Pfizer and BioNTech have started participant enrolment in a Phase III clinical trial of their Covid-19 vaccine candidate in South Africa.
The Phase III programme is set to enrol about 44,000 participants globally, with focus on trial population diversity, including those with chronic, stable HIV, hepatitis C or hepatitis B infection.
Designed to assess the safety and efficacy of the vaccine candidate, the trial will involve nearly 800 subjects at four sites across Gauteng, Limpopo and the Western Cape in South Africa.
The South African Health Products Regulatory Authority (Sahpra) granted regulatory approval for the trial on 22 September 2020.
Dr Essack Mitha has been appointed as the trial’s national principal investigator.
Dr Mitha said: “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.”
Pfizer and BioNtech have already enrolled more than 35,000 volunteers worldwide, following the US Food and Drug Administration (FDA) approval.
Pfizer South Africa medical director Dr Bha Ndungane-Tlakula said: “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.”
Last month, Pfizer said that Phase III trial participants were experiencing mild-to-moderate side effects with its investigational Covid-19 vaccine candidate.
On an investor conference call, the company executives noted that more than 12,000 study participants had received a second dose of the vaccine candidate.
Pfizer added that it was continuously analysing the safety and tolerability of the candidate in its trial.