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Results of BCG vaccine trial expected soon

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Bacille Calmette-Guerin (BCG) is a vaccine primarily used against tuberculosis (TB)

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CAPE TOWN – Researchers conducting a clinical trial to test whether the Bacille Calmette-Guerin (BCG) vaccine can help stem the tide of Covid-19 infections among health workers expect to get results later this month.

The year-long study, the first to focus solely on front-line health workers in the country, began in May and involves Stellenbosch University, the University of Cape Town and TASK, a company that develops and tests new drugs and vaccines.

BCG is a vaccine primarily used against tuberculosis (TB).

Founder and chief executive of TASK, Professor Andreas Diacon, said an independent board that worked with the researchers would, after receiving latest data, inform them whether there was evidence of an effect of BCG vaccination for protection from Covid-19.

Health Minister Zweli Mkhize said on Thursday that South Africa would be receiving 1 million doses of vaccines this month and 500 000 more in February from the Serum Institute of India. Diacon said the researchers were hoping for positive results from the study.

“We are hoping for a stopgap measure that could in future be used also for other epidemics of a similar nature, until more specific protective vaccines become available. It would also provide basic protection independent of any virus mutations or variation,” said Diacon.

He said accessibility of the BCG vaccine was important and would need to be managed, just like with the Covid-19 vaccines.

“If BCG works there will be interest and production will be ramped up. There is a limited supply of available doses that must be allocated. We would use a small supply for the participants that received a placebo on our study, then the continued supply for babies must be secured for TB protection, and available doses in excess of that should be rolled out in a manner that considers the risk of Covid-19 and the potential benefits in groups of persons that might want to be vaccinated. Health authorities and the wider community would be involved in these decisions,” explained Diacon.

Dr Caryn Upton at TASK said BCG had protective non-specific effects against respiratory-tract infections.

“In the clinical trial we want to see if the vaccine can help the body to respond better, faster and more aggressively to infections and viruses that affect the chest and respiratory system such as Covid-19.

“We believe that BCG can train the immune system’s response in protecting high-risk people and prevent symptoms and severe Covid-19 diseases,”  she said.

A total of 1,000 participants took part in the study and were spread out across three facilities. 450 were vaccinated by TASK in Cape Town, 50 in George, and 500 more at the UCT Lung Institute.

Diacon said the Stellenbosch University and other laboratories were now busy with laboratory testing of samples.

He said there were no unexpected side effects from the vaccinations.

“As expected with the second wave we have been collecting events recently at quite a pace and enter those into the database as fast as we can,” Diacon added.

He said one of the lessons learnt so far from the study was it was “harder to motivate” people to enter the study than anticipated.

“There were many misconceptions about such research, how it is done and how it works. There is an urgent need to offer the community information and education about clinical trials and particularly the intense regulation in place to keep the participants safe and maximise potential benefits for the community that takes part,” Diacon added.

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