If they have total immunity from FDA regulations, how are you going to be confident it actually works and is safe at scale? The regulations are there for good reasons.
I haven’t heard of a single one of the available vaccines being held back by regulations, only the speed at which they could go through human trials.
> I haven’t heard of a single one of the available vaccines being held back by regulations, only the speed at which they could go through human trials.
The vaccine trials were drastically slowed down by the regulations against human challenge trials.
Err.. why not? Not sure how asserting this without explaining why helps. From my understanding, Moderna made their vaccine in a day in early 2020 (https://nymag.com/intelligencer/2020/12/moderna-covid-19-vac...) and HCT basically means deliberately infecting people. One day to make the vaccine, four weeks for it to take effect, infect everybody, four weeks to see who gets sick - that's 2 months to make and test a vaccine with HCT. It took us 11 months without HCT.
You still need the phase I trial to determine that it is somewhat safe, the phase II trial to determine that it is somewhat effective for some people, and the phase III trial to see if it is safe and effective on a large diverse population and to characterize side effects.
If you were dealing with a disease that is rare so that it might take a long time for enough people in phase II or III to get exposed to it naturally, an HCT might be able to cut the amount of time you need for phase II and maybe phase III.
With COVID, there should be enough people getting exposed naturally to make that unnecessary in phase III and probably in phase II.
What an HCT might do for a COVID vaccine is let you figure out early that your vaccine does not work. That might let you abandon an ineffective vaccine during phase II instead of not finding out it doesn't work until after you have spent a lot of time and money on phase III.
I haven’t heard of a single one of the available vaccines being held back by regulations, only the speed at which they could go through human trials.