Novavax Files Final Data on Covid Vaccine to U.S. Regulators

Novavax Inc. submitted the final data package for its Covid-19 vaccine candidate to U.S. regulators, bringing it one step closer to clearance. The submission to the Food and Drug Administration included details on chemistry, manufacturing and controls for the shot known as NVX-CoV2373, Novavax said in a statement. The company expects to file a request for emergency use authorization in one month, in line with the FDA’s guidance around such filings. If authorized, the shot would become the fourth Covid vaccine cleared in the U.S. and the first of its kind. European regulators and the World Health Organization cleared the product this month after months of delays. Novavax has grappled with manufacturing problems despite securing some of the largest funding from the Trump administration in the early stages of the pandemic.