On Nov. 11, 2020, Moderna announced that it had completed case accrual for the first interim analysis of the Phase 3 COVE study of mRNA-1273, its COVID-19 vaccine candidate. The Phase 3 study was designed in collaboration with the FDA and NIH to evaluate Americans at the highest risk of severe COVID-19 disease and included more than 7,000 Americans over the age of 65.

Moderna had seen a significant increase in the rate of case identification across sites. As a result, the Company expected the first interim analysis will include substantially more than 53 cases, the targeted trigger point for the analysis. The data on these cases was 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.