Vowing transparency at interim COVID-19 vaccine readout, Moderna expects ‘dialogue’ with FDA about unblinding study

Contrasting comments from Pfizer management on Tuesday, Moderna promised full transparency with regard to interim results from its Phase III COVE study of COVID-19 vaccine mRNA-1273. The company pledged to report either a positive or negative result, or merely a determination that the study should continue to the next analysis, at each of three planned readouts, including one likely to occur next month.

Moderna Inc. (NASDAQ:MRNA) CMO Tal Zaks also suggested the company expects to have a dialogue with FDA concerning circumstances under which the study could be unblinded before it is completed. An FDA advisory committee last week urged trial sponsors to keep studies blinded for as long as possible, and concluded that an emergency use authorization (EUA) based on an interim result should not cause the sponsor to unblind a trial...