There's more information on the process with Europe's regulator, because they're a bit less tight-lipped than the FDA. But data sharing (particularly on adverse events) has been continually happening throughout many jurisdictions and we should see approvals in a similar timeframe between Europe and the US.
I'm seeing that Pfizer and Moderna are participating in a rolling review in Europe, but I haven't yet found anything about that in the US. Is it automatically part of the Fast Track program?
Sure, the application is an "atomic event" in both Europe and the US, even if data has been previously shared and technical assistance from the regulator has been previously offered.
In the end, regulators need to give an emergency authorization or not, based on information at a certain point in time, which is also an atomic event.
Adding 'covid' to this yields https://www.biopharma-reporter.com/Article/2020/11/10/Novava...
etc.
There's more information on the process with Europe's regulator, because they're a bit less tight-lipped than the FDA. But data sharing (particularly on adverse events) has been continually happening throughout many jurisdictions and we should see approvals in a similar timeframe between Europe and the US.