Novavax Begins Phase III Efficacy Trial of COVID-19 Vaccine

Novavax announced in a Sept. 24, 2020 press release that it has initiated its first Phase III study to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373, the company’s COVID-19 vaccine candidate. The trial is being conducted in the United Kingdom (UK), in partnership with the UK Government’s Vaccines Taskforce. Up to 10,000 adults between the ages of 18 and 84, with and without relevant comorbidities, will be enrolled and vaccinated 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, president of R&D at Novavax, in the press release. “The data from this trial is expected to support regulatory submissions for licensure in the UK, EU [European Union], 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 can be handled as an unfrozen, liquid formulation that can be stored at 2 °C to 8 °C and distributed using standard vaccine channels. Novavax has continued to scale-up its manufacturing capacity. It is expected to be able to produce 2 billion doses annually, once all capacity has been brought online by mid-2021.