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U.S drug company starts covid 19 vaccine trial in South Africa

American vaccine development company Novavax says it has begun a Phase 2b clinical trials in South Africa to evaluate the efficacy of a covid 19 vaccine candidate. 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 Bill and Mellinda Gates foundation, the company said in a statement on Monday (17 August)

"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 safely and immunogenicity data for NVX -Cov2373 said Gregory M. Glenn, president of Research and Development at Novavax. "We appreciate the continued support of the Bill and Melinda Gates foundation and CEPI, and our commitment to produce and deliver a safe, effective vaccine across the globe ". Novavax said tha the trial will consist of two cohorts. The first cohort will evaluate efficacy, safety and immunogenicity in approximately 2,665 healthy adults.

The second cohort will evaluate safety and immunogenicity in approximately 240 medically stable, HIV-positive adults. This allow for evaluation of the vaccine across a diverse, representative study population it is said. Novavax expects that, If approved in South African, it's Covid 19 vaccine will ultimately be supplied to in the country through a recently announced collaboration with the Serum Institute of India. "The major motivation for the Covid 19 vaccine being evaluated at an early stage in South African is to generate evidence in the African context on how well these vaccine work in settings such as our own "said Madhi, " I am pleased to work with Novavax as the principal investigator in this clinical trial, following Novavax Covid 19 vaccines positive pha1data, which provides strong rationale for moving development forward in a large subset of adult" South Africa is fifth worst affected country with 583 653 corona virus cases and 11 677 death, according to Reuters tally. The Bill and Melinda Gates foundation is providing a $15 million grant towards the clinical trial, the company said. Novavax said intends to initiate the Phase 2 portion of this trial in the United States and Australia in the near future and that it would include about 1 500 candidates

Earlier this month, Glenn told Reuters the company would start much larger late stage clinical trials soon and could potentially glean enough data to obtain regulatory approvals as early December. The UA government in July had awarded Novavax $ 1.6 billion to cover testing and manufacturing of a potential vaccine for the novel corona virus in the united state with the aim of delivering a 100 million doses by January. Last month, ArtraZeneca and Oxford university are under way in South Africa and due to start in the united states ,where prevalence is higher

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Melinda Gates Mellinda Gates Novavax Shabir Madhi South Africa

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