Moderna Receives FDA “Fast Track” Designation for mRNA Vaccine (mRNA-1273) Against COVID-19; Company Finalizing Protocol for Phase 3 Study of mRNA-1273, Expected to Begin in Early Summer of 2020

On May 12, 2020, Moderna, Inc., (Nasdaq: MRNA) a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2). “Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” said Tal Zaks, MD, PhD, 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. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application. Moderna 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 U.S. Food and Drug Administration (FDA) completed its review of the 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. Moderna is finalizing the protocol for a Phase 3 study, expected to begin in early summer of 2020. Funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S.
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