Moderna says FDA refuses its application for new mRNA flu vaccine

[muriel_volestrangler]

Source: Associated Press

WASHINGTON (AP) — The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday.
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Moderna received what’s called a “refusal-to-file” letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today. That trial concluded the new vaccine was somewhat more effective in adults 50 and older than that standard shot.

The letter from FDA vaccine director Dr. Vinay Prasad said the agency doesn’t consider the application to contain an “adequate and well-controlled trial” because it didn’t compare the new shot to “the best-available standard of care in the United States at the time of the study.” Prasad’s letter pointed to some advice FDA officials gave Moderna in 2024, under the Biden administration, which Moderna didn’t follow.

According to Moderna, that feedback said it was acceptable to use the standard-dose flu shot the company had chosen — but that another brand specifically recommended for seniors would be preferred for anyone 65 and older in the study. Still, Moderna said, the FDA did agree to let the study proceed as originally planned.

Read more: https://apnews.com/article/moderna-vaccine-flu-mrna-2fc551cb2fb45735e67db0a4e2e2b0fb

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As science writer Tom Levenson points out:

Which is to say that the stated reason for this blanket refusal to see if this shot could save some of the multitudes of Americans who die of the flu each year (45,000 estimated in the 2024-25 season, with a recent high of 52,000 in 2017-18) is a fig leaf to cover the actual policy decision here.

That would be to shadow ban vaccine research as a prelude to barring US access to as many vaccines as possible. To refuse to evaluate a vaccine application is to shut down years and millions of dollars of research. No one in the for profit drug business is going to put their resources into such work. Why should they?

And this move, if left to stand, will have a similar chilling effect on not-for-profit research. Grants won’t flow and researchers would have less and less incentive to stake their careers on work that might go nowhere. Not because of any scientific shortfall, but because anti-vaccine cultists have decided they’d rather hold power than save lives.
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What to do? I’m not sure, but calling your senators and representative and screaming in rage can’t hurt.

https://balloon-juice.com/2026/02/10/those-fkers/