Moderna’s mRNA Vaccine (mRNA-1273) Against Novel Coronavirus Awarded Fast-Track Designation by FDA

Moderna, Inc. (Cambridge, MA, USA) has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2).

mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein. The FDA recently 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. The planned Phase 2 study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. Moderna is also finalizing the protocol for a Phase 3 study, which is 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, 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.”

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