South Africa’s first paediatric vaccine trial participant received the first shot of the Sinovac Covid-19 vaccine, CoronaVac, on Friday at the Sefako Makgatho Health Sciences University (SMU) in Tshwane.
The adolescent, who is a minor and thus cannot be named, is part of the first trial group in the country comprising children aged 12 to 17. In all, 2 000 children from South Africa will participate in the trial testing the efficacy, safety and effectiveness of the CoronaVac. They are among the 14 000 people from five countries aged six months to 17 years.
Over 13 months, this first-of-its-kind Covid-19 vaccine trial will see half of the children receiving the vaccine, while the other half will be given a placebo.
“If it is proven effective, the placebo group will also get the vaccine. We will start with the 12 to 17 group and will also be starting slowly with the babies as well, dosing one baby with the first dose,” said Sanet Aspinall, the project director and principal coordinator of the study in South Africa.
Sixty million of the two-dose vaccines have already been administered to 40-million children aged three to 17 years in China. More than one billion people worldwide have been vaccinated with CoronaVac.
According to The Lancet, a study found that the CoronaVac was well tolerated and safe, and induced antibody responses in children and adolescents aged three to 17, and encouraged that further studies be conducted on this cohort.
“The CoronaVac is a safe vaccine for Covid-19, it has been tested in phase 3 trials in adults. We know that we’ve got good data on adults. The vaccine has been rolled out into China on children aged three to 17 years. We are working with the same vaccine and we are going to do the phase 3 trial on children,” said Aspinall.
She said the primary objective of the trial was to evaluate the safety of the two-dose vaccine. The efficacy and the safety of the vaccine would be monitored over seven visits by the participants to the various trial sites, with some of the focus being on how the vaccine performed against the Covid-19 variants currently circulating in the country.
Evaluations for safety will be conducted 30 minutes after the first dose is administered. It will then be followed by further evaluations seven days after vaccination and another evaluation on day 28.
Extra care has been taken to ensure the safety of the trial participants and the sites have been set up to accommodate children from the different demographics.
The Pretoria-based Numolux Group is the locally authorised subsidiary of Sinovac, which has been authorised by the South African Health Product Regulatory Authority (SAHPRA) to conduct the multi-centre trial.
“Today we can say successfully that the vaccine for children has arrived. As we have witnessed the launch where the first child was jabbed, a first of its kind in SA and Africa, we dedicate it to all the children that have died from the virus,” Numolux group chief executive officer Hilton Klein said at the launch.
Although children are less likely to have serious illness from Covid-19, they are more likely to get infected and spread the disease to vulnerable groups such as those aged 60 years and above.
The July monthly report by the National Institute for Communicable Diseases (NICD), showed that between March 2020 and July 2021, there were 184 187 confirmed Covid-19 cases in children under the age of 19. When the report was released, 380 children had died from the virus while in hospital, 146 of them adolescents aged 15 to 19, and 121 children under the age of one.
“This vaccine will be a crucial tool in stopping the pandemic. We hope that no child will die from this deadly monster. We call on other vaccine manufacturers to ensure that we vaccinate the young people, including the children of Africa,” Klein said.Klein said talks were underway with Sinovac to establish a vaccine manufacturing plant in the country, and that South African adults would hopefully soon be able to get the vaccine which has section 21 approval from the SAHPRA.