Phase 3 of coronavirus vaccine trial starts in South Africa

 ·30 Sep 2020

Medical companies Pfizer and BioNTech have announced the enrolment of South Africa for phase 3 of their Covid-19 vaccine trial.

The recently expanded study will include approximately 44,000 global participants, allowing a further increase in trial population diversity, and include people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection.

The expanded study will also provide additional safety and efficacy data.

Pfizer said that 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 will be the study’s national principal investigator. Mitha has more than 16 years’ experience in research and development (clinical trials) in the medical and pharmaceutical sectors.

“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 US Food and Drug Administration (FDA) to proceed with the phase 3 clinical trials of the vaccine trial, 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.

Increasing Covid-19 numbers

The Gauteng Department of Health meanwhile, is concerned about the 6% increase in the number of Covid-19 active cases since the country moved to level 1 of the lockdown.

South Africa moved to level 1 of the lockdown on 21 September 2020.

Gauteng remains the epicentre of the virus with 219,373 cases to date followed by KwaZulu-Natal with 118,889, the Western Cape 110,541 and Eastern Cape 89,076.

“The rise in infections has been attributed to among other factors to non-adherence to non-pharmaceutical interventions by some members of the public,” the provincial department said.

The areas of concerns include Johannesburg’s Inner City, Soweto, Sedibeng and Tshwane.

“It is important that we emphasise to the public that the fight against COVID-19 is far from over. We want to caution communities that we need to continue adhering to non-pharmaceutical interventions,” said Gauteng acting MEC of Health, Jacob Mamabolo.

The MEC called on everyone to play their part by wearing facemasks, social distancing, sanitising and washing hands.

According to the provincial department, 1,200 people are currently hospitalised in public and private health facilities.

Meanwhile, South Africa recorded 903 new COVID-19 cases in the last 24 hours bringing the cumulative number of detected infections to 672,572.

In addition, 81 more people succumbed to the respiratory disease pushing the death toll to 16,667.

Of the latest deaths, 28 are from Gauteng, 11 from KwaZulu-Natal, 10 from the Northern Cape, eight from the Eastern Cape and the North West, six from the Western Cape, and five from Limpopo and Free State.

“We extend our condolences to the loved ones of the departed and thank the healthcare workers that treated the deceased patients,” said health minister, Dr Zweli Mkhize.

Meanwhile, recoveries now stand at 605,520 which translates to 90%.

The data is based on the 4 164 491 tests conducted of which 12,011 were performed since the last report.

Globally, there have been 33,249 563 confirmed cases of Covid-19, while the death toll has now surpassed 1 million, the World Health Organisation reported.

Read: Government is ready to turn its attention back to NHI: Mkhize

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