GAITHERSBURG, Md. (WJZ) -- A Maryland based biotechnology company announced the coronavirus vaccine it developed is moving into an efficacy trial phase.
Novavax announced Monday the 2b phase of its clinical trial will begin in collaboration with Professor of Vaccinology Dr. Shabir Madhi and Wits University in South Africa.
The Bill & Melinda Gates Foundation is providing $15 million grant toward the trial, Novavax said.
The trial will determine just how effective the NVX-CoV2373 vaccine candidate for COVID-19 is.
"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, M.D., President, Research and Development at Novavax. "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."
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The trial will be randomized, observer-blinded and placebo-controlled. It will include two cohorts: one cohort will evaluate efficacy, safety and immunogenicity in approximately 2,665 healthy adults, while the second cohort will evaluate safety and immunogenicity in approximately 240 medically stable, HIV-positive adults.
"The major motivation for the COVID-19 vaccines being evaluated at an early stage in South Africa is to generate evidence in the African context on how well these vaccines work in settings such as our own," said Shabir Madhi, M.B.B.C.H., FCPaeds, Ph.D. "I am pleased to work with Novavax as the principal investigator in this clinical trial, following Novavax' COVID-19 vaccine's positive Phase 1 data, which provides strong rationale for moving development forward in a larger subset of adults.
Phase 1 of the clinical trial was conducted in Australia and was generally well-tolerated. The data has been submitted to the U.S. Food and Drug Administration (FDA) and an independent safety monitoring committee.
The second phase of this trial will be initiated in the U.S. and Australia in the near future and will include 1,500 subjects -- including older adults.
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