Aug. 17 (UPI) -- U.S. biotech Novavax said Monday it's proceeding with a second-stage clinical trial of its COVID-19 vaccine candidate in South Africa.
The company said it's received $15 million in funding from the Bill & Melinda Gates Foundation for the trial. Two weeks ago, Novavax announced positive results in the stage-one portion of the study for its candidate, NVX-CoV2373.
"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," Novavax President Gregory Glenn said in a statement.
The stage-one study, conducted in Australia, found NVX‑CoV2373 to be generally well-tolerated and that it produced antibody responses numerically superior to that seen in human convalescent sera.
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The new study involving 2,600 subjects will be led by Dr. Shabir Madhi of Wits University in Johannesburg. Novavax said if the vaccine is approved in South Africa, it will be supplied there through an agreement with the Serum Institute of India.
A separate, second-phase study involving 1,500 subjects will be initiated in the United States and Australia "in the near future," Novavax said.
The British government said Friday it has a deal with Novavax for 60 million doses of its vaccine, which includes a commitment to fund a stage-three trial with 9,000 subjects in Britain.
Russian President Vladimir Putin said last week Russia registered the world's first coronavirus vaccine, although it never went through a late-stage trial. Dr. Anthony Fauci, the United States' top infectious diseases expert, said he "seriously" doubts the Russian vaccine will be proven safe and effective.
A number of potential coronavirus vaccines are now in various stages of development. Click here for our COVID-19 vaccine tracker.
