Does President Donald Trump know that one of his top regulators is in the process of killing hundreds, maybe thousands, of senior citizens?
Hundreds of thousands of Americans are hospitalized for flu each year; tens of thousands die from it — and drug bureaucrat Dr. Vinay Prasad looks determined to maximize the death toll, which is always mainly seniors.
That is, Prasad — who heads the Food and Drug Administration’s Center for Biologics Evaluation and Research — is blocking what should be the last stage of approval for a vaccine that actually targets this year’s most likely flu strain in the United States.
(It should be available in Canada, so you might want to plan a trip there this fall.)
The jab Americans will be able to get targets other strains, which may dominate elsewhere around the globe.
It’s impossible to say how many US lives this decision will cost, but the rough math is inescapable: Prasad’s intervention is deadly.
So why did he do it?
His stated reason is blatantly ridiculous, plainly ginned up because he doesn’t dare ’fess up to his real motive.
More detail: Prasad recently overruled career staff and longstanding practice to simply refuse to OK a final review of Moderna’s new flu vaccine — a review that amounts to basically just checking that the company made no paperwork mistakes in its Phase Three trials of the jab’s efficacy.
Initial results from the trial with 41,000 participants (half getting the standard jab, half Moderna’s) showed the vaccine to be 27% more effective at preventing death, 49% better at preventing hospitalization.
Prasad, completely out of the blue, claimed the control group should’ve instead gotten a “high-dose” vaccine — arbitrarily inventing a new standard that makes no sense at all; FDA staff had signed off on the protocol Moderna used in advance of the trial.
What might be his real reason? It could be RFK Jr.’s hostility to all vaccines; it could be paranoia against MRNA jabs — which have a bad rap only because they’re the ones that the COVID-crazed mandated during the pandemic.
The story gets worse: In a development that happens about one year in five, the chief flu strain expected across North America this fall is “egg-resistant” — meaning no pharma company can make a traditional vaccine that targets it, as old-school production involves growing the bug in eggs.
So the jab that will be available in this country will target other strains, and so not much better than getting no shot at all..
Ironically, Canadians will have access to the Moderna vaccine (along with Europeans, Aussies and others), because Prasad can’t stop other nations from doing the due-diligence final check of the company’s trial results.
Again, this is basically a pro-forma review: The FDA historically only stops the process at this point in 4% of cases, and for obvious causes like missing information or gross violations of agreed-upon protocols.
Speculation is that Prasad nixed it now simply because it was his only chance: Jumping in any later would be even harder to justify.
Beyond the lives Prasad’s move will take this fall, he’s also suffocating future vax and drug development, by making FDA approvals utterly unpredictable.
It costs billions to qualify a new pharmaceutical for use; if a company can do everything right and still get shut down at the last minute, that investment will look like a complete sucker’s bet — and it won’t get made.
Indeed, other industries will have to factor in the risk that their regulators could turn as arbitrary as this: Prasad is discouraging innovation across the entire US economy.
Strangling innovation by way of weaponized regulation is not a good look for any Republican, especially a Trump Republican.
Moderna has to slog through the FDA appeals process before it can even go to court to get Prasad’s call overturned; even if the company triumphs in the end, it’ll be far too late to produce and distribute.
Americans will die needlessly — unless the White House steps in to control RFK Jr’s most crazed tendencies and at the very least overrule Prasad.
The main number there is (202) 456-1414.
Thank you for your attention to this matter.
This story originally appeared on NYPost
