On Aug. 17, 2020, Novavax announced the beginning of a Phase 2b clinical trial in South Africa to evaluate the efficacy of NVX-CoV2373, Novavax COVID-19 vaccine candidate. Dr. Shabir Madhi, Professor of Vaccinology at Wits University, lead the clinical trial, which was supported in part by a $15 million grant from the Bill & Melinda Gates Foundation. NVX-CoV2373 is a stable, prefusion protein made using Novavax proprietary nanoparticle technology and includes Novavax proprietary Matrix-M adjuvant.

The randomized, observer-blinded, placebo-controlled Phase 2b clinical trial of NVX-CoV2373 will include two cohorts. One cohort will evaluate efficacy, safety and immunogenicity in approximately 2,665 healthy adults. The second cohort will evaluate safety and immunogenicity in approximately 240 medically stable, HIV-positive adults. This allows for evaluation of the vaccine across a diverse, representative study population. Novavax expects that, if approved in South Africa, its COVID-19 vaccine would ultimately be supplied to South Africa through Novavax’ recently announced collaboration with the Serum Institute of India.

In the Phase 1 portion of the Phase 1/2 clinical trial, conducted in Australia, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. These data have been submitted to the U.S. Food and Drug Administration (FDA) and an independent safety monitoring committee, and have also been submitted for peer-review to a scientific journal and are posted online at the preprint server medRxiv.org. Novavax intends to initiate the Phase 2 portion of this trial in the U.S. and Australia in the near future. This trial will include approximately 1,500 subjects and will include older adults.

The Coalition for Epidemic Preparedness Innovations (CEPI) is funding the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial.