• ExtremeDullard@piefed.social
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    24 days ago

    FDA refuses to review Moderna’s mRNA flu vaccine

    That alone makes the Moderna mRNA flu vaccine trustworthy.

    Anything the FDA says or does - or doesn’t do, assume it’s not good for your health.

    • T͏i͏d͏b͏i͏T͏@mander.xyz
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      24 days ago

      I mean really, as a scientist in the general field, we need more review and analysis of mRNA vaccines. While it sucks to say, there is some validity to the concerns surrounding mRNA vaccines as their uptake mechanism needs fine tuning. Subtle errors with administration can lead to myocarditis, as the heart uptakes some and produces the viral proteins on it’s surface. This results in the immune system attacking the heart and boom, myocarditis. So while it’s not the 100% safe molecules requiring mercury to function as intended (drastically different than the hazardous molecular structures with mercury), due to the speed it was pushed through testing, there are still a few things we need to iron out. For mRNA vaccines to work as well as the other fully safe vaccines we’ve used to massively increase our average life span, we need to learn how to alter the nano-lipids and make them more selective to which cells uptake them. While the anti-vaxers see this as a win, it’s impeding the research needed to be able to fix one of the very few things they actually had correct.

    • SendMePhotos@lemmy.world
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      24 days ago

      It’s weird how my stance has gone from “trust the government they’re doing what they can” to “do not trust the government agencies”

  • deafboy@lemmy.world
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    24 days ago

    Moderna noted that neither the FDA’s regulation nor its guidance to industry makes any reference to a requirement of the “best-available standard of care” in comparators.

    But shouldn’t they at least pretend that the new drug is better than the currently available options? Otherwise what’s the point of making it?

    edit: It’s like Intel comparing their new CPUs with their last generation instead of what their competitors offer today.

    • T͏i͏d͏b͏i͏T͏@mander.xyz
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      23 days ago

      It’s about knowing your audience and phrasing things in a way to increase the likelihood of acceptance. So despite the FDA reviewing and accepting the trial design in April '24 and August '25, plus the trial demonstrating the vaccine to be more effective than the currently available vaccines, I’d bet my last dollar they phrased it like this just for RFK and friends…

      • Porco@feddit.org
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        17 days ago

        They phrased it that way because the FDA did. Without any legal basis as it seems.

        Moderna said the FDA reviewed and accepted its trial design on at least two occasions (in April 2024 and again in August 2025) before it applied for approval of mRNA-1010. It also noted that Fluarix has been used as a comparator vaccine in previous flu vaccine trials, which tested vaccines that went on to earn approval.

        But in a letter dated February 3, Vinay Prasad, the FDA’s top vaccine regulator under the Trump administration, informed Moderna that the agency does not consider the trial “adequate and well-controlled” because the comparator vaccine “does not reflect the best-available standard of care.”

  • Diplomjodler@lemmy.world
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    24 days ago

    The FDA used to be the good standard for medical safety in the world. Yet another institution completely ruined by the morons. And yet another bit of US soft power gone.

    • Tollana1234567@lemmy.today
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      23 days ago

      RFK jr would reccommened worm egg therapy, not the “good ones” that has potential to alleviate immune problems. probably recommend picking up roadkill with bare hands, and consuming it.

  • RobotToaster@mander.xyz
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    24 days ago

    The FDA has always stood against progress, it’s the main reason it takes nearly 20 years to go from research to practice.

    • teft@piefed.social
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      24 days ago

      I’d rather they stand against progress when progress can sometimes kill you. 20 years for long term research into compounds isn’t horrible. Some things take that long to figure out they are causing issues.