On Nov. 30, 2020, Moderna announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirmed the high efficacy observed at the first interim analysis. The data analysis indicated a vaccine efficacy of 94.1%.

Safety data continued to accrue and the study continued to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB). The Company also announced that, Moderna planned to request an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA).

The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and was being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.