What's crazy here is that FDA finally has a great head who actually tries to speed things up using Bayesian data modeling and understands drugs quite well (Marty
Makary) and does everything to make drug approval process cheaper and more efficient without compromising safety.
Unfortunately it seems like this decision was overwritten by his boss for political a win.
For individuals arguing on the internet, "Do your own research" has long meant cherry pick others' research to support your own worldview, regardless (or in spite) of its scientific flaws.
Doublespeak has a way of becoming exactly the opposite of what it says on the tin, regardless of its origins. It's literally in the name.
The people 'in the know' know what "Department of Peace" means, and the masses use it to laugh at anyone who dares to think they invent wars. That's the point.
He is, and he's publicly admitted to both mercury poisoning (which leads to cognitive impairments and potentially insanity) and having part of his brain eaten by a worm[1].
You didn’t read the article at all, did you. Well, that’s okay; I didn’t either. But you can read the comments downthread here and you will see that there was a good reason for this which had nothing to do with politics.
I can't find a specific source right now, but I remember reading that RFK's war on mRNA vaccines only applies the ones used for flu/Covid. They haven't gone after cancer vaccines.
> In a release Tuesday, Moderna said the FDA did not identify any safety or efficacy concerns with the vaccine. Instead, it said the FDA took issue with the “comparator” in its clinical trial — the vaccine the company used as a benchmark to evaluate its own shot.
> The FDA said the use of the standard flu shot as a comparator “does not reflect the best-available standard of care.”
Are they implying that a placebo should be the comparator?
"Except for vaccination for adults aged ≥65 years, ACIP makes no preferential recommendation for a specific vaccine when more than one licensed and recommended vaccine is available. Among adults aged ≥65 years any one of the following higher dose or adjuvanted influenza vaccines is preferentially recommended: HD-IIV3, RIV3, or aIIV3. If none of these three vaccines is available at an opportunity for vaccine administration, any other available age-appropriate influenza vaccine should be used (4,5)"
Trial designs are rarely perfect, and drug companies will try to stack the deck.
That being said, trial designs aren't made in isolation without consultation. Moderna's press release about this (https://feeds.issuerdirect.com/news-release.html?newsid=7346...) indicates that 2024 CDC said that performing an efficacy trial without using the higher dose would likely cause complications for recommending the mRNA vaccine for the >65 age group, but would not impact overall approval.
There’s a flu shot for old people. It appears Moderna chose not to administer that when appropriate. Maybe technically they aren’t required to. The whole thing sounds messy but who knows.
"Influenza vaccination is associated with significantly lower odds of myocardial infarction (MI), according to a large meta-analysis published late last week in BMC Public Health."
It’s a good thing the specific criticism of this trial is that they didn’t use the most effective vaccine for 65+ people, since you’re concerned about having the most effective vaccines.
Does this refer to the administration of the shot or not administering the shot? I'm assuming based on your paranoia that you believe alleged medicine kills people.
The chances of someone trying to take advantage of you with fake medicine are nearly zero.
To be fair, a lot of doctors were sounding the alarm in 2021 that forcing the Covid shot was going to cause blow back. They said word for word, that we might see the rise of measles and other similar diseases. It's actually very well documented on zdoggmd youtube channel (podcast) during this time. But there were tons of doctors saying the same thing.
Because the docs knew that far too many people would rather face risk to avoid doing what they’re told to do. And far too many people just don’t give a shit about other people. The npc’s aren’t real or pertinent.
The best way to keep immunocompromised and people who literally can’t take vaccines safe is by having so much herd immunity that the likelihood they a virulent load of a virus cannot get to those people.
A great way to get herd immunity is through mass vaccination.
Except herd immunity for COVID isn’t feasible or even possible. It mutates too much, the vaccines don’t confer effective enough immunity, etc.
It’s unfortunate, but it’s the reality of this disease. I’m not immunocompromised, but I still modify my behavior to try and protect myself: mask on planes, avoid certain situations, etc.
- Reduced demand on emergency rooms and other limited medical resources
- Decreased insurance claims, which are paid for by other patients in the form of premium increases
- Prevented burdens on taxpayers from illness or premature deaths of workers (welfare payments, orphanned children, lawsuits, etc.)
No one in a developed, Western society is an island. They borrow from society in childhood and pay society back as an adult. And they use common resources like drugs, hospitals, and (in the case of insurance) risk.
If we made everyone over 300lbs lose 100lbs, we’d also see those benefits.
Same if we limited the amount of cigarettes or alcohol people purchased.
Certainly the same if we enforced our drug laws around things like fentanyl (although ODing in a Waffle House parking lot at 32 might actually save the taxpayer some money in the long run).
> If we made everyone over 300lbs lose 100lbs, we’d also see those benefits.
> Same if we limited the amount of cigarettes or alcohol people purchased.
We already attempt to do these things through public health campaigns and laws against the purchase of cigarettes/alcohol by minors.
You're actually making my point for me, because public interventions to reduce smoking have saved tens of millions of lives and many billions of dollars of taxpayer money.
> Certainly the same if we enforced our drug laws around things like fentanyl (although ODing in a Waffle House parking lot at 32 might actually save the taxpayer some money in the long run).
In what universe is the US not trying to enforce laws around fentanyl?
Your point being ? That we should not do anything unless we do everything with no exception (that's an absurd way to view things and not a counter argument whatsoever), or that those things should be done (which is probably true but doesn't change his point at all) ?
> No one in a developed, Western society is an island
And you know the anti-vaxxers know this because they also intersect heavily with the set who get very mad/judgemental about unemployed people or about people who don't eat well and exercise.
It's my experience that a major part of the "anti covid vax and measures" point of view depends on refusing to understand that people who get grave form of covid but don't die from it still saturated hospital causing side deaths from other causes.
Can people stop flagging dham's comment when they simply disagree?
FWIW, I think what you're saying here and in another comment, about this burning a century of good will, is true.
People turn it into a liberal vs right partisan issue, but that's a convenient simplification.
The people protesting the lockdowns, mandatory vaccination, ID checks everywhere were not politically homogenous: if you looked at who was vocal about it, there were people on the right, but the other half were wokes, hippies, liberals, leftists, socialists, antifascists.
What burned goodwill is the authoritarian measures, the weak arguments, the demonisation of those against it for political gain and status (Trudeau and Biden would routinely accuse those opposed to mandatory vaccination and lockdowns of various -isms in public speeches).
The pandemic was indeed a major public health issue, but the way this was managed made it about a fight against the erosion of rights and societal polarisation.
While it's understandable that intelligent people eventually come to the conclusion of figuring out how they can change themselves, we need to stop absolving the destructionists of responsibility. The political machine that made a public health emergency into a political issue did much more damage to our country than the vaccines being practically, but temporarily, mandatory.
It's not temporary though. The Covid vaccine push has caused an entire generation to now doubt simple life-saving vaccines. They erased a century of goodwill.
It really didn’t. It caused a subset of people already predisposed to such things to become harder stance on it and it expanded that insanity by making it a political talking point; but it is *not* a whole generation, it’s likely 30% of one country; and, over time, hopefully less.
A century of goodwill? It's not like US vacvine skeptics are a new thing. Ol' ben franklin was a vaccine skeptic until his son died to smallpox.
The new thing is the right has recently embraced antivaxxers as part of the coaltion.
Giving it a mainstream platform for a few political points was a deal with the devil, and they deserve to be condemed for that.
The only thing most people know or remember about the covid vaccines are that they're the reason the lockdowns ended and things got back to normal. The only people still mad about it are the types who were easily manipulated to be mad about it from the start.
> In the US for adults 65+ (a key high-risk group in the trial), the ACIP preferentially recommends higher-antigen or adjuvanted options like Sanofi, Seqirus adjuvanted, recombinant high-antigen Flublok, etc as the "best-available standard of care",
Did this recommendation come before or after RFK Jr. fired all members of the ACIP and replaced them with his hand-picked choices? I suspect you already know the answer.
> * The "standard flu shot" Moderna used is likely not one of the above, or they would have said so
They didn't have to. The FDA told them they could continue to use standard flu shot if they wanted to as long as some statements were included in consent forms.
> The idea here is to see if the new shot is meaningfully better than the best existing/approved option for the target demographic, not to see if it's better than a standard shot you give a healthy 20-year-old.
No that's not the idea at all.
> All-in-all feels like a nothingburger.
No, it's not a nothingburger. It's a systematic assault on science and medicine.
Except this is not how medical regulation has worked in the US. This particularly is a new and stricter standard required for this particular vaccine. Even the new Trump policies for COVID vaccines now specifically requires a placebo -- comparison against standard-of-care would not be accepted.
Huh? The FDA's main guidance document on this topic, issued in 2007 with no major overhaul since [0], states that comparative efficacy or effectiveness data is valuable when:
- The comparator vaccine is indicated for the same population.
- The comparator has existing clinical effectiveness data.
In other words, the trial design should use a benchmark that makes sense given what doctors and guidelines actually recommend today. For older adults, evidence over the past 15+ years has shown that enhanced flu vaccines often provide better protection than standard-dose ones. The study used standard-dose vaccines as far as we can see.
The only oddity here is that the FDA apparently approved the study previously
The document describes proof of effectiveness as supported by demonstrating "non inferiority to... a US licensed product". So yes, a (licensed) benchmark, but I see no references to a requirement for only testing against the best standard of care. It's a separate question about whether it should be though, and the cfr is quite vague throughout, so I would probably expect this isn't an illegal move (assuming arbitrary and capricious isn't held by a court), but I don't see it supported by precedent.
What's crazy here is that FDA finally has a great head who actually tries to speed things up using Bayesian data modeling and understands drugs quite well (Marty Makary) and does everything to make drug approval process cheaper and more efficient without compromising safety.
Unfortunately it seems like this decision was overwritten by his boss for political a win.
> Unfortunately it seems like this decision was overwritten by his boss for political a win.
I think RFK is actually mentally damaged. He's been on his "do your own research" anti-vax crusade forever.
To be fair, once you start making fun of "do your own research", you have already lost the debate from a long term point of view.
> you have already lost the debate from a long term point of view
I don't get what this is alluding to - can you expand, specifically wrt the long term part?
Except for it being doublespeak.
For individuals arguing on the internet, "Do your own research" has long meant cherry pick others' research to support your own worldview, regardless (or in spite) of its scientific flaws.
Except kelipo is still 100% correct to say that.
Doublespeak has a way of becoming exactly the opposite of what it says on the tin, regardless of its origins. It's literally in the name.
The people 'in the know' know what "Department of Peace" means, and the masses use it to laugh at anyone who dares to think they invent wars. That's the point.
> I think RFK is actually mentally damaged
He is, and he's publicly admitted to both mercury poisoning (which leads to cognitive impairments and potentially insanity) and having part of his brain eaten by a worm[1].
1. https://cnas.ucr.edu/media/2024/05/08/rfk-jr-revealed-he-had...
On one hand it’s horrifying, on the other, this is what the administration was elected to do.
You didn’t read the article at all, did you. Well, that’s okay; I didn’t either. But you can read the comments downthread here and you will see that there was a good reason for this which had nothing to do with politics.
I did read it, and it seems like a political witchhunt. Also, comments on HN are actually not that credible on average.
This technology is going to cure cancer someday. Too bad we won't get to use it. The FDA just killed 'future you'.
I can't find a specific source right now, but I remember reading that RFK's war on mRNA vaccines only applies the ones used for flu/Covid. They haven't gone after cancer vaccines.
This press release seems to confirm this: https://biontechse.gcs-web.com/news-releases/news-release-de...
https://archive.ph/sGvJW
> In a release Tuesday, Moderna said the FDA did not identify any safety or efficacy concerns with the vaccine. Instead, it said the FDA took issue with the “comparator” in its clinical trial — the vaccine the company used as a benchmark to evaluate its own shot.
> The FDA said the use of the standard flu shot as a comparator “does not reflect the best-available standard of care.”
Are they implying that a placebo should be the comparator?
No, they're implying that Moderna should have used a high dose flu vaccine in the >65 age group as the control condition in the efficacy trial.
EDIT: To be clear, I'm pretty sure that's just some pretext.
Context from the CDC guidance from August 2025 (https://www.cdc.gov/mmwr/volumes/74/wr/mm7432a2.htm)
"Except for vaccination for adults aged ≥65 years, ACIP makes no preferential recommendation for a specific vaccine when more than one licensed and recommended vaccine is available. Among adults aged ≥65 years any one of the following higher dose or adjuvanted influenza vaccines is preferentially recommended: HD-IIV3, RIV3, or aIIV3. If none of these three vaccines is available at an opportunity for vaccine administration, any other available age-appropriate influenza vaccine should be used (4,5)"
Is sandbagging like this normal in getting FDA approvals or did someone at Moderna f this up?
Trial designs are rarely perfect, and drug companies will try to stack the deck.
That being said, trial designs aren't made in isolation without consultation. Moderna's press release about this (https://feeds.issuerdirect.com/news-release.html?newsid=7346...) indicates that 2024 CDC said that performing an efficacy trial without using the higher dose would likely cause complications for recommending the mRNA vaccine for the >65 age group, but would not impact overall approval.
That was 2024. I wonder what could possibly be different about today, in 2026?
This is specifically a political attempt by RFK Jr. to stop people from getting mRNA flu vaccines.
There’s a flu shot for old people. It appears Moderna chose not to administer that when appropriate. Maybe technically they aren’t required to. The whole thing sounds messy but who knows.
currently endorsed production technology is not responsive enough to produce an effective vaccine in time for unexpected viral antigen shift.
we need to cut the required lead time down to weeks, rather than months.
we also need to stand up a surveilance network again.
Unfortunate, just recently I read
"Influenza vaccination is associated with significantly lower odds of myocardial infarction (MI), according to a large meta-analysis published late last week in BMC Public Health."
https://www.cidrap.umn.edu/influenza-vaccines/new-analysis-l...
We will still have flu vaccines, just not this vaccine.
Older flu vaccines become less effective, as there are many flu strains and the dominant one changes. Different flu vaccine is recommended every year.
The question isn't whether or not we have vaccines, it is whether or not we have the most effective vaccines.
It’s a good thing the specific criticism of this trial is that they didn’t use the most effective vaccine for 65+ people, since you’re concerned about having the most effective vaccines.
yes, lets find more ways to kill people besides bringing back the measles. God what a race to the bottom for this administration..
[flagged]
Does this refer to the administration of the shot or not administering the shot? I'm assuming based on your paranoia that you believe alleged medicine kills people.
The chances of someone trying to take advantage of you with fake medicine are nearly zero.
Good luck
> Does this refer to the administration of the shot or not administering the shot?
I'm fairly certain "this administration" in the GP refers to the Trump administration; under its watch, measles have been resurrected.
> The chances of someone trying to take advantage of you with fake medicine are nearly zero.
The steelman for this position is unintentional, unforeseen harm, not malicious vaccine manufacturers.
> I'm fairly certain "this administration" in the GP refers to the Trump administration
Why would the presidency matter?
> The steelman for this position is unintentional, unforeseen harm, not malicious vaccine manufacturers.
...accidental administration of the vaccine? How would that work?
To be fair, a lot of doctors were sounding the alarm in 2021 that forcing the Covid shot was going to cause blow back. They said word for word, that we might see the rise of measles and other similar diseases. It's actually very well documented on zdoggmd youtube channel (podcast) during this time. But there were tons of doctors saying the same thing.
Because the docs knew that far too many people would rather face risk to avoid doing what they’re told to do. And far too many people just don’t give a shit about other people. The npc’s aren’t real or pertinent.
How did taking it benefit other people?
The best way to keep immunocompromised and people who literally can’t take vaccines safe is by having so much herd immunity that the likelihood they a virulent load of a virus cannot get to those people.
A great way to get herd immunity is through mass vaccination.
Except herd immunity for COVID isn’t feasible or even possible. It mutates too much, the vaccines don’t confer effective enough immunity, etc.
It’s unfortunate, but it’s the reality of this disease. I’m not immunocompromised, but I still modify my behavior to try and protect myself: mask on planes, avoid certain situations, etc.
It's easy to say this in hindsight
- Reduced demand on emergency rooms and other limited medical resources
- Decreased insurance claims, which are paid for by other patients in the form of premium increases
- Prevented burdens on taxpayers from illness or premature deaths of workers (welfare payments, orphanned children, lawsuits, etc.)
No one in a developed, Western society is an island. They borrow from society in childhood and pay society back as an adult. And they use common resources like drugs, hospitals, and (in the case of insurance) risk.
If we made everyone over 300lbs lose 100lbs, we’d also see those benefits.
Same if we limited the amount of cigarettes or alcohol people purchased.
Certainly the same if we enforced our drug laws around things like fentanyl (although ODing in a Waffle House parking lot at 32 might actually save the taxpayer some money in the long run).
> If we made everyone over 300lbs lose 100lbs, we’d also see those benefits.
> Same if we limited the amount of cigarettes or alcohol people purchased.
We already attempt to do these things through public health campaigns and laws against the purchase of cigarettes/alcohol by minors.
You're actually making my point for me, because public interventions to reduce smoking have saved tens of millions of lives and many billions of dollars of taxpayer money.
> Certainly the same if we enforced our drug laws around things like fentanyl (although ODing in a Waffle House parking lot at 32 might actually save the taxpayer some money in the long run).
In what universe is the US not trying to enforce laws around fentanyl?
Your point being ? That we should not do anything unless we do everything with no exception (that's an absurd way to view things and not a counter argument whatsoever), or that those things should be done (which is probably true but doesn't change his point at all) ?
> No one in a developed, Western society is an island
And you know the anti-vaxxers know this because they also intersect heavily with the set who get very mad/judgemental about unemployed people or about people who don't eat well and exercise.
Actually there has been an unholy alliance between Christ clowns and new age hippies against modern medicine looooong before COVID.
Yeah but they used to live on the fringes of social media. Now they run the executive.
And the alternative was… what? Continue having people die because of Covid
It's my experience that a major part of the "anti covid vax and measures" point of view depends on refusing to understand that people who get grave form of covid but don't die from it still saturated hospital causing side deaths from other causes.
Can people stop flagging dham's comment when they simply disagree?
FWIW, I think what you're saying here and in another comment, about this burning a century of good will, is true.
People turn it into a liberal vs right partisan issue, but that's a convenient simplification.
The people protesting the lockdowns, mandatory vaccination, ID checks everywhere were not politically homogenous: if you looked at who was vocal about it, there were people on the right, but the other half were wokes, hippies, liberals, leftists, socialists, antifascists.
What burned goodwill is the authoritarian measures, the weak arguments, the demonisation of those against it for political gain and status (Trudeau and Biden would routinely accuse those opposed to mandatory vaccination and lockdowns of various -isms in public speeches).
The pandemic was indeed a major public health issue, but the way this was managed made it about a fight against the erosion of rights and societal polarisation.
While it's understandable that intelligent people eventually come to the conclusion of figuring out how they can change themselves, we need to stop absolving the destructionists of responsibility. The political machine that made a public health emergency into a political issue did much more damage to our country than the vaccines being practically, but temporarily, mandatory.
It's not temporary though. The Covid vaccine push has caused an entire generation to now doubt simple life-saving vaccines. They erased a century of goodwill.
It really didn’t. It caused a subset of people already predisposed to such things to become harder stance on it and it expanded that insanity by making it a political talking point; but it is *not* a whole generation, it’s likely 30% of one country; and, over time, hopefully less.
A century of goodwill? It's not like US vacvine skeptics are a new thing. Ol' ben franklin was a vaccine skeptic until his son died to smallpox. The new thing is the right has recently embraced antivaxxers as part of the coaltion.
Giving it a mainstream platform for a few political points was a deal with the devil, and they deserve to be condemed for that.
The only thing most people know or remember about the covid vaccines are that they're the reason the lockdowns ended and things got back to normal. The only people still mad about it are the types who were easily manipulated to be mad about it from the start.
[flagged]
> The study was on people age 50+,
So?
> In the US for adults 65+ (a key high-risk group in the trial), the ACIP preferentially recommends higher-antigen or adjuvanted options like Sanofi, Seqirus adjuvanted, recombinant high-antigen Flublok, etc as the "best-available standard of care",
Did this recommendation come before or after RFK Jr. fired all members of the ACIP and replaced them with his hand-picked choices? I suspect you already know the answer.
> * The "standard flu shot" Moderna used is likely not one of the above, or they would have said so
They didn't have to. The FDA told them they could continue to use standard flu shot if they wanted to as long as some statements were included in consent forms.
> The idea here is to see if the new shot is meaningfully better than the best existing/approved option for the target demographic, not to see if it's better than a standard shot you give a healthy 20-year-old.
No that's not the idea at all.
> All-in-all feels like a nothingburger.
No, it's not a nothingburger. It's a systematic assault on science and medicine.
The recommendation came in 2022, before RFK, this trial, etc. Misrepresenting the truth doesn’t serve your argument.
Except this is not how medical regulation has worked in the US. This particularly is a new and stricter standard required for this particular vaccine. Even the new Trump policies for COVID vaccines now specifically requires a placebo -- comparison against standard-of-care would not be accepted.
Huh? The FDA's main guidance document on this topic, issued in 2007 with no major overhaul since [0], states that comparative efficacy or effectiveness data is valuable when:
- The comparator vaccine is indicated for the same population.
- The comparator has existing clinical effectiveness data.
In other words, the trial design should use a benchmark that makes sense given what doctors and guidelines actually recommend today. For older adults, evidence over the past 15+ years has shown that enhanced flu vaccines often provide better protection than standard-dose ones. The study used standard-dose vaccines as far as we can see.
The only oddity here is that the FDA apparently approved the study previously
[0] https://www.fda.gov/regulatory-information/search-fda-guidan...
The document describes proof of effectiveness as supported by demonstrating "non inferiority to... a US licensed product". So yes, a (licensed) benchmark, but I see no references to a requirement for only testing against the best standard of care. It's a separate question about whether it should be though, and the cfr is quite vague throughout, so I would probably expect this isn't an illegal move (assuming arbitrary and capricious isn't held by a court), but I don't see it supported by precedent.
[flagged]
Good how?
[flagged]
Not an RCT, and no mention of it's clinical significance. Call me back when it's clinically significant.
This feels like a psy-op to read through.