BARDA offers Moderna opportunity to expand domestic manufacturing of SARS-CoV-2 vaccine

As part of an expansion to their existing partnership, the Biomedical Advanced Research and Development Authority (BARDA) and MODERNATX, Inc. will increase the domestic manufacturing capacity of the mRNA-1273 vaccine, a candidate to stop the spread of COVID-19.

The relationship has been ongoing since April 16, when BARDA contracted ModernaTX to accelerate vaccine development through licensure and manufacturing scale-up of its product. In this, BARDA was supported by the National Institutes of Health and the Coalition for Epidemic Preparedness Innovations (CEPI). In advanced development at this point, BARDA now hopes to manufacture mRNA-1273 rapidly.

Delivery of material should begin sometime mid-year, with vaccine availability on the calendar for as early as this year. Moderna will be working with Lonza in the U.S. to achieve this. This is part of a larger push by the U.S. government to expand domestic manufacturing, though, and to get vaccines to its population quicker, emphasizing the speed of manufacturing and the possibility of economic recovery over medical certainty. That push is in cooperation with the White House’s Operation Warp Speed.

A phase 1 study of mRNA-1273 is still underway as part of an NIH-Investigator New Drug Application. BARDA has also supported a phase 2 study attached to that application. Simultaneously, a phase 3 study is being finalized between NIH, BARDA, and Moderna. This vaccine represents the first COVID-19 product to shift from NIH to BARDA for advanced development.