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Novavax's COVID-19 Vaccine Candidate Gets FDA Fast Track Status

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Novavax Inc. (NVAX) Monday announced that its coronavirus vaccine candidate was granted fast-track designation by the U.S. Food and Drug Administration.

NVX-CoV2373, the company's COVID-19 vaccine candidate, is currently in late-phase clinical development. NVXCoV2373 is a stable, prefusion protein made using Novavax' nanoparticle technology and includes its proprietary MatrixM adjuvant.

"The FDA's decision to grant Fast Track Designation for NVX-CoV2373 reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine," said Gregory Glenn, President of Research and Development, Novavax.

Novavax said it expects to begin its pivotal Phase 3 clinical trial in the US and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S.

The company's ongoing Phase 3 clinical trial in the UK to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 is expected to be fully enrolled by the end of November. Interim data in the UK trial are expected as soon as early first quarter 2021.

The FDA approval comes on the same day that Pfizer announced that its coronavirus vaccine candidate had a 90% efficacy rate in late-stage trials. The company plans to seek emergency-use authorization from the FDA.

NVAX is currently trading at $91.87, up $2.01 or 2.24%, on the Nasdaq.

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