When the FDA Finally Means NO

Updated

By Tracy Beanz & Michelle Edwards

The US Food and Drug Administration (FDA) didn’t “deny” Moderna’s mRNA flu shot in the way most people associate with a rejection. The agency didn’t convene a panel or run a full review. It did something colder and more compelling. It sent a Refusal to File letter. That is the bureaucratic equivalent of sliding Moderna’s paperwork back across the counter to them and saying, “We’re not even opening this.” According to Moderna, the letter is dated February 3, 2026, and blocks the FDA from starting a substantive review of the company’s biologics license application for its investigational seasonal influenza “vaccine,” mRNA-1010.

The Highwire summed up the scenario in one sentence that frames it perfectly, writing in all caps, “The FDA just slammed the brakes on Moderna’s mRNA flu shot.” So why did the FDA take this approach? It wasn’t because the agency declared the products dangerous, or because it found a smoking gun in the safety data. Nope. Moderna’s statement about the matter emphasized that the FDA’s refusal did not identify “any specific safety or efficacy concerns.” Instead, the refusal was “based solely” on Moderna’s choice of comparator in its trials.

The FDA didn’t say, “Your mRNA flu shot failed.” It said, “Your test doesn’t count.” So what does that mean? The FDA’s refusal centers around the control arm of Moderna’s clinical trial. The embittered company ran a large Phase 3 trial in adults aged 50 and up. With tens of thousands of participants, it compared its candidate against a licensed standard-dose seasonal flu shot. Per the FDA, that standard-dose comparator did not reflect the “best-available standard of care” in the United States at the time, especially for older adults who often received higher-dose or enhanced formulations.

In other words, if you’re over 65, the FDA’s position is essentially: why would we accept a study design that might leave seniors in the control group with something less protective than what the US market already treats as “preferred.” That is the agency’s clean, ethical argument, and it’s nothing to ignore. But here’s where the story blew up. According to Moderna, it had prior feedback from the FDA on its Phase 3 design. CIDRAP reported that Moderna stated the FDA previously signaled that a standard-dose comparator was acceptable, with “preferentially recommended” vaccines for participants over 65. With this in mind, Moderna insists it believed it had aligned its approach with regulators before spending money on the trial and enrolling participants.

That is why the FDA’s position doesn’t read like a regulatory hiccup. Instead, it reads as the FDA has finally decided to draw a line in the sand and put the health of Americans first, over Big Pharma. For years, the FDA’s posture on vaccines—especially anything that could be framed as routine—has leaned on speed, immunobridging, and a kind of institutional autopilot that conveniently aligned with an industry that cares most about its bottom line. The FDA was fine with annual products, annual campaigns like the flu shot, and, of course, annual profits. All while the public played along and kept the machine moving.

But guess what? This time, the machine hit a big wall, and not by accident. The Refusal-to-File letter wasn’t signed by a midlevel reviewer cleaning up a messy submission. Instead, it was signed by Vinay Prasad, the agency’s top biologics official. Prasad has been openly vocal about tightening vaccine regulation, even when that stance enraged the usual “don’t slow down the pipeline” crowd. Late last year, STAT reported on a controversial internal memo by Prasad that linked child deaths to the COVID shots and called for stricter standards. And they can’t come soon enough. Calling into question whether COVID shots killed “more healthy than it saved,” Prasad wrote in the memo:

“For the first time, the US FDA will acknowledge that Covid vaccines have killed American children.” 

As expected, the memo triggered widespread pushback for its courageous claims and implications, but the broader point is unmistakable. Indeed, Prasad has been signaling, for months, that the era of streamlined, rubber-stamped vaccine policy is over. And this is not just about COVID. Multiple outlets have reported that Prasad also wrote an internal memo last year indicating that the FDA’s long-standing streamlined approach to annual flu shot updates (where immune response data often stands in for hard clinical outcomes) would no longer be allowed. Prasad’s position on flu shots is clearly disruptive to companies like Moderna, which seek to profit from the flu market. Why? Because the flu market relies on predictability and speed. If the evidentiary bar is raised, the entire process is slowed, and the business model is threatened.

So, for those rushing to describe the FDA’s Refusal-to-File as unusual or shocking, the uncomfortable reality for them is that this course correction is long overdue. If the FDA believes that older adults should not be used as a means of scaffolding against a weaker comparator when better options exist, then the ethical boundary presented by the letter is refreshing. If the FDA is serious about ending the era where vaccine approvals glide on surrogate endpoints and convenient comparisons, then the FDA is demonstrating exactly how seriousness shows up. Yes, in decisions that disrupt expectations.

And now, enter Dr. Pierre Kory, who, in one short post, gave voice to the public’s suspicion about the narrative at hand regarding Big Pharma. Kory summed up what we’ve all witnessed since the pandemic opened our eyes. The goalposts get moved when convenient, the rules shift when convenient, and outcomes are regularly manufactured. Indeed, Kory’s message is on target because for far too long, we’ve watched government institutions defend decisions by Big Pharma with religious certainty, and then pretend those decisions were “always evolving” when the narrative breaks down.

But this time, the game is different. Now, the villain isn’t the FDA tightening its standards. The villain is the corrupt system that trained Americans to view scrutiny as sabotage. Moderna’s complaint is essentially “you should have let us in the door and debated this later.” Yet, this time, the FDA’s response is a hard no—not with this design, not with this comparator, and not with seniors in the balance.

As expected, Moderna states it wants a Type A meeting to find a path forward and will pursue regulatory review abroad. Fine. Let other regulators decide how much rigor is negotiable. The FDA’s job is not to keep Moderna’s calendar on track. The agency’s job is to decide whether the evidence is strong enough to justify what comes next—especially when the company standing on the other side of the counter has every financial reason on earth to get to “yes” quickly.

So no, this isn’t a story about loving or, more appropriately, hating mRNA. Although that is an entirely appropriate aspect. But this time, the issue at hand is about whether the referee finally remembers it’s authorized to blow the whistle. And if Big Pharma is angry about that, it might be the first encouraging sign we’ve seen in a long

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Tracy Beanz & Michelle Edwards

Tracy Beanz is an investigative journalist, Editor-in-Chief of UncoverDC, and host of the daily With Beanz podcast. She gained recognition for her in-depth coverage of the COVID-19 crisis, breaking major stories on the virus’s origin, timeline, and the bureaucratic corruption surrounding early treatment and the mRNA vaccine rollout. Tracy is also widely known for reporting on Murthy v. Missouri (Formerly Missouri v. Biden), a landmark free speech case challenging government-imposed censorship of doctors and others who presented alternative viewpoints during the pandemic.