Novavax Submits EUA Request to FDA for Covid-19 Vaccine Candidate -- Update

By Josh Beckerman

Novavax Inc. submitted a request to the U.S. Food and Drug Administration for Emergency Use Authorization for its Covid-19 vaccine candidate, saying the drug "offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative" to existing vaccines.

Shares were recently 8% higher at $89.69.

The company said it provided data for NVX-CoV2373 including "results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90 percent and a reassuring safety profile." It is seeking authorization for people 18 and up.

Vaccines from Pfizer Inc., Moderna Inc. and Johnson & Johnson are available in the U.S.

Novavax said Nov. 1 that Indonesia became the first country to authorize use of its Covid-19 vaccine. Last year, Novavax investors were concerned about the timing of approvals, including a delay in seeking U.S. emergency authorization.

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(END) Dow Jones Newswires

01-31-22 1426ET