SA Covid-19 vaccine trials could resume within a week

Covid-19 vaccine clinical trials to treat the pandemic could resume within a week, SA Medical Research Council president and CEO Professor Glenda Gray said yesterday.

Among the central figures in the country’s fight against the coronavirus that has globally left over a million people dead, with over 18,000 reported in South Africa, Gray has echoed views of medical experts who found it necessary for there to be a global pause in clinical trials to safeguard the health and safety of volunteering participants.

Trials in SA and in other countries paused after an ill participant in the United Kingdom sparked worldwide concern. According to Dr Clare Cutland of Wits University’s Respiratory and Meningeal Pathogens Research Unit, administering protocols at Oxford’s SA trial sites, headed by professor Shabir Madhi, include:

• Oxford-Astra Zeneca trial enrolled at seven sites nationally: five in Gauteng (1 596 participants) and two in the Western Cape (433 participants) – with a sample size required being 2,070 participants. There were 3,009 people screened for participation to date and 2,029 enrolled.
• Novavax trial covering nine sites, which has to date 2,069 screened and 1,215 participants enrolled. Its required sample size is 2,640.
• J&J AD26 trial, locally led by Gray, is said to be the biggest study globally with 60,000 participants, covering SA, Latin America and the United States. While hopeful that trials would resume next week, Gray said the pause was important.

“We expect pauses to happen. Because of the epidemic, there is a need to work fast and urgently. But that cannot be at the expense of health and safety. There are a lot of safety rules built into these clinical trials, because safety is paramount.

“If something happens during the trial, you want to investigate it completely, to make sure it is not vaccine-related,” said Gray.

Also welcoming the clinical trial suspensions was Caryn Fenner, technical director of Afrigen Biologics, who said the moved reassured that highest safety standards were being applied “to this all-important experiment”.

“The decision to pause the trial means that the very highest clinical practices and necessary safety protocols are in place. We have to remember that often a participant falls ill due to causes unrelated to the trial.

“Half of the recipients are receiving the placebo, so if they do fall ill, it may have no relation to the vaccine trial.”

Fenner says South Africa, along with Brazil, the UK and the United States, were proactive in getting involved in the trial due to the importance of understanding the effects of the vaccine within our local context.

“It’s not enough to test the vaccine in higher-income populations. We need to know how it will work across diverse economic, ethnic and age groups,” said Fenner.

Amid reports that the UK could get three vaccines before Christmas, Gray said: “The most important thing for South Africa is to make sure that there is availability. The biggest issue with the vaccine, which is found to be affective, is how to deal with global demand.

“One has to make sure that when there is global demand, poorer countries are given access to a commodity. There are three ways to access the vaccine: through a global financing mechanism, a financial agreement with a pharmaceutical company or making use of a bi-national agreement with a country which has the vaccine.

“It is important for South Africa to look at all options to access vaccine for its citizens,” she said.

– brians@citizen.co.za

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