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Moderna says FDA refusing to review application for its first mRNA-based flu shot
Posted on 2/11/26 at 8:56 am
Posted on 2/11/26 at 8:56 am
21
Posted on 2/11/26 at 8:59 am to Ailsa
Sounds like they just called the Covid shot the "Flu shot" in order to trick people into taking it.
Posted on 2/11/26 at 9:05 am to Ailsa
The agency says Moderna's phase three trial design was off—they compared it to an older standard-dose flu shot instead of the best available option out there, so it doesn't meet their bar for "adequate and well-controlled" data.
If they skipped a crucial step, frick 'em. This isn't the rubber stamp it was prior to Kennedy.
If they skipped a crucial step, frick 'em. This isn't the rubber stamp it was prior to Kennedy.
Posted on 2/11/26 at 9:06 am to Ailsa
This is the Way…
Posted on 2/11/26 at 9:08 am to Ailsa
Many people dont know that vaccines dont go through the same FDA approval process as other therapies.
If they make this therapy go through the regular drug approval process with long term safety data, no emergency use protection and no legal protection and it passes so be it.
But mRNA therapy was not defined as a vaccine until covid and should be treated separately from existing flu and other vaccines that have been on the market for decades even while I believe the vaccine class needs to be rereviewed in a more rigorous way to remove concerns and demonstrate transparency as to what people are treating their children with.
If they make this therapy go through the regular drug approval process with long term safety data, no emergency use protection and no legal protection and it passes so be it.
But mRNA therapy was not defined as a vaccine until covid and should be treated separately from existing flu and other vaccines that have been on the market for decades even while I believe the vaccine class needs to be rereviewed in a more rigorous way to remove concerns and demonstrate transparency as to what people are treating their children with.
Posted on 2/11/26 at 9:09 am to Ailsa
Loading Twitter/X Embed...
If tweet fails to load, click here. Are these idiots ever going to learn? DNA is transcribed to RNA and then translated into proteins. RNA can not be transcribed into DNA without a reverse transcriptase which is not included in these vaccines. Therefore all the laws of biology dictate that mRNA vaccines cannot modify DNA.
Posted on 2/11/26 at 9:09 am to Ailsa
Great, NOW they revert to the accurate term ‘shot’
Took Moderna eight years to get the term correct
Took Moderna eight years to get the term correct
Posted on 2/11/26 at 9:43 am to Ailsa
This is the slippery slope that redefining "vaccine" and "vaccinated" hath wrought. Some of us predicted this in 2020.
Posted on 2/11/26 at 11:03 am to Ailsa
quote:LINK
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.
The OP's X post is misleading. The FDA rejected the application not because there was anything wrong with the mRNA technology, but because Moderna did not set up the trials correctly and did not follow the FDA's advice on how to set up the trials for it. This a f**k up by Moderna and the FDA would reject the application of any new drug if the drug company did not do as advised.
Posted on 2/11/26 at 11:17 am to Ailsa
quote:Good!
FDA refusing to review application for its first mRNA-based flu shot
Not needed. Risk-Benefit does not align.
mRNA is inevitably going to be inferior to traditional existing vaccines.
The advantage of mRNA is it can be deployed 5-10x more quickly in a novel instance than traditional vaccines. That is inapplicable in the case of seasonal flu.
Posted on 2/11/26 at 11:19 am to WeeWee
quote:Even better.
The FDA rejected the application not because there was anything wrong with the mRNA technology, but because Moderna did not set up the trials correctly and did not follow the FDA's advice on how to set up the trials for it. This a f**k up by Moderna and the FDA would reject the application of any new drug if the drug company did not do as advised.
Posted on 2/11/26 at 11:22 am to Ailsa
quote:
mRNA uses aids to bypass your defenses and modifies your DNA to produce the disease so your body can fight it for the rest of your life.
This statement is complete garbage. This is how you know that just about everyone that is active on social media is a friggin idiot.
This is a catastrophically dumb statement. It's a level of ignorance that I can't even begin to articulate.
Posted on 2/11/26 at 11:26 am to WeeWee
quote:No. Learning is not ... wait4it ... in their DNA.
Are these idiots ever going to learn?
Posted on 2/11/26 at 11:30 am to Ailsa
One small battle won for today but the war still rages on.
They will keep trying until one day, it will be approved.
They will keep trying until one day, it will be approved.
Posted on 2/11/26 at 12:01 pm to Ailsa
Pretty sure they’ve harmed enough of the population already
Posted on 2/11/26 at 12:05 pm to WeeWee
quote:
the FDA would reject the application of any new drug if the drug company did not do as advised.
That depends.
Pfizer pays a 2.8 million application fee to the FDA to get their vaccines approved.
Posted on 2/11/26 at 12:07 pm to NC_Tigah
quote:
mRNA is inevitably going to be inferior to traditional existing vaccines.
You sure about that doc?
quote:
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 data showed it was more effective than traditional shots.
quote:
Not needed. Risk-Benefit does not align.
The predominant flu strain so far this flu season has been the subclad K variant. Subclad K appeared after the flu shot for this year went into production and therefore the flu shot for this year is ineffective. This year flu shot would have been a metric shitload more effective if a midseason booster (for lack of a better term) to cover the subclad K variant could be produced and given. The benefits of having a flu shot that actually covered the predominant strain would outweigh the risk (especially since most of the adverse effects of mRNA vaccines were due to the inflammatory and properties of the covid spike protein which would not be present in a influenza vaccine). For example, I have three patients with severe COPD in the hospital right now for post-influenza pneumonia. A flu vaccine or booster that covered subclad K would likely have kept them from getting pneumonia. The speed of production of current flu vaccines does not allow for that to happen. By the time a booster for the predominant variant was produced flu season would be over. The greater speed of production for mRNA vaccines would make producing a midseason booster to cover the predominant variant theoretically possible.
quote:
The advantage of mRNA is it can be deployed 5-10x more quickly in a novel instance than traditional vaccines.
You just contradicted yourself because the flu mutates in such a manner that new variants are able to slip past immunity from the most current vaccine. This year is a perfect example of that.
quote:
That is inapplicable in the case of seasonal flu.
Only because of the regulatory approval time does not currently make a midseason booster viable even with the increased speed of production for mRNA vaccines. Pfzer and Moderna had the ability to produce mRNA boosters for each new variant of covid in a timeframe that would have actually been beneficial against the predominant strain. The covid boosters would have been infinitely more effective if the booster for alpha was approved when alpha was still the predominant strain. Instead the current regulatory approval process slowed the production and distribution of the booster so much that we giving out boosters for the omicron variant months after Mu became the predominant strain which kind of made getting a covid booster against omicron pointless. Of course changing the approval process is a whole new can of worms to open.
This post was edited on 2/11/26 at 12:15 pm
Posted on 2/11/26 at 12:22 pm to Ailsa
I’ll never get another shot in my life unless it’s life saving or a local anesthetic.
Posted on 2/11/26 at 12:23 pm to WeeWee
quote:
A flu vaccine or booster that covered subclad K would likely have kept them from getting pneumonia. The speed of production of current flu vaccines does not allow for that to happen. By the time a booster for the predominant variant was produced flu season would be over. The greater speed of production for mRNA vaccines would make producing a midseason booster to cover the predominant variant theoretically possible.
This is plausible and if it worked would be very useful, but isn't how Prasad is thinking. He wants to RCT more & more and that'll end up slowing down approvals and they're also going to be favoring presumably the older, slower platforms unless there's some equally fast platform to mRNA that I don't know about, so faster vaccine tech doesn't seem in the offing anytime soon.
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