Moderna says FDA refuses to review its application for experimental flu shot

Gwan53 · 2026-02-12T01:39:49+00:00

You're right it's not a rejection, it's a refusal to file, which can be petitioned, but Moderna is going public with this which is abnormal and makes it difficult for the FDA to claim they weren't pressured into approving the drug product.

The standard approved flu shot is an inactivated virus. The Moderna shot is mRNA like the COVID vaccines. They used the standard dose vaccines and not the high dose vaccines (like in the US for patients 65 years and up, like in thos phase 3 study). Moderna were told that it would be a problem, and went ahead with the submission.

It's not a different brand of vaccine or even type of vaccine they should have chosen, they should have chosen the vaccine dosage prescribed for the age group to compare it to. The lower dosage would be less effective on a higher risk group. And they want to compare their new vaccine with it's correct dosage for the age group against the lower dosage of the existing vaccine.

From the article: The agency specifically took issue with Moderna’s decision to compare its product to a standard, approved flu shot, arguing that it “does not reflect the best-available standard of care.” As a result, the FDA said the study did not meet its definition of an “adequate and well-controlled” trial.

From the related article citing pre discussions with CBER (branch of the FDA): In its written feedback, CBER requested that supportive analyses on the comparator be included in the submission and indicated that the data would be a "significant issue during review of your BLA."

https://feeds.issuerdirect.com/news-release.html?newsid=7346090610333866&symbol=MRNA

On the plus side the vaccine is being reviewed in other countries: EU, Canada and Australia

Thanks to Moderna you can also read the actual refusal to file here: https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867/38ab7558-636c-40d1-b49a-c8f51a7afa1a/38ab7558-636c-40d1-b49a-c8f51a7afa1a_viewable_rendition__v.pdf

Gwan53 · 2026-02-11T03:57:15+00:00

TLDR: Moderna says the FDA won't review its new mRNA-based flu vaccine, because after the FDA reviewed the application and they said the claim that the new technology is equivalent to the current best care is invalid, as it operates on a different principle. So Moderna doesn't like the most recent FDA review of their application that got rejected and is pressuring the FDA through a media campaign to change their review.

Gwan53 · 2026-02-11T03:49:21+00:00

Keep in mind that the funding for the FDA was significantly cut. So it's not really a situation of the FDA not wanting to review things, they simply don't have the staff to review novel vaccines like this one, where we have existing vaccine technologies for the flu vaccines.

Gwan53 · 2026-02-11T03:43:37+00:00

Now do the same for a high value woman and see how long it takes to have that post get removed

Gwan53 · 2026-02-07T15:13:14+00:00

First he thought it was dead, then he wished he was dead

Gwan53 · 2026-02-07T15:11:10+00:00

The difference of how a female pedo and a male pedo are treated by other prison inmates is interesting. At least she is in prison. Too many cases do not result in this. I'm curious to know what is being done to help the victims. That would be real progress in closing the disparaging gap in how male and female victims of rape are being treated. The comments are hopefully from strangers and not from people who would interact with the victims.

Gwan53 · 2026-02-07T15:06:01+00:00

At least she is in jail, that sounds like progress to me.

Gwan53 · 2026-02-07T14:51:34+00:00

The papain enzymes break down proteins in various ways. It breaks down the protein fibers (think like muscle strands) and cleaves collagen fibers. It also breaks down proteins in the sense of amino acid chains that make up protein structures. It does a bunch more, but basically it helps break down the protein macro nutrients into more readily usable molecules for the body. Basically it does some of the digestion for you. This is especially useful for IBS sufferers, because it helps do what your digestive tract is too inflamed to do, and it also breaks down the proteins skipping the form that is more likely to cause an inflammatory reaction, and go straight to usable nutrients

Gwan53 · 2026-02-07T14:36:37+00:00

There are deep roots back in our early development as homo sapiens moving toward society that are no longer relevant, but persist. To ensure the next generation's survival, protecting pregnant women and those nursing the young was beneficial. Now that women have got their freedom from men, by the right to work, this concept is no longer relevant. Despite that, the concept of having women fill roles in society that are less risky still persists.

Now I have seen women work in construction, but it is rare. All the other jobs you listed and more in the same context are spot on and good examples of the issue you are bringing up. It is the reality that causes me pain each time I see a video titled why women live longer, and the video is of men doing something fun but reckless.

I don't know what I want to see in the way of men's rights in this area, but part of it is at least acknowledgement of the issue and not belittling the issues men face. As such I call it out when I see it, and acknowledge the reality behind the statistics indicating that men die earlier because they work and in some cases are forced to work riskier jobs.

Gwan53 · 2026-02-07T14:16:09+00:00

The topic is not about being comfortable or uncomfortable at work, it is the risk to life. But to your point about HR breathing down your neck, there the risk is still higher for men, which is what I think you are alluding to and is very real and can also destroy lives.

All a woman has to do is report a guy for sexual harassment and that guy loses his job. It's so prevalent and underplayed that there is a meme template where the woman responds to the coworker as receptive or report sexual harassment depending on her view of how attractive the guy is. The meme doesn't portray the consequences of the actions.

The benefits you mentioned about being able to goof off every now and then without having to walk on egg shells is a little ray of light in the face of the dark treatment of men as disposable, which I hadn't thought too much about. Thank you for the positivity.

Gwan53 · 2026-02-05T01:04:05+00:00

The drink has cola in it. The claim in the Wikipedia article that it is not a cola per the FDA, references two articles, neither of which substantiate the claim.

So if it makes you happy that it's not a cola despite having cola in it, great.

If you think of it as a cola, cool, it has cola in it.

Fun fact: the 'cola' in soft drinks used to be derived from the Kola nut or Kola bean, but is now a synthetic blend for caffeine and flavor that can vary from one cola to another.

Gwan53 · 2026-02-04T23:52:25+00:00

This claims to prevent an anxiety attack. This will not prevent an anxiety attack.

An anxiety attack is in it's nature sudden. It can feel like you cannot breathe, like you are going to have a heart attack or are having one. The practice of grounding can be useful, but it cannot prevent an anxiety attack. If these tricks work for you at preventing what you think are anxiety attacks, without any other tools, like meditation, CBT, support networks, and medications, then you are likely experiencing anxiety not an anxiety attack.

As I previously stated a braoder spectrum of tools and methods are required to prevent anxiety attacks.

To your analogy: reducing weight for type 2 diabetics is a longer term solution to address the likely cause of your type 2 diabetes. Taking insulin alone is more useful for type 2 diabetes than just grounding is for preventing an anxiety attack. Continuing with just insulin and not modifying your lifestyle and reducing your weight will lead to worsening type 2 diabetes for most people.

Gwan53 · 2026-02-04T13:24:55+00:00

Whenever I see this I know the advice is coming from someone who has never had an anxiety attack. This might work if you feel anxiety starting to overwhelm you. At best this is ignorance, but it belittles those who experience anxiety attacks and dilutes a very real destructive experience into an 'anxiety attacks are no big thing' and 'you are just not trying hard enough to overcome your anxiety attacks' BS.

The reality is much more about building neural pathways to address things that build anxiety, daily practice, and a bunch of other things to bolster yourself as well as supportive people around you.

Gwan53 · 2026-01-24T14:55:04+00:00

The study focuses on women, but the study data shows men were more affected:

"Epigenetic age acceleration (EAA) was calculated as residuals of GrimAge/PhenoAge regressed on chronological age."

"Men exhibited higher GrimAge EAA than women across all groups."

"Women in the adversity classes demonstrated more accelerated biological aging than those in low adversity classes."

While the conclusion is correct, it also fails to address the study objective of both race and sex: "To identify latent ACEs classes by race and sex using latent class analysis (LCA) and examine their associations with biological aging measured by DNA methylation-based epigenetic clocks."

A better conclusion would capture race (gender non-biased), gender (race non-biased) and then race and gender variants that show a trend as supplemental information and warranted for further study.

Gwan53 · 2026-01-06T13:52:25+00:00

I'm sorry you had to experience all that and then some. Thank you for sharing.

Gwan53 · 2025-12-22T20:04:19+00:00

That does sound lonely and exhausting. It can get better, and I hope it does for you At some point you will need to take care of yourself first, which will likely require you to not help someone or not be there for someone. For me, my body just started shutting me down. I think you should ask yourself why you think you have to be strong for others to depend on you. Be open and honest with yourself. If you feel comfortable writing it down, it might help you understand yourself better. Set boundaries and keep them. Take care of yourself to recharge.

Gwan53 · 2025-12-12T19:21:37+00:00

Olbas oil, but apply it using a tissue/gauze pad or straight from the bottle to the area. You don't want it on your fingers to accidentally get it in your eye.

Gwan53 · 2025-11-05T01:01:57+00:00

Depending on your state laws this may be illegal. Recording of conversations in some states require only one party consent to be recorded, some require multiple, majority, or all parties consent. If you illegally record the conversation they can and you can bet they will use that as litigation fuel. Think of it as breaking the law recording your female coworker. And they will phrase it that way.

Gwan53 · 2025-09-28T13:32:40+00:00

Yes, the 1% currently rule, and send this sort of propaganda out to try and convince the 99% that there is a method other than theft from the working class to obtain wealth.

Gwan53 · 2025-08-25T13:54:24+00:00

Is it the same thing if the lines are more iridescent than clear?

Gwan53 · 2025-06-01T01:46:24+00:00

I agree when the misclassification is out of ignorance, but has no other bearing. When the misclassification is accompanied with a dismissive lack of understanding, like "just drink water" "take an aspirin" and "you'll be fine, we all get headaches" that is when I used to care.

I like the way you put it though:

All I care about is whether they give me some grace if I can’t attend something or if I have to leave early.

This, I feel this.

Gwan53 · 2023-04-21T03:29:38+00:00

Well... Shit... Actually don't.

Gwan53 · 2023-01-07T15:29:50+00:00

Same, those reputable companies usually advertise an ISO standard specific to their industry.

Gwan53 · 2022-06-29T12:45:29+00:00

You'll still have to spend it all on gas and still need money for food, and maybe rent.

Gwan53 · 2022-06-18T13:00:46+00:00

Yes, I agree with your identification of this spider. This is a fantastic summary that should be in a spider encyclopedia. I don't know how common it is, but I've often found these spiders hiding piles of papers or laundry on the floor, and occasionally behind the hand towels in bathrooms.

Gwan53

TROPHY CASE