3 ms·

There's thousands and thousands of pages of trial data, and if there's a significant screw-up, it would destroy public trust in all vaccines for decades. https

There's thousands and thousands of pages of trial data, and if there's a significant screw-up, it would destroy public trust in all vaccines for decades. https://en.wikipedia.org/wiki/Dengvaxia_controversy https://en.wikipedia.org/wiki/Dengvaxia_controversy

modeless 6y ago
It's been almost two weeks. That's more than enough time to read thousands of pages if they are literally the most important thousands of pages in the world right now.
- apsec112 6y ago
  What makes you so confident? If someone gave you the source code to a major software project, even with a large team of highly qualified engineers working as fast as they could, how long would it take to read over the entire thing and be absolutely sure that there were no serious mistakes?
  - lacker 6y ago
    If a team from the UK had already done it, I would just go ahead and accept their analysis. The US should give emergency approval now, based on the UK approval.
    - apsec112 6y ago
      That's a reasonable position, but if I were making a list of American government pandemic mistakes, this honestly wouldn't even crack the top hundred.
    - mattmanser 6y ago
      And if it turns out the UK approval process, like so much else of its bureaucracy because of years of austerity cuts, has been under-staffed, under-funded and simply bowed to political pressure? I wouldn't be so quick to trust anything British right now. We're in a bit of a state. The only reason we're not the laughing stock of the world right now is because the Americans managed to fuck up even more than us.
    - nucleardog 6y ago
      I’d prefer to see multiple agencies independently evaluating this. Swiss cheese model. Each agency is going to have holes, and many previously unknown ones could be exposed given the unusual time and societal pressures they’re working under. If the UK approves something and everyone goes “eh, good enough” that’s significantly riskier than if we wait the extra week or two and get consensus from the UK, EU, US, etc. The chances of large holes showing up in the processes of all of those agencies that align to miss something is much less. We’re talking about things we’re going to be injecting into literally hundreds of millions of people very quickly. The risks of a fuckup here are pretty severe and it’s quite likely a severe mistake would cause more harm than delaying another week or two.
  - ascorbic 6y ago
    Add to that the fact that the whole world is watching, and hundreds of thousands of lives are at stake
  - modeless 6y ago
    Well for starters, it would be stupid to pipeline the process so that nobody could start reviewing the code until after it was done. Secondly, I don't believe it's a valid analogy because the process of reviewing clinical trial evidence is not similar to the process of reviewing executable code. Thirdly, there is no amount of review that guarantees a lack of mistakes, so it's simply a question of risk tolerance which you have to balance against the harm of delay.
    - apsec112 6y ago
      They started rolling review back in October: https://www.pharmamanufacturing.com/industrynews/2020/uk-regulators-use-rolling-review-to-speed-pfizer-astrazeneca-vaccines/ https://www.pharmamanufacturing.com/industrynews/2020/uk-reg...
      - modeless 6y ago
        That's good (though it should have been earlier) but makes the approval delay even less acceptable. Edit: Actually FDA Fast Track was approved in July. There should be no surprises for the FDA in this submission. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-granted-fda-fast-track-designation-two https://www.pfizer.com/news/press-release/press-release-deta...
    - pfranz 6y ago
      > Well for starters, it would be stupid to pipeline the process so that nobody could start reviewing the code until after it was done. I imagine the expedited process also means summaries and overviews that would normally be presented were skipped--detailed documentation if we're continuing the source code metaphor.

modeless 6y ago

It's been almost two weeks. That's more than enough time to read thousands of pages if they are literally the most important thousands of pages in the world right now.

apsec112 6y ago
What makes you so confident? If someone gave you the source code to a major software project, even with a large team of highly qualified engineers working as fast as they could, how long would it take to read over the entire thing and be absolutely sure that there were no serious mistakes?
- lacker 6y ago
  If a team from the UK had already done it, I would just go ahead and accept their analysis. The US should give emergency approval now, based on the UK approval.
  - apsec112 6y ago
    That's a reasonable position, but if I were making a list of American government pandemic mistakes, this honestly wouldn't even crack the top hundred.
  - mattmanser 6y ago
    And if it turns out the UK approval process, like so much else of its bureaucracy because of years of austerity cuts, has been under-staffed, under-funded and simply bowed to political pressure? I wouldn't be so quick to trust anything British right now. We're in a bit of a state. The only reason we're not the laughing stock of the world right now is because the Americans managed to fuck up even more than us.
  - nucleardog 6y ago
    I’d prefer to see multiple agencies independently evaluating this. Swiss cheese model. Each agency is going to have holes, and many previously unknown ones could be exposed given the unusual time and societal pressures they’re working under. If the UK approves something and everyone goes “eh, good enough” that’s significantly riskier than if we wait the extra week or two and get consensus from the UK, EU, US, etc. The chances of large holes showing up in the processes of all of those agencies that align to miss something is much less. We’re talking about things we’re going to be injecting into literally hundreds of millions of people very quickly. The risks of a fuckup here are pretty severe and it’s quite likely a severe mistake would cause more harm than delaying another week or two.
- ascorbic 6y ago
  Add to that the fact that the whole world is watching, and hundreds of thousands of lives are at stake
- modeless 6y ago
  Well for starters, it would be stupid to pipeline the process so that nobody could start reviewing the code until after it was done. Secondly, I don't believe it's a valid analogy because the process of reviewing clinical trial evidence is not similar to the process of reviewing executable code. Thirdly, there is no amount of review that guarantees a lack of mistakes, so it's simply a question of risk tolerance which you have to balance against the harm of delay.
  - apsec112 6y ago
    They started rolling review back in October: https://www.pharmamanufacturing.com/industrynews/2020/uk-regulators-use-rolling-review-to-speed-pfizer-astrazeneca-vaccines/ https://www.pharmamanufacturing.com/industrynews/2020/uk-reg...
    - modeless 6y ago
      That's good (though it should have been earlier) but makes the approval delay even less acceptable. Edit: Actually FDA Fast Track was approved in July. There should be no surprises for the FDA in this submission. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-granted-fda-fast-track-designation-two https://www.pfizer.com/news/press-release/press-release-deta...
  - pfranz 6y ago
    > Well for starters, it would be stupid to pipeline the process so that nobody could start reviewing the code until after it was done. I imagine the expedited process also means summaries and overviews that would normally be presented were skipped--detailed documentation if we're continuing the source code metaphor.