• Nougat@fedia.io
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    2 days ago

    Other reporting states that FDA is looking to change their recommendations, not their approvals. I’m not sure what to believe here, but it seems ridiculous to approve vaccinations for some people without “additional testing,” and deny approval for the vaccine for other people, especially when the denied group is defined as healthier.

    Not saying this isn’t the case, because :gestures_widely:, but I’m seeing inconsistent reporting on this.

    • baltakatei@sopuli.xyz
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      1 day ago

      “The F.D.A. will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” the officials wrote.

      During a “town hall” live streamed on Tuesday afternoon, Dr. Prasad said he thought the new approach to Covid vaccination was “a reasonable compromise,” leaving the shots available to many Americans “but also generating evidence.”

      Before approving Covid vaccines for wider use, the F.D.A. “anticipates the need” for new clinical trials in which participants under 65 are randomly assigned to receive the new shots or a placebo, Dr. Prasad and Dr. Makary wrote in the journal.

      In other words, Vinay Prasad (appointed by Trump to the FDA for claiming the political left was using the COVID-19 pandemic to end democracy) needs to see more evidence (people dying of COVID-19) before devoting resources towards vaccine development.

      I suspect Prasad is a podcast charlatan using his oncologist credentials to advance his career by stoking conservative resentment against mask mandates in order to gain popularity and name brand recognition to sell his personal philosophy books.

    • jacksilver@lemmy.world
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      2 days ago

      Haven’t read the article, and assume there is some Republican fuckery here.

      However, usually things like vaccines/medicine the question is risk vs reward. If you are likely to get it and have a severe case, then the risk of “untested” vaccine/medicine might be worth it. For healthy people the risk of “untested” methods usually isn’t worth it.

      That being said, I think in this case its about politics and not risk vs reward.

      • Nougat@fedia.io
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        2 days ago

        Someone elsewhere pointed to the paper talking about it - yes, they intend to withhold approvals.