5 ms·

There would be no emergency use authorization allowed if there was an existing possible treatment. https://www.fda.gov/media/97321/download#page12 https://www.

There would be no emergency use authorization allowed if there was an existing possible treatment. https://www.fda.gov/media/97321/download#page12 https://www.fda.gov/media/97321/download#page12 Go to page 12 in the PDF (document page 8) then read section D. Pharma companies could not distribute experimental treatments unless they lied to us about existing useful drugs. Reminder: Pfizer: Phase 3 trial estimated end date 2023 https://clinicaltrials.gov/ct2/show/NCT04368728 https://clinicaltrials.gov/ct2/show/NCT04368728 Moderna: estimated end date 2022 https://clinicaltrials.gov/ct2/show/NCT04470427 https://clinicaltrials.gov/ct2/show/NCT04470427 Johnson & Johnson (it’s actually a Janssen Product which is a subsidiary of J&J): estimated end date 2023 https://clinicaltrials.gov/ct2/show/NCT04505722 https://clinicaltrials.gov/ct2/show/NCT04505722 AstraZeneca: estimated end date 2023 https://clinicaltrials.gov/ct2/show/NCT04516746 https://clinicaltrials.gov/ct2/show/NCT04516746

wrycoder 5y ago
That would depend on the efficacy of the existing possible treatment. Ivermectin is 70%, so it's not as effective as a vaccine. But it's a hell of lot better than nothing.
- raarts 5y ago
  Doctors often combine multiple drugs/treatments. Not every single part of the combination needs to be as good as a vaccine.
- pbak 5y ago
  You have reversed the logical sequence. You can't know how efficient a vaccine is without a trial. You need an authorization first to do that. But you wouldn't get an authorization if something exists, even "only" 70% better, because that 70% would make Covid less lethal than the yearly flu. Hence 70% is enough to block emergency vaccines trial authorization.
javagram 5y ago
Dexamethasone is an approved drug recommended by the FDA for treatment of Covid and it didn’t stop the vaccine EUA. The vaccines are 95-100% effective in trials, no other drug comes close.
- fda_hates_u 5y ago
  Please do not spread fake news. All current vaccines are less than 1% effective. https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(21)00069-0/abstract https://www.thelancet.com/journals/lanmic/article/PIIS2666-5...
  - jimmydorry 5y ago
    For anyone reading the above comment: * The quoted 95% etc. numbers are in terms of Relative Risk (ie, the ratio of attack rates with and without a vaccine—which is expressed as 1–RR) * These numbers are essentially a reported efficacy and useless to compare between studies held under different conditions. With this in mind, from the lancet article linked above: > However, RRR should be seen against the background risk of being infected and becoming ill with COVID-19, which varies between populations and over time. Although the RRR considers only participants who could benefit from the vaccine, the absolute risk reduction (ARR), which is the difference between attack rates with and without a vaccine, considers the whole population. >__ARRs tend to be ignored because they give a much less impressive effect size than RRRs: 1.3% for the AstraZeneca–Oxford, 1.2% for the Moderna–NIH, 1.2% for the J&J, 0.93% for the Gamaleya, and 0.84% for the Pfizer–BioNTech vaccines.__
    - javagram 5y ago
      “ ARRs tend to be ignored because they give a much less impressive effect size than RRR” This is an odd statement. Why would that be the reason to ignore it? ARR is extremely specific to a time frame and location. Without wide deployment of vaccines, almost everyone would eventually naturally catch the coronavirus at some point in the next several years. As vaccines are deployed, the risk reduces since vaccines reduce the R0 of the virus in that population. Any calculation of ARR would be highly speculative and have to include models about how widely the vaccine would be deployed, the transmissibility and mutation of the virus, and the RRR of the vaccine itself, as well as being stated only for a specific timeframe and location. Given all this it’s obvious why RRR is the typically reported number and the one that makes sense to use in discussions.

wrycoder 5y ago

That would depend on the efficacy of the existing possible treatment. Ivermectin is 70%, so it's not as effective as a vaccine. But it's a hell of lot better than nothing.

raarts 5y ago
Doctors often combine multiple drugs/treatments. Not every single part of the combination needs to be as good as a vaccine.
pbak 5y ago
You have reversed the logical sequence. You can't know how efficient a vaccine is without a trial. You need an authorization first to do that. But you wouldn't get an authorization if something exists, even "only" 70% better, because that 70% would make Covid less lethal than the yearly flu. Hence 70% is enough to block emergency vaccines trial authorization.

javagram 5y ago

Dexamethasone is an approved drug recommended by the FDA for treatment of Covid and it didn’t stop the vaccine EUA. The vaccines are 95-100% effective in trials, no other drug comes close.

fda_hates_u 5y ago
Please do not spread fake news. All current vaccines are less than 1% effective. https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(21)00069-0/abstract https://www.thelancet.com/journals/lanmic/article/PIIS2666-5...
- jimmydorry 5y ago
  For anyone reading the above comment: * The quoted 95% etc. numbers are in terms of Relative Risk (ie, the ratio of attack rates with and without a vaccine—which is expressed as 1–RR) * These numbers are essentially a reported efficacy and useless to compare between studies held under different conditions. With this in mind, from the lancet article linked above: > However, RRR should be seen against the background risk of being infected and becoming ill with COVID-19, which varies between populations and over time. Although the RRR considers only participants who could benefit from the vaccine, the absolute risk reduction (ARR), which is the difference between attack rates with and without a vaccine, considers the whole population. >__ARRs tend to be ignored because they give a much less impressive effect size than RRRs: 1.3% for the AstraZeneca–Oxford, 1.2% for the Moderna–NIH, 1.2% for the J&J, 0.93% for the Gamaleya, and 0.84% for the Pfizer–BioNTech vaccines.__
  - javagram 5y ago
    “ ARRs tend to be ignored because they give a much less impressive effect size than RRR” This is an odd statement. Why would that be the reason to ignore it? ARR is extremely specific to a time frame and location. Without wide deployment of vaccines, almost everyone would eventually naturally catch the coronavirus at some point in the next several years. As vaccines are deployed, the risk reduces since vaccines reduce the R0 of the virus in that population. Any calculation of ARR would be highly speculative and have to include models about how widely the vaccine would be deployed, the transmissibility and mutation of the virus, and the RRR of the vaccine itself, as well as being stated only for a specific timeframe and location. Given all this it’s obvious why RRR is the typically reported number and the one that makes sense to use in discussions.