FDA declines to review Moderna's mRNA flu shot | Hacker News Reader

FDA declines to review Moderna's mRNA flu shot

nbcnews.com

166 pointsbikenaga118 comments

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.

> 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.

The other hand is also horrifying.

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...

"Moderna curbing investments in vaccine trials due to US backlash, CEO tells Bloomberg TV"

https://www.reuters.com/business/healthcare-pharmaceuticals/...

Those are for immunization against viruses. They're not the same kind of vaccine that will be used to cure many types of cancer.

So we should feel better about this? And watch as Europe gets better vaccines? Apparently COVID and Flu vaccines have many health benefits. https://medicalxpress.com/news/2026-02-analysis-links-flu-va...

Future me would have a really high quality EV with an amazing charging network, clean air and water, a habitable planet for my grand children, no domestic political extrajudicial paramilitary surveilling everyone with megawarehouse detention cities everywhere, outright ideological warfare against urban areas, etc.

We had a choice between Star Trek future world and Blade Runner+MadMax+Idiocracy, and we predictably chose the one we deserve because memes and a podcast.

> because memes and a podcast.

What a weird thing to say, after we spent 20+ trillion dollars on a bipartisan war on terror.

More than enough to make America's energy 100% renewable, feed the planet, house every American, and so much else.

Instead we made Dick Cheney's friends a lot of money, killed a couple million innocent people, and sat on the Epstein files for decades.

Which part of all that are you blaming on memes and a podcast?

Biontech, the one that had the first mrna vaccine, has a bunch of phase 3 trials this year, and they're all about curing cancer - it's literally how they're using all of the covid vaccine revenue, as funding for that endeavor.[1]

1 https://european-biotechnology.com/latest-news/2026-a-year-o...

https://archive.ph/sGvJW

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.

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.

So, the majority of us, people under 65 are completely unaffected. And yes, the vaccine can be approved for 65- while not approved for 65+.

The fall 2025 approval was limited to 65+/preexisting conditions.

If this vaccine wasn’t being tested for 65+, it might not be approved at all based on that.

How do you know if you don’t do a study?

You can call anything a criticism, but it doesn’t make it true.

Older flu vaccines become less effective, as there are many flu strains and the dominant one changes. Different flu vaccine is recommended every year.

Let's just be plain as possible because online commenters are some of the most obtuse people.

1. Vaccines are good, everyone should get the fucking flu shot

2. There will be new vaccines targeting current strains of influenza available this season from other manufacturers using older methods

3. I have no fucking clue if an mRNA flu vaccine is good or bad, but I also don't care

4. I get mrna vaccines can be developed faster, we might be better served, but we are not losing existing capabilities

5. If we are short on vaccines produced with older methods that is likely poor business planning and not an actual technical limitation

6. I hate you

> 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.

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.

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)"

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.

That's true some years, but not all. Usually, the difference is over 55 (or whatever) you get a quadrivalent vaccine instead of trivalent. That is, vaccine for the usual strains, plus a 4th. It's not totally different.

yes, lets find more ways to kill people besides bringing back the measles. God what a race to the bottom for this administration..

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

Yes, but it's also an argument against trying to require COVID vaccination going forward with the justification that it would provide herd immunity.

Was also easy to say with foresight for many of us.

- 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.

> 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.

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).

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) ?

I'm agreeing that the current implementation of our public health system is a worst-of-all-worlds option.

Weigh 500lbs, don't work, and drink a six pack a day? You get free healthcare via Medicaid, making the taxpayer shoulder your burden.

Self-employed, 35, and can run a 7 minute mile, but broke a bone? Expect outrageous healthcare costs, deductibles, etc.

The current approach to public health is the epitome of a moral hazard.

> 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?

Sure, and I'm saying that under that same justification, we should extend the same requirements to these other public health crises that President Biden tried to create for COVID vaccination.

Federal worker? BMI needs to be below 30, because otherwise you're costing the system too much. https://pmc.ncbi.nlm.nih.gov/articles/PMC7990296/

Private sector business with 100 more employees? Nobody is allowed to smoke on premises because of the risk of second hand smoke, just like the OSHA justification for vaccination requirements.

>In what universe is the US not trying to enforce laws around fentanyl?

Oregon passed Measure 110, decriminalizing heroin, methamphetamine, and fentanyl, only backtracking because the policy was so bad. California has Prop 47, knocking possession down to misdemeanors on par with jaywalking. New York has safe injection sites, and I'm going to guess this isn't for safe injection of insulin.

Enforcement of laws around these drugs would mean arresting and prosecuting the flocks of fentanyl users bent over in Philly's Skid Row, SF's tenderloin, or basically all of Portland: https://www.dailymail.co.uk/news/article-9372555/Philadelphi...

So basically what you are saying it's ok for the government to take away peoples bodily autonomy, as long as it benefits the economy? Wild.

And if you really want to make this calculation, any vaccine that predominately helps old people actually increases costs to society in the long run.

> ok for the government to take away peoples bodily autonomy, as long as it benefits the economy

No. That's a straw man and you know it. I'm against forced vaccinations. No one in the US was forced to be vaccinated.

However, most of the people against vaccination in the US are against abortion rights, so how could this debate really be about bodily autonomy? Forced birth is actually forced by the government, unlike vaccination programs. There is no situation where you could be put in jail for refusing a vaccine.

Funny how bodily autonomy is all that important when it comes to right wing fear of vaccines, but completely irrelevant when it comes to abortions, womens rights in general, sexual abuse, trans rights and generally rights of anyone disliked by this admin.

> any vaccine that predominately helps old people actually increases costs to society in the long run

I think that big difference between the political sides is that one of them does not see "kill all old people" as ethical strategy.

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.

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.

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.

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.

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.

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.

Could have something to do with vaccines going from recommended by doctors after decades of trials to entirely new vaccine methods being YOLO'd onto everyone via government policies.

This was evident in the dialogue from the antivaxers who had done their research on mRNA changing your genome and being activated by 5G radiation.

The good news is if you didn't trust the accelerated process you could choose masking/testing for moments away from YouTube and Joe Rogan.

> This was evident in the dialogue from the antivaxers who had done their research on mRNA changing your genome and being activated by 5G radiation.

Well, no, it was evident in the fact that mRNA vaccine manufacturers would only sign contracts with countries that agreed to give them blanket immunity from any and all possible legal consequences.

Bit of a red flag, that.

It really isn't, even considered in an absolute vacuum.

I guess you could call it crimson, but still, really bright red. Unless you're colorblind.

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.

Yeah I saw this blowback coming, but two wrongs (to the extent you see the first as a wrong) don't make a right.

There's no reason to be hindering availability of safe and effective vaccines because a previous administration made it mandatory for some people to get some vaccines.

In what sense was anyone in the US forced to get a Covid shot? I know many acquaintances who never did.

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?

> Why would the presidency matter?

Trump fired a ton of competent people and hired an absolute unqualified morons for high level government positions.

> Why would the presidency matter?

> ...accidental administration of the vaccine? How would that work?

Do you intend to have a sincere discussion on this topic?

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.

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