First SA child officially jabbed as part of Sinovac vaccine trial
The first South African child has been vaccinated as part of the local Sinovac paediatric trial.
He was jabbed at the Sefako Makgatho Health Sciences University on Friday.
South Africa currently does not have an approved vaccine for children.
This is phase three of the global vaccination trial which will see 14 000 children vaccinated in five countries to test the efficacy of CoronaVac, which was developed in China.
Some 2000 children will form part of the trial in South Africa, with ages ranging from 6 months old to 17.
The first child is in the 12 to 17 age bracket.
The Numolux group partnered with Sinovac to bring the trial to the country in seven clinical research sites.
"The study has been designed to enroll participants in various age strata in this pediatric population. So, we start off with the 12 to 17 years old, then work our way to the 6 to 11 years, then 3-to-five-year old's and then the babies.
“But we are going to start with a baby soon because we don't want to push the babies right to the end, we will start with one baby, then looking at the safety and then four babies, checking the safety and then enrolling all the babies," said Numolax's Dr Sanet Aspinall.
Numolax is working alongside the South African Health Products Regulatory Authority (SAPHRA) and other organisations to ensure the safety of the study.
Aspinall said the primary objective is to evaluate the efficacy of two doses of the CoronaVac.
The South African Medical Research Council (SAMRA) has welcomed the trial.
President, Dr Glenda Gray, who is a pediatrician, said excluding children from vaccination rollout will have a negative impact on the battle against the virus.
"To contain Covid-19 it is important that we include children in vaccination roll-out programs as the often constitutes up to 30% of the population in especially low to middle-income countries like South Africa. And delay in the inclusion of children into covid vaccine trial involves a potential denial to the child, their families, and extended families," she said.
Gray said they are looking forward to data from the research.
Monitoring & assessments
All vaccinated children will be observed in the first 30 minutes after they get jabbed.
Aspinall said they will observe for the first seven days for local adverse effects and a further 28 days.
"All the participants will be observed for serious adverse events right throughout the trial," Gray said.
The participants will be grouped in terms of safety.
Some will have to return twice to the clinic, Aspinall says those who are under the safety category will come back seven-time and their anti-bodies will be assessed.
"So, this study is also going to look at the anti-body level over the period of a year to see if they are decreasing and whether they are still protective after six months and after one year. So, the study will look at various aspects including efficacy and immunogenicity," she added.
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