Inner City Gazette

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Est 2009 Issue 38 - 2020

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Inner-City Gazette

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1 - 8 October 2020

Website : www.inner-city-gazette.com Inner City Gazette

Phase 3 Covid -19 vaccine trial starts Dr Bha Ndungane-Tlakula

“The rise in infections has been attributed to among other factors to non-adherence to non-pharmaceutical interventions by some members of the public. Areas of concern include Johannesburg inner-city, Soweto, Sedibeng and Tshwane. The fight against Covid-19 is far from over. We caution communities that we need to continue adhering to nonpharmaceutical interventions.”

Johannesburg - Medical companies Pfizer and BioNTech have announced the enrolment of South Africa for their Phase 3 Covid-19 vaccine trial. The recently expanded study will include about 44 000 global participants, allowing a further increase in trial population diversity, and include people with chronic, stable HIV, Hepatitis C, or Hepatitis B infection. The study will also provide additional safety and efficacy data. Pfizer said 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 about 800 participants, and conducted in four sites across Gauteng, Limpopo and the Western Cape. The trials have received approval from the South African Health Products Regulatory Authority (SAHPRA). Dr Essack Mitha, who has over 16 years’ experience in research and development, clinical trials, in the medical and pharmaceutical sectors; will be the study’s national

principal investigator in the programme. “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 groundbreaking study, and that medical science will prevail in this pandemic,” Dr Mitha said. 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 recruited more than 35 000 participants globally. Pfizer’s medical director for South Africa Dr Bha Ndungane-Tlakula said: “We are proud to bring 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.” The Gauteng Health department is concerned about the 6% increase in the number of Covid-19 active cases since the country moved to lockdown Level 1. “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 department said. The areas of concern include Johannesburg’s inner-city, Soweto, Sedibeng and Tshwane. Acting Gauteng Health MEC Jacob Mamabolo said: “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.” Mamabolo called on everyone to play their part by wearing facemasks, social distancing, sanitising and washing hands. According to the department, 1 200 people are currently hospitalised in public and private health facilities. Meanwhile, recoveries stand at 90%. The data is based on the 4 164 491 tests conducted of which 12 011 were performed since the last report. The World Health Organisation (WHO) reported that globally, there have been 33 249 563 confirmed Covid-19 cases, while the death toll has surpassed one million.


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