The FDA has fast-tracked Moderna’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2).
“Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” said Tal Zaks, Chief Medical Officer at Moderna.
“As we await the full set of clinical data from the NIAID-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2.”
Moderna previously received Fast Track designation for its investigational Zika vaccine (mRNA-1893) and its methylmalonic acidemia (MMA; mRNA-3704) and propionic acidemia (PA; mRNA-3927) programs.
Earlier this month, the FDA completed its review of the Company’s Investigational New Drug (IND) application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly. Moderna is finalizing the protocol for a Phase 3 study, expected to begin in early summer of 2020.
Funding from the Biomedical Advanced Research and Development Authority supported the planning for these studies and will also support the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing both at the company’s facilities and that of its strategic collaborator, Lonza.