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Novavax To Begin Late-stage COVID-19 Vaccine Trial In U.S. And Mexico By November-end

Novavax Inc. (NVAX) said Tuesday that it will begin a late-stage trial of its COVID-19 vaccine in the United States and Mexico by the end of November. Previously, it was reportedly expected to start this month. The company also expects interim data from an ongoing phase 3 U.K. trial of its COVID-19 vaccine in the first quarter of 2021.

In an update on its phase 3 clinical development program of its COVID-19 vaccine candidate, NVX-CoV2373, Novavax said that it has made significant progress in large-scale manufacturing, with delays experienced versus original timing estimates.

The company said its pivotal Phase 3 trial is being conducted with support from the U.S. Government through Operation Warp Speed. The trial design is harmonized with those of other leading companies, and calls for the enrollment of up to 30,000 participants in the U.S. and Mexico.

In addition, the company announced that it will present data from its ongoing Phase 1/2 clinical trial, including new Phase 2 reactogenicity data, on October 30 during the United States Center for Disease Control and Prevention's Advisory Committee on Immunization Practices' meeting.

Novavax said it has been developing large-scale manufacturing processes at multiple sites around the world and plans to use production from its contract manufacturing site at FUJIFILM Diosynth Biotechnologies' Morrisville, North Carolina site in this Phase 3 clinical trial.

Meanwhile, Novavax said it expects interim data from the ongoing phase 3 UK trial of its coronavirus vaccine in the first quarter of 2021.

The company noted that it will expand phase 3 U.K. trial, begun in September in partnership with the U.K. Government's Vaccines Taskforce, to 15,000 volunteers from 10,000. The increased enrollment is likely to facilitate assessment of safety and efficacy in a shorter time period.

Novavax has enrolled over 5,500 participants to date in the United Kingdom trial. It expects the trial to be fully enrolled by the end of November.

NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. It contains Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

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