Sinovac will start phase three clinical trials of a Covid-19 vaccine for children, with the first child to be vaccinated at the MeCRU Clinical Research Unit, based at the Sefako Makgatho Health Sciences University (SMU) in South Africa, on Friday.
The study is a multi-centre, randomised, double-blind, placebo-controlled Phase Ⅲ Clinical Trial to evaluate the efficacy, immunogenicity and safety of the Sinovac inactivated Covid-19 vaccine (CoronaVac®) in children and adolescents aged 6 months to 17 years, Numolux, which distributes Sinovac in South Africa announced on Thursday.
Currently, the country is not vaccinating children under the age of 18.
“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 aged 6 months to 17 years. Efficacy will also be evaluated against hospitalisation and severe Covid-19 cases.”
The study worldwide will enrol 14,000 children and adolescents in various pediatric age group cohorts across five countries namely South Africa, Chile, Philippines, Malaysia and Kenya.
Numolux has partnered with seven clinical research sites across South Africa to enrol 2,000 participants from 6 months to 17 years.
Participants in the trial will receive 2 doses of CoronaVac® or placebo 28 days apart.
Efficacy assessments to include the surveillance for Covid-19-like symptoms and the laboratory confirmation of SARS-CoV-2 infection by RT-PCR, and any confirmed Covid-19 case will be followed by the investigators until resolution.
The trial has been approved by the South African Health Products Regulatory Authority (SAHPRA).
“This study has public health importance globally because a vaccine that prevents Covid-19 disease and transmission in pediatrics would be a crucial tool to assist in curbing the pandemic. Although children and adolescents have a milder form of the disease than adults, they remain susceptible to infection and severe manifestations across all ages,” said Numolux.
“Sinovac is committed to the research and development of a safe and effective vaccine that protects people of all ages and comorbidities against Covid-19.”
Compiled by Vhahangwele Nemakonde