4 ms·

It’s not authorised in the US and the federal regulators keep raising their eyebrows at the data.

kmlx 6y ago
this is something i don’t get: if it works all around the world why aren’t the federal regulators simply fast tracking its approval? are they not allowed to do that?
- dtf 6y ago
  Observational studies are a lower standard of evidence than randomised controlled trials. Countries with higher levels of vaccine skepticism (eg the US) seem to be erring on the side of doing things by the book. The UK, by comparison, enjoys a high degree of trust in its healthcare system and can afford to be a little more gung-ho.
  - kmlx 6y ago
    interesting thanks. how long would a randomised controlled trial take?
    - dtf 6y ago
      The AstraZeneca US phase 3 trial took about 7 months. https://clinicaltrials.gov/ct2/show/NCT04516746 https://clinicaltrials.gov/ct2/show/NCT04516746 In this case, US regulators took issue with the company's press release, rather than the results of the trial itself.
- levosmetalo 6y ago
  Who says AZ works around the world? It's the vaccine of the last resort, people will get it only if they can't get anything else because it's still better than nothing, at least for now. And "better than nothing" is just temporary because AZ is very to completely ineffective against all virus mutations that are currently spreading. If Russian and Chinese Sputnik and Sinovac vaccines were approved in the EU, we could save so many lives, but politics will rather try to force AZ than accept that they failed.
  - kmlx 6y ago
    > Who says AZ works around the world? all the authorities that have approved it? all the people that got it? we're talking tens of millions of people and authorities across the planet.
    - levosmetalo 6y ago
      and those authorities approved it because it's good and effective, or because it's the only one available on the market?
- tinus_hn 6y ago
  Because normally they can get away with a drawn out process that takes years, and if in one country some medication is curing cancer and in another country is not approved, nobody bats an eyelid. It’s a big bunch of fiefdoms that all want to do their own checks and it is a political minefield. Witness the ridiculous situation with the vaccination shutdown last week. Has nothing to do with science, everything with public image and politics. And it’s setting themselves up to fail as well because in this situation if a manufacturer has contracts with countries A and B and A pays more, they’ll just focus on approval for country A and delay approval for country B, so it’s perfectly defensible to only deliver to country A and not the country who isn’t going to use it anyway. Unfortunately this is all smoke and mirrors that goes way over the head of the general public so there’s no backlash for failing.

kmlx 6y ago

this is something i don’t get: if it works all around the world why aren’t the federal regulators simply fast tracking its approval? are they not allowed to do that?

dtf 6y ago
Observational studies are a lower standard of evidence than randomised controlled trials. Countries with higher levels of vaccine skepticism (eg the US) seem to be erring on the side of doing things by the book. The UK, by comparison, enjoys a high degree of trust in its healthcare system and can afford to be a little more gung-ho.
- kmlx 6y ago
  interesting thanks. how long would a randomised controlled trial take?
  - dtf 6y ago
    The AstraZeneca US phase 3 trial took about 7 months. https://clinicaltrials.gov/ct2/show/NCT04516746 https://clinicaltrials.gov/ct2/show/NCT04516746 In this case, US regulators took issue with the company's press release, rather than the results of the trial itself.
levosmetalo 6y ago
Who says AZ works around the world? It's the vaccine of the last resort, people will get it only if they can't get anything else because it's still better than nothing, at least for now. And "better than nothing" is just temporary because AZ is very to completely ineffective against all virus mutations that are currently spreading. If Russian and Chinese Sputnik and Sinovac vaccines were approved in the EU, we could save so many lives, but politics will rather try to force AZ than accept that they failed.
- kmlx 6y ago
  > Who says AZ works around the world? all the authorities that have approved it? all the people that got it? we're talking tens of millions of people and authorities across the planet.
  - levosmetalo 6y ago
    and those authorities approved it because it's good and effective, or because it's the only one available on the market?
tinus_hn 6y ago
Because normally they can get away with a drawn out process that takes years, and if in one country some medication is curing cancer and in another country is not approved, nobody bats an eyelid. It’s a big bunch of fiefdoms that all want to do their own checks and it is a political minefield. Witness the ridiculous situation with the vaccination shutdown last week. Has nothing to do with science, everything with public image and politics. And it’s setting themselves up to fail as well because in this situation if a manufacturer has contracts with countries A and B and A pays more, they’ll just focus on approval for country A and delay approval for country B, so it’s perfectly defensible to only deliver to country A and not the country who isn’t going to use it anyway. Unfortunately this is all smoke and mirrors that goes way over the head of the general public so there’s no backlash for failing.