Moderna Accumulates Sufficient COVID-19 Vaccine Trial Data for Early Readout by November End

Moderna, Inc. (Cambridge, MA, USA) has completed case accrual for the first interim analysis of the Phase 3 COVE study of mRNA-1273, its COVID-19 vaccine candidate, and is expected to release crucial data in the coming days.

On October 22, the Phase 3 COVE study of mRNA-1273 completed enrollment of 30,000 participants in the US. 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. It also included more than 5,000 Americans who are under the age of 65, but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease. These medically high-risk groups represent 42% of the total participants in the Phase 3 COVE study. 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.

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. With enough data for a first interim analysis of the late-stage trial of its COVID-19 vaccine, Moderna expects to make an announcement on the vaccine’s efficacy in the coming days.

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