Signaler un abus

@bubu12
 

The 371 individuals excluded from Pfizer vaccine efficacy analysis

Another reason we need more data is to analyse an unexplained detail found in a table of FDA’s review of Pfizer’s vaccine : 371 individuals excluded from the efficacy analysis for “important protocol deviations on or prior to 7 days after Dose 2.” What is concerning is the imbalance between randomized groups in the number of these excluded individuals : 311 from the vaccine group vs 60 on placebo. (In contrast, in Moderna’s trial, there were just 36 participants excluded from the efficacy analysis for “major protocol deviation”—12 vaccine group vs 24 placebo group.)

What were these protocol deviations in Pfizer’s study, and why were there five times more participants excluded in the vaccine group ? The FDA report doesn’t say, and these exclusions are difficult to even spot in Pfizer’s report and journal publication.