FLC | BARDA expands Moderna partnership for COVID-19 vaccine production

BARDA expands Moderna partnership for COVID-19 vaccine production

June 8, 2020

The Biomedical Advanced Research and Development Authority (BARDA) is expanding an existing partnership with Cambridge, Massachusetts-based Moderna, Inc to increase the domestic manufacturing capacity of Moderna’s mRNA-1273 vaccine being developed for the prevention of COVID-19. Expansion activities are expected to begin mid-year to deliver material and could be available as soon as the end of 2020. Moderna previously announced its new collaboration with Lonza in the U.S., and this funding supports that manufacturing capacity expansion.

BARDA awarded a contract to Moderna on April 16 to accelerate vaccine development through licensure and manufacturing scale-up of mRNA-1273 development initiated with support from support from the National Institutes of Health (NIH) and CEPI. This vaccine is the first COVID-19 product to transition from NIH to BARDA for advanced development.

The process used to manufacture mRNA-1273 is rapid and scalable. By expanding to additional domestic manufacturing suites (scale-out), the U.S. government can make available more COVID-19 vaccines earlier and faster.

The NIH is conducting the Phase 1 study of mRNA-1273 under an NIH-Investigator New Drug Application (IND). Moderna, with support from BARDA, began a Phase 2 study under Moderna’s own IND in June. Concurrently, NIH, BARDA, and Moderna are finalizing the Phase 3 clinical trial plan. The expansion of domestic manufacture will allow significant manufacturing capacity to produce and make mRNA-1273 available to the US sooner.