality rarely keeps pace with public demand. Even the most determined reformers can’t move faster than the machinery they’re trying to dismantle.
So where does that leave us?
Facing the hardest task of all—staying in the fight.
Progress may feel glacial, but it is underway.
The CDC has removed routine Covid-19 vaccine recommendations for healthy children and pregnant women. Prasad’s new framework has halted low-risk approvals unless backed by RCTs.
Yes, the mRNA platform is still alive—and still fiercely protected—but reform was never going to be easy. And it was never going to come all at once.
thank you Dr Demasi,
I also reviewed the legislative steps that Moderna had taken in respect of this approval, and the legislation in place as to whether or not this new incoming team of Kennedy, Bhattacharya, Makary, and Prasad could have done anything different, knowing as we all do their deep seated oppositions towards this modRNA drug platform - which all here know has killed and maimed millions
short answer is this - Moderna had lodged their application for this approval way back in September 2024 - before the new Trump administration - so all of the legislative machinery in place at that time (September 2024) applied to this approval, irrespective of recent statements from Prasad and Makary about a new regime of clinical trials 'to be adopted' for drugs targeted at the generally healthy
the language of recent statements is important and needs to be wighed with the changes in US legislation that need to be made to make those statements into new law
.. on 30 April 2025 the HHS stated that “all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure”
.. note "new"
on 20 May FDA leadership published a New England Journal of Medicine perspective stating any new COVID-19 vaccine “must now be evaluated in placebo-controlled studies” for healthy people under 65
.. note "now" .. meaning, from May 2025
so for this application lodged last September, the FDA applied the pre-existing framework to mNEXSPIKE .. and as Dr Demasi points out, the final approval carved out aligns exactly with the new policy: mNEXSPIKE was licensed only for the high-risk populations - age ≥65 or 12–64 with underlying conditions - for whom FDA continued to rely on immunogenicity and comparative efficacy
so bound by pre-new-administration regulations, and keeping to the new policy, this approval was able to squeeze through the gate
and a final consideration of note - new FDA guidance is typically prospective, not retroactive - meaning again, applied moving forward from the date it is announced .. had the FDA sought, in some fashion, to retrospectively apply the new guidance and policy statements to this approval, then they would likely seen themselves carted off to court by Moderna to have a court point out this point of 'prospective' enforcement .. a battle the FDA in the absence of being able to include 'emergency' reasons for having done so, would have been unlikely to win
.. I will park the sundry emergency issues we could all point to .. Bobby et al do not need reminding, nor do I believe they will ever surrender those points .. they are just waiting for a better day to use them, with effect
returning to it ..
yes, many here like me hate that this approval squeezed through .. but the very real Leviathans which are the pharma infected FDA, CDC, and NIH cannot be tamed and brought under a new controlling force and influence after just a few short months of this new administration
much new legislation needs to be drawn for reform, and that reforming legislation needs to be passed by what still remains a largely Pharma owned Congress and Senate .. many corrupt Senators and Congressmen and Congresswomen need to be brought to heel first, to pass the laws Bobby Kennedy Jr and his team require for ousting the disease which is Pharma which infests the very corridors Bobby is meant to have authority over, but which he quite simply doesn't .. for now
despite the above reservations and caveats I still do not give this Moderna approval a pass due to one issue - the drug was approved once again as a 'vaccine' and not as a Gene Therapy
how long must this charade be maintained for?
recall, we set out the legal framework showing these products to be indisputably Gene Therapies by direct reference to the FDA's own guidance and laws, in our Citizen Petition we know Bobby and Jay have read and are pondering how to answer: https://www.regulations.gov/document/FDA-2025-P-0335-0001
Bobby and his team well know this 'new' product is not a vaccine, and like its Covid-19 pandemic predecessors, should have also been dealt with as a Gene Therapy application requiring a whole different suite of approval steps, let alone a battery of additional safety studies to be submitted by Moderna, well before final approval considerations could have begun
here again the same lie has been trotted out in everyone's face, to the readers here and abroad who again understandably feel their their intelligence has been insulted .. well, it has been .. that "gut punch"
for mine, though Bobby and Vinay and Marty could have finally ended this lethal lie using emergency powers to step-in and pause the approval, and require Moderna to go down the Gene Therapy pathway where it belonged, that would have come at huge political and economic costs
.. as had they done so a massive can of worms would have been opened in respect of the Covid era 'vaccines', with ramifications I will not go into detail here, but will say are ramifications that have global consequences not of a favourable kind .. being likely outcomes and consequences for having this Gene Therapy truth finally addressed, in respect of this drug platform, that many here would pause for and reflect upon
which is to say, though I abhor the continuation of this lethal fiction, addressing it without being very careful could also be lethal to innocent folk
sorry to be somewhat cryptic on this issue, but it is complex and is being dealt with carefully behind the scenes
and that really is the view and take away from this recent affair in the whole context of the Covid betrayal and all the falsehoods we had to bear .. undoing this great saga cannot be done overnight
many vested interests have made billions and can and do apply those profits to maintaining lies and fictions and keeping their next investments in the same space on safe keels
while the very act of transforming the US Congress and Senate to a state where it is no longer inhabited by countless corrupted representatives, paid well by big Pharma to block every legislative reform Bobby, Jay, Mary, and Vinay need to see, for restoring the FDA and CDC to the People .. and as a guiding beacon for the globe
.. well .. that will be one of the historic feats of MAGA/MAHA we have to simply remain in our seats for, to see happen
So the upshot is - more people are going to be killed!