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Is it your opinion that trials for the Covid vaccine should have been skipped to vaccinate people earlier, or that proper trials should have actually been done

Is it your opinion that trials for the Covid vaccine should have been skipped to vaccinate people earlier, or that proper trials should have actually been done to know the efficacy and safety before testing it on the public?

bhickey 3y ago
Either would've been preferable to what was done. Waiting on a provably fruitless trial in the midst of pandemic is regulatory homicide. Throughout 2020, more than 9% of all people in nursing homes died of covid. Depending on age case fatality rates were upwards of 50%. The vaccine should've been offered to these people on a compassionate use basis. Even at the time it was obvious that actual harm posed by the virus vastly outweighed any hypothetical risk of adverse vaccine reaction. Drastically expanding the vaccinated population through compassionate use would have rapidly provided efficacy and safety data.
- _heimdall 3y ago
  > Throughout 2020, more than 9% of all people in nursing homes died of covid. Depending on age case fatality rates were upwards of 50%. That's just about most difficult population to determine primary cause of death for. Most people in nursing homes have multiple comorbidities and a long list of medications. Its easy enough to know when someone died with Covid, its much more difficult (if not impossible) to know after the fact whether that's what caused their death or if the infection began after an existing condition worsened and weakened their immune system further. > Drastically expanding the vaccinated population through compassionate use would have rapidly provided efficacy and safety data. That wouldn't have helped get efficacy or safety data for the general public though. Vaccinating that population could absolutely have helped determine efficacy for that population and I agree it feels like a reasonable action given the potential risks for that population, but the data wouldn't be useful for the general public that are younger and/or in better health prior to infection.
  - bhickey 3y ago
    > That's just about most difficult population to determine primary cause of death for. Nursing home quality, COVID-19 deaths, and excess mortality https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8776351/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8776351/ At the peak, excess nursing home mortality was nearly 6000 per week. Quibbling about "died with covid" versus "died of covid" isn't a useful exercise. Dead is dead and the excess mortality came from somewhere.
    - _heimdall 3y ago
      > Quibbling about "died with covid" versus "died of covid" isn't a useful exercise. It isn't quibbling when the specific topic is whether or not to treat a population with an untested vaccine (assuming the trials were skipped for at risk populations as proposed above). In a general sense, I totally agree the "with" versus "of" debate isn't useful. But when considering giving an at risk population an untested vaccine, how is that not important? Any intervention could have downsides, and more importantly an preventative intervention for a secondary infection may not be worth the risk depending on the risk profiles. One tricky question that would have to be answered is whether the excess deaths were related to changes in nursing home treatment and general conditions. Nursing homes were effectively locked down in many areas, reducing human contact and potentially negatively impacting care. Vaccines would have no impact there, and if the untested vaccine has negative side effects we would have only made things worse.
      - wbl 3y ago
        Vaccine risks tend to be very quickly detectable. The phase three trial timing was driven by needing enough infections and there weren't enough.
        _heimdall 3y ago
        Totally fair, by far the most common vaccine issues show up soon after injection. There is still the population challenge though. Dealing specifically with patients with multiple comorbidities and prescriptions would make it pretty tricky to recognize and then isolate the risk factors of anything that does show up. Strokes, heart attacks, circulatory issues, etc are likely pretty common in that population and any increase there after treatment may go unnoticed as a change. If you do recognize it they'd have to stop treatments entirely as you wouldn't know whether its a risk to everyone or specific to some combination of age, comorbidities, and/or other medications.
- pfisch 3y ago
  If something would've gone wrong with rushing the vaccine like that it would've given the anti-vax people a massive boost and the vaccine refusal rates would've skyrocketed. The refusal rates were already too high with anti-vax people making up lies/distorting data. If they actually had real data things would've been much worse.
  - r00fus 3y ago
    > If something would've gone wrong Anti-vaxxers simply don't care about truth vs. falsehoods. They don't care about the actual 3-phase clinical trial with tens of thousands of participants.
  - someuser2345 3y ago
    Something did go wrong; of the 3 vaccines the FDA approved, 1 of them had to be recalled due to causing fatal blood clots.
    - pfisch 3y ago
      Which effected almost no one, yet here you are talking about it. Imagine if an early covid vaccine had killed thousands. That would have had a massive chilling effect on vaccine uptake.
      - someuser2345 3y ago
        > Which effected almost no one, yet here you are talking about it. So you think the FDA was wrong to recall it? And yes, I'm talking about it because plenty of people were skeptical of the vaccines because they thought they were undertested. And given the recall, they were absolutely right. > Imagine if an early covid vaccine had killed thousands. That would have had a massive chilling effect on vaccine uptake. You're making it sound like the chilling effect would be a bad thing, when it would actually be the correct response. There are plenty of examples in the history of medicine of the cure being worse than the disease.
        3y ago

bhickey 3y ago

Either would've been preferable to what was done. Waiting on a provably fruitless trial in the midst of pandemic is regulatory homicide. Throughout 2020, more than 9% of all people in nursing homes died of covid. Depending on age case fatality rates were upwards of 50%. The vaccine should've been offered to these people on a compassionate use basis. Even at the time it was obvious that actual harm posed by the virus vastly outweighed any hypothetical risk of adverse vaccine reaction. Drastically expanding the vaccinated population through compassionate use would have rapidly provided efficacy and safety data.

_heimdall 3y ago
> Throughout 2020, more than 9% of all people in nursing homes died of covid. Depending on age case fatality rates were upwards of 50%. That's just about most difficult population to determine primary cause of death for. Most people in nursing homes have multiple comorbidities and a long list of medications. Its easy enough to know when someone died with Covid, its much more difficult (if not impossible) to know after the fact whether that's what caused their death or if the infection began after an existing condition worsened and weakened their immune system further. > Drastically expanding the vaccinated population through compassionate use would have rapidly provided efficacy and safety data. That wouldn't have helped get efficacy or safety data for the general public though. Vaccinating that population could absolutely have helped determine efficacy for that population and I agree it feels like a reasonable action given the potential risks for that population, but the data wouldn't be useful for the general public that are younger and/or in better health prior to infection.
- bhickey 3y ago
  > That's just about most difficult population to determine primary cause of death for. Nursing home quality, COVID-19 deaths, and excess mortality https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8776351/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8776351/ At the peak, excess nursing home mortality was nearly 6000 per week. Quibbling about "died with covid" versus "died of covid" isn't a useful exercise. Dead is dead and the excess mortality came from somewhere.
  - _heimdall 3y ago
    > Quibbling about "died with covid" versus "died of covid" isn't a useful exercise. It isn't quibbling when the specific topic is whether or not to treat a population with an untested vaccine (assuming the trials were skipped for at risk populations as proposed above). In a general sense, I totally agree the "with" versus "of" debate isn't useful. But when considering giving an at risk population an untested vaccine, how is that not important? Any intervention could have downsides, and more importantly an preventative intervention for a secondary infection may not be worth the risk depending on the risk profiles. One tricky question that would have to be answered is whether the excess deaths were related to changes in nursing home treatment and general conditions. Nursing homes were effectively locked down in many areas, reducing human contact and potentially negatively impacting care. Vaccines would have no impact there, and if the untested vaccine has negative side effects we would have only made things worse.
    - wbl 3y ago
      Vaccine risks tend to be very quickly detectable. The phase three trial timing was driven by needing enough infections and there weren't enough.
      - _heimdall 3y ago
        Totally fair, by far the most common vaccine issues show up soon after injection. There is still the population challenge though. Dealing specifically with patients with multiple comorbidities and prescriptions would make it pretty tricky to recognize and then isolate the risk factors of anything that does show up. Strokes, heart attacks, circulatory issues, etc are likely pretty common in that population and any increase there after treatment may go unnoticed as a change. If you do recognize it they'd have to stop treatments entirely as you wouldn't know whether its a risk to everyone or specific to some combination of age, comorbidities, and/or other medications.
pfisch 3y ago
If something would've gone wrong with rushing the vaccine like that it would've given the anti-vax people a massive boost and the vaccine refusal rates would've skyrocketed. The refusal rates were already too high with anti-vax people making up lies/distorting data. If they actually had real data things would've been much worse.
- r00fus 3y ago
  > If something would've gone wrong Anti-vaxxers simply don't care about truth vs. falsehoods. They don't care about the actual 3-phase clinical trial with tens of thousands of participants.
- someuser2345 3y ago
  Something did go wrong; of the 3 vaccines the FDA approved, 1 of them had to be recalled due to causing fatal blood clots.
  - pfisch 3y ago
    Which effected almost no one, yet here you are talking about it. Imagine if an early covid vaccine had killed thousands. That would have had a massive chilling effect on vaccine uptake.
    - someuser2345 3y ago
      > Which effected almost no one, yet here you are talking about it. So you think the FDA was wrong to recall it? And yes, I'm talking about it because plenty of people were skeptical of the vaccines because they thought they were undertested. And given the recall, they were absolutely right. > Imagine if an early covid vaccine had killed thousands. That would have had a massive chilling effect on vaccine uptake. You're making it sound like the chilling effect would be a bad thing, when it would actually be the correct response. There are plenty of examples in the history of medicine of the cure being worse than the disease.
      - 3y ago