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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Generac Power Systems is recalling 325,735 units of Generac and DR 6500 Watt and 8000 Watt portable generators for potential risk of finger amputation and crushing hazards, a statement by the U.S. Consumer Product Safety Commission (CPSC) showed. These include 4,575 units sold in Canada. Omaha, Nebraska- based Greater Omaha Packing is recalling around 295,236 pounds of raw beef products citing the possible presence of E. coli O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS said. The raw beef products intended for non-intact use were produced on July 13. Consumer goods giant Procter & Gamble Co. (PG) on Friday reported a four percent increase in profit for the fourth quarter from last year, driven by net sales growth across its operating segments, partially offset by a reduction in operating margin. Both revenue and core earnings per share for the quarter beat analysts' estimates. Looking ahead, the company also initiated outlook for fiscal 2022.
Follow RTT