The trial kicks off at the at the Sefako Makgatho Health Sciences University (SMU) in Pretoria on Friday, 10 September 2021, where the first child will be vaccinated.
The trial targets children aged from six months to 17 and will test the efficacy of two doses of CoronaVac vaccine against confirmed symptomatic COVID-19 cases in children and adolescents Efficacy will also be evaluated against hospitalisation and severe Covid-19 cases.
According to the Numolux Group, the participants in the trial will receive 2 doses of vaccine or placebo 28 days apart.
“Any confirmed COVID-19 case will 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. 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 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 Numolux Group
SAHPRA approves Sinovac’s child vaccination trial
The study worldwide will enroll 14 000 children and adolescents in various pediatric age group cohorts across 5 countries including, Chile, Philippines, Malaysia and Kenya.
The trial has already been given the greenlight by the South African Health Products Regulatory Authority (SAHPRA).
“This study has public health importance globally because a vaccine that prevents COVID-19 disease and transmission in pediatrics would be a crucial tool to assist in curbing the pandemic. 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 Numolux Group
All this comes as government had said it was looking into vaccinating children as soon as adults have received their jabs. So far just over 14 million vaccines have been administered across the country.