| "Getting a bit more speculative, why aren’t scientists at Pfizer and Moderna already in conversation with decision makers at the FDA so that the evaluation process can be started based on preliminary data?" 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). |