August 17, Monday, Novavax Inc. started mid-stage study clinical trials in South Africa to evaluate the efficacy of NVC-CoV2373.
South Africa is the fifth-worst affected country with 583,653 coronavirus cases and 11,677 deaths, according to a Reuters tally.
According to President, Research and Development of Novavax, Gregory M. Glenn, M.D., “Because South Africa is experiencing a winter surge of COVID-19 disease, this important Phase 2b clinical trial has the potential to provide an early indication of efficacy, along with additional safety and immunogenicity data for NVX-CoV2373.”
The trial of Novavax’s NVC-CoV2372, backed by a $15 million grant from Bill & Melinda Gates Foundation.
“We appreciate the continued support of the Bill & Melinda Gates Foundation and CEPI, and our strong ongoing collaboration with Wits University, all of whom are united with us in our commitment to produce and deliver a safe, effective vaccine across the globe,” Glenn added.
Dr. Shabir Madhi, Professor of Vaccinology at Wits University, will lead the clinical trial, which is supported in part by a $15 million grant from the Bill & Melinda Gates Foundation. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’s proprietary nanoparticle technology and includes Novavax’s proprietary Matrix‑M adjuvant.
In a previous phase 1 safety trial of the Novavax vaccine, healthy volunteers given two doses of the vaccine showed only mild side effects, such as headache, fatigue, and tenderness or pain at the injection site, according to a report posted Aug. 6 to the preprint server medRxiv.
According to this preliminary data, which has not been peer-reviewed, all of the phase 1 participants also generated neutralizing antibodies, which can prevent the virus from entering cells, after receiving a second dose of the vaccine. Novavax will continue to evaluate this immune response in the phase 2b trial in South Africa, as well as a phase 2 trial to be organized in the U.S. and Australia “in the near future,” according to the statement.