Pharmaceutical giants Pfizer and BioNTech have announced that they will be commencing with the Phase 3 trial of their respective COVID-19 vaccine trials. The recently expanded study will include 44 000 participants from across the globe to increase the trial population’s diversity. This will now include individuals who have HIV, Hepatitis C or Hepatitis B infections.
According to Pfizer, South Africa was selected as a global participant due to the local scientific expertise and capabilities, the epidemiology of the virus and the country’s prior experience in running clinical trials.
A total of 800 South Africans will partake in the trial, with sites spread across the Western Cape, Gauteng and Limpopo. The trials received regulatory approval from the South African Health Products Regulatory Authority (Sahpra) on September 22.
“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,” Dr Essack Mita told BusinessTech. “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.”
Pfizer and BioNtech have also received approval from the US Food and Drug Administration (FDA) to proceed with the Phase 3 clinical trials.
“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.
While South Africa has moved down to level 1 of the lockdown as of September 21, the Gauteng Department of Health is concerned about the 6% increase in COVID-19 active cases reported in the province.
Gauteng is currently the epicentre of the virus, with 219 373 confirmed cases to date. It is followed by KwaZulu-Natal with 118 889, the Western Cape 110 541 and Eastern Cape 89 076 cases.
Globally, there have been 33 249 563 confirmed cases of COVID-19. The global death toll has now surpassed 1-million.