Novavax initiates phase III efficacy trial of COVID-19 vaccine, NVX-CoV2373, in the United Kingdom.

Novavax, Inc. announced that it has initiated its first Phase III study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate . The trial is being conducted in the United Kingdom (UK), in partnership with the UK Government’s Vaccines Taskforce, and is expected to enroll and immunize up to 10,000 individuals between 18-84 (inclusive) 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 III 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 stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology that includes Novavax’ proprietary MatrixM adjuvant. The vaccine has a favorable product profile that will allow handling in an unfrozen, liquid formulation that can be stored at 2°C to 8°C, allowing for distribution using standard vaccine channels.