Moderna's Coronavirus Vaccine Candidate Gets Fast Track Designation

(RTTNews) - Moderna Inc. (MRNA) Tuesday announced that it received FDA Fast Track designation for mRNA vaccine candidate mRNA-1273 against the novel coronavirus.

"Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus," said Tal Zaks, M.D., Ph.D., 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."

Fast Track is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need.

Moderna had 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.

On May 6, the FDA completed its review of the Investigational New Drug application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly.