Moderna announced Tuesday its fast-track designation awarded by the Food and Drug Administration (FDA) to accelerate the development of an effective COVID-19 vaccine.
The purpose of fast track is to expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need, Moderna officials wrote in a company statement.
"Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” Tal Zaks, M.D., Ph.D., chief medical officer at Moderna, wrote in a company statement. "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.”
The FDA gave its approval for Moderna to enter a Phase 2 study for mRNA-1273, which is expected to begin shortly. The Phase 2 study involves two vaccinations of mRNA-1273 administered 28 days apart. Moderna plans to enroll 600 healthy participants in two cohorts, one with adults ages 18-55 and the other with adults over the age of 55. Each participant will receive a placebo, 50 microgram dose or 250 microgram dose at both vaccinations.
The company said participants will be followed through 12 months after the second vaccination.
Moderna said a Phase 3 study could begin in the early summer of this year.