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Novavax Sounds Out Delay In Start of US Late-Stage COVID-19 Vaccine Study

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Novavax Sounds Out Delay In Start of US Late-Stage COVID-19 Vaccine Study

Novavax, Inc. (NASDAQ: NVAX) shares were recovering from a weak start Monday as traders digested an update issued by the company on its coronavirus vaccine program.

What Happened: The pivotal Phase 3 study of NVX-CoV2373, Novavax's investigational coronavirus vaccine, has completed enrollment, while the Phase 3 study planned in the U.S. and Mexico is expected to begin in the coming weeks, the Gaithersburg, Maryland-based company said in a statement.

In its previous update issued in its third-quarter earnings release, Novavax said the late-stage study in the U.S. would begin by the end of November.

More than 100 trial sites have been selected, with some alternate sites in place should they be needed, the company said in Monday's statement. 

Related Link: The Week Ahead In Biotech: Hematology Conference Gets Underway, Vanda And BioCryst Await FDA Decisions

Regarding the progress of its late-stage study in the U.K., Novavax said it has completed enrollment of 15,000 participants as planned to determine safety and efficacy.

The company expects interim data from the trial as early as the first quarter of 2021, although the schedule is contingent on the overall COVID-19 rate in the region.

More than 25% of the trial participants are over the age of 65, and a large proportion of volunteers have underlying co-morbid conditions, generally representative of the population, Novavax said.

The company also said the Phase 2b trial underway in South Africa is also now fully enrolled, with a total of 4,422 volunteers taking part in the trial, including 245 medically stable HIV-positive participants.

Why It's Important: Given that Moderna Inc (NASDAQ: MRNA) and Pfizer Inc. (NYSE: PFE)/ BioNTech SE – ADR (NASDAQ: BNTX) are on the cusp of obtaining emergency use authorization, Novavax's delay could come as a setback.

The company is likely to lose out on the early mover advantage unless it can quickly resolve all issues and get the trial going in the U.S.

At last check, Novavax shares were rising 8.55% to $136.44.

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates

 

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