EMA starts rolling review of mRNA 1273 for COVID-19.- Moderna

Moderna announced that the European Medicines Agency (EMA) human medicines committee (CHMP) has started a rolling review of mRNA 1273, the Company’s vaccine candidate against COVID-19, following the confirmation of eligibility of mRNA 1273 for submission on October 14, 2020. Yesterday, Moderna announced that the independent, U.S. NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase III study of mRNA 1273 has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is 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.