- The first Covid-19 vaccine trials in children start on Friday.
- Sinovac will start investigating the efficacy of their two-dose vaccine on children.
- 2 000 South African children will be enrolled in the phase three trials.
In a first for South Africa, Sinovac will start phase three clinical trials of a Covid-19 vaccine for children from Friday.
Currently, the country has no Covid-19 vaccine approved for children.
According to Numolux, which has the approval to distribute Sinovac in South Africa, the trials will be conducted on 2 000 children aged six months to 17 years. They will be conducted at seven research sites across the country.
The trials will enrol 14 000 children from South Africa, Chile, the Philippines, Malaysia and Kenya.
Sinovac currently has conditional approval from the South African Health Products Regulatory Authority (Sahpra). The conditions include regular safety data updates and that they only be administered to people aged 18 to 59. The vaccine is not yet distributed for adults.
In a statement on Thursday, Numolux said the study would evaluate the efficacy of two doses of the vaccine against confirmed symptomatic Covid-19 cases in children and adolescents. Efficacy will also be evaluated against hospitalisation and severe Covid-19 cases.
They would also investigate the efficacy of the vaccine against hospitalisation.
Participants in the trial will receive two doses of vaccine or placebo 28 days apart. Efficacy assessments to include the surveillance for Covid-19 like symptoms and the laboratory confirmation of infection. An interim analysis will be done when 47 Covid-19 cases have been reported.
A recent paper published in journal The Lancet found that two doses of the vaccine were safe and had generally good reactions in children and teenagers aged three to 17 years old. More than 96% of children and adolescents who received two doses of the vaccine developed antibodies against Covid-19.
News24 reached out to Sahpra for comment, but was unsuccessful.
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