Moderna has announced a $483 million award from the Biomedical Advanced Research and Development Authority (BARDA), to fund manufacturing scale-up and the development of the company’s SARS-CoV-2 vaccine mRNA-1273 to FDA licensure.
A Phase 1 study of mRNA-1273, being conducted by the National Institutes of Health, began on March 16, 2020. The open-label study has completed enrollment of the original study: 45 healthy adult volunteers ages 18 to 55 years in three dose cohorts. The NIH recently amended the Phase 1 protocol to include an additional six cohorts: three cohorts of older adults (ages 56 -70) and three cohorts of elderly adults (age 71 and above).
If supported by safety data from the Phase 1 study, the drugmaker will start a Phase 2 study of mRNA-1273 under its own Investigational New Drug application in the second quarter of 2020. A Phase 3 study could begin as soon as fall 2020.
BARDA funding will support these late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020 to enable potential pandemic response. To support the scale-up, Moderna plans to hire up to 150 new team members in the U.S. this year. This includes a significant increase in its skilled manufacturing staff to expand manufacturing capacity from two shifts per day, 5 days per week to three shifts per day, 7 days per week, engineers to manage process scale-up, and clinical and regulatory staff to support clinical development.
Read the press release
