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Novavax's U.S. COVID-19 Vaccine Late-stage Study Delayed Again

Novavax Inc.'s (NVAX) late-stage trial of its COVID-19 vaccine in the United States and Mexico is delayed for the second time.

The phase 3 trial was originally expected to begin in October before the company pushed out the start date to the end of November.

The company now expects to begin the trial in the coming weeks, Novavax said in a statement.

In an update on its phase 3 clinical development program of its COVID-19 vaccine candidate, NVX-CoV2373, Novavax said that more than 100 trial sites have been selected in the countries with some alternate sites in place.

Novavax said it will use vaccine material produced at commercial scale for the trial. So, it has been working closely with the U.S. the Food and Drug Administration to complete trial-initiation gating activities related to its commercial-scale production at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina.

NVX-CoV2373 is a stable, purified SARS-CoV-2 spike (S) glycoprotein made using the company's recombinant protein nanoparticle technology that includes proprietary MatrixM adjuvant.

Novavax said it completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K. to determine efficacy and safety of NVX-CoV2373. Interim data in this event-driven trial are expected as soon as early first quarter 2021.

According to the company, the Phase 2b trial taking place in South Africa to evaluate safety and provide an early indication of efficacy is now fully enrolled. A total of 4,422 volunteers are taking part in the trial, which includes 245 medically stable, HIV-positive participants.

As in the U.K., availability of efficacy data depends on the illness rate in South Africa and may be available as soon as the first quarter 2021.

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