Grossman’s Folly: How a Policy Analyst Mistook a Science Fight for a Political Fairy Tale

A Medpage opinion author seems desperate to use spin to hold onto the slightest thread of hope that Trump might actually side with vaccine zealots over MAHA. Here is a detailed, in-the-know critique.

Steven Grossman’s MedPage Today piece — “RFK Jr.’s Anti-Vaccine Stance Infiltrated FDA. Trump Is Reining It In” — is framed as a defense of FDA’s institutional integrity. It reads, instead, as a case study in how to write confidently about a regulatory dispute while systematically ignoring its scientific substance. Grossman, a policy analyst and former Senate staffer, trades in process and politics. What he cannot do — and never attempts — is engage the actual evidentiary questions at the heart of the Moderna refusal-to-file decision. That omission is not a minor oversight. It is the piece’s defining failure, his lack of comprehension, or desire to reframe what he knows full well drives the article thesis It leads Grossman to construct a narrative that is not merely incomplete but demonstrably misleading.

The Vanishing Science

Grossman dispatches the FDA’s stated rationale for refusing Moderna’s application in a single parenthetical: Prasad claimed the application lacked “an adequate and well-controlled trial” and, Grossman adds archly, this was valid “if valid at all.” That hedge is doing enormous work — and it collapses the moment you look at what the public record actually shows.

The FDA’s refusal-to-file letter identified a specific, substantive methodological problem: Moderna’s Phase 3 efficacy trial compared mRNA-1010 against a standard-dose flu vaccine across adults aged 50 and older, pooling the 65-and-over cohort into the broader age group rather than analyzing it separately. For adults over 65 — the population most vulnerable to influenza and most in need of a genuinely superior vaccine — the current U.S. standard of care is not a standard-dose shot. The Advisory Committee on Immunization Practices preferentially recommends high-dose, adjuvanted, or recombinant formulations for this age group, because those products have demonstrated superior clinical performance in this population. Comparing a new vaccine to a weaker, non-preferred product in seniors does not establish that the new vaccine is better than what seniors should actually be receiving. It establishes that it is better than something they should not be receiving. That is a biased yardstick, and it is exactly the problem FDA cited under 21 CFR 314.126.

Grossman ignores all of this. He ignores that Moderna’s headline “26.6% more effective” claim rested on that weakened comparator across a pooled age group. He ignores that Moderna submitted immunogenicity data — immune response measurements — against a high-dose comparator for older adults, rather than clinical efficacy data, even after being warned by FDA that would not be sufficient. These are not equivalent things. Immunogenicity can demonstrate biological potential; it does not measure whether people get sick less often. The FDA has been explicit on this point. In his November 2025 internal memo — widely reported and publicly discussed — CBER Director Prasad stated plainly that FDA would no longer treat antibody titers and surrogate endpoints as adequate substitutes for clinical efficacy in vaccine approvals. Moderna had fair warning that the evidentiary bar had shifted, in writing, months before submitting its application.

None of this appears in Grossman’s account. “If valid at all” is the entirety of his engagement with the scientific question. For a piece that presents itself as a defense of science-based FDA decision-making, the absence of any actual science is remarkable.

The Goalposts That Were Never Moved

Grossman’s framing relies heavily on the widespread and false idea that Prasad ambushed Moderna with novel demands after the fact — that FDA agreed to a trial design and then repudiated it at the finish line. This is Moderna’s preferred narrative, and Grossman adopts it wholesale. The full documentary record tells a more complicated story.

In April 2024, FDA told Moderna in writing that a standard-dose comparator was acceptable but explicitly recommended using a high-dose or adjuvanted vaccine for participants over 65, in order to generate data that would inform ACIP’s future recommendation for seniors. The distinction between “acceptable” and “sufficient” is not semantic hairsplitting — it is the core of the dispute. FDA did not say the standard-dose design was ideal, or that it would satisfy the evidentiary requirements for the most vulnerable age group. It said it would not impose a clinical hold on that basis. Moderna chose to proceed without incorporating the recommended comparator for older adults in its primary efficacy trial, instead running a separate study in seniors that measured only immunogenicity against a high-dose vaccine — surrogate data, not the clinical efficacy evidence FDA had signaled it needed.

When FDA flagged the comparator issue again at a pre-submission meeting in August 2025, after the trial was complete, Moderna included supplementary analyses in its submission. What it did not include was efficacy data for the >65 population against the preferred comparator. That is precisely what FDA demanded. And that is precisely what Moderna ultimately agreed to generate, in the amended proposal that resolved the impasse. Moderna did not simply meet a bureaucratic procedural threshold. It conceded the scientific point. The age-stratified accelerated approval pathway it proposed — with post-marketing efficacy requirements specifically for the 65-and-older cohort — is an acknowledgment that the original submission left a clinically critical question unanswered.

Grossman describes the amendment and FDA’s subsequent acceptance as a “widely hailed” victory for Moderna. He does not tell his readers what Moderna actually agreed to, or why. That omission allows him to sustain a narrative in which the reversal was purely political — a White House intervention with no scientific content. The record does not support that narrative.

A Contradiction Left Unresolved

To be fair, Grossman does identify something real. His account of a post-RTF phone call between the White House and FDA Commissioner Marty Makary — and his argument that political pressure around mid-term elections shaped the administration’s recalibration on vaccine messaging — may well be accurate. Presidential frustration with inconsistent regulatory optics is not difficult to imagine, and the timing is suggestive. If Grossman had integrated this political dimension into an analysis that also took the science seriously, he might have produced a nuanced and genuinely useful piece.

However, you could have to knock me over with a feather that messaging of an politician might change in a period coming up to an election.

Instead of seeing politics for what they are, Grossman presents his political explanation as the only explanation, and this is where his piece collapses into self-contradiction. Grossman opens by insisting that FDA’s reputation rests on “science-based decision-making” and warns against politicization of the regulatory process. He closes by treating his perceived politically motivated White House intervention as a welcome correction. If political interference is the disease, it is strange medicine to celebrate it when the politics happen to align with your priors. Grossman does not resolve this contradiction — he does not appear to notice it.

What he cannot acknowledge, because his framing forecloses it, is the possibility that both things are true simultaneously: that the administration’s broader posture toward vaccines is genuinely aligned with the fact that vaccine risk, injury and death have been underplayed, and some would say buried, and that the specific evidentiary demands underlying the Moderna RTF were scientifically defensible. These are not mutually exclusive. But Grossman has built a story in which every action by Prasad is anti-vaccine sabotage and every action by Trump is political rescue. That binary leaves no room for scientific nuance, regulatory complexity, or the possibility that Moderna’s trial design had real weaknesses. Remember: Moderna, not FDA, reversed course.

The Procedural Argument Has More Merit Than Grossman Admits

The strongest version of Grossman’s critique — which he never quite articulates — is procedural rather than substantive. A refuse-to-file is an extreme instrument, typically reserved for applications with gross deficiencies or format failures. The more conventional response to a trial design dispute of this nature would be to accept the filing, convene an advisory committee, issue a Complete Response Letter, and negotiate additional study requirements — all of which would have happened in public, with stakeholder input, consistent with decades of FDA practice. There is a legitimate argument that even if Prasad’s scientific concerns were valid, a summary RTF was the wrong tool for expressing them. Whether Prasad in fact did override career staff who had recommended accepting the application occurred or not is a matter of conjecture, and whether past officers in his position yielded similar final say would determine the extent of any procedural irregularity.

Those may or may not be worth arguing. Arguing it requires acknowledging the underlying science — because the procedural critique only lands if you can show that the substantive concerns did not rise to the level warranting summary refusal. Grossman skips the science entirely and goes straight to the alleged procedural indictment, which leaves his argument resting on air.

What Grossman Owes His Readers

Grossman describes himself as a “policy analyst and regulatory expert.” His readers — physicians, clinicians, health policy professionals — deserve analysis that matches that credential. What they receive instead is a political melodrama narrative in which complex scientific and regulatory questions are reduced to a referendum on RFK Jr.’s influence at FDA. Grossman tells his readers that Prasad’s rationale was dubious “if valid at all,” without examining whether it was valid. That’s just casting shade. Nothing more. He tells them Moderna’s amendment was a political capitulation, without telling them what Moderna actually conceded. He tells them the reversal vindicated FDA’s traditional processes, without acknowledging that the reversal was driven by the same political dynamics he decries.

The Moderna episode does raise serious questions — about the appropriate use of refuse-to-file procedures, about how FDA communicates shifting evidentiary standards to sponsors, about whether overriding career staff on high-profile product decisions is consistent with institutional integrity, and yes, about the broader climate of vaccine policy under the current administration. These are all worth examining. But they cannot be examined honestly without first understanding what the scientific dispute was actually about.

Grossman chose not to do that work. He chose narrative over analysis, and in doing so produced a piece that flatters his readers’ political assumptions while leaving them less informed about what actually happened. That is not a defense of science-based decision-making. It is a substitution of politics for science, wearing the borrowed language of regulatory expertise.

The irony would be richer if the stakes were lower.