Novavax announced updates on its Phase 3 clinical development program of NVX-CoV2373, its COVID-19 vaccine candidate, along with a delay to its late-stage U.S. trial. The experimental vaccine trial will be pushed to the end of November.
NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes Novavax’ proprietary Matrix‑M adjuvant. The company announced that it will present data from its ongoing Phase 1/2 clinical trial, including new Phase 2 reactogenicity data, on Friday, Oct. 30 during the U.S. Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices’ (ACIP) meeting.
Novavax currently expects the clinical trial to begin in the United States and Mexico by the end of November. According to Novavax, the company has made significant progress in large-scale manufacturing, with delays experienced versus original timing estimates. 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.
Novavax’ pivotal Phase 3 clinical trial is being conducted with support from the U.S. Government through Operation Warp Speed. The trial design calls for the enrollment of up to 30,000 participants in the U.S. and Mexico, with proportional representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age and those living with co-morbidities. The trial protocol will be posted on Novavax’ website upon initiation.
Novavax has enrolled over 5,500 participants to date in the U.K. trial, which it has expanded to 15,000 volunteers. It expects this trial to be fully enrolled by the end of November, and dependent on the overall COVID-19 attack rate, interim data in this event-driven trial are expected as soon as early first quarter 2021. These data are expected to serve as the basis for global licensure.
Read the Novavax statement