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Moderna’s COVID-19 Vaccine Candidate Gets FDA Fast Track Status

Moderna Inc. (MRNA) announced on Tuesday that its experimental coronavirus vaccine has been granted fast track status by the U.S. Food and Drug Administration (FDA).The fast track status designation is awarded to speed up the regulatory review of its novel coronavirus vaccine candidate (mRNA-1273).Last week, the FDA completed its review of Moderna’s Investigational New Drug (IND) application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly. The clinical stage biotech company said it is finalizing the protocol for a Phase 3 study, expected to begin in early summer of 2020.“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...