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Moderna Says FDA Refuses To Review Its Application for Experimental Flu Shot (cnbc.com) 247

Posted by msmash from the tussle-continues dept.
An anonymous reader shares a report: The Food and Drug Administration has refused to start a review of Moderna's application for its experimental flu shot, the company announced Tuesday, in another sign of the Trump administration's influence on tightening vaccine regulations in the U.S. Moderna said the move is inconsistent with previous feedback from the agency from before it submitted the application and started phase three trials on the shot, called mRNA-1010. The drugmaker said it has requested a meeting with the FDA to "understand the path forward."

Moderna noted that the agency did not identify any specific safety or efficacy issues with the vaccine, but instead objected to the study design, despite previously approving it. The company added that the move won't impact its 2026 financial guidance. Moderna's jab showed positive phase three data last year, meeting all of the trial goals. At the time, Moderna said the stand-alone flu shot was key to its efforts to advance a combination vaccine targeting both influenza and Covid-19.
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Moderna Says FDA Refuses To Review Its Application for Experimental Flu Shot More

Moderna Says FDA Refuses To Review Its Application for Experimental Flu Shot

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  • I hope the rest of the world is large enough (Score:5, Insightful)

    by gweihir ( 88907 ) on Wednesday February 11, 2026 @08:35AM (#65981982)

    To make this still a success. Irrationality is not everywhere in power. And a better flu shot is overdue.

    • Re: (Score:2)

      by zlives ( 2009072 )

      Mexico, please provide medical assistance to US. at least to its citizens who long for the days when we believed in science.

    • It'll be a good test case in whether countries outside the US are willing to pay for all that R&D plus the expected profit margin.

  • Anti-Vax attitudes will get people killed (Score:5, Insightful)

    by JoshuaZ ( 1134087 ) on Wednesday February 11, 2026 @08:42AM (#65981996) Homepage
    It is one thing to promote anti-vax attitudes among your own voter base. That still endangers people outside that base, since people who are elderly or immunocompromised become more likely to get sick if the overall vaccination rate is lower. I for example have some immune issues and cannot currently get an MMR booster for medical reasons, so I'm actively endangered by the reduction in measles vaccination and the spread of cases. But note that what the Trump administration is doing now is much worse than just promoting anti-vax attitudes among their base. They are using government power to actively prevent the development and use of vaccines by others. There's a sad irony to this in that one of the very few bright spots of the first Trump administration was Operation Warp Speed and some other things they did to help with early covid vaccine development.

    • Re:Anti-Vax attitudes will get people killed (Score:5, Informative)

      by dohzer ( 867770 ) on Wednesday February 11, 2026 @08:48AM (#65982018)

      Anti-Vax attitudes have gotten people killed

    • Re: (Score:2)

      by gweihir ( 88907 )

      Excessive "group-think" type stupidity always gets people killed. The sad fact is that these are often not part of the stupid. We have way too many malicious people in the human race.

    • Re:Anti-Vax attitudes will get people killed (Score:4, Insightful)

      by gtall ( 79522 ) on Wednesday February 11, 2026 @10:31AM (#65982258)

      It also matters to babies who have brain-dead parents who will gladly expose them to measles, polio, etc. just so they can remain pure anti-vaxxers. And to teenagers with respect to the HPV vaccine, there the problem is the anti-vaxxers and the Christian nutjobs; the latter think that if their kid gets the HPV vaccine, they will turn into sex-crazed maniacs. They figure if kids are scared of HPV, then they stop screwing. Hint: it won't.

      • Re: (Score:2, Interesting)

        by dgatwood ( 11270 )

        It also matters to babies who have brain-dead parents who will gladly expose them to measles, polio, etc. just so they can remain pure anti-vaxxers. And to teenagers with respect to the HPV vaccine, there the problem is the anti-vaxxers and the Christian nutjobs; the latter think that if their kid gets the HPV vaccine, they will turn into sex-crazed maniacs. They figure if kids are scared of HPV, then they stop screwing. Hint: it won't.

        HPV is kind of the long tail in terms of vaccine usefulness, IMO. The theory is that because HPV is detected in some cancers, preventing HPV will reduce the risk of those cancers. But the reality is that the vaccine hasn't been around long enough for the first women who got it to be in the sweet spot for getting cervical cancer, so all the data is based on a 90% reduction in the rate of rare early cervical cancer cases. That could only be a 1% reduction in total cases, for all we know. Or it could just

        • So far they've shown a dramatic decrease in a variety of cancers in both men and women with a huge sample size. HPV doesn't just cause cervical cancer.

          https://www.cancer.org/cancer/... [cancer.org]

        • If someone offers me a shot that reduces my risk of early onset cancer by 90% and has no promises of longer term onset of that cancer I'm going to ask them to give it to me.

        • Re: (Score:3)

          by ceoyoyo ( 59147 )

          Ah yes, that is completely reasonable. A vaccine that prevents cancer is of limited use because there isn't yet direct evidence that it prevents your special category of cancer. Smart!

          The theory is that because HPV is detected in some cancers, preventing HPV will reduce the risk of those cancer

          Also, this is 100% bullshit you made up. The mechanism by which HPV causes cancer is well established.

    • Re: (Score:2)

      by HiThere ( 15173 )

      It's not just the immune compromised. Vaccines aren't perfect, and the only reason they're so effective is that they enhance "herd immunity". They decrease the probability of catching the disease if exposed and also decrease the probability of spreading it to others once you catch it. So if nearly everybody is vaccinated, they're pretty effective. If only a few are vaccinated, they're a LOT less effective.

      • Yeah, and the related thing is that if a disease has a high R0, then it only takes a small reduction in the percentage who are vaccinated to lose herd immunity. Measles is a really good example of this. Since measles has an R0 of around 12 to 18, that translates to a needed percentage for effective herd immunity of around 1-1/12 to 1-1/18 so around 92% need to be vaccinated. Its really easy to drop below that.

  • purebloods (Score:4, Informative)

    by clovis ( 4684 ) on Wednesday February 11, 2026 @09:03AM (#65982046)

    And it seems we have these to avoid.
    https://www.dailykos.com/stori... [dailykos.com]

  • RFK Jr's own words (Score:5, Insightful)

    by ArchieBunker ( 132337 ) on Wednesday February 11, 2026 @09:31AM (#65982102)

    I don't want to seem like I'm being evasive, but I don't think people should be taking medical advice from me." https://www.cbsnews.com/news/r... [cbsnews.com]

    Imagine the headlines if Obama appointed a longtime heroin junkie to run the FDA. https://www.pbs.org/newshour/h... [pbs.org]

  • And you're savings and your 401K with it.

    They know this and you know this and everybody knows this. We all know that the Republican party is bad for the economy if you work for a living. The only people who come out ahead during a republican administration are a handful of people to just own shit for a living. You have to own a lot of shit to come out ahead.

    Why do I bring this up? Because this anti-vax bullshit is what they are offering voters in exchange for destroying the economy and your savings

    • That post belongs in a Bitcoin debate, not here.

  • If your profits depend on activities that are not politically acceptable, you can relocate to a less insanely self-destructively stupid country.

    Sure, it'll hurt financially to move, but not as much as trying to continue operating in a political environment that wants you out of business.

  • Synthetic mRNA problems [youtube.com]:

    “Now, in this next uh group of graphics from ARY, we're going to look at the modified ribboucleic acid and how it's been changed and the harmful effects that this can potentially have. So, here we see a strand of RNA, the ribboucleic acid. But the problem is it's not riboucleic acid. It's modified ribboucleic acid. It's been modified to avoid the immune system and to last much longer.”

  • The previous cry under the Biden administration was that vaccinations were being forced on people who didn't want them. Although there's certainly a public interest motivation to that push for vaccination, there is at least some moral and legal logic to allowing people the choice to be vaccinated or not. However, now that the anti-vaxxers are in power, the viewpoint is completely reversed. Instead of allowing choice, the policy now is to remove choice by preempting the availability of at least some vacci

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