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Novavax Initiates Phase 3 Trial Of COVID-19 Vaccine

Shares of Novavax, Inc. (NVAX)) gained over 7% in after-hours trading Thursday after the biotechnology company announced that it will start a Phase 3 trial of its COVID-19 vaccine.

Novavax said it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. The trial is being conducted in the UK, in partnership with the UK Government's Vaccines Taskforce. The company is expected to enroll and immunize up to 10,000 individuals between 18-84 years of age, with and without relevant comorbidities, over the next four to six weeks.

"With a high level of SARS-CoV-2 transmission observed and expected to continue in the UK, we are optimistic that this pivotal Phase 3 clinical trial will enroll quickly and provide a near-term view of NVX-CoV2373's efficacy," said Gregory M. Glenn, M.D., President, Research and Development at Novavax. "The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries. We are grateful for the support of the UK Government, including from its Department of Health and Social Care and National Institute for Health Research, to advance this important research."

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 and contains Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

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