Novavax, Inc. (NASDAQ: NVAX) has taken another step toward obtaining emergency use authorization for NVX-CoV2373, its recombinant protein-based vaccine candidate against the novel coronavirus.
What Happened: Maryland-based Novavax said it has completed enrollment of the PREVENT-19, pivotal Phase 3 study in the U.S. and Mexico, that is evaluating the efficacy, safety and immunogenicity of NVX-CoV2373.
“The full enrollment of PREVENT-19 is another important step in building a body of evidence to demonstrate that NVX-CoV2373 will be safe and effective across diverse, representative populations,” Gregory Glenn, president of R&D at Novavax, said in a statement.
The PREVENT-19 trial, funded by U.S. governmental agencies, enrolled 30,000 volunteers and also largely reached its demographic goals even amid the concurrent rollout of vaccines authorized for emergency use.
The company noted that 20% of the volunteers enrolled were Latin American, 13% belonged to the African American community, 6% were Native Americans and 5% Asian Americans. About 13% were adults 65 older.
What’s Next: Having already reported positive interim efficacy results from the U.K. leg of the Phase 3 trial, Novavax could soon file for emergency use authorization with regulatory agencies.
The company has already begun rolling review submissions with the regulatory agencies in the U.S., U.K., Europe and Canada.
Last week, the company announced a deal to supply 1.1 billion doses of its vaccine candidate to Gavi’s COVAX alliance.
In premarket trading Monday, Novavax shares were down 2.06% to $272.15.
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