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The Phase III clinical trial of NVX-CoV2373 is expected to be fully enrolled in the UK and will begin in the US and Mexico by the end of November 2020.
Novavax’ Phase III clinical trial of NVX-CoV2373, its COVID-19 vaccine candidate, is expanding enrollment in the United Kingdom (UK) and will begin in the US by the end of November, the company reported in an Oct. 27, 2020 press release. The company has enrolled over 5500 participants in the UK trial and plans expanded enrollment to 15,000 volunteers by the end of November. The larger numbers of participants are expected to allow assessment of safety and efficacy in a shorter time period. Interim data in this event-driven trial may be available as soon as early first quarter 2021.
“We are pleased with the significant progress made in our Phase 3 clinical trial since it began in the United Kingdom at the end of September,” said Gregory M. Glenn, president of R&D at Novavax. “We are grateful for the support of the UK Government’s Vaccines Taskforce (VTF) and the National Institute for Health Research (NIHR) for our pivotal trial. Recognizing the recent, large increase in the number of COVID-19 cases in the UK, as well as the rapid progress in participant enrollment for our trial, in consultation with the VTF and NIHR, we adjusted our plans and increased enrollment.”
The company plans to begin its Phase III clinical trial in the US, with support from the US government’s Operation Warp Speed, and in Mexico by the end of November. The company said in the press release that although it experienced delays compared to original timing estimates, it has made significant progress in large-scale manufacturing. Large-scale manufacturing is being developed at multiple sites around the world. Production from contract manufacturer Fujifilm Diosynth Biotechnologies in Morrisville, NC will be used in the Phase III trials in North America.
NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes Novavax’ proprietary Matrix‑M adjuvant.