Johnson & Johnson begins Phase 3 COVID-19 vaccine candidate trial in SA

Johnson & Johnson has commenced the Phase 3 trial of its COVID-19 vaccine candidate in South Africa. The first South African participants in the ENSEMBLE trial were dosed last week. Ludovic de Beaucoudrey, Medical Affairs Director at Janssen South Africa, joined CNBC Africa to discuss the technical aspects of the trial and the significance of the study. Following positive results in animal testing, including non-human primates, the vaccine candidate progressed to Phase 1, 2a trials in humans. This phase demonstrated good vaccine activity, leading to the initiation of the Phase 3 trial. The Phase 3 trial aims to vaccinate 60,000 individuals in various countries, with a focus on South Africa. The study will span a period of two years, with interim analyses conducted to assess efficacy and safety. Johnson & Johnson's commitment to a non-profit basis for the emergency use of the vaccine ensures equitable access to low-income and developing countries. Additionally, the company has secured 500 million doses for these regions. The trial includes adult participants across different age groups, emphasizing the importance of diverse representation, including individuals with comorbidities and various ethnicities. South Africa's involvement in the trial provides unique opportunities for the country. Not only does it offer early access to the vaccine, but it also positions local health authorities to make informed decisions based on confidential data shared by Johnson & Johnson. The inclusion of South African participants addresses concerns about underrepresentation in clinical trials, potentially leading to more comprehensive and effective outcomes.