Excellent @mattyglesias article on Human Challenge Trials. slowboring.com/p/the-case-for…
A few things he doesn't mention is that the Stage 3 trials only took around two months to reach statistical significance and could have been approved in early Oct. instead of mid-December, particularly minus the 5-6 week data review by the FDA.
Second, one could have done the same trials, but layered them a bit so that we get through them all a lot faster. I.e., start Stage 2 before stage 1 approval is complete, and take a large control group from Stage 1 and make it into part of the Stage 3 group, etc., so we get
statistical significance faster. Also, once you do 500 stage 2 injections and see no harmful side effects, they could have commenced immediately with the first (small) batch of stage 3 injections, and then continued only if no complications arise.
As I understand, the stage II participants from June did not show up in the stage 3 trial, which only began the end of July for Moderna.
Since, in stage II, you are still worried about safety, you could make a large control group to increase statistical significance without putting any more people at risk.
And, of course we should do human challenge trials as well.
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