SOUTH AFRICA – Scientist are poised to launch a phase 3 pediatric clinical trials of Chinese manufacturer Sinovac Biotech’s coronavirus vaccine in South Africa, as part of an international study that aims to evaluate the efficacy of two doses of the Coronavac shot.
The study will evaluate the efficacy, immunogenicity and safety of the CoronaVac vaccine on children and adolescents aged 6 months to 17 years, the firms said in a statement.
The trial has been approved by South African drugs regulator SAHPRA, and the first child will be vaccinated at the MeCRU Clinical Research Unit based at the Sefako Makgatho Health Sciences University.
“The primary objective of the study is to evaluate the efficacy of two doses of CoronaVac against confirmed symptomatic COVID-19 cases in children and adolescents, efficacy will also be evaluated against hospitalisation and severe COVID-19,” Sinovac and Numolux said.
Sinovac, which was granted conditional authorization for use by SAPHRA in July, might be added to the national immunization programme alongside shots developed by Pfizer and Johnson & Johnson which have been administered so far, according to government sources.
This was attributed to inadequate information on effectiveness against the Delta variant and lack of data on Sinovac in populations with HIV.
South Africa’s vaccination campaign started slowly due to onerous negotiations with pharmaceutical companies and the emergence of the Beta coronavirus variant which scampered plans to use AstraZeneca’s shot from February.
So far, more than 10.3 million of its roughly 60 million people have received at least one dose of vaccine, equivalent to around 17% of the population.
Deaths have reached 84,152, while recoveries have climbed to 2,618,386, leaving the country with a balance of 134,235 active cases. The total number of vaccines administered is 14,126,008.