4 ms·
Yes, but figuring out whether something is safe is different than figuring out whether is something is effective. To answer the efficacy question you would loo
by nfw2 6y ago
Yes, but figuring out whether something is safe is different than figuring out whether is something is effective.
To answer the efficacy question you would look at the infection and mortality rate of the experimental group and compare it to the rates of the control group. There is a minimum number of infection events needed in the control group for the comparison to be statistically significant, hence the long trial periods.
To answer the safety question I assumed you would wait some X period of time and evaluate the incidence of severe side effects that may have been caused by the vaccine. This analysis wouldn't be dependent on results to the control group. I assume this analysis can be sufficiently done with the current phase 3 trial data we have based on Fauci saying the only thing we are waiting for is events in the control group.
I didn't consider the potential safety issue that the vaccine could potentially make the vaccine worse. This safety analysis would also be dependent on control group events.
- mumblemumble 6y agoEstablishing safety also involves a comparison with the control group. Otherwise you can't tell if the outcome in question is significantly more or less likely in the treatment population than in control.