mRNA specialist Moderna has announced that it has completed enrollment of 30,000 participants for the Phase III COVE study of mRNA-1273, its vaccine candidate against COVID-19.
The study is being conducted in collaboration with 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 US Department of Health and Human Services.
So far, more than 25,650 participants have received their second vaccination. Boston-based Moderna will decide whether to submit a dossier to the US Food and Drug Administration requesting Emergency Use Authorization based on an assessment of whether the potential benefit of the vaccine outweighs the potential risks once the two months of median safety follow-up have accrued.
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