Nov 9 (Reuters) – Novavax Inc said on Monday its experimental coronavirus vaccine had gained the U.S. Food and Drug Administration’s “fast-track” status.
The U.S. drug developer, which is testing the drug in a late-stage trial in the UK, said a U.S. and Mexico-based late-stage trial was on track to begin by the end of November, and data from that trial could support U.S. authorization.
The company last month delayed the start of the trial of the vaccine, NVX-CoV2373, by roughly a month due to delays in scaling up the manufacturing process.
The fast-track status makes companies eligible to submit sections of a marketing application on a “rolling” basis as soon as some data becomes available, rather than wait for all the data before submitting the application. (Reporting by Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila)
