EMA starts rolling review, company to submit for USFDA EUA in coming weeks
The independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of Moderna’s mRNA-1273, its vaccine candidate against COVID-19, has informed that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5 per cent.
This study, known as the COVE study, enrolled more than 30,000 participants in the US 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.
Meanwhile, the European Medicine Agency’s (EMA) human medicines committee (CHMP) has started a ‘rolling review’ of data on mRNA-1273, based on preliminary results from non-clinical studies and early clinical studies in adults which suggest that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defences) that target the virus.