Child vaccine trial launched
Sinovac and Numolux announced on Friday that they were ready to launch phase 3 of the paediatric Covid-19 vaccine study, with the first child vaccinated at the MeCRU clinical research unit based at the Sefako Makgatho Health Sciences University (SMU), north of Pretoria.
The clinical trial to evaluate the efficacy and safety of Covid-19 vaccines in children and adolescents aged six months to 17 years has kicked off in Pretoria.
The study is a phase III clinical trial by the Numolux Group of Pretoria.
The group is the authorised representative in South Africa of Sinovac Life Sciences, a subsidiary of the Sinovac Biotech of Beijing, China.
Sinovac and Numolux announced on Friday that they were ready to launch phase 3 of the paediatric Covid-19 vaccine study, with the first child vaccinated at the MeCRU clinical research unit based at the Sefako Makgatho Health Sciences University (SMU), north of Pretoria.
SMU said the primary objective of the study was to evaluate the efficacy of two doses of CoronaVac against confirmed symptomatic Covid-19 cases in children and adolescents aged six months to 17 years.
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“Efficacy will also be evaluated against hospitalisation and severe Covid-19 cases.
“The worldwide study will enrol 14 000 children and adolescents in various paediatric age groups across five countries, namely South Africa, Chile, Philippines, Malaysia and Kenya.”
It said Numolux had partnered with seven clinical research sites across South Africa to enrol 2 000 participants from six months to 17 years.
SMU said participants in the trial would receive two doses of CoronaVac or a 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.
“Any confirmed Covid-19 case will be followed by the investigators until resolution.”
Safety would be evaluated in terms of solicited local and systemic adverse events during seven days following vaccination, and of unsolicited adverse events during 28 days post-vaccination, the university said.
SMU said in South Africa, the trial was approved by the South African Health Products Regulatory Authority (SAHPRA), Pharma Ethics and SMUREC.
It was listed on the South African clinical trial registry.
“This study has public health importance globally because a vaccine that prevents Covid-19 disease and transmission in paediatrics would be crucial to 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.”
The university said Sinovac was committed to the research and development of a safe and effective vaccine that protected people of all ages and comorbidities against the virus.
Phase I/II study in children had been conducted in China and the results had been published in The Lancet on June 28.
CEO of the Numolux Group Hilton Klein said: “The children of Africa are the future of Africa and something must be done to protect the future of Africa against the deadliest pandemic the world has ever seen.
“Numolux Group has joined Sinovac in the fight against this deadly monster to ensure that the children of Africa have access to a safe and effective children’s vaccine to protect them against Covid-19.”
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