After Sinovac said they will start clinical trials of Covid-19 vaccines for children under 18 on Friday, the South African Health Products Regulatory Authority (Sahpra) has boosted efforts to vaccinate children.
Sahpra announced they have approved the use of the Pfizer Comirnaty vaccine in terms of Section 21 of the Medicines and Related Substance Act 101 of 1965 (The Medicines Act) to include individuals 12 years and older, the statement read.
Saphra CEO Dr Boitumelo Semete said the decision was based on a review of the updated safety and efficacy
information submitted as conditions of Section 21 initially authorised in March.
Saphra does have the power to authorise the use of medicine subject to certain conditions.
Sinovac said they intend on starting 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.
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.
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 was approved by Sahpra.