Novavax provides phase III NVX-CoV2373, COVID-19 vaccine clinical development update.

Novavax, Inc. announced updates on its Phase III clinical development program of NVX-CoV2373, its COVID-19 vaccine candidate. NVX-CoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes Novavax’ proprietary Matrix-M adjuvant. The Company also announced that it will present data from its ongoing Phase 1/II clinical trial, including new Phase II reactogenicity data, on Friday, October 30 during the United States (U.S.) Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices’ (ACIP) meeting.

U.K. Phase III Clinical Trial Update: Novavax has enrolled over 5,500 participants to date in the United Kingdom (U.K.) trial, which it has expanded to 15,000 volunteers. The increased enrollment is likely to facilitate assessment of safety and efficacy in a shorter time period. Novavax 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.

U.S. Phase III Clinical Trial Update: Novavax currently expects the pivotal clinical trial to begin in the United States and Mexico by the end of November. The Company has made significant progress in large-scale manufacturing, with delays experienced versus original timing estimates. Novavax 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 III clinical trial.

Additional Phase III Clinical Trial Information:

United Kingdom: Novavax’ first pivotal Phase III clinical trial, begun in September in partnership with the U.K. Government’s Vaccines Taskforce, will be expanded from 10,000 to 15,000 volunteers, some of whom have been recruited through the National Health Service (NHS) Vaccine Registry. The trial protocol calls for unblinding of data once 152 participants have achieved mild, moderate or severe endpoints. Two interim analyses are planned once 66 and 110 endpoints have occurred.

United States/Mexico: Novavax’ pivotal Phase III clinical 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, 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.