Moderna Says FDA Refuses To Review Its Application for Experimental Flu Shot (cnbc.com)
- Reference: 0180770272
- News link: https://science.slashdot.org/story/26/02/11/1219230/moderna-says-fda-refuses-to-review-its-application-for-experimental-flu-shot
- Source link: https://www.cnbc.com/2026/02/10/moderna-fda-flu-shot.html
> The Food and Drug Administration has [1]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."
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> 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.
[1] https://www.cnbc.com/2026/02/10/moderna-fda-flu-shot.html
I hope the rest of the world is large enough (Score:5, Insightful)
To make this still a success. Irrationality is not everywhere in power. And a better flu shot is overdue.
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Mexico, please provide medical assistance to US. at least to its citizens who long for the days when we believed in science.
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" We know what runs that country. " Yup, those are the cartels importing guns from America.
USA is 75% of the market - rest not enough (Score:1)
Americans are 5% of the worlds population but pay for 75% of the commercialization of new drugs and procedures. As much as the rest of the world criticizes US healthcare we are fine leaching off it and accepting the new drugs it produces. In fact of the remaining 25% of bringing new stuff to market the Bill and Melinda Gates foundation has been responsible for some of it. They don't spend a lot in global terms but they are very effective in what they do spend on.
Re: USA is 75% of the market - rest not enough (Score:2)
The gates foundation, which is no longer the bill and Melinda Gates foundation since she had her name taken off of it for Bill-gave-her-an-STD-from-Epstein-Island (or perhaps ranch) reasons, is very effective at making Bill Gates rich again. And isn't that what philanthropy is all about?
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Source?
(note: Truth Social is not a source)
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It's not about paying for the commercialization. It's about making a huge profit by selling in the US.
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> Americans are 5% of the worlds population but pay for 75% of the commercialization of new drugs and procedures.
Americans are 15% of the world's GDP and account for 64-78% of [1]pharmaceutical profits [maplevalleyrx.com]. The US has about 75% of pharmaceutical venture capital as well, but again it's wrong to equate venture capital with "commercialization of new drugs and procedures". There's a lot of VC simply because the US healthcare system is so extractive; that doesn't give you a distinction between people doing useful stuf
[1] https://www.maplevalleyrx.com/the-global-impact-of-the-american-pharmaceutical-industry.html
Anti-Vax attitudes will get people killed (Score:5, Insightful)
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)
> Anti-Vax attitudes have gotten people killed
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Excessive "group-think" type stupidity always gets people killed. The sad fact is that these are often not part of the stupid. We have way too many malicious people in the human race.
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It also matters to babies who have brain-dead parents who will gladly expose them to measles, polio, etc. just so they can remain pure anti-vaxxers. And to teenagers with respect to the HPV vaccine, there the problem is the anti-vaxxers and the Christian nutjobs; the latter think that if their kid gets the HPV vaccine, they will turn into sex-crazed maniacs. They figure if kids are scared of HPV, then they stop screwing. Hint: it won't.
Re: Why I NO LONGER trust "vaccines". DEATH JABS. (Score:2)
Never attribute to idiocy that which is best explained by being a propaganda bot
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> Never attribute to idiocy that which is best explained by being a propaganda bot
I also wondered if Eadon-com was mocking the standard ant-whatever diatribe people.
Then I looked at his posting history which includes his calling us "brain-washed wankers". That's not true. I know why I'm a wanker.
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Look at his (?) other posts, he/she/it is serious.
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The biggest lie in your post is when you said you could read.
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No. You were banned from spreading lies. There is a difference, even if you are clearly far too deep in delusion to be able to understand that. Or you are just a fundamentally corrupt and deeply malicious person. Would not rule that out.
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"pureblood" So, you support Voldemort? Also, all your food has been genetically modified. What do you think selective breeding is?
You: Doctor, Doctor, help me, I cannot stop dancing.
Doctor: Hmmm.....I see. You have Watusi disease.
You: Doctor, Doctor, is there a cure?
Doctor: Yup, I have a mRNA vaccine for that.
You: Doctor, Doctor, I won't take no stinking mRNA vaccine. I only want a real vaccine.
Doctor: mRNA is a real vaccine, we've been testing it since Bush Jr. started funding it, although it had prior fun
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Selective breeding is not GMO/vice versa because GMO techniques allow ends which cannot occur in nature, and also because we create these modified organisms and then ensure their success with external means — where if nature somehow did somehow impossibly produce them, they would vanish again anyway because they are designed for conditions which do not exist naturally.
I'm with you on the rest of what you said, and things aren't inherently bad because they're GMO either, but that doesn't make GMO and s
Re:humiliation for the US (Score:2)
We'll spend a century claiming we are Canadian when we travel abroad. At least we got practice under "Ireq" Bush.
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Note that bill C-3 in Canada back in December 2025 changed how birthright citizenship works, and quite a few people who were pretending might not need to pretend anymore.
purebloods (Score:4, Informative)
And it seems we have these to avoid.
[1]https://www.dailykos.com/stori... [dailykos.com]
[1] https://www.dailykos.com/stories/2021/9/21/2053575/-Unvaccinated-TikTokers-embrace-eugenicist-fascism-of-Potter-fantasy-by-identifying-as-pureblood
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And in actual reality, no actual expert ever claimed it would "prevent" the spreading. Because that is not how things work. It is about slowing things down and reducing the death toll, and not just by a bit.
You are a clueless asshole. Please shut up before you get more people killed.
Absolute bollocks (Score:5, Informative)
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: Absolute bollocks (Score:2)
Ssssh the laypeople may hear you and have to confront their own ignorant bullshit. That will make them feel bad about their intelligence and themselves and we canâ(TM)t have our snowflakes melting under a little heat and pressure.
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> That will make them feel bad about their intelligence and themselves
That reaction requires activation of the "introspection" gene, of which most ignorant people lack.
Re:Idiocy (Score:5, Insightful)
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.
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It isn't forestry that we want the cabinetmaker to learn, it is that we don't want them to stack their errors.
Imagine if the cabinetmaker made the first cabinet they built against the blueprints, but then they built each successive cabinet against the previous one instead of the blueprint. With each generation, the errors stack up and before long, your cabinets look like something Dr. Seuss would draw.
How badly have the errors stacked up in this case? We have no idea. We haven't done actual placebo trial
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Wrong, doing a placebo trial is flat out unethical, because it means you need to deliberately infect someone with something that can be lethal and give them NOTHING to deal with it. No one will do a placebo trial for vaccines, they would lose their medical license and any company who did it would sued into oblivion. What you are proposing is the realm of literal evil medical experimentation, like the Tuskagee experiment evil.
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Others have pointed out the ethical reasons we don't do what you're asking.
The tests we currently do are "is this more effective than what we had before?"
It's literally the opposite of the scenario you're describing. We know that the starting point isn't perfect. We're taking some steps to improve it and then testing to ensure that it really is better than the previous one. And then we repeat.
We're starting with a flawed but usable cabinet, and making it a little bit better with each iteration.
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You're not stacking up errors here. To translate your carpentry example into proper math, let the cabinet's origin be located at point A, the first pin at point B, and the second pin at point C. You state that measuring (C-A) has less error than measuring ((B-A) + (C-B)), which is true. (Although by the way, your comment about randomly distributed errors is completely wrong...randomly distributed errors still accumulate, just typically increasing by the square root of the number of operations).
But nobody
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Imagine if someone wanted to test a new material for use in safety glasses. Instead of comparing it to the current state of the art, they decided to give the control group of cabinetmakers safety glasses that are known to offer no protection to see how many of them lose an eye.
Seems irresponsible, right?
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It'd stack the errors if you only referred to the previous studies, but you use the old/baseline product as one of the experimental groups in your new study. So Group A gets traditional flu vaccine, Group B gets mRNA, maybe Group C gets both to see if that's better or worse (can be either depending on the details!) But no, there are blank placebos given in /animal/ model experiments when defining the disease model. You don't need that data from humans and shouldn't want to do a controlled study in humans
RFK Jr's own words (Score:5, Insightful)
I don't want to seem like I'm being evasive, but I don't think people should be taking medical advice from me." [1]https://www.cbsnews.com/news/r... [cbsnews.com]
Imagine the headlines if Obama appointed a longtime heroin junkie to run the FDA. [2]https://www.pbs.org/newshour/h... [pbs.org]
[1] https://www.cbsnews.com/news/rfk-jr-medical-advice-vaccine-question-hearing/
[2] https://www.pbs.org/newshour/health/recounting-heroin-addiction-and-spiritual-awakening-rfk-jr-urges-focus-on-prevention-and-community
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Moderna just need to make a larger "facilitation payment". The anti-vax thing is just a way for them to extract a bit more money from the pharma industry.
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While that's probably true for Trump ... For JFK Jr and the bulk of anti-vaxers, not so much. They really seem to believe everything they're fed through their "trusted" channels. And they think everyone else are the brainwashed ... by that science bogeyman.
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There's no way to know what R FK Jr actually thinks. Believing that anything he says has any relation to his personal beliefs is naive at best.
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Again, I would agree if your were talking about Trump. He changes his mind every day.
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Fuck off
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What makes this flu vaccine bad but the dozens of vaccines you've received over the years good? Is it scary mRNA? That was discovered in the 1960s and has been researched ever since. [1]https://pmc.ncbi.nlm.nih.gov/a... [nih.gov]
[1] https://pmc.ncbi.nlm.nih.gov/articles/PMC8483746/
The Republican party will destroy the economy (Score:1, Troll)
And you're savings and your 401K with it.
They know this and you know this and everybody knows this. We all know that the Republican party is bad for the economy if you work for a living. The only people who come out ahead during a republican administration are a handful of people to just own shit for a living. You have to own a lot of shit to come out ahead.
Why do I bring this up? Because this anti-vax bullshit is what they are offering voters in exchange for destroying the economy and your savings
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That post belongs in a Bitcoin debate, not here.
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The Bitcoin guys were screwed either way. The Democrats in charge would have regulated the money laundering and Bitcoin would have crashed because of that. The Republicans crashing the wider economy had the same result for a different reason.
Here are the reason it matters is because the reason we are getting a push against vaccines from the mainstream Republican party is because they don't have any ideas that can help the economy or your pocketbook.
But they need to give voters a reason to vote for t
Time to relocate (Score:2)
If your profits depend on activities that are not politically acceptable, you can relocate to a less insanely self-destructively stupid country.
Sure, it'll hurt financially to move, but not as much as trying to continue operating in a political environment that wants you out of business.
Synthetic mRNA problems (Score:2)
[1]Synthetic mRNA problems [youtube.com]:
“Now, in this next uh group of graphics from ARY, we're going to look at the modified ribboucleic acid and how it's been changed and the harmful effects that this can potentially have. So, here we see a strand of RNA, the ribboucleic acid. But the problem is it's not riboucleic acid. It's modified ribboucleic acid. It's been modified to avoid the immune system and to last much longer.”
[1] https://www.youtube.com/watch?v=fAl-ghlnx3g
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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:2)
they gave my buddy water and he died that night.
morbid jokes appart, its not like the COVID vaccines were without hiccups.. or the flu vaccines before that. these are company who's goal is making money, not, save humanity. science is not, in fact, a product.
TFA has zero real information about why it's been refused - so its FUD in all directions.
it turns out - very few humans are able to have a real sense of criticism.
Re:mRNA is dangerous (Score:5, Funny)
You were lucky! My head fell off
Re:mRNA is dangerous (Score:5, Insightful)
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, Insightful)
What he is mocking is bullshit, and it should be mocked. And so should cowards.
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Think that's bad, I ended up with Gavino's head!
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It turned me into a newt!
....
I got better.
You should read the vaers database (Score:1, Troll)
There is a report that following vaccination with mRNA someone had their skin turned green, they experienced rapid uncontrolled muscle growth and heightened aggression. And that's before we get into all the reports of turbo penis...
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I remember seeing a multi-part documentary about that guy.
Re:mRNA is dangerous (Score:4, Insightful)
Such a pity modern medicine gave you a chance to survive, without it we'd be without you and with an improved gene pool.
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You probably confuse mRNA with the Astra Zeneca vaccine, of which heart muscle inflammation was in some cases a side effect. (Please check your sources next time you want to be a contrarian).
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Most people who complain about the mRNA vaccine don't know what mRNA is, or often how it is different from DNA.
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My first shot was Astra Zenaca, then the Canadian government banned it due to the heart problems. Second was Moderna.
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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.
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> 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.
In fairness, the OP just said the uncle died. He didn't say the uncle didn't get run over by a bus or fell off a cliff or was forced to watch the Home Shopping Network.
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True. And likely, the people he tries to get with that nonsense would not even notice.
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Did you write that will eating McDonalds and sucking on a Zyn pouch?
Re:mRNA is dangerous (Score:4, Informative)
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.
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"Turbo cancer"
LOL! Hey everybody! Iit's the turbo cancer guy again!
I'd have figured you'd come up with some appropriately pseudosciency name for your bullshit by now, but you're sticking with "turbo cancer."
Imma coin the term "I have no idea what I'm talking about but I feel very strongly about it cancer" just for you.
Re: mRNA is dangerous (Score:2)
Yes, rando crackpot on the internet. Iâ(TM)ll gladly set aside my 10 years of clinical trial experience and advanced STEM degrees in favor of your blogpost!
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We should ban ice cream because ice cream sales are correlated with higher crime stats.
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Was your uncle hit by a bus? Because this really begs for the kind of a punchline.
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My grandfather died the day after I set up snapshotting on my filesystem. Never again will I set up snapshotting on my filesystem.
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I had a stroke several weeks after an mRNA vaccine (not kidding). Of course, my high blood pressure, high cholesterol and inactivity couldn't be factors. Nope, it was the mRNA.
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my friend got the covid shot and then 2 years later bam, herpes