Novavax Provides Phase 3 COVID-19 Vaccine Clinical Development Update
5,500 volunteers enrolled to date in pivotal Phase 3 clinical trial in the U.K.
- Study expanded to 15,000 participants
- Full enrollment expected by end of November
- Event-driven interim data expected as soon as early first quarter 2021
U.S. pivotal Phase 3 clinical trial planned to begin by end of November
- Significant progress in large-scale manufacturing achieved with some delay from original timeline
Company to present data from its ongoing Phase 1/2 clinical trial, including new Phase 2 reactogenicity data, during public CDC Advisory
Committee on Immunization Practices (ACIP) meeting on October 30
GAITHERSBURG, Md., Oct. 27, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced updates on its Phase 3 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 1/2 clinical trial, including new Phase 2 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 3 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.
“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, M.D., President of Research and Development at Novavax. “We are grateful for the support of the U.K. 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 U.K., 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.”