4 ms·

I'm probably going to be downvoted for this...pointing out any issues in any measures towards covid seems to have this effect. But how is astrazeneca's methodo

I'm probably going to be downvoted for this...pointing out any issues in any measures towards covid seems to have this effect. But how is astrazeneca's methodology reasonable? https://www.astrazeneca.com/media-centre/press-releases/2020/azd1222hlr.html https://www.astrazeneca.com/media-centre/press-releases/2020... >Over 23,000 participants are being assessed following two doses of either a half-dose/full-dose regimen or a regimen of two full doses of AZD1222 or a comparator, meningococcal conjugate vaccine called MenACWY. The placebo in the study was a meningitis vaccine that actually caused issues that halted the study and because astrazeneca's vaccine was deemed more effective than that, the vaccine was deemed a success. In what way is that anywhere near a reasonable clinical study?

cmrdporcupine 6y ago
Their process was not reasonable. Which is why it was considered a failure and I believe they had to go back to the drawing board. They will have to do a proper job, if they haven't already. With the other two vaccines already approved, national health boards will be in no rush to fast track it.
- Exmoor 6y ago
  Not sure where you're getting your data, but it's incorrect. It was not considered a failure. There have been some questions about what the best dosage and timing might be for the highest effectiveness, but I've heard the UK may approve it as early as tomorrow. The USA may wait until the trial being run inside the USA is completed, but that has more to do with ensuring the vaccine is safe and works on their wide demographics than any concerns with how the UK and Brazil studies were done.
  - respinal 6y ago
    >the UK may approve it as early as tomorrow. https://news.ycombinator.com/item?id=25549454 https://news.ycombinator.com/item?id=25549454
    - respinal 6y ago
      Update: They did https://news.ycombinator.com/item?id=25579391 https://news.ycombinator.com/item?id=25579391
mlyle 6y ago
Having a placebo which has some degree of side effects is not insane, even though it caused problems here. The vaccines have lots of side effects. If you give something with lots of side effects and compare it to a placebo with none, people have a good guess of what group they're in and behave differently. This is often considered more reasonable than comparing to a saline injection, and it's a reason why lots of drugs now are compared to e.g. ritalin-- something relatively benign with some side effect that feels like it is "doing something". The half-dose/full-dose regimen was a mistake in a clinic administering the trial, though. A mistake that happened to look more effective than the overall vaccine population, which is a bit troublesome and a primary reason why AstraZeneca has problems now. Now that we have effective COVID vaccines, we can run noninferiority trials-- e.g. comparing Moderna's vaccine to a potential new vaccine-- which get around a lot of the problems here.
- respinal 6y ago
  > The half-dose/full-dose regimen was a mistake in a clinic administering the trial, though. More on that here: https://news.ycombinator.com/item?id=25548342 https://news.ycombinator.com/item?id=25548342
deleted 6y ago
[deleted]
ashtonkem 6y ago
The placebo has to be something that feels like a vaccine, otherwise the double-blind aspect will be broken. But since we know the precise risks associated with meningitis vaccines, we can trivially determine the relative risk of the covid vaccine compared to something else of a known risk level. Oh, and it's not like the meningitis vaccine will confer any protection from covid.

cmrdporcupine 6y ago

Their process was not reasonable. Which is why it was considered a failure and I believe they had to go back to the drawing board. They will have to do a proper job, if they haven't already. With the other two vaccines already approved, national health boards will be in no rush to fast track it.

Exmoor 6y ago
Not sure where you're getting your data, but it's incorrect. It was not considered a failure. There have been some questions about what the best dosage and timing might be for the highest effectiveness, but I've heard the UK may approve it as early as tomorrow. The USA may wait until the trial being run inside the USA is completed, but that has more to do with ensuring the vaccine is safe and works on their wide demographics than any concerns with how the UK and Brazil studies were done.
- respinal 6y ago
  >the UK may approve it as early as tomorrow. https://news.ycombinator.com/item?id=25549454 https://news.ycombinator.com/item?id=25549454
  - respinal 6y ago
    Update: They did https://news.ycombinator.com/item?id=25579391 https://news.ycombinator.com/item?id=25579391

mlyle 6y ago

Having a placebo which has some degree of side effects is not insane, even though it caused problems here. The vaccines have lots of side effects. If you give something with lots of side effects and compare it to a placebo with none, people have a good guess of what group they're in and behave differently. This is often considered more reasonable than comparing to a saline injection, and it's a reason why lots of drugs now are compared to e.g. ritalin-- something relatively benign with some side effect that feels like it is "doing something". The half-dose/full-dose regimen was a mistake in a clinic administering the trial, though. A mistake that happened to look more effective than the overall vaccine population, which is a bit troublesome and a primary reason why AstraZeneca has problems now. Now that we have effective COVID vaccines, we can run noninferiority trials-- e.g. comparing Moderna's vaccine to a potential new vaccine-- which get around a lot of the problems here.

respinal 6y ago
> The half-dose/full-dose regimen was a mistake in a clinic administering the trial, though. More on that here: https://news.ycombinator.com/item?id=25548342 https://news.ycombinator.com/item?id=25548342

deleted 6y ago

[deleted]

ashtonkem 6y ago

The placebo has to be something that feels like a vaccine, otherwise the double-blind aspect will be broken. But since we know the precise risks associated with meningitis vaccines, we can trivially determine the relative risk of the covid vaccine compared to something else of a known risk level. Oh, and it's not like the meningitis vaccine will confer any protection from covid.