Moderna coronavirus vaccine candidate receives fast-track designation from the FDA

The U.S. Food and Drug Administration has given a "fast track" designation to a COVID-19 vaccine candidate in development from Moderna Therapeutics.

Moderna announced on Tuesday that its vaccine candidate has received fast track approval from the FDA, Time reports, with its chief medical officer, Dr. Tal Zaks, saying this "underscores the urgent need for a vaccine against the novel coronavirus." Moderna President Dr. Stephen Hoge also told Time this is "validation that the FDA believes this is a very credible exercise."

The fast track designation, the FDA explains, helps "expedite the review" of the vaccine's development process, with "early and frequent communication between the FDA" and the company. Cutting through some of the red tape will help the vaccine trials accelerate alongside other candidates; health experts like Dr. Anthony Fauci say we likely need more than one vaccine to effectively fight COVID-19 and meet demand.

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Last week, Moderna announced it received clearance from the FDA to proceed with phase two testing of this mRNA vaccine candidate, planning for a phase three study in early summer. Modern Chief Executive Officer Stéphane Bancel described the "imminent" start of phase two as a "crucial step forward," and Moderna says its phase two study with 600 participants is "expected to begin shortly." According to CNBC, "If all goes well, its vaccine could be in production as early as July."