So... a challenge trial at phase III will still have risks. Right now, I don’t think we have any vaccines ready to enter phase III?
COVID19 does seem to be actively spreading in the population currently. So I don’t think there would be an issue finding participants for a phase III trial.
At the point that we’re ready for phase III trials. If there is no population where COVID19 is actively spreading, perhaps challenge trials could be considered?
I realize for many that won't be an option. But with the way things are going in America right now, I'm afraid it might not be an option for anyone; it may be a requirement just to get a job or go to school. That frightens me.
That was approved in Europe but not the US.
1 in 55000 people who took pandemrix got narcolepsy.
The risk is small, but the outcome is a severe debilitating illness that requires constant care for the rest of their life.
We may decide that risk is acceptable, but we need to know about it.