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.
...
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/

[rampartd]

1. would you still be making drugs in the usa?

the first person that rfk can claim was sickened by a vaccine will sue, with rfk's backing" and win a bundle.

[Puppyjive]

2. Why comply with the FDA?

They have no expertise anymore. The wheels have fallen off the bus.

[BadgerKid]

3. Unfortunately, existing standard of care sets the bar

and you can look up drug therapies that have gotten EU approval but not US approval.

[sinkingfeeling]

4. The FDA is now just a political pawn like all of the federal government.

[3Hotdogs]

5. Dunno. The article says Moderna violated directives that were set up by the Biden administration.

[muriel_volestrangler]

7. No, not "directives". There was initial advice to do something different, but the FDA OKed the trial anyway

See the last 2 paragraphs excerpted in the OP. Nowhere in the article does "directives" appear.

It's important not to give in to bad faith arguments by the Trump regime by misreading them and assuming they are being reasonable.

[Wonder Why]

6. Tp paraphrase Marie Antoinette, "Let them eat death!"

[Javaman]

8. I guess the covid pandemic wasn't enough for these fucks nt

[NNadir]

9. I have been professionally involved in drug development for nearly 40 years...

...in a multitude of capacities.

While we are all suspicious of the brain worm guy and his dangerously illiterate contempt for vaccines, the announcement is typical of many similar announcements over many decades.

All clinical trials compare the standard of care. Many fail on this basis. Some fail based on risk/reward basis. I may have reservations about some rejections; I disagreed with the decision in the 1990s to not approve Omapatrlat, which may have addressed a population, largely African American who did not respond to blood pressure drugs, but I fully recognize that the drug, which cost billions of dollars to develop, had very real risks of death to a subpopulation. (This was during the Clinton administration. ) To be clear, there are a large number of scientists at FDA who are vastly smarter than I am.

I certainly support the development of vaccines, and I am thrilled with the science connected with RNA based approaches. However few people here are qualified to stand in judgement of clinical trial approvals.

This is not an unusual event and the assumption it is political is probably without basis.

[popsdenver]

10. Your comments

are definitely informative, and well stated........

However, any one wishing to have their business approved, including Big Pharma, must acknowledge the fact that doing anything without the pre-requisite kneeling down, kissing the ring, and putting a shitload of cash in Trump's personal pocket, is going to fail dramatically......A Fact That Has Been Shown To Be The Case On Countless Occasions........

[SpankMe]

11. mRNA vaccines are a no-brainer

The technology allows faster development, better targeting of desired pathogens, better safety than conventional vaccines and a whole list of other benefits. mRNA vaccines cannot cause DNA damage as anti-vax crazies believe.

RFK Jr. cancelled all US mRNA research in the first weeks of his tenure. This assures that the US will fall behind in life-saving medical technology.

[PSPS]

12. Trump just wants his vig