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.
