POLL | Would you let your child be part of a vaccination trial?
SA has started the vaccination of children and adolescents as part of the global phase 3 clinical trials of China’s Sinovac Biotech vaccine.
The trial was launched on Friday, with the first two participants jabbed in Pretoria.
The trial is testing the efficacy of Sinovac's two-dose CoronaVac on 14,000 children aged between six months and 17 years in various countries, including SA and Kenya.
The first two children were vaccinated at the Mecru Clinical Research Unit (MeCRU), based at the Sefako Makgatho Health Sciences University (SMU).
The university said the efficacy of the vaccine will also be evaluated against hospitalisation and severe Covid-19 cases.
Sinovac’s local representative, Numolux, partnered with seven clinical research sites across the country to enrol 2,000 participants.
The trial has been approved by the SA Health Products Regulatory Authority (Sahpra) and Pharma-Ethics.
“The study has public health importance globally, because a vaccine that prevents Covid-19 and transmission in paediatrics would be a crucial tool to assist in curbing the pandemic,” said the SMU Research Ethics Committee (Smurec).
“Although children and adolescents have a milder form of the disease than adults, they remain susceptible to infection and severe manifestations across all ages.”
The university said any confirmed Covid-19 case would be followed by the investigators until resolution.
“Whole viral genome sequencing to detect mutations or variants of concern among all the confirmed Covid-19 cases during the trial will be done. An interim analysis will be done when 47 Covid-19 cases have been reported,” it said.
Safety will be evaluated in terms of solicited local and systemic adverse events during seven days after vaccination and of unsolicited adverse events during 28 days post-vaccination.
“The occurrence and relationship of serious adverse events will be monitored from the first dose to 12 months after the last dose. The humoral immune response across a subset of all paediatric age group cohorts will be evaluated and cell-mediated immune response in a subset of vaccinated participants in Chile will be investigated,” said Smurec.