A US-based vaccine development company is set to begin the second phase of human testing for its COVID-19 vaccine in South Africa, which is in the midst of a surge in coronavirus cases.
Novavax said in a statement that the clinical trials will include 2,665 healthy adults in South Africa. The trials will also compare the vaccine’s effect on 240 medically stable adults with HIV whose immune responses may differ from individuals without HIV.
Preliminary findings from the first trial showed people receiving the two doses generated neutralizing antibodies, which can prevent the virus from entering cells, after receiving a second dose of the vaccine.
Along with evaluating the immune response in the phase 2b trial in South Africa, Novavax will also organize a phase 2 trial in the United States and Australia in the near future.
In Novavax’s statement, Dr Gregory Glenn, president of research and development at Novavax said, South Africa’s surge in COVID-19 cases lends importance to the Phase 2b clinical trial, with the potential to provide an early indication of efficacy, along with additional safety and immunogenicity data for the vaccine.
South Africa is the fifth most affected country worldwide, with more than 583,000 coronavirus cases and more than 11,600 deaths. Novavax said the trial in South Africa is made possible in part from a $15 million grant from The Bill & Melinda Gates Foundation.
The Coalition for Epidemic Preparedness Innovations is providing money to manufacture doses of the vaccine needed for the trial. Last month, the US government awarded Novavax a $1.6 billion contract to cover testing and development of a vaccine for the coronavirus in the United States with the goal of providing 100 million doses by January.