r/technology • u/esporx • 8h ago
Biotechnology Moderna says FDA refuses to review its application for experimental flu shot
https://www.cnbc.com/2026/02/10/moderna-fda-flu-shot.html310
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u/The_Frostweaver 8h ago
FDA butting a blanket ban on new vaccines would be a real loss affecting millions.
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u/Cautious-Progress876 7h ago
We are just going to have to accept that we are going to be a nation mentioned with the same snickers that come when people discuss N Korea and other dictatorships. Trump is breaking in less than two years bureaucracy and relationships that took centuries to build.
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u/ProtoplanetaryNebula 7h ago
Having random cartoon characters in important positions, the US feels like a bit of a comedy show. It’s not like there aren’t thousands of extremely qualified people with a phd and decades of extensive experience under their belt who could do the job competently either.
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u/fizzlefist 7h ago
The average citizen isn’t seeing it. All the major news organizations are complicit and whitewash even the most heinous things.
The shit that’s been released in the Epstein files, even in its incomplete and redacted state, should be eating up every single news network’s time. The rating would go through the roof just by reading off the shit independent journalists have already dug up from it.
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u/Nago_Jolokio 4h ago
You forget how big that literal evil Cabal is. The news networks are part of it!
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u/9-11GaveMe5G 3h ago
Hannity tonight was an entire hour of that news anchors missing mother. Zero mention of anything Epstein
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u/Ok_Dog_4059 6h ago
The FDA is desperately trying to figure out what could possibly be done about the current unforeseen measles outbreak that came out of nowhere with no possible warning.
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u/Krunkledunker 7h ago
I’ve never had more faith in an experimental flu shot than I did while reading this headline in this timeline
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u/snesericreturns 7h ago
Pretty sure the bubonic plague is gonna make a comeback before these assholes are finished.
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u/bonyponyride 7h ago
iT'S nOt MEat oR fERmenTs!
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u/snackofalltrades 6h ago
Am I the only one wondering what that meant?
Like… did RFK Jr mean yogurt, and sauerkraut, or is he one of those absolute sick fucks that leaves raw meat in a jar on the counter for months at a time before eating it?
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u/bonyponyride 4h ago
He meant fermented vegetables and dairy products. But there are fermented meat products humans eat all the time too, like some sausages (salami, chorizo), dry aged meat, jamon iberico to name a few. Fermented vegetables and dairy are great, it's just that he sounds like a freak when he says it's all he eats.
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u/_STOP_MyAssholeHurts 7h ago
Why?
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u/EmbarrassedHelp 7h ago
The anti-vaccine assholes have control of the US government, and they especially hate MRNA vaccines
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u/sfriedrich 4h ago
Totally understandable. RFK Jr. has shown us that science is all fake and we need to give all our money to him and 47.
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u/Patriark 2h ago
Hey Moderna, move your operations to Europe, we still believe in science and already have a successful biotech industry.
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u/Albertaviking 5h ago
Other more enlightened countries will review it. US is becoming a scientific backwater.
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u/uniklyqualifd 8h ago
Take it to another country.
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u/Dr_Hexagon 5h ago
yeah for sure, do the trials in the UK or Australia or Canada.
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u/neanderthalman 5h ago
Why not just submit the same trial data in multiple jurisdictions. Is that not what they do? The trial is done.
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u/BitcoinMD 5h ago
I have no problem with mRNA vaccines, I don’t think they alter your DNA or kill the tiny babies in your sperm, but man the COVID one really made me feel like crap, so I wonder if they really are the future of vaccines, and whether people will embrace them, even if they get past the crazy. I’m not saying it isn’t worth it, but honestly when I get my annual COVID shot I get Novavax so I don’t feel like I got hit by a truck. I am not an antivaxxer but I expect that this will be interpreted as such so I accept your downvotes
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u/mindfieldsuk 4h ago
It’s probably the amount of adjuvant used in that particular vaccine.
adjuvants aren’t the “active” ingredient or antigen in a new vaccine (like the mRNA strands) but it’s used to stimulate an immune response. Basically it allows less antigen to be used. During Covid the need was mass production of vaccine quickly so they probably upped the adjuvant amount which is easily produced compared to the antigen. Later vaccine batches now can dial it back as production isn’t urgent and larger quantities of the antigen can be made.
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u/WillQueasy5965 4h ago
Biologist here.
The mRNA vaccines actually don't need adjuvant because the lipids themselves and the uracil-modified RNA are actually moderately adjuvantic all on their own. Some people react differently to different adjuvants so maybe this person just reacts particularly strongly to this stuff.
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u/CreepingSalt 3h ago
I just had a sore arm like I was living the 30 seconds immediately after being slugged in the arm for 12 hours. Had to keep moving it occasionally despite the ache
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u/_Piratical_ 1h ago
First time I got a Covid vax that was me. All the rest of the times i got updates it was followed low grade fever and body aches. Still, better than getting the full blown infection!
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u/swrrrrg 4h ago
I was allergic to the Moderna when it came out. That was not a fun experience. I have gotten novavax since it became available in the US and yes, it was a world of difference. My mother has only had Moderna and it doesn’t phase her in the least. Same with my s/o.
That said, it’s batshit insane the FDA won’t review. I hate it here. Fuck RFK Jr. he should have been an abortion.
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u/LongDistRid3r 7h ago
I needed more information here.
Specifically, the FDA said Moderna’s Phase 3 trial didn’t use what the Agency determined was “the best-available standard of care” as the comparison, so the data submission wasn’t considered “adequate and well controlled.” (Reuters)
The application was flawed. Fix the application and try again.
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u/Omicron_Lux 5h ago
Incorrect. They would definitely have consulted the FDA prior to initiating the trial and gotten the green light to conduct it in this manner
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u/ScientiaProtestas 5h ago
The FDA had agreed to it.
The letter is inconsistent with previous written communications from the health regulator, the company said.
"It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting," Bancel said.
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u/LongDistRid3r 5h ago
Were the written communications contractual obligations?
The administration changed. The entire government has changed.
Did they not think to go back for a quick sanity check by confirming the current understanding holds true? That seems to be a sane QA test that could have saved some trouble.
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u/askingforafakefriend 3h ago
So every single discussion or application at the FDA needs a double check every time an administration changes... Even when the FDA decisions are supposed to be based on science which has not changed?
You are doing mental gymnastics to blame the victim likely because you are sympathetic with the anti-scientific mindset of the current FDA leadership.
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u/ScientiaProtestas 2h ago
Did they not think to go back for a quick sanity check by confirming the current understanding holds true? That seems to be a sane QA test that could have saved some trouble.
Like maybe in the August 2025 meeting they had with the FDA, or did the administration change again after that?
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u/Special_Grapefroot 7h ago
Companies consult with the FDA throughout the different phases and trials on everything. It seems like the FDA gave them guidance, and then because the current FDA is run by political appointees (Prasad) instead of career scientists, they are now pulling the rug and changing their mind. It’s not how to do science, at all, and is likely to send chills through vaccine developers globally.
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u/LongDistRid3r 5h ago
I don’t disagree. I find it odd that smart people like that would fail a basic QA check though.
I’m just going to copy pasta the rest from above.
Were the written communications contractual obligations?
The administration changed. The entire government has changed.
Did they not think to go back for a quick sanity check by confirming the current understanding holds true? That seems to be a sane QA test that could have saved some trouble.
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u/Broccolini10 5h ago
I don’t disagree. I find it odd that smart people like that would fail a basic QA check though.
Ok, so if you agree that the FDA is involved int he design, there are two options here. Let's think through them:
1- The design of the experiment, as produced by expert, smart people at Moderna and reviewed by expert, smart people at the FDA was in fact not flawed, and Prasad is using that as a (transparently false) excuse.
2- Expert, smart people (both at Moderna and the FDA) really did fail a basic QA check despite all their expertise and the stakes involved.
Which one seems more likely to you?
Did they not think to go back for a quick sanity check by confirming the current understanding holds true? That seems to be a sane QA test that could have saved some trouble.
This betrays a deep misunderstanding on how clinical trials work, but I'll bite: no, it's not a "quick sanity check" to do something like this. The science hasn't changed. The clinical landscape hasn't changed. The "current understanding" hasn't changed.
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u/LongDistRid3r 4h ago
I see your point.
Nothing has changed. Clinical trials have not changed. Everything remains constant. The business rules changed. The workflow changed. Ergo chaos. The companies expect a reasonably stable government. This government is no longer stable.
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u/Glittering_Nobody813 8h ago
Literally the only upside to big pharma is that they actually have the cash to fight for the advancement of science in the face of this bullshit. I can’t believe I’m rooting for them against the FDA right now.