Moderna announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up to $472 million to support late stage clinical development including the expanded Phase 3 study of mRNA-1273 against COVID-19.
After discussions with the U.S. FDA and consultations with Operation Warp Speed over the past several months, Moderna has decided to conduct a significantly larger Phase 3 clinical trial, leaving a gap in BARDA funding that will be closed by this contract modification.
Under the terms of the revised contract, BARDA is expanding their support for late stage clinical development of mRNA-1273, including the execution of a 30,000 participant Phase 3 study in the U.S. The full contract is now worth approximately $955 million.
After released more details about an early study of 45 healthy participants showing that its mRNA vaccine candidate produced antibodies at every dosing level with no serious side effects, Moderna began manufacturing doses at-risk for commercial distribution.
According to Moderna, they remain on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the internal U.S. manufacturing sites and strategic collaboration with Lonza.
Read the press release about the BARDA contract expansion
