Ethan
Money List Winner
A word on safety in clinical in clinical trials. It is impossible to prove a negative. Nobody can ever prove that there is no risk.
Safety assessment is about probability. We saw X% of people had headaches in the vaccine group, X% in the placebo group, unlikely to be a vaccine-related effect on headache.
The problem comes when there is a rare event, because the statistical comparison is more difficult. One case of something obscure in one group, compared 2 or 3 cases in the other is more difficult to interpret.
Safety assessment is complicated and the correct approach is to consider benefit-risk, to the individual usually, but a degree of societal benefit too is usually considered for vaccines.
Safety assessment is about probability. We saw X% of people had headaches in the vaccine group, X% in the placebo group, unlikely to be a vaccine-related effect on headache.
The problem comes when there is a rare event, because the statistical comparison is more difficult. One case of something obscure in one group, compared 2 or 3 cases in the other is more difficult to interpret.
Safety assessment is complicated and the correct approach is to consider benefit-risk, to the individual usually, but a degree of societal benefit too is usually considered for vaccines.