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Novavax Slips on Reported Delay to Seek FDA Vaccine Clearance

Novavax isn't expected to seek FDA emergency-use authorization for its virus vaccine until at least June, a report says. The stock is lower.

Shares of Novavax  (NVAX) - Get Report slipped Monday after a report said the biotech company is unlikely to seek emergency-use authorization for its experimental coronavirus vaccine in the U.S. until June at the earliest.

Shares of the Gaithersburg, Md., company at last check fell 5.1% to $166.99.

Novavax reports first-quarter earnings on Monday after the closing bell.

Delays in clinical-trial results coupled with manufacturing delays have slowed the process by which the company would seek U.S. Food and Drug Administration clearance, people briefed on the matter told the Washington Post.

Results from the company’s coronavirus vaccine trial in North America were expected to be disclosed “right at the beginning, maybe” of the second quarter, Gregory Glenn, Novavax’s president of R&D, had said at a Washington Post event in February.

Those results now are not expected until the end of May, the people told the paper.

Novavax then would not seek emergency clearance for the U.S. at least until June, due in part to a regulatory manufacturing issue related to an assay, the people said.

Assays are tests used throughout the manufacturing process to check the contents and quality of vaccines, The Post reported.

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A Novavax spokeswoman told the paper that the company has “consistently said its major vaccine trial would report results in the second quarter.”

The spokeswoman, Amy Speak, did not respond to questions from the Post about manufacturing delays that could hold up a regulatory filing.

She added the status of the trial will be updated later Monday.

Last week, Novavax had held production discussions with the U.S. Trade Representative and had planned to disclose details of its late-stage study in the coming weeks.

On May 6, President Joe Biden indicated his support for waiving patent protections linked to proprietary COVID technology.

Biden last week had mentioned Novavax's COVID-19 vaccine candidate in a speech at the White House.

"The problem is right now we have other vaccines like Novavax and others coming on, probably," Biden had said in response to a question about aid to India amid an outbreak of the virus there. 

"And I think we will be in a position to share vaccines as well as knowhow in countries who have a real need."