Agency says application rejected due to lack of ‘adequate and well controlled’ trial, but experts say ‘they’re just coming up with reasons’

A senior US Food and Drug Administration (FDA) official says Moderna’s clinical trial on a new, potentially more effective flu vaccine was a “brazen failure” and that the FDA is now calling it into question.

The FDA unexpectedly refused to consider Moderna’s application for a flu shot based on messenger RNA (mRNA) technology in a decision that experts say is already having a chilling effect on vaccine development.

Officials say the issue is the design of the study, in which control group participants over the age of 65 should have received a high-dose flu shot instead of a standard flu shot.

Outside experts say the reasons seem to go deeper. “It’s all pretext and obfuscation when the real agenda is rejecting conventional science and serving a predetermined anti-vaccine agenda,” said Richard Hughes IV, a partner with Epstein Becker Green and law professor at George Washington University.

  • tempest@lemmy.ca
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    5 hours ago

    I wonder if these idiots would be perfectly content to take an oral vaccine . I literally saw an ad on tv for dukerol so it must be selling.

  • BarneyPiccolo@lemmy.today
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    10 hours ago

    As if American Health Care wasn’t already a disaster, now we’re rejecting cutting edge medical research because one psychopath put another psychopath in charge of our entire health care system, and a whole bunch of other psychopaths approved it.

    All because they think it’s hilarious when Libz get upset by this.

    • EchoCranium@lemmy.zip
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      7 hours ago

      And funding cuts ended a lot of ongoing research projects. The US will be at least a decade behind in breakthroughs because we have morons in charge who value conspiracy theory over scientific method.

      • BarneyPiccolo@lemmy.today
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        7 hours ago

        When we take our country back, we should force these rich hyenas to fund the repairs out of their personal fortunes. Whatever is left, gets confiscated to fund Universal Health Care and UBI. They won’t need it, they’ll all be in prison, if they’re lucky.

      • ramble81@lemmy.zip
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        7 hours ago

        This will be interesting to see because one of the arguments I always hear about why our prescription prices are so much higher than the rest of the world is that “companies do their R&D here and need to recoup the cost”…. What’s going to be their excuse when companies pull out and we still have high prices.

        • EchoCranium@lemmy.zip
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          6 hours ago

          Those companies, like Pfizer, do very little of their R&D. They spend money buying up companies to control the IP after most of the work is done. And that work is often funded by government grants. So American citizens have their tax money go towards research (which is great, I’m all for that) but for-profit companies come in at the end to carry the ball over the line, and make billions doing it (which we pay for too). Broken system.

  • bajabound@lemmy.world
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    5 hours ago

    I’m surprised there wasn’t a large donation to a nonexistent library to make this speed bump go away.

    • NABDad@lemmy.world
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      8 hours ago

      None of you people appreciate how difficult it was to find people who met President Pedophile’s requirements.

      They actually all had to be more stupid and incompetent than him.

      Do you realize how much that limits the application pool?

      • nova_ad_vitum@lemmy.ca
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        6 hours ago

        It also helps if they’re actually guilty of crimes that the president can hold over them to ensure loyalty.

    • HobbitFoot @thelemmy.club
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      8 hours ago

      They’re fine with saying not to get vaccinations up to when there’s an actual epidemic on their hands which they have to deal with.

  • ThePantser@sh.itjust.works
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    10 hours ago

    How much trouble would it be if you went to say Canada to get the shot? Living in MI it’s an easy option if they would even give it.

    • EchoCranium@lemmy.zip
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      7 hours ago

      Or we have to go to Mexico. Moderna just signed an agreement with the government there to do vaccine production.

  • Optional@lemmy.world
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    9 hours ago

    Journalist 1: well we can’t say they know what they’re talking about, because then it’ll seem like we agree with them, and the administration is absolutely wrong

    Journalist 2: Put “experts claim” and then it makes it seem like they might just be wrong and we haven’t picked a side, even though, in a court of law, you literally have an expert testimony to determine the truth.

    Journalist 1: billionaires are our betters!

    Journalist 2: they sure are