The FDA guidance document would establish a clear and immutable benchmark. However, the guidance would also be issued well in advance of any chance to see the interim data from the ongoing clinical trials. Nobody knew at that time how effective the vaccines were going to be. If you had asked me, I would have guessed 60 or 70 percent based on the earlier data that I had reviewed for the Pfizer vaccine. Before the data from the vaccine’s pivotal study was available, I didn’t expect the vaccine to be 95 percent effective, and I suspect few others did.
