SA to launch Covid-19 vaccine trial for children
The first South African child will be vaccinated against Covid-19 at the launch of Phase III pediatric Covid-19 vaccine trial on Friday.
The child will be vaccinated at the Sefako Makgatho Health Sciences University in Pretoria.
South Africa is one of five countries to participate in the global children's vaccine trial in partnership with SINOVAC Biotech.
A total of 2 000 South African children will be part of the trial, involving a total of 14 000 children aged 6 months to 17 years.
In a statement, the Numolux Group says the primary objective of the study is to evaluate the efficacy of two doses of vaccines against confirmed Covid-19 cases in children.
“Interim analysis will be done when 47 Covid-19 cases have been reported. Safety will be evaluated in terms of solicited local and systemic adverse events during 7 days following vaccination and of unsolicited adverse events during 28 days post-vaccination.
“Occurrence and relationship of serious adverse events will be monitored from first dose to 12 months after the last dose.”
The group says the trial has been approved by the South African Health Products Regulatory Authority (SAHPRA).
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