Fast Track will facilitate the development and expedite the review of Moderna’s vaccine candidate (mRNA-1273).
“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.”
On May 6, the FDA completed its review of Moderna’s Investigational New Drug application for mRNA-1273, allowing the company to move forward with phase two of their vaccine trial study.
As part of phase two, 600 healthy participants will be assigned to receive a placebo, a 50 μg dose, or a 250 μg dose of the vaccine twice, given 28 days apart.
The protocol for phase three of the study is being finalized, which is expected to begin in the early summer of this year.
News credit whdh.com