“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.”
“The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued.”
I am no expert, but possible the calculation of the confidence interval is not valid for such adaptive rules where the evaluation is triggered by the number of disease cases.
Indeed, Biontech and Pfizer state that they will the assess the precision of the estimated vaccine efficacy using a Bayesian framework with a particular prior distribution described on p. 102-103 of their study plan. Alas, I know very little of Bayesian analysis so I abstain from computing the posterior distribution given the data at hand.
But even absent the full-fledged Bayesian analysis, the numbers really look like very good news.
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