I saw this in the news and was wondering what 'dopers think about it. Apparently, China has waved phase 3 trials and is going ahead with a broader test of a vaccine candidate for use by their military. Also, Brazil might be allowing for volunteers to test this candidate as well. I’d quote some from the article, but I can’t figure out how to do that, so I’ll leave it to anyone interested to take a look.
Does this seem like a good idea? Leaving aside that this is China, and they don’t have exactly a stellar reputation wrt vaccines or testing, is it a good idea to skip this phase before going to more general trials? How much might this speed up (or slow down) the process?
In the EU there’s a thing called Conditional Approval - I assume most countries have something similar - which is used in situations of great need. It’s used to address unmet need in the case of serious disease. It’s a risk/benefit thing that you would implement for a strong candidate as soon as you felt able. Basically, the regulator’s position is that the need is so great that (as Phase III is just beginning, say) we’ll go with the evidence you currently have. Continue with Phase III trials and intensively monitor use in the community. Report all new data to us on an expedited basis. If it works, great, we’ll convert your conditional authorisation to a regular one. If it doesn’t work, we’ll withdraw the authorisation.*
I had always assumed that vaccines would be conditionally approved on the basis of Phase !! and limited phase III (with intensive post-authorisation monitoring, of course), and wouldn’t be surprised if a strong candidate got conditionally approved on the basis of Phase II only. It looks like this is what is happening in China. Makes sense to me. Plus, the military must be a hell of a breeding ground for COVID - it’s a great potential source of data from a low risk population. It would be better if this was restricted to volunteers within the military - do we know if that’s what’s happening? If not, I guess you have to say - well hey, it’s China, I guess.
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PS - expect such withdrawals, by the way. That’s not a bad thing. Risk/Benefit is a relative thing. It can good decision to conditionally approve vaccine A, even if you withdraw the approval a year later when Vaccine B proves to be much better. For a year, vaccine A at least offered some protection, when the alternative at the time was none. The existence of vaccine B changes the Risk/Benefit of vaccine A.
