First African Covid-19 vaccine trial kicks off on SA soil

In a major milestone for the country, the continent and the global fight against the pandemic the first participants from across Africa will be vaccinated this week in a South African A trial as the world searches for a prevention against acquiring Covid-19.

Called The South African Ox1Cov-19 Vaccine VIDA-Trial, it has enrolled 1,950 adult volunteers, ages 18 to 65, all of whom are HIV negative.

Additionally, 50 HIV-positive volunteers have enrolled.

All are intended to remain on the trial for a year.

Researchers at sites in Gauteng will begin testing the Covid-19 vaccine in human volunteers on Wednesday, and the study may be extended to sites in Cape Town over the next few weeks.

In addition to the SA cohort, 5,000 Brazilians are enrolled, and in earlier phases of the trial, after the vaccine was developed at the Oxford Jenner Institute, 4,000 Britons were enrolled and plans for an additional 10,000 participants are under way.

An even larger study (of the same vaccine) is planned for the US where up to 30,000 will be enrolled.

“The objective of the trial is to investigate if the vaccine will protect against Covid-19, doesn’t cause unacceptable side effects, and if it induces satisfactory immune responses,” according to Wits University.

By vaccinating volunteers with ChAdOx1 nCoV-19, scientists hope to make the human body recognise and develop an immune response that will help stop the SARS-CoV-2 virus from entering human cells and causing Covid-19.

Wits University is collaborating with Oxford University on the trial, with funding from the SA Medical Research Council and the Bill and Melinda Gates Foundation.

Prior to the launch, the South African study was subject to rigorous review and has been approved by the SA Health Products Regulatory Authority (SAHPRA) and the Human Research Ethics Committee of the University of the Witwatersrand.

At the helm is Prof Shabir Madhi, professor of vaccinology at Wits University who is also on the Covid-19 advisory committee to the government.

He said on Tuesday, “SA is nearing the mark that countries like the UK and Italy reached at their peak — when around 35,000 new cases were appearing each week”.

He said this phase of the vaccine trial will be concluded in mid-August and that follow-up will take place for all participants over the next year.

If successful, further work involves preparing manufacturing facilities plus global distribution.

He added, “for at least the next two years, we will not have access to vaccines and we need to adhere strictly to non-pharmaceutical interventions like social distancing, masks and hand hygiene.”

He said this week marks a “landmark moment for SA and Africa at this stage of the Covid-19 pandemic” and that “as we enter winter in SA and pressure increases on public hospitals, now more than ever we need a vaccine to prevent infection by Covid-19”.

Dr Sandile Buthelezi, the director-general in the national department of health, said the department was “excited” about the launch of the trial and believes it will “go a long way to cement SA’s leadership in the scientific space”.

He added, “With Covid-19 infections increasing every day, the development of the vaccine will be the last solution in the long term, and we are fully behind the team leading this trial.”

Prof Helen Rees, chair of SAHPRA and executive director of the Wits Reproductive Health and HIV Institute (Wits RHI), said: “It is essential that vaccine studies are performed in southern hemisphere countries, including in the African region, concurrently with studies in northern hemisphere countries.

“As the world rallies to find health solutions, a South African endeavour for the development of an effective Covid-19 vaccine is testament to our commitment to  supporting health-care innovation to save lives,” says Prof Glenda Gray, president and CEO of the SA Medical Research Council.

Source: timeslive.co.za