the FDA would be largely locked into the guidance that they had already issued where, as a practical matter, the agency’s criteria meant that they would have to wait for the conclusion of the trial, and couldn’t base an authorization on an interim analysis of that data. I couldn’t help but think: Would the agency’s bar have been set differently had the FDA constructed its framework with knowledge of how well the vaccines would pan out? Would the FDA have used its discretion to authorize the vaccines sooner for the highest risk patients, based on an interim analysis, if it knew how effective
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