4 ms·

Yeah, I do wonder what might have caused such a massive difference between the two placebo groups (17.6 and 42.2 per 10K). Small samples? The confidence inter

by aix1 4y ago

Yeah, I do wonder what might have caused such a massive difference between the two placebo groups (17.6 and 42.2 per 10K). Small samples? The confidence intervals look pretty wide.

em500 4y ago
Here's the full paper: https://reader.elsevier.com/reader/sd/pii/S0264410X22010283 https://reader.elsevier.com/reader/sd/pii/S0264410X22010283 As I understand it, these are results from two different trials done separately by Pfizer and Moderna, with slightly different protocols and reporting standards: "Moderna reported SAEs [serious adverse effects] from dose 1 whereas Pfizer limited reporting from dose 1 to 1 month after dose 2." "For reasons that are not documented in the trial protocol, Moderna included efficacy outcomes in its SAE tabulations, while Pfizer excluded them. As a result, Moderna’s SAE table did not present a traditional SAE analysis but rather an all-cause SAE analysis. " Thus, only numerical comparisons between treatment and control within the same trial are valid (assuming proper randomization), not between the two trials.
- rurban 4y ago
  https://www.sciencedirect.com/science/article/pii/S0264410X22010283?via%3Dihub https://www.sciencedirect.com/science/article/pii/S0264410X2... Pfizer reported serious adverse effects in 127 vaccine and 93 placebo. Moderna reported serious adverse effects in 206 vaccine and 195 placebo. => Headline: "Serious adverse events of special interest following placebo vaccination in randomized trials in adults"
- LorenPechtel 4y ago
  Normally there aren't competing drugs racing to market, thus the FDA doesn't have any system in place to ensure apples-to-apples comparisons in a case like this. Each company decides it's test protocols and gets FDA approval, they aren't working in cooperation.
LorenPechtel 4y ago
The number of test subjects isn't small, but the number that have something bad happen is small (they're not going to accept test subjects with obvious, serious problems because that makes the data noisier.) Reducing noise means increasing the sample size--to get clean data here you would need a truly huge test group. I wouldn't be surprised if you would have to use the whole nation as your test group--and what's the point??

by aix1 4y ago

Yeah, I do wonder what might have caused such a massive difference between the two placebo groups (17.6 and 42.2 per 10K). Small samples? The confidence intervals look pretty wide.

em500 4y ago

Here's the full paper: https://reader.elsevier.com/reader/sd/pii/S0264410X22010283 https://reader.elsevier.com/reader/sd/pii/S0264410X22010283 As I understand it, these are results from two different trials done separately by Pfizer and Moderna, with slightly different protocols and reporting standards: "Moderna reported SAEs [serious adverse effects] from dose 1 whereas Pfizer limited reporting from dose 1 to 1 month after dose 2." "For reasons that are not documented in the trial protocol, Moderna included efficacy outcomes in its SAE tabulations, while Pfizer excluded them. As a result, Moderna’s SAE table did not present a traditional SAE analysis but rather an all-cause SAE analysis. " Thus, only numerical comparisons between treatment and control within the same trial are valid (assuming proper randomization), not between the two trials.

rurban 4y ago
https://www.sciencedirect.com/science/article/pii/S0264410X22010283?via%3Dihub https://www.sciencedirect.com/science/article/pii/S0264410X2... Pfizer reported serious adverse effects in 127 vaccine and 93 placebo. Moderna reported serious adverse effects in 206 vaccine and 195 placebo. => Headline: "Serious adverse events of special interest following placebo vaccination in randomized trials in adults"
LorenPechtel 4y ago
Normally there aren't competing drugs racing to market, thus the FDA doesn't have any system in place to ensure apples-to-apples comparisons in a case like this. Each company decides it's test protocols and gets FDA approval, they aren't working in cooperation.

LorenPechtel 4y ago

The number of test subjects isn't small, but the number that have something bad happen is small (they're not going to accept test subjects with obvious, serious problems because that makes the data noisier.) Reducing noise means increasing the sample size--to get clean data here you would need a truly huge test group. I wouldn't be surprised if you would have to use the whole nation as your test group--and what's the point??