Moderna Says FDA Refuses To Review Its Application for Experimental Flu Shot
15 247An anonymous reader shares a report: The Food and Drug Administration has refused to start a review of Moderna's application for its experimental flu shot, the company announced Tuesday, in another sign of the Trump administration's influence on tightening vaccine regulations in the U.S. Moderna said the move is inconsistent with previous feedback from the agency from before it submitted the application and started phase three trials on the shot, called mRNA-1010. The drugmaker said it has requested a meeting with the FDA to "understand the path forward."
Moderna noted that the agency did not identify any specific safety or efficacy issues with the vaccine, but instead objected to the study design, despite previously approving it. The company added that the move won't impact its 2026 financial guidance. Moderna's jab showed positive phase three data last year, meeting all of the trial goals. At the time, Moderna said the stand-alone flu shot was key to its efforts to advance a combination vaccine targeting both influenza and Covid-19.
15 comments
I hope the rest of the world is large enough (Score: 5, Insightful)
by gweihir ( 88907 ) on Wednesday February 11, 2026 @07:35AM (#65981982)
To make this still a success. Irrationality is not everywhere in power. And a better flu shot is overdue.
Anti-Vax attitudes will get people killed (Score: 5, Insightful)
by JoshuaZ ( 1134087 ) on Wednesday February 11, 2026 @07:42AM (#65981996)
It is one thing to promote anti-vax attitudes among your own voter base. That still endangers people outside that base, since people who are elderly or immunocompromised become more likely to get sick if the overall vaccination rate is lower. I for example have some immune issues and cannot currently get an MMR booster for medical reasons, so I'm actively endangered by the reduction in measles vaccination and the spread of cases. But note that what the Trump administration is doing now is much worse than just promoting anti-vax attitudes among their base. They are using government power to actively prevent the development and use of vaccines by others. There's a sad irony to this in that one of the very few bright spots of the first Trump administration was Operation Warp Speed and some other things they did to help with early covid vaccine development.
Re:Anti-Vax attitudes will get people killed (Score: 5, Informative)
by dohzer ( 867770 ) on Wednesday February 11, 2026 @07:48AM (#65982018)
Anti-Vax attitudes have gotten people killed
RFK Jr's own words (Score: 5, Insightful)
by ArchieBunker ( 132337 ) on Wednesday February 11, 2026 @08:31AM (#65982102)
I don't want to seem like I'm being evasive, but I don't think people should be taking medical advice from me." https://www.cbsnews.com/news/r... [cbsnews.com]
Imagine the headlines if Obama appointed a longtime heroin junkie to run the FDA. https://www.pbs.org/newshour/h... [pbs.org]
Re:mRNA is dangerous (Score: 5, Insightful)
by Anonymous Coward ( None ) on Wednesday February 11, 2026 @07:35AM (#65981984)
That's what happened when they gave my uncle ivermectin to treat COVID. He died that night. They need to ban ivermectin and sue the doctors that prescribed it.
Re:mRNA is dangerous (Score: 5, Funny)
by BadgerStork ( 7656678 ) on Wednesday February 11, 2026 @07:37AM (#65981986)
You were lucky! My head fell off
Re:mRNA is dangerous (Score: 5, Insightful)
by greytree ( 7124971 ) on Wednesday February 11, 2026 @07:42AM (#65981998)
They also need to ban defibrillators.
I mean, how many people have died after being connected to one of them ?!
Also, hospitals seem to be a common link in a LOT of deaths. We need to do some research and then maybe we can set up an anti-hospital movement, get a demented politician to back us. Actually, forget the research.
Re:mRNA is dangerous (Score: 5, Funny)
by arglebargle_xiv ( 2212710 ) on Wednesday February 11, 2026 @09:13AM (#65982212)
It turned me into a newt!
I got better.
Re: mRNA is dangerous (Score: 5, Insightful)
by drinkypoo ( 153816 ) on <drink@hyperlogos.org> on Wednesday February 11, 2026 @08:14AM (#65982078)
What he is mocking is bullshit, and it should be mocked. And so should cowards.
Re:mRNA is dangerous (Score: 5, Insightful)
by Anonymous Coward ( None ) on Wednesday February 11, 2026 @07:39AM (#65981990)
Such a pity modern medicine gave you a chance to survive, without it we'd be without you and with an improved gene pool.
Re:mRNA is dangerous (Score: 5, Insightful)
by gweihir ( 88907 ) on Wednesday February 11, 2026 @08:11AM (#65982070)
Cool story, bro. But you need to work on the lie. A death the next day is not even remotely credible. Just claim he dies a week later. You may also want to replace "heart strain" with something else, because if you actually get that from one shot (which is very, very rare), you will NOT get a second one.
Re:mRNA is dangerous (Score: 5, Informative)
by Gilgaron ( 575091 ) on Wednesday February 11, 2026 @08:33AM (#65982108)
You're chock full of mRNA, as is everything you eat every day. Any sequelae in your muscle tissue would be due to the binding sites the virus uses, which have correlated to heart issues, which means you'd be in worse shape if you became infected with the real live virus. You can avoid mRNA vaccines if you choose, of course, but I would recommend staying up to date on all vaccines for coronaviruses as you must be at much higher risk than the general population.
Re:mRNA is dangerous (Score: 5, Informative)
by dgatwood ( 11270 ) on Wednesday February 11, 2026 @12:49PM (#65982620)
... there was no reason to force this untested drug on billions of people for a cold that had a 99.98% survival rate if you were under sixty and a 98% survival rate if you were over 60.
The case fatality rate of COVID worldwide was about 1%. For your numbers to be correct, about half the world's population would have to be over 60. The median age worldwide is, in fact, half that.
The actual survival rate was only 99.7% in people under 29 (15x the fatality rate you claim for people under 60).
From there, it just gets more depressing:
Source: JAMDA [nih.gov]
Your numbers are lies, and you should be ashamed of yourself for repeating them.
Absolute bollocks (Score: 5, Informative)
by Wdi ( 142463 ) on Wednesday February 11, 2026 @08:41AM (#65982124)
First, phase 3 studies are by definition not safety studies, but efficacy studies on a large number of test subjects. Safety studies are phase 1.
Second, ethics guidelines stipulate that you must provide state of the art care for those subjects which do not get the new vaccine, with very tight exceptions. For flu shots, it means that everyone gets a shot, either with a traditional vaccine or the new one, since it is universally accepted outside the new FDA that a classical shot is better than placebo.
And of course you can compare the outcomes. Comparing the new vaccine to an established one wrt efficacy and side effects is actually more informative than comparing against placebo.
Re:Idiocy (Score: 5, Insightful)
by Gilgaron ( 575091 ) on Wednesday February 11, 2026 @08:45AM (#65982140)
It is often more ethical to design a study where you compare efficacy to a known efficacious solution and see if there's a benefit, because you don't need an untreated group. Especially for dangerous pathogens. It's also normally done for combination treatments where comparing to baseline is pointless, you want to see if two treatments together is more effective than one. I have not figured out the ringwing obsession with double blind placebo trials, I can only figure it is because that's what they go over first in elementary school science for the scientific method. It is like making the cabinet installer learn forestry and milling before learning how to install high end cabinets, then starting over with plywood production forestry and lamination techniques before installing mid grade cabinets. It's a bunch of extra expense, risk, and work for no tangible benefit. The administration is also putting pressure on animal models, which is the ethical way to do placebo studies, the whole MAHA approach to infectious disease is fraught.