3 ms·

While this is technically true, it's only because the FDA abandoned all previous procedure for full approval.

by linuxftw 5y ago

junon 5y ago
Expedited approval in the middle of a pandemic is not the same as "abandoning all previous procedure".
- linuxftw 5y ago
  Except that it is. They were already able to distribute the product under EUA. The push for 'full approval' was entirely political. What's the bar for full approval? Whatever the FDA says it is. Usually that includes convening the advisory committee. That didn't happen. Recently, 3 members resigned from said committee. While these resignations weren't about the vaccines, they were about a lack of trust in FDA (interim) leadership. If you want to continue to believe everything is just okie-dokie, knock yourself out, but you're not going to convince anyone.
  - junon 5y ago
    > If you want to continue to believe everything is just okie-dokie, knock yourself out Seeing as how I'm in Germany and I have close friends at RKI, I choose to believe them - as they are unequivocally the experts on the topic - over American politics. > but you're not going to convince anyone. Please argue in good faith next time.
  - Retric 5y ago
    People avoiding vaccination and thus dying because the FDA hasn’t done full approval is more than a political issue. It’s a real heath issue and exactly the kind of public health problem the FDA is concerned with. The general public doesn’t understand that expedited approval was a well understood category years before COVID and designed exactly for situations like this. Check the way back machine of your feeling paranoid. As to the actual science we have vastly more data on COVID vaccinations than most drugs or vaccines the FDA is approving. It really isn’t some ad hoc process it’s well designed procedures and massive quantities of scientific data.
    - deleted 5y ago
      [deleted]
    - linuxftw 5y ago
      > As to the actual science we have vastly more data on COVID vaccinations than most drugs or vaccines the FDA is approving Who is we? We never received the raw trial data. The data that the general public does have access to, while very flawed, says these vaccines are the most deadly ever to be widely administered. > People avoiding vaccination and thus dying because the FDA hasn’t done full approval is more than a political issue. It’s a real heath issue and exactly the kind of public health problem the FDA is concerned with. People mistook the desire for long term safety studies and completion of phase 3 clinical trials as "FDA approval." The two things were previously synonymous, at least to the lay person. FDA approval was merely a proxy, now it's meaningless. > The general public doesn’t understand The general public can't add 2 fractions, what they think is irrelevant.
    - TeeMassive 5y ago
      > People avoiding vaccination and thus dying because the FDA hasn’t done full approval is more than a political issue People can refuse medical treatments, even if deemed in their utmost interest.
      - Retric 5y ago
        This isn’t about the option to refuse, this is about the reasons someone refuses. The FDA does quite a bit of outreach over heath and food safety because information has real public health implications. Ex: https://www.fda.gov/food/buy-store-serve-safe-food/selecting-and-serving-produce-safely https://www.fda.gov/food/buy-store-serve-safe-food/selecting... Which isn’t to say their doing a great job, just that they consider it part of their mandate and they get funding for it.
deleted 5y ago
[deleted]

While this is technically true, it's only because the FDA abandoned all previous procedure for full approval.

junon 5y ago

Expedited approval in the middle of a pandemic is not the same as "abandoning all previous procedure".

linuxftw 5y ago
Except that it is. They were already able to distribute the product under EUA. The push for 'full approval' was entirely political. What's the bar for full approval? Whatever the FDA says it is. Usually that includes convening the advisory committee. That didn't happen. Recently, 3 members resigned from said committee. While these resignations weren't about the vaccines, they were about a lack of trust in FDA (interim) leadership. If you want to continue to believe everything is just okie-dokie, knock yourself out, but you're not going to convince anyone.
- junon 5y ago
  > If you want to continue to believe everything is just okie-dokie, knock yourself out Seeing as how I'm in Germany and I have close friends at RKI, I choose to believe them - as they are unequivocally the experts on the topic - over American politics. > but you're not going to convince anyone. Please argue in good faith next time.
- Retric 5y ago
  People avoiding vaccination and thus dying because the FDA hasn’t done full approval is more than a political issue. It’s a real heath issue and exactly the kind of public health problem the FDA is concerned with. The general public doesn’t understand that expedited approval was a well understood category years before COVID and designed exactly for situations like this. Check the way back machine of your feeling paranoid. As to the actual science we have vastly more data on COVID vaccinations than most drugs or vaccines the FDA is approving. It really isn’t some ad hoc process it’s well designed procedures and massive quantities of scientific data.
  - deleted 5y ago
    [deleted]
  - linuxftw 5y ago
    > As to the actual science we have vastly more data on COVID vaccinations than most drugs or vaccines the FDA is approving Who is we? We never received the raw trial data. The data that the general public does have access to, while very flawed, says these vaccines are the most deadly ever to be widely administered. > People avoiding vaccination and thus dying because the FDA hasn’t done full approval is more than a political issue. It’s a real heath issue and exactly the kind of public health problem the FDA is concerned with. People mistook the desire for long term safety studies and completion of phase 3 clinical trials as "FDA approval." The two things were previously synonymous, at least to the lay person. FDA approval was merely a proxy, now it's meaningless. > The general public doesn’t understand The general public can't add 2 fractions, what they think is irrelevant.
  - TeeMassive 5y ago
    > People avoiding vaccination and thus dying because the FDA hasn’t done full approval is more than a political issue People can refuse medical treatments, even if deemed in their utmost interest.
    - Retric 5y ago
      This isn’t about the option to refuse, this is about the reasons someone refuses. The FDA does quite a bit of outreach over heath and food safety because information has real public health implications. Ex: https://www.fda.gov/food/buy-store-serve-safe-food/selecting-and-serving-produce-safely https://www.fda.gov/food/buy-store-serve-safe-food/selecting... Which isn’t to say their doing a great job, just that they consider it part of their mandate and they get funding for it.

deleted 5y ago

[deleted]