Pretoria – Young lad Simphiwe (not his real name) is seated quietly inside the vaccination room at Sefako Makgatho Health Science University’s MeCru Research Unit.
He is facing in the opposite direction from the glare of cameras and journalists and surrounded by a group of scientists and doctors, who were part of the entourage to witness the launch of a phase III pediatric Covid-19 vaccine study involving children under the ages of 18.
The study, which was approved by the South African Health Products Regulatory Authority (Sahpra), is headed by Sinovac and Numolux Group (Pty) Ltd of Pretoria.
Numolux is the authorised representative in South Africa of Sinovac I Life Sciences Co. Ltd., a subsidiary of the Sinovac Biotech Ltd. (“SINOVAC”) of Beijing, China.
As the study got under way yesterday Simphiwe became the first child to be administered a Sinovac’s CoronaVac vaccine.
His identity was hidden and his real name can’t be disclosed as part of the privacy and confidentiality clauses contained in the contract he signed before taking part in the study.
Minutes before the vaccine could be administered, doctors in the room inquired from photographers if they were ready to capture the moment in history. They gave a nod and within seconds the vaccination was done. A round of applause followed to mark the historic vaccination of a first child in South Africa.
There was another participant, also a boy, who was next in line to take his shot.
Both their ages were not given away except to say they were between 12 and 17.
Their families could not be interviewed to protect the integrity of the study that is expected to last between 13 to 14 months.
The two boys were among the 2 000 participants selected for the trial in the country, where seven sites have been set up for the study. Two of them are in Cape Town, one in Paarl, Sandton, Brits and New Town in Johannesburg.
The trial is taking place in five countries; such as Brazil, Indonesia, Kenya and South Africa and will see all in all 14 000 children as participants.
Dr Sanet Aspinall, project director and principal co-ordinator for the study in South Africa said: “The vaccine has been tested in phase trials in adults in Brazil, Chile, Indonesia and in the Philippines and it has also been shown to be very effective in these studies ranging from 51% in the healthcare population to 93% in the Indonesian population and 87% in Chile.”
She added that on July 1 CoronaVac was approved in South Africa for emergency use and was available in another 50 countries.
In China the vaccine has already been rolled out for children between the ages of three to 17 years with at least 19 million of them, so far, vaccinated.
Aspinall said the trial would test the safety and immunogenicity as well as efficacy of CoronaVac in children aged six months to 17 years.
Participants in the trial will receive two doses of CoronaVac or placebo 28 days apart with the primary objective to evaluate the efficacy of the two doses.
The efficacy assessments would include the surveillance for Covid-19 like symptoms and the laboratory confirmation of SARS- CoV-2 infection by RT-PCR.
“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,” Numolux said.
Two weekly reports will be submitted to Sahpra and the ethics committee during the trial.
All those vaccinated will be observed for the first 30 minutes to evaluate safety.
They will also be observed for the first seven days following vaccination and of unsolicited adverse events during 28 days post-vaccination.
Occurrence and relationship of serious adverse events will be monitored from the first dose to 12 months after the last dose.
Emphasising the importance of vaccinating children, Aspinall said: “Covid-19 affects children but the disease is not as severe as it affects adults. It is a mild and moderate type of disease, but the children also get infection while at school and they bring it back to their families and especially now to the unvaccinated population. And during this pandemic there has been very little done for the children and this trial will address a big need in terms of having vaccines that can be tested and can be made available for children.”
Sinovac medical director of clinical research department, Gang Zeng said the beginning of the trial in the country was very exciting.
“CoronoVac can help protect South African kids from Covid-19,”he said.
He said according to studies across the world the vaccine has been proven to be safe and effective.
Pretoria News
