They -are-. The FDA has been in the loop every step of the way.
Still, there is a need for comprehensive review of safety and for everyone to understand the possible risks. You can really only begin to complete this when you have a full application.
I hope the FDA manages to shave a few days off the process from our anticipated mid-December timeline, but it's not like a few days makes very much difference. We'll have approximately the same number of doses produced and administered by December 31st no matter when approval happens; moving forward the timeline a day or two doesn't stop very many cases. Production is the critical path.
On the other hand, fully vetting an application and detecting a substantial gotcha could make a very big difference.
We're already talking of approving this with far less safety and efficacy data, and calendar time, than we're used to. There's not too much fat left to trim in the process. (This is why an initial EUA may be fairly narrowly crafted, too, and not authorize giving the vaccine to all subpopulations... with a few more months opening the door to wider use).
I'm sure a lot of people are staying up late as the EUA applications come in, and skimming the documents and working to identify remaining weaknesses that can be proactively addressed. But sometime in this, they need to get a good night's sleep, and begin meticulously going through the document and make sure the remaining, necessary (i.e. not waived) conditions for emergency use approval are met.
Adding 'covid' to this yields
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?
What do press releases like these mean:
Are they announcing the _conclusion_ of the application process? It sort of presents the application as an atomic event.
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.
The process has been incredibly dramatically shortened, but without actually rushing. All of the data required for an EUA is still required. Some timelines have been permitted to be shortened in exchange for dramatically increasing the number of people involved in trials, but they haven't been allowed to be shortened beyond what we know about biological response times. People at press conferences may use general terms like "in a few days," but that's not because they're treating this casually, it's because humans communicate in human ways when talking to other humans. If you're on the FDA, you know the timeline to a T, but if you're part of the general public, "December" and "April" are all you really need.
The FDA has been heavily involved in every step of the trials, which is how things have moved as quickly as they have.
These are the fastest any vaccine has ever been created or approved, by more than four years!
I guess I'm left wondering why you wrote a whole post of your own to ask questions that you could have answered by searching for the large amount of information that is already out there about this process, possibly the most-closely-tracked vaccine development process in history. But hey, it's a free internet, more or less.