May 12, 2020

Moderna receives FDA Fast Track designation for mRNA vaccine (mrna-1273) against novel coronavirus

Massachusetts-based Moderna, Inc. 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 against the novel coronavirus.

The aim of Fast Track is 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.