(Reuters) – Novavax Inc said on Monday it was on track to begin a delayed U.S.-based, late-stage study of its experimental coronavirus vaccine later this month.
The company also said the vaccine, NVX-CoV2373, had been given “fast-track” status from the U.S. Food and Drug Administration and that it expected data from the trial could support U.S. authorization and approval.
Novavax, which is testing the vaccine in a late-stage study in the UK, last month postponed the start of its U.S. trial by roughly a month, due to delays in scaling up the manufacturing process.
A handful of companies are testing their experimental coronavirus vaccines in late-stage studies. Pfizer Inc said on Monday initial data from the pivotal trial of its experimental COVID-19 vaccine developed with German partner BioNTech showed that it was more than 90% effective.
Novavax on its quarterly results conference call said Pfizer’s data was a good sign for other vaccines in development.
Fast-track status allows companies 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 seeking approval.
The company said a Phase II vaccine trial in South Africa has reached 50% of its enrollment target. It’s UK trial has enrolled 60% of its intended participants, Novavax said.
(Reporting by Manas Mishra and Mrinalika Roy in Bengaluru and Carl O’Donnell in New York; Editing by Sriraj Kalluvila and Bill Berkrot)