The FDA published "enhanced" guidance for vaccine manufacturers, as discussed previously here (link). A large number of experts immediately issued a warning against the "median" rule, which you already know makes little sense, as it allows participants with barely any observation time to influence the finding of the interim analyses.
What needs to be said is how the media, while decrying the politicization of vaccine trials, inadvertently promote politicization. Yes, they did, with headlines like this:
The headline writer - on whose authority? - believes that the vaccine could have been authorized by early November when most experts not involved in these trials have said over and over again that such a timeline is impossible. I explain the simple math in this post (link).
Instead, the headline could have written as:
U.S. FDA guidelines close loophole that may allow unsafe
COVID-19 vaccine authorization before election
This headline describes better what's happening.
(As reported above, many experts are unhappy with the new guidlines. In fact, we fear that the new guidelines set a low bar. This is the problem of "proficiency testing". If one sets a minimum passing standard, one ends up with lots of samples that just meet the minimum, pushing down the average standard.)
The suggested headline might still be considered political, although how one can say it is political while accepting the Reuters headline as apolicitical is beyond me. The following should be non-controversial:
U.S. FDA safety guidelines confirm COVID-19 vaccine
authorization not likely before election
The truth is no vaccine was going to appear before November. These guidelines just confirm that to be the case.
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