Novavax, Inc. (NASDAQ:NVAX), which has been assiduously stitching up production and supply partnerships, announced Monday another milestone event in the clinical development of its coronavirus vaccine, codenamed NVX-CoV2373.
What Happened: Gaithersburg, Maryland-based Novavax said it has initiated a Phase 2b clinical trial in South Africa to evaluate the efficacy of NVX-CoV2373. The study is supported by a $15 million grant from the Bill & Melinda Gates Foundation and will be led by Dr. Shabir Madhi, Professor of Vaccinology at Wits University.
"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," said Gregory M. Glenn, President, R&D at Novavax.
Novavax' Study Design: The Phase 2b randomized, observer-blinded, placebo-controlled trial will enroll participants into two cohorts. The first cohort will evaluate efficacy, safety and immunogenicity in about 2,665 healthy adults, while the second cohort will assess safety and immunogenicity in about 240 medically stable HIV-positive patients.
If approved in South Africa, the vaccine will ultimately be supplied to South Africa through the recently announced collaboration with the Serum Institute of India, Novavax said.
What's Next? After reporting positive safety and immunogenicity data from the Phase 1 portion of a Phase 1/2 study conducted in Australia, the company is on track to start the Phase 2 portion of the study in the U.S. and Australia in the near future.