> But what’s the rush, asks Peter Doshi, and is just six months of data from now unblinded trials acceptable?
> Unblinded and without a control group—what about safety?
There shouldn't be a rush. Now that such a large number of people who wanted it has gotten it, we might as well do the full 10-years-plus process of seeing all the effects and going through the normal process. It shouldn't be used as a reason to say "no more studies needed, since it got approval", or "emergency authorisation seems to have worked, so let's just skip to full approval".
I believe the crux of the issue and the reason for the push to approval is contained in this section:
> Finally, it may affect the potential for vaccine mandates: “It is unlikely these vaccines will be mandated while an EUA is in place. Remember that currently these vaccines are still considered experimental.”
While still under EUA, an increasing number of educational and other institutions have already mandated vaccines, but debates over the legality of these actions has hinged on the distinction between authorisation and approval.
Hmm, I would say 600k deaths in the US alone qualifies as a rush when the vaccines are reducing these to 0. There is in fact quite a lot of data out there.
> Unblinded and without a control group—what about safety?
There shouldn't be a rush. Now that such a large number of people who wanted it has gotten it, we might as well do the full 10-years-plus process of seeing all the effects and going through the normal process. It shouldn't be used as a reason to say "no more studies needed, since it got approval", or "emergency authorisation seems to have worked, so let's just skip to full approval".
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