Pretoria - With the first two children to receive the Covid-19 vaccine still in a good state of health, the Medunsa Clinical Research Unit (MeCru) at Sefako Makgatho Health Sciences University (SMU) has enrolled 270 more children to be vaccinated.
The university announced that following the success of the first two children vaccinated as part of the phase 3 paediatric Covid-19 programme on September 10, they had ramped up the enrolment of more children to take part in the trial.
The study was conducted in partnership with MeCRU and the Sinovac, Numolux Group.
The unit's principal Investigator, Dr Vongane Maluleka maintained constant contact with the two children a boy aged 15 and a 17-year old girl since they received their jabs.
In line with the study protocol, they called the children within seven days in the first week after they were inoculated and conducted followed up calls once every week.
The children were administered a second dose after 28 days and the same follow-up procedures were followed.
According to the university, the parents of the children were also engaged and they too confirmed that the children were in a good state of health, to the extent that the parents also gave them permission to return to school when the September school vacation ended.
Following on the success of the first two children, MeCRU has since ramped up the numbers and to date completed the enrolment of 270 children.
This includes 157 children between 12-17 years, 76 between 6-11 years, as well as 37 toddlers aged 3-5 years.
The university said 237 of these had already received their second dose and it was anticipated that the remaining 37 participants would have received their second dose by the second week of December.
The unit stressed however that it would not be enrolling children between the 6 months to 3 years age group.
The trial being conducted at MeCRU is part of the worldwide study looking to enrol 14 000 children and adolescents in various paediatric age cohorts across 5 countries namely, South Africa, Chile, Philippines, Malaysia and Kenya.
The unit is one of several clinical research sites across South Africa targeting to enrol 2 000 participants from 6 months to 17 years.
The study is a multi-centre, randomised, double-blind, placebo-controlled phase 3 clinical trial to evaluate the efficacy, immunogenicity and safety of Sinovac Covid-19 vaccine in children and adolescents.
The primary objective of the study is to evaluate the efficacy of the two doses of CoronaVac® against confirmed symptomatic Covid-19 cases in children.
The study timelines were 8-10 weeks from the first participants enrolled, with the follow-ups to continue for 12 months after the second vaccination. The study is expected to be completed by December 2022.
"All the vaccinated children are being strictly monitored in line with the research project protocols and will be followed up for a year," said SMU's communication manager Phaladi Seakgwe.
Pretoria News