South Africa approved Pfizer Inc.’s vaccine for use for children aged 12 and over, a boost to the country’s immunization program.
“This was as a consequence of the review of updated safety and efficacy information submitted as conditions of Section 21 initially authorised on 16 March 2021,” Boitumelo Semete, the CEO of the South African Health Products Regulatory Authority (Sahpra) said in a statement.
“Section 21 of the Medicines Act is a mechanism that enables emergency use access and also enables Sahpra to authorise the use of medicine subject to certain conditions.”
Semete said that the move doesn’t translate into a procurement decision as Sahpra’s mandate is limited to determine the safety, quality and efficacy of health products.
Africa’s most developed country has been the hardest hit by the pandemic, reporting the highest number of infections.
Around 12% of the nation has been fully vaccinated, with the country of about 60 million people now bracing for a fourth wave of infections to hit in early December.
The approval comes after Sinovac Biotech Ltd. said a Covid-19 vaccine trial in infants, children and adolescents would take place in South Africa as part of a global study.
The Numolux Group is also in talks with Sinovac to produce its Covid-19 vaccine in South Africa.
“This clinical trial is a precursor to the establishment of a South African vaccine manufacturing facility partnered by Sinovac and Numolux Group that will cover the entire spectrum of vaccinations beyond just the Covid-19 response,” Numolux Group CEO Hilton Klein said.
“We are in talks with Sinovac to set up a vaccine manufacturing facility. A phase 1 will do bottling and labelling so that we can get vaccines out to the people of Africa as soon as possible.”
The South African leg of the trial will see 2,000 children and adolescents enrolled to establish the efficacy, immunogenicity and, safety of the Coronavac vaccine on children aged six months and older.
Reporting with Bloomberg