Biotech Values

[JohnWayne]

PFE/BNTX PR clarification: the press release states that this was actually the first interim analysis, as they had decided to drop the previous first interim analysis at 32 events based on FDA feedback, and make the interim at 62 events the first interim analysis. However, it seems that by the time they had made this amendment to the protocol, they already had accrued 94 events.

At least that's how I read it, but I admittedly haven't been following the vaccine race with a ton of precision, so please let me know if I'm off base! Not sure if this had any material impact on the statistics/ability to meet the stopping threshold at the 1st interim, or if it's just trivia.

After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases.