from the one-flu-over-the-cuckoo’s-nest dept
Dr. Vinay Prasad is currently the FDA’s top vaccine regulator. He’s also one of many medical goons hand-picked by RFK Jr. to help lead his decidedly anti-vaxxer movement. In fact, the last time we discussed Prasad, it was over his selective censorship attempts at avoiding public criticism for his anti-vaxxer nonsense. If you show clips of Prasad spewing his anti-vaxxer views to critique them, he’ll have your YouTube channel axed. If you show those same clips to praise his nonsense, you get to continue on unmolested.
He’s an asshat, in other words. An anti-science, anti-medicine asshat. And he’s also someone who is unilaterally keeping us from making progress on vaccines, apparently out of pure joy in exercising such power.
Moderna is producing a new influenza vaccine, this one utilizing mRNA technology, a la the COVID vaccine. Moderna sent an application to the FDA for a review of the vaccine it has produced, as well as the data from the trials the company conducted to demonstrate its efficacy. We learned last week that the FDA flatly refused to review any of this data.
In a news release late Tuesday, Moderna said it was blindsided by the FDA’s refusal, which the FDA cited as being due to the design of the company’s Phase 3 trial for its mRNA flu vaccine, dubbed mRNA-1010. Specifically, the FDA’s rejection was over the comparator vaccine Moderna used.
In the trial, which enrolled nearly 41,000 participants and cost hundreds of millions of dollars, Moderna compared the safety and efficacy of mRNA-1010 to licensed standard-dose influenza vaccines, including Fluarix, made by GlaxoSmithKline. The trial found that mRNA-1010 was superior to the comparators.
Moderna said the FDA reviewed and accepted its trial design on at least two occasions (in April 2024 and again in August 2025) before it applied for approval of mRNA-1010. It also noted that Fluarix has been used as a comparator vaccine in previous flu vaccine trials, which tested vaccines that went on to earn approval.
This looks for all the world like Moderna did what it was supposed to do in getting the proper sign-offs from the FDA to conduct its trials. Prasad himself sent the refusal notice to Moderna, however, and cited within it that the trials Moderna conducted, which were signed off on by the FDA, were not appropriate. The letter didn’t bother to indicate why.
But in a letter dated February 3, Vinay Prasad, the FDA’s top vaccine regulator under the Trump administration, informed Moderna that the agency does not consider the trial “adequate and well-controlled” because the comparator vaccine “does not reflect the best-available standard of care.”
In its news release, Moderna noted that neither the FDA’s regulation nor its guidance to industry makes any reference to a requirement of the “best-available standard of care” in comparators.
Everyone at Moderna was understandably confused. The company has already reached out asking to meet with the FDA, ostensibly to sit down in a conference room with them, look them in the eye, and ask “wut?”.
The answer is unlikely to be satisfying. And it should be quite alarming to the rest of us. That’s because the rejection of a review of all of this data reportedly came from Prasad and Prasad alone, over the objections of his own scientists at the FDA.
Vinay Prasad, the Trump administration’s top vaccine regulator at the Food and Drug Administration, single-handedly decided to refuse to review Moderna’s mRNA flu vaccine, overruling agency scientists, according to reports from Stat News and The Wall Street Journal.
Stat was first to report, based on unnamed FDA sources, that a team of career scientists at the agency was ready to review the vaccine and that David Kaslow, a top career official who reviews vaccines, even wrote a memo objecting to Prasad’s rejection. The memo reportedly included a detailed explanation of why the review should proceed.
According to those same sources, Prasad’s reason for refusing to review Moderna’s vaccine makes little sense. The story goes like this. As Moderna was seeking guidance for its trials for the vaccine, it chose a currently licensed flu vaccine against which to compare its own vaccine. At one point, the FDA suggested a different comparative vaccine be used. Moderna declined that suggestion and moved forward with the comparative vaccine it originally chose. Despite that difference the FDA reviewed the company’s plans for its trial on several occasions and at no point suggested its choices were a show-stopper.
That’s it. That’s the whole thing. Prasad is claiming that the choice Moderna made for a comparative vaccine, for which the company received only mild feedback from the FDA, is why the FDA is refusing to review this mRNA flu vaccine entirely.
Because that reasoning is almost certainly bullshit. As evidence of that, these same sources from within the FDA offered up this:
This wasn’t enough for Prasad, who, according to the Journal’s sources, told FDA staff that he wants to send more such refusal letters that appear to blindside drug developers. The review staff apparently pushed back, noting that such moves break with the agency’s practices and could open it up to being sued. Prasad reportedly dismissed concern over possible litigation. Trump’s FDA Commissioner Marty Makary seemed similarly unconcerned, suggesting on Fox News that Moderna’s trial may be “unethical.”
The explanation here is remarkably simple. This current government is being run by anti-vaxxers. And these anti-vaxxers are particularly anti-vaxxer-y about mRNA vaccines. And so folks like Prasad are throwing up every roadblock they can dream up to make it as difficult as possible to get new vaccines utilizing new technology approved. Or, as in this case, even reviewed.
Now, if that reads like the opposite of scientific progress to you, give yourself a gold star, because you’re right. Thomas Jefferson once said “I tremble for my country when I reflect that God is just” when, hypocritically, discussing slavery in America. I think we should tremble for our country as well when I reflect that we are getting sicker as a nation, given that we have morons at the helm of the nation’s health.
Filed Under: fda, flu, flu vaccine, health & human services, mrna, rfk jr., science, vaccines, vinay prasad
Companies: moderna
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