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

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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.