Moderna Awarded $483 Million by BARDA for Coronavirus Vaccine

Moderna has been promised up to $483 million from the U.S. Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) to accelerate development of its mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2).

mRNA-1273 is an mRNA vaccine encoding for a prefusion stabilized form of the Spike (S) protein. The S protein complex is necessary for membrane fusion and host cell infection and has been the target of vaccines against the coronaviruses responsible for Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). mRNA-1273 was selected by Moderna in collaboration with investigators at the NIAID Vaccine Research Center (VRC).

Under the terms of the agreement, BARDA will fund the advancement of mRNA-1273 to FDA licensure. A Phase 1 study of mRNA-1273 is being conducted by the NIH. The Phase 1 open-label study, which began on March 16, has completed enrollment of the original study: 45 healthy adult volunteers ages 18 to 55 years in three dose cohorts (25 µg, 100 µg and 250 µg). 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). Enrollment for these cohorts is ongoing.

If supported by safety data from the Phase 1 study, Moderna intends to begin a Phase 2 study of mRNA-1273 under its own Investigational New Drug (IND) application in the second quarter of 2020. Subject to data from these studies and discussions with regulators, a Phase 3 study could begin as early as this fall. BARDA funding will support these late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020 to enable its use as a  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. (Source: Moderna Website, 16 April, 2020)