South Africa
Phase 3 trials of #Covid19 vaccine to begin in SA─── 06:00 Fri, 02 Oct 2020
Phase 3 clinical trials for a potential Covid-19 vaccine candidate are set to commence in South Africa.
Wednesday’s announcement signalled the start of the enrolment of the Pfizer and BioNTech SE study in the country.
On September 12, the pharmaceutical company and biotechnology corporation announced plans to expand the trials to include a wider population range to provide more information related to the candidate vaccine's efficacy and safety.
The BNT162 study will include as many as 44 000 participants from across the globe, and will include individuals with chronic, stable HIV, Hepatitis C or Hepatitis B infections.
The study in South Africa will include up to 800 participants at four sites in Gauteng, Limpopo, and the Western Cape.
The trials received regulatory approval from the South African Health Products Regulatory Authority on September 22.
“We are confident that the South African sites will contribute high-quality data to this ground-breaking study,” said national principal investigator Essack Mitha.
Pfizer and BioNtech have received regulatory approval from the FDA to proceed with the trials.
