US FDA misses deadline for decision on Novavax’s COVID-19 vaccine

(Reuters) -The U.S. Food and Drug Administration has missed its deadline for making a decision on traditional approval for Novavax (NASDAQ:NVAX)’s COVID-19 vaccine, the company told Reuters on Wednesday.

The delay comes on the heels of the FDA’s top vaccine scientist Peter Marks’ exit from the agency, which will be effective April 5. Marks, who played a key role in developing COVID-19 vaccines during U.S. President Donald Trump’s first term, was forced to resign, according to media reports.

His departure led to a selloff in drugmakers’ stocks on Monday and some analysts said it could put pressure on companies that currently have therapies under regulatory review.

The regulator had set an April 1 deadline to decide on the vaccine, the company told Reuters in an emailed statement.

"As of today, we continue to wait on action from the agency and have not yet received an official decision from the U.S. FDA," Novavax said.

Senior leaders at the FDA said the company’s application needed more data and was unlikely to be approved soon, according to the Wall Street Journal, which first reported on the matter.

The company, however, said it had responded to all of the FDA’s information requests as of April 1 and it believes its application is "ready for approval".

The FDA and the Department of Health and Human Services did not immediately respond to Reuters’ requests for comment.

Novavax’s traditional protein-based COVID shot offers an alternative technology to messenger RNA-based rivals from Pfizer-BioNTech and Moderna (NASDAQ:MRNA), but has failed to make a mark in the U.S. vaccine market.

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The vaccine was initially authorized for emergency use in 2022.

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