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Trump threatened to fire the FDA administrator unless he authorized it today. That's not the hallmark of a careful analysis. https://www.washingtonpost.com/hea

Trump threatened to fire the FDA administrator unless he authorized it today. That's not the hallmark of a careful analysis. https://www.washingtonpost.com/health/2020/12/11/trump-stephen-hahn-fda-covid-vaccine/ https://www.washingtonpost.com/health/2020/12/11/trump-steph... From a personal perspective, I want a safe and effective vaccine as soon as anyone would. I do not want to be propagandized into taking something potentially dangerous just because it lets the business community make money. What I want is a careful, rigorous, and non-politicized decision making process before I can trust the output of an experimental process. This has clearly not happened.

ummonk 6y ago
I hate Trump's bullying tactics as much as the next person, but let's be clear - the FDA had completed its data analysis and released it a few days ago, and then the advisory panel yesterday supported its endorsement. At this point it was clear the vaccine was safe and effective, and an EUA should be rapidly announced by the FDA, whether the Trump would pressure them or not.
- tehjoker 6y ago
  I don't understand then, why would the FDA need to be threatened? Wouldn't they try to move as fast as possible within the bounds of reason?
  - macksd 6y ago
    Trump threatening someone does not imply they needed to be threatened.
    - tehjoker 6y ago
      It is possible he was just pissed at any delay at all. I am just feeling extremely skeptical about believing any of these people as their goal is to get us to forget about the pandemic and get back to work at maximum productivity regardless of whether this thing works.
  - zaroth 6y ago
    I mean obviously this was not the case, since they announced they would definitely approve it but not for a few more days. We are talking about government bureaucrats here after all.
    - tssva 6y ago
      Actually prior to the threat they stated that they would approve it as fast as possible and were targeting Saturday morning. Trumps bullying sped things up by about 12 hours.
      - newacct583 6y ago
        Note that the approval date has absolutely nothing to do with the production schedule, which is the real limiting factor here. Having a few hundred people get their shots on Saturday instead of Tuesday or whatever isn't realistically going to move the needle. Every dose we can get is going into a patient somewhere.
        WalterBright 6y ago
        I saw on the news today that the vaccine was sitting waiting for the approval to ship. So yeah, getting approval sooner will get the vaccine shipping sooner.
        lbeltrame 6y ago
        Scale-up work and production started at the end of the summer.
        newacct583 6y ago
        Yes, and every dose produced so far is ready to go into a patient immediately, they don't have a stockpile for the whole society, not remotely. Two days or whatever isn't going to matter that much. The timing of the first few thousand doses will change, the timing of the first ten million doses has to do with production and shipping, not approval.
davidf560 6y ago
The FDA announced early this morning that they were definitively going to authorize it[1], but they didn't actually issue the authorization at that point, with people telling the press that authorization would come "in the next few days". If someone called up the FDA after that and said "hey, you've already told everyone you're going to approve this, so just sign the papers and make it official today rather than going home for the weekend and finishing it up on Monday", I have no problem with that. That's not pressure to prematurely authorize it (since they already confirmed they would), that's just cutting through the red tape/BS and making it official faster (IMO). Put it into a tech perspective - if your company's cloud product went down and you were losing $millions every hour, and the devs found the bug and fixed it, but the product manager said "hey great, we'll fill out the release paperwork in the next few days and maybe approve pushing the change to prod on Monday", would anyone go for that? No way - they'd say we're not going home until this is fixed and released. Replace $millions with actual human lives and that's basically what we have here, isn't it? [1] https://www.fda.gov/news-events/press-announcements/fda-statement-vaccines-and-related-biological-products-advisory-committee-meeting https://www.fda.gov/news-events/press-announcements/fda-stat...
- tehjoker 6y ago
  This makes more sense to me. Thank you.
- lupire 6y ago
  Remember when the Challenger shuttle was ready to launch so they skipped the final checks of the frozen O-ring data analysis?
tzs 6y ago
No need to worry in this case. They were going to hold their meeting to give final approval on Saturday. All Trump's blustering did was move that to late Friday. It did not change any deliberations or analysis, nor did it change when the vaccine will actually go into use.

ummonk 6y ago

I hate Trump's bullying tactics as much as the next person, but let's be clear - the FDA had completed its data analysis and released it a few days ago, and then the advisory panel yesterday supported its endorsement. At this point it was clear the vaccine was safe and effective, and an EUA should be rapidly announced by the FDA, whether the Trump would pressure them or not.

tehjoker 6y ago
I don't understand then, why would the FDA need to be threatened? Wouldn't they try to move as fast as possible within the bounds of reason?
- macksd 6y ago
  Trump threatening someone does not imply they needed to be threatened.
  - tehjoker 6y ago
    It is possible he was just pissed at any delay at all. I am just feeling extremely skeptical about believing any of these people as their goal is to get us to forget about the pandemic and get back to work at maximum productivity regardless of whether this thing works.
- zaroth 6y ago
  I mean obviously this was not the case, since they announced they would definitely approve it but not for a few more days. We are talking about government bureaucrats here after all.
  - tssva 6y ago
    Actually prior to the threat they stated that they would approve it as fast as possible and were targeting Saturday morning. Trumps bullying sped things up by about 12 hours.
    - newacct583 6y ago
      Note that the approval date has absolutely nothing to do with the production schedule, which is the real limiting factor here. Having a few hundred people get their shots on Saturday instead of Tuesday or whatever isn't realistically going to move the needle. Every dose we can get is going into a patient somewhere.
      - WalterBright 6y ago
        I saw on the news today that the vaccine was sitting waiting for the approval to ship. So yeah, getting approval sooner will get the vaccine shipping sooner.
      - lbeltrame 6y ago
        Scale-up work and production started at the end of the summer.
        newacct583 6y ago
        Yes, and every dose produced so far is ready to go into a patient immediately, they don't have a stockpile for the whole society, not remotely. Two days or whatever isn't going to matter that much. The timing of the first few thousand doses will change, the timing of the first ten million doses has to do with production and shipping, not approval.

davidf560 6y ago

The FDA announced early this morning that they were definitively going to authorize it[1], but they didn't actually issue the authorization at that point, with people telling the press that authorization would come "in the next few days". If someone called up the FDA after that and said "hey, you've already told everyone you're going to approve this, so just sign the papers and make it official today rather than going home for the weekend and finishing it up on Monday", I have no problem with that. That's not pressure to prematurely authorize it (since they already confirmed they would), that's just cutting through the red tape/BS and making it official faster (IMO). Put it into a tech perspective - if your company's cloud product went down and you were losing $millions every hour, and the devs found the bug and fixed it, but the product manager said "hey great, we'll fill out the release paperwork in the next few days and maybe approve pushing the change to prod on Monday", would anyone go for that? No way - they'd say we're not going home until this is fixed and released. Replace $millions with actual human lives and that's basically what we have here, isn't it? [1] https://www.fda.gov/news-events/press-announcements/fda-statement-vaccines-and-related-biological-products-advisory-committee-meeting https://www.fda.gov/news-events/press-announcements/fda-stat...

tehjoker 6y ago
This makes more sense to me. Thank you.
lupire 6y ago
Remember when the Challenger shuttle was ready to launch so they skipped the final checks of the frozen O-ring data analysis?

tzs 6y ago

No need to worry in this case. They were going to hold their meeting to give final approval on Saturday. All Trump's blustering did was move that to late Friday. It did not change any deliberations or analysis, nor did it change when the vaccine will actually go into use.