On Apr. 27, 2020, Moderna announced it had submitted an Investigational New Drug application to the U.S. Food and Drug Administration (FDA) for the company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2) to evaluate mRNA-1273 in Phase 2 and late-stage studies, if supported by safety data from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases.

Subject to data from the Phase 1 and Phase 2 studies and discussions with regulators, a Phase 3 study could begin in the fall of 2020. Funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, supported the planning for these studies and also supported the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing.