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Phase III examines both the efficacy and safety of the vaccine. These are independent questions. Just because a trial takes x years to determine efficacy, it
by nfw2 6y ago
Phase III examines both the efficacy and safety of the vaccine. These are independent questions.
Just because a trial takes x years to determine efficacy, it doesn't necessarily take the same amount of time to determine safety.
Fauci said certain vaccines could be approved as soon as there were enough events in the control group. Any dangerous side effects would only be in the experimental group and not dependent on events in the control group. If the only blocking factor is number of events in the control group, that to me suggest that the question of safety has already be sufficiently resolved for some of the candidate vaccines.
- maxerickson 6y agoYes, I directly addressed that. A potential safety issue with vaccines is making the course of the infection worse. So you have to look at vaccinated people that get infected (an 'event') to check on that. Phase II checks if the vaccines directly causes problems, but doesn't look at a lot of events.
- nfw2 6y agoI see, thanks for the clarification