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Wits team ready to stop COVID-19 vaccine trial if found to be unsafe

The university will begin trials for the first African COVID-19 vaccine on Wednesday.

FILE: Medical swabs to test for the coronavirus. Picture: Eyewitness News.

JOHANNESBURG - Principal investigator and director of vaccines and infectious diseases unit at Wits University professor Shabir Madhi said if the COVID-19 vaccine being tested was found to be unsafe, trials would be stopped immediately.

The university will begin trials for the first African COVID-19 vaccine on Wednesday.

Two thousand volunteers between the ages of 18 and 65 will take part in the trial in South Africa to determine the safety and efficacy of the vaccine.

The South African Medical Research Council has partnered with the Bill Gates Foundation to develop the first COVID-19 vaccine in Africa.

Lead researcher Madhi said: “We anticipate to enrol the first subject on Wednesday in Gauteng and the 2,000 subjects over two months to conclude by end of August.”

He said the two-month trial would determine if the vaccine has at least 60% efficacy among HIV negative and positive people.

But the safety of volunteers was paramount: “If there’s any suggestion that the vaccine is doing any harm irrespective of how many it will be terminated immediately - the data safety monitoring committee will be able to tell investigators to stop immediately.”

If it passes the test, the vaccine will be rolled out from the end of the year to the third quarter of 2021.

Executive director of the Wits Reproductive Health and HIV Unit professor Helen Rees said the COVID-19 vaccine trial must ensure that Africa was not left behind like it was with HIV antiretroviral and the pandemic flu vaccine.

There are at least 100 vaccines being developed around the world for COVID-19.

Rees said it’s good that South Africa has made the continent part of the trials but it was not enough.

“We had the same issue with access to antiretroviral and we are seeing a replay potentially with access to a successful (COVID-19) vaccine.

She called on the media to take an interest in the global debate: “This is a drum we must hit hard in our region otherwise we will be left behind like we were with the pandemic flu vaccine. Africa got very little and months too late we cannot allow that to happen again.”

In addition to the 2,000 volunteers in South Africa, 7,000 are in the United Kingdom and 10,000 in the United States.

If the trials are successful the vaccine will be produced in South Africa, India and Europe.

AFRICANS MUST BE USED FOR TRIALS?

The team said many people had come forward to participate in the covid19 vaccine trial and this showed that it was not just scientists who wanted to be part of the endeavour.

The organisations clarified this following much publicised controversy involving French doctors who said Africans must be used for clinical trials.

Rees said the leaked conversation by the French doctors had not gone unnoticed by peers on the continent.

“Ita was interpreted as being an oppressive and exploitative approach and it has caused a lot of discussion and concern in the African region.”

But she said that had not discouraged scientists or governments.

“We want to participate and we want to be part of the scientific endeavour; we are leading. The African Union and Minister Zweli Mkhize has already entered into that dialogue about access for the African region and are totally supportive of South Africa’s participation in trials.”

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