Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX)announced today the start of enrollment in South Africa for the Phase 3 pivotal COVID-19 vaccine trial. The recently expanded study will enroll approximately 44,000 global participants, which will allow a further increase in trial population diversity, and include people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data.
The selection of South Africa as one of the global hosts of the study was based on the local scientific expertise and capabilities, the epidemiology of the disease, and South Africa’s prior experience in running clinical trials. The study will include approximately 800 participants and will be conducted in four sites across Gauteng, Limpopo and the Western Cape. The trials received regulatory approval from the South African Health Products Regulatory Authority (SAHPRA) on 22 September 2020.
Dr Essack Mitha, who has more than 16 years’ experience in research and development (clinical trials) in the medical and pharmaceutical sectors, working with both local and international companies in the conduct of more than 100 clinical trials, and who has served 3 terms as an executive member of the South African Clinical Research Association, will be the study’s National Principal Investigator.
“We are proud and excited to be given the opportunity to take part in this global research effort. South African patients will play a critical role in the fight against COVID-19. We are confident that the South African sites will contribute high quality data to this ground-breaking study, and that medical science will prevail in this pandemic,” said Dr. Mitha.
Having secured regulatory approval from the U.S. Food and Drug Administration (FDA) to proceed with the Phase 3 clinical trials of BNT162, Pfizer and BioNtech have commenced and have already recruited more than 35,000 participants globally.
“As Pfizer, we are proud to be bringing this important study to the country, and to the African Continent, to add to the growing knowledge of this virus so we can find a lasting and sustainable solution to end this pandemic,” said Dr. Bha Ndungane-Tlakula, Pfizer’s Medical Director for South Africa.