FDA Reverses Decision and Agrees To Review Moderna's Flu Vaccine (nytimes.com)
- Reference: 0180822078
- News link: https://science.slashdot.org/story/26/02/18/1423207/fda-reverses-decision-and-agrees-to-review-modernas-flu-vaccine
- Source link: https://www.nytimes.com/2026/02/18/health/fda-moderna-flu-vaccine-mrna.html
> Last week, the agency [2]rejected Moderna's application for review of a new flu vaccine, saying the company's research design was flawed. But in subsequent discussions the company said that the agency had relented and agreed to begin a review.
>
> Moderna said it split its application for the flu vaccine based on age, seeking a traditional approval for people 50 to 64 years old, and accelerated approval for those 65 and older. The company also said it agreed to conduct an additional study among those 65 and older once the vaccine reached the market. Moderna said on Wednesday that the F.D.A. set a deadline of August to decide whether to approve the vaccine. If it is authorized, it would be available for those older adults in the flu season that begins later this year.
>
> The vaccine uses messenger RNA technology, which Health Secretary Robert F. Kennedy Jr. has repeatedly criticized as unsafe and ineffective. The mRNA approach, which instructs the body to produce a fragment of a virus that sets off an immune response, was widely successful in Covid vaccines and is considered generally safe by public health experts and scientists.
[1] https://www.nytimes.com/2026/02/18/health/fda-moderna-flu-vaccine-mrna.html
[2] https://science.slashdot.org/story/26/02/11/1219230/moderna-says-fda-refuses-to-review-its-application-for-experimental-flu-shot
Somebody threatened a lawsuit... (Score:2)
And they would have won. And the damages could have been extreme.
Re:Somebody threatened a lawsuit... (Score:5, Informative)
The damages have already happened. The major vax producers have announced cuts to the mRNA research and are going close a few facilities and going to lay off some workers. Exactly as those intellectual midgets, RFK and the anti-vaxxers and the Maggots intended. Now they are trying to eat their cake and everyone else's too.
mRNA is the most exciting of the vaccine technologies. They were working on anti-cancer vaccines, and those were mRNA as well.
To the pearl clutching anti-vaxxers and Maggots who got their dainty little panties in a twist by hearing mRNA and thinking DNA, mRNA is not taken up by cells to produce DNA. mRNA codes for amino acids, not DNA. You are pissing up the wrong tree, dolts. Learn how those vaccines (and DNA and RNA and mRNA) work before you lose what's left of your reasoning capabilities. Here's a helpful wiki so you have no excuse to wallow in ignorance any longer:
[1]https://en.wikipedia.org/wiki/... [wikipedia.org]
[1] https://en.wikipedia.org/wiki/Messenger_RNA
Re: (Score:2)
That doesn't really have anything to do with mRNA vaccines in general
Re: (Score:2)
"Damages" not "damage". I do agree on the damage.
Re: (Score:1)
Hi, you are a fucking idiot.
Re: (Score:2)
The check must have cleared.
"I snorted coke off of toilet seats." (Score:5, Insightful)
"Also, vaccines are unsafe and cause autism."
I'm assuming we're days away from, "Just have your kids snort coke off of toilet seats. Look what it's done for me!"
Re: (Score:2)
There does not seem to be a moderation for sad but too likely true.
Re: (Score:2)
Wait until you find out what the coca in coca cola was.
Just think 100 years ago there were kids running to the local soda fountain to get their hit of Colombian Nose Powder and no one cared. This is why most soda fountains were in drug stores. They were dispensing cocaine.
85 years ago your grandparents (or now great grandparents) were running around Europe killing NAZIs and blasted out of their minds on Pervitin... YES IT IS CRYSTAL METHAMPHETAMINE! How did you guess?
Got a cold? Great! I have just the
Re: (Score:2)
> Wait until you find out what the coca in coca cola was.
> Just think 100 years ago there were kids running to the local soda fountain to get their hit of Colombian Nose Powder and no one cared. This is why most soda fountains were in drug stores. They were dispensing cocaine.
> 85 years ago your grandparents (or now great grandparents) were running around Europe killing NAZIs and blasted out of their minds on Pervitin... YES IT IS CRYSTAL METHAMPHETAMINE! How did you guess?
> Got a cold? Great! I have just the decongestant for you! It's orally administered heroin! Made by Eli Lilly Co. They even had coupons during cold and flu season to get your heroin at a discount!
Some snake-oils were actually a blend of coke, heroin, and alcohol. And people today claim they had no effect whatsoever.
Re: (Score:2)
Coca Cola was a century ago. We're talking about the admitted longtime heroin junkie in charge of the FDA.
Re: (Score:2)
> Yeah, but from a toilet seat?
That Coke (TM) cost extra.
Re: (Score:2)
Have you watched his new video with Kid Rock? They're exercising shirtless in a sauna and then drinking milk in a hot tub.
[1]https://www.the-independent.co... [the-independent.com]
Looks kinda gay honestly.
[1] https://www.the-independent.com/news/world/americas/us-politics/rfk-jr-kid-rock-workout-video-reactions-b2922439.html
Re: (Score:2)
> Have you watched his new video with Kid Rock? They're exercising shirtless in a sauna and then drinking milk in a hot tub.
> [1]https://www.the-independent.co... [the-independent.com]
> Looks kinda gay honestly.
Kid Rock is the wanna-be rock version of Kanye. I haven't been able to stand that dude since I was aware of his existence. He keeps proclaiming himself the savior of various forms of rock, all of which are whatever form is the most popular at the time. Him and Corey Feldman should just start a shitty bar band and stay off the national stage for good.
[1] https://www.the-independent.com/news/world/americas/us-politics/rfk-jr-kid-rock-workout-video-reactions-b2922439.html
Re: (Score:2)
This was his childhood home [1]https://tasteofcountry.com/kid... [tasteofcountry.com]
He likes to cosplay as trailer trash because it pays the bills. Another grifter.
[1] https://tasteofcountry.com/kid-rock-childhood-home-pictures/
Re: (Score:2)
> There is no safety or cost reason to prefer this over normal analog protein vaccines. Only advantage MRNA has is reduced up front capex.
Well, good thing capex doesn't matter because we don't use capitalism
Re: (Score:2)
mRNA research is decades old now. Only during the pandemic did it get additional funding and resources to be viable. You probably do more damage to your body via ionizing radiation in a passenger jet than from this vaccine.
Re: (Score:2)
> mRNA research is decades old now.
What is the relevance of this statement? What is it responsive to?
> Only during the pandemic did it get additional funding and resources to be viable. You probably do more damage to your body via ionizing radiation in a passenger jet than from this vaccine.
Speaking for myself if I could select flights on a passenger jet that didn't damage ones "body via ionizing radiation" and those flights were otherwise the same except cheaper I wouldn't fly on the damaging flight either.
There is an irreducible problem with mRNA vaccines whereby LNPs may enter any cell in the body and cause damage and inflammation from vaccine induced cell death / immune response that would not be the case with other approac
Re: (Score:3)
> "There is no safety or cost reason to prefer this over normal analog protein vaccines. Only advantage MRNA has is reduced up front capex."
Nice attempt at shaping the discussion to flow down the limited paths you prefer. In reality world the gigantic advantages of having straightforward yearly influenza vaccines be mRNA-based is that (1) after enough experience it would become possible to reformulate the vaccine midseason if the dominant flu strain changes (2) if a 1918 Kansas Flu boils up out of a giant p
Re: (Score:2)
> The one decision I agreed with worm brain on ... There is no safety or cost reason to prefer this over normal analog protein vaccines
If you weren't a worm-brain you'd realize you're arguing for approval, because it's not the FDA's job to decide which drugs are preferable for obtuse reasons. It's their job to evaluate them for safety and effectiveness. If it's equally effective and equally safe, then it's up to doctors to choose which to prescribe.
Re: (Score:2)
And fail. What mRNA allows is adding in the COVID vaccine. And any future bird/swine/whatever flu mRNA vaccine. And it gives better reaction time, which is pretty critical to a flu vaccine. This is a massive qualitative improvement.
Please get better information.
Re: (Score:3)
Additionally separates flu vaccine manufacture from relying on eggs, which is a bad dependency for whenever we get a pandemic bird flu.
Morons in charge! (Score:5, Insightful)
This kind of cassette loaded methodology for the production of vaccines, may be one of the grater medical advances of the century. And the "brilliant" zeros of the tRump administration have decided to trip it up at every opportunity. Shame, shame, shame on the thirty-nine percenters who back this garbage no matter what!
Re: (Score:2)
You're right, it's the idiots in charge.
As it says, public health experts and scientists do believe mRNA can work fine but it's just these people that have been laid off and idiots like the Orange One and RFK have taken over.
Luckily they are (yet) to cross the oceans.
Re: (Score:1)
Monoclonal antibodies is so much more effective and direct than this roundabout mRNA nonsense, THAT is what they should be pursuing. Looking at public documents about what they're spending on, it sure and hell isn't mRNA research anymore. My immune system is too damn slow. I want to spit in a machine, have it find out what the pathogen is, make an antibody, clone it, inject it, and kill all the pathogens without harming any other tissue. It was miracle cure level for COVID and needs to be pursued because I
Re: (Score:2)
> Monoclonal antibodies is so much more effective and direct than this roundabout mRNA nonsense
And yet we just went through a pandemic which proved the exact opposite. Maybe one day we can find the cure for people who have huffed too much lead as a baby and you'll come around to the side of logic.
No reason against mRNA (Score:5, Informative)
I cannot see any reason why anyone with the slightest understanding how vaccines work would consider the mRNA part of mRNA vaccines to be dangerous.
An mRNA vaccine is injected in your body, and tells your body to produce something as close as possible to the real virus, but not causing damage. After one day, the mRNA vaccine itself dies. It disappean from your body with no trace at all. Claims that they would cause changes to your DNA are pure nonsense. Claims that they would cause autism are pure nonsense. The mRNA vaccine does nothing but convince your body to produce something similar to the virus for one day.
The advantage of mRNA vaccines is that when a new vaccine is needed, 90% of the work is already done, and has been tested in real life by hundreds of millions of people. All that needs doing is to "program" it to produce a possibly modified virus, which is about six weeks of work. It can also be programmed to produce multiple different viruses, so one mRNA vaccine can protect against multiple flu variants, or multiple flu variants and the latest Covid variant. Six weeks is much faster than what we have now, where we wait for the flu season in Australia and hope we get the same flu six months later in the northern hemisphere.
Re: (Score:3)
> I cannot see any reason why anyone with the slightest understanding how vaccines work would consider the mRNA part of mRNA vaccines to be dangerous.
I see the problem. "You cannot reason a person out of a position they did not reason themself into in the first place." Well, the "anyone with the slightest understanding" part is a problem too.
When you've decided that Fear, Uncertainty and Doubt are your logic, you become the perfect servant of grifters.
Re: (Score:2)
> It disappean from your body with no trace at all.
If even Jar-jar can understand mRNA vaccines, maybe there's somebody out there who can explain to Wormdome?
Re: (Score:2)
> I cannot see any reason why anyone with the slightest understanding how vaccines work would consider the mRNA part of mRNA vaccines to be dangerous.
You have it all there already: The anti-vaxx idiots not understand how vaccines work and they understand mRNA even less. They also have zero clue about risk management.
I always find it hilarious that the direct lie about autism from vaccines was not even anti-vaxx. It was specifically against one vaccine to promote another one. But for the anti-vaxxers, that is already a far too complex idea and far outside of their level of understanding.
Re: (Score:1)
Because every time your body produces a protein, there is a danger there. That is how mutations and various disorders start. There's a big difference between human cell division and tricking your cell into making a protein that resembles a virus but compare that to the traditional method. They make a virus via normal replication, disable it, then inject it. Your body sees the surface proteins and makes antibodies them remembers that protein sequence. Simple, effective, safer because the virus makes viruses,
Re: (Score:2)
One thing I never saw was confirmation that your body ever stopped creating the proteins after any period of time. If it doesn't your immune system reacting to something your body is producing is an auto immune disorder.
Being able to design new proteins in short periods of time is great. But why does that need to occur in the human body itself? Doesn't the current flu vaccine get produced in something like eggs? Couldn't bacteria or something be reprogrammed with the mRNA and then the protein that is produc
Re: No reason against mRNA (Score:2)
Iâ(TM)m for the mRNA vaccines, but have a question about a statement you make. âoeAfter one day, the mRNA vaccine itself dies.â
First, this implies the mRNA is alive. I find that worrisome if it is. Second, how do we know that it is âdeadâ(TM) or inactive after a day? Is that itâ(TM)s half life or is there something that hard limits it to about one day? If itâ(TM)s âliveâ(TM) in the vial for weeks before administering it, what changes to make it go kaput. I woul
So this is actually been studied (Score:2)
And it's one of the few social studies that is repeatable.
Basically the universe is really chaotic and bad things happen for no reason.
In a universe like that you need to feel like you have some agency and that you can understand the decisions you are making and that those decisions will have a positive outcome for you and your family.
As a result people do not like relying on experts because you're basically forced to give in to chaos when you do that. Because you have had to acknowledge that yo
Re:Letting apes... (Score:4, Informative)
mRNA vaccines can't permanently alter your DNA. They instruct your cells to make proteins and that's all. Even this [1]US government website [genome.gov] admits that.
[1] https://www.genome.gov/about-genomics/fact-sheets/Understanding-COVID-19-mRNA-Vaccines
Re: (Score:3)
> Would you get on a plane that only had 6 months on the draft table?
No, but I would get on a plane where the frame, fuselage, engines, control systems, and electronics had been studied and deployed for years, and the avionics software was being upgraded after a 6 months review. Nice strawman disguised as an analogy though!
Re: Letting apes... (Score:2)
Someone who clearly has NOT done any research into mRNA, what it is, what it does, and how much your body produces all the time.
Open a biology book, not Facebook.
Re: (Score:2)
> Open a biology book, not Facebook.
Great :)
Now tell the FDA leaders.
Re: (Score:2)
Make sure not to eat any nucleic acids in your diet, they may reprogram those cells of yours.
Re: (Score:2)
Sure just make sure you don't get too close to anyone without a respiratory mask or you'll get all the affects you're nervous about. You're necessarily at less risk transcribing one viral protein vs the whole set. But here I ate an entire apple so from parents' posts understanding of RNA I am as good as dead already.
How much did moderna (Score:1)
Have to pay the FDA to get them to change their mind?
Re: (Score:2)
A gold-plated trinket called the "Moderna Peace Prize" did the trick.
Trump probably stepped in (Score:2)
After all, he did get life saving Covid-19 treatment at a military facility in his first term. Maybe someone gave him a reminder.
What?! (Score:1)
We'll study it further to see if it's dangerous once it reaches the market? But it's fine because we're testing it on old people so if there's a long term bad effect, they'll die anyway. WHAT? Gee, I wonder why the FDA took issue with that.
Trans panic is winding down (Score:2)
Moral panics can't last forever because sooner or later people figure out that the scary thing you were told about didn't happen.
So nobody cut your son's dick off and he doesn't think he's a girl because rapid onset gender dysphoria isn't real and also women's sports have not been destroyed and you still don't care about them.
Now the right wing does not have any viable economic solutions for the problems you face. Just more trickle down economics repackaged yet again.
So they have to offer an alt
Re: TACO (Score:1)
Em.... what?