Moderna completes enrollment of phase III COVE study of mRNA vaccine against COVID-19 (mRNA-1273).

To date, more than 25,650 participants have received their second vaccination. Moderna will determine whether to submit a dossier to FDA requesting Emergency Use Authorization based on an assessment of whether the potential benefit of the vaccine outweighs the potential risks once the 2 months of median safety follow-up have accrued. The Phase III COVE study was designed in collaboration with the FDA and NIH to evaluate Americans at the highest risk of severe COVID-19 disease . As of today, the COVE study includes more than 7,000 Americans over the age of 65. It also includes 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 III COVE study. Moderna has also worked to develop a vaccine for everyone, including communities that have historically been under-represented in clinical research and are disproportionately impacted by COVID-19. In early September, the Company announced a slowing of enrollment to ensure the representation of those communities of color in COVE. Today, Moderna is pleased to share that the study includes more than 11,000 participants from communities of color, representing 37% of the study population and similar to the diversity of the U.S. at large. This includes more than 6,000 participants who identify as Hispanic or LatinX, and more than 3,000 participants who identify as Black or African American. The company expects to have preliminary data from the trial by next month.