About 2 000 South African children and adolescents from the age of six months to 17 years will take part in a global vaccine trial.
They will be among the 14 000 children from five countries — South Africa, Chile, Philippines, Malaysia and Kenya.
The Numolux Group, a subsidiary of the Chinese-based vaccine manufacturer, Sinovac Biotech, has been given approval by the South African Health Products Regulatory Authority, together with Pharma Ethics and Sefako Makgatho Health Sciences University Research and Ethics Committee, to conduct the trials.
The multi-centre, randomised, double-blind, placebo-controlled phase three clinical trial will be run from seven clinical research sites in South Africa to evaluate the efficacy of two doses of CoronaVac against confirmed symptomatic Covid-19 cases, as well as the evaluation against hospitalisation and severe Covid-19 cases in children and adolescents.
The participants will receive two doses of the CoronaVac or a placebo 28 days apart, with safety evaluations being done seven days after vaccination and another 28 days after vaccination.
The participants will be monitored for Covdi-19 symptoms and genomic mutations of any of the variants of concern. Investigators will follow confirmed Covid-19 cases until resolution.
Until now, children from South Africa and other parts of the world were not eligible for any of the Covid-19 vaccines.
The United Kingdom is one of the few countries where children aged 12 to 17 have received the two-dose Pfizer vaccine.
At least two million children in South Africa stand to benefit from the approval of a paediatric Covid-19 vaccine, should the CoroVac meet the regulatory authority’s safety and efficacy standards of at least 50%.
What children think about vaccination
Given concerns about their safety around unvaccinated adults and confusion emanating from rumours and anti-vaccination sentiments, children are thinking about what decision they would take should they be eligible for vaccination.
Atlegang Moleke,16, who attends a high school in Thembisa, Gauteng, said she was concerned about her safety at school. She did not fully understand why people aged 60 and above were prioritised but still thought this decision was a good one.
“I think they did a good thing by vaccinating older people first. I would also get vaccinated should children be allowed to, because I don’t think it is wrong to get vaccinated even though people are saying negative things about vaccines, especially about the side-effects. But I think it is fine, as long as I am going to benefit from it [the vaccine].”
Her friend, Anita Vava, who is also 16, said she did not know anything about the vaccines but had heard rumours that they were bad.
“I would get vaccinated but I also don’t think it would be a good idea because a lot of people say negative things about vaccines,” she said. “I haven’t heard people saying positive things about them. Plus you also have to wait for hours when you get to vaccination sites.”
Although Atlegang said would not feel safe being taught by an unvaccinated teacher, she thought that people, including teachers, had the right to choose.
Anita agreed, saying: “I wouldn’t feel safe being taught by a teacher who hasn’t been vaccinated. But it is honestly their choice and not mine. At my school, they are all vaccinated. They didn’t want the vaccine at first but ended up getting vaccinated.”