(Reuters) -Novavax on Wednesday said the U.S. Food and Drug Administration has asked the company to commit to produce more data on its COVID-19 vaccine if it is approved, after the agency missed a deadline to grant the shot a traditional approval.
Shares of the biotech, which have fallen 23% so far this year, were up 13% at $7.07 in premarket trading.
The FDA had missed its April 1 deadline for making a decision on traditional approval for the company’s shot. Novavax’s vaccine has been available in the U.S. since 2022 after the FDA authorized its emergency use.
“We have recently received formal communication from the FDA in the form of an information request for a post marketing commitment to generate additional clinical data,” the company said in a regulatory filing.
Novavax said it will work with the agency to “expeditiously” address its request and “move to approval as soon as possible.”
The company said it believes its marketing application is “approvable” based on its conversations with the FDA on April 1 and through Wednesday.
The Department of Health and Human Services, which oversees FDA and other health agencies, did not immediately respond to a request for comment.
Novavax’s protein-based COVID shot offers an alternative technology to messenger RNA-based rivals from Pfizer-BioNTech and Moderna, but has failed to make a mark in the U.S. vaccine market.
(Reporting by Bhanvi Satija and Manas Mishra in Bengaluru; Editing by Leroy Leo)
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