4 ms·

Smells a little bit like what some of us (developers) occasionally do when under pressure. As in, trying to save some crucial time in a rush, by focusing on tes

Smells a little bit like what some of us (developers) occasionally do when under pressure. As in, trying to save some crucial time in a rush, by focusing on testing just the things that were specifically worked on, instead of running it through the entire test suite (or QA dept) before deploying. If something comes up, user feedback will certainly bubble through quickly enough and can be worked on. Which, to be perfectly frank, often does work out just fine.

TotempaaltJ 6y ago
I'm pretty certain this has nothing to do with pressure. The risks profile is very different, and for the same reason my trials aren't run on pregnant women. It hardly makes sense (and would be immoral) to include people in a clinical trail who you know are more likely to get adverse affects (up to death) from the drug/vaccine. Especially for vaccines you know there will be certain subgroups that can't be vaccinated anyway, and because of herd immunity that doesn't matter too much.
- mittermayr 6y ago
  Why let those subgroups participate in the first vaccinations though? If they were clearly aware of this, why go ahead in one of the most-watched "deployments" (in my life-time), and invite the potential risk (and it's a huge risk) in only after it's gone "live" with the real population? I mean, if I knew those subgroups would be problematic, I sure as hell would make sure the first week of those vaccinations would go as smooth as possible (with all the media and the rest of humanity carefully watching), and give it to people I am most certain will be fine with it. Everything else, the trials should've caught, or should catch in the near future? Why play the risk on day one?!
  - rsynnott 6y ago
    While they haven't said yet, it's fairly clear this was an error; either the people with a history of allergies ignored the warnings (every vaccine I've had as an adult has come with allergy warnings) or the warnings weren't given (which would be bad and must be fixed).
ajmurmann 6y ago
> which is reflected in the MHRA’s emergency approval protocol Makes me think this is an acknowledged limitation and a closer metaphor would be removing some use cases and cutting scope. I'm not sure I follow why this is news and a changed in protocol if it was known since the approval
rsynnott 6y ago
This is entirely normal for drug development. AIUI they also didn't test on pregnant people. Given that the aim here is to produce herd immunity, rather than sterilising immunity in 100% of the population, this should all broadly be fine.
- mittermayr 6y ago
  Sure, yet, I wonder why this seems to trickle out the day AFTER the first run, when, if it's true what you say (and I have no idea, so you certainly know more about it) they would have been able to avoid this entire report / potential fiasco (think of the anti-vaxxers) by announcing it a bit more boldly beforehand, no? Why let that bit of negative information overshadow the second day?
  - rsynnott 6y ago
    It's more or less standard. _Any_ new drug is highly likely to exclude certain classes of people. This is particularly the case with vaccines where the risks of excluding a small number of people are generally low, as you're relying on herd immunity anyway. I'm not sure if this was talked about before, but the fact that (like basically every vaccine ever) it won't initially be available to pregnant women was certainly talked about ahead of time. This isn't a fiasco; it's normal.
    - s0l1dsnak3123 6y ago
      I think you miss the point entirely. The broader public's perception of the drug is instrumental to its adoption. If the public are led to believe that the medicine is unsafe, the result will be a reduced level of herd immunity as fewer people will take the vaccine. Medical institutions (CDC, BMJ, Public Health England), the Government, and the broader media (newspapers, TV stations, companies like Facebook) are responsible for encouraging safe and efficacious use of medicine for the good of society, but they can't do that when the narrative is co-opted by anti-vaxxers, the right, and other shameless opportunists.
btian 6y ago
Nope. You learn nothing by testing on people with known allergies to the ingredients.

TotempaaltJ 6y ago

I'm pretty certain this has nothing to do with pressure. The risks profile is very different, and for the same reason my trials aren't run on pregnant women. It hardly makes sense (and would be immoral) to include people in a clinical trail who you know are more likely to get adverse affects (up to death) from the drug/vaccine. Especially for vaccines you know there will be certain subgroups that can't be vaccinated anyway, and because of herd immunity that doesn't matter too much.

mittermayr 6y ago
Why let those subgroups participate in the first vaccinations though? If they were clearly aware of this, why go ahead in one of the most-watched "deployments" (in my life-time), and invite the potential risk (and it's a huge risk) in only after it's gone "live" with the real population? I mean, if I knew those subgroups would be problematic, I sure as hell would make sure the first week of those vaccinations would go as smooth as possible (with all the media and the rest of humanity carefully watching), and give it to people I am most certain will be fine with it. Everything else, the trials should've caught, or should catch in the near future? Why play the risk on day one?!
- rsynnott 6y ago
  While they haven't said yet, it's fairly clear this was an error; either the people with a history of allergies ignored the warnings (every vaccine I've had as an adult has come with allergy warnings) or the warnings weren't given (which would be bad and must be fixed).

ajmurmann 6y ago

> which is reflected in the MHRA’s emergency approval protocol Makes me think this is an acknowledged limitation and a closer metaphor would be removing some use cases and cutting scope. I'm not sure I follow why this is news and a changed in protocol if it was known since the approval

rsynnott 6y ago

This is entirely normal for drug development. AIUI they also didn't test on pregnant people. Given that the aim here is to produce herd immunity, rather than sterilising immunity in 100% of the population, this should all broadly be fine.

mittermayr 6y ago
Sure, yet, I wonder why this seems to trickle out the day AFTER the first run, when, if it's true what you say (and I have no idea, so you certainly know more about it) they would have been able to avoid this entire report / potential fiasco (think of the anti-vaxxers) by announcing it a bit more boldly beforehand, no? Why let that bit of negative information overshadow the second day?
- rsynnott 6y ago
  It's more or less standard. _Any_ new drug is highly likely to exclude certain classes of people. This is particularly the case with vaccines where the risks of excluding a small number of people are generally low, as you're relying on herd immunity anyway. I'm not sure if this was talked about before, but the fact that (like basically every vaccine ever) it won't initially be available to pregnant women was certainly talked about ahead of time. This isn't a fiasco; it's normal.
  - s0l1dsnak3123 6y ago
    I think you miss the point entirely. The broader public's perception of the drug is instrumental to its adoption. If the public are led to believe that the medicine is unsafe, the result will be a reduced level of herd immunity as fewer people will take the vaccine. Medical institutions (CDC, BMJ, Public Health England), the Government, and the broader media (newspapers, TV stations, companies like Facebook) are responsible for encouraging safe and efficacious use of medicine for the good of society, but they can't do that when the narrative is co-opted by anti-vaxxers, the right, and other shameless opportunists.

btian 6y ago

Nope. You learn nothing by testing on people with known allergies to the ingredients.