Acceleration in rate of COVID-19 disease across trial sites; Company expects more than 53 cases will be submitted to Data Safety Monitoring Board for the first interim analysis
#MRNA "announced that it has completed case accrual for the first interim analysis of the Phase 3 COVE study of mRNA-1273, its COVID-19 vaccine candidate.
Moderna has seen a significant increase in the rate of case identification across sites in the last week. As a result, the Company expects the first interim analysis will include substantially more than 53 cases, the targeted trigger point for the analysis. The data on these cases is being prepared for submission to the independent Data Safety Monitoring Board (DSMB) for analysis and recommendation. Moderna remains blinded to whether these participants received vaccine or placebo.
On October 22, the Phase 3 COVE study of mRNA-1273 completed enrollment of 30,000 participants in the U.S. The randomized, 1:1 placebo-controlled Phase 3 trial is studying mRNA-1273 at the 100 µg dose. The primary endpoint is the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2. The ClinicalTrials.gov identifier is NCT04470427" (see detailed report and press release HERE).
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