Originally Posted by
Diplomatico
The announcement today that the FDA will meet on 26 Feb (3 weeks from now) to discuss the J&J vaccine approval is maddening. Seriously? Is there something that's more important right now?
An application to the FDA for emergency authorization can be many hundreds of pages long (I’ve seen documents for full approval that are thousands of pages). It will include everything from cell and animal test results to clinical trial design details to manufacturing and labeling specifics. Every page gets read and critically reviewed by scientific subject experts. You really want a pair of commercially unbiased eyes to make sure that everything is as the manufacturer claims it to be. It takes time.