South African regulator approves use of Pfizer COVID-19 vaccine for children

Pfizer’s Comirnaty vaccine approved for use in children 12 years and older under certain conditions.



On Friday 10 September, the South African Health Products Authority (SAHPRA) announced that the use of the Pfizer Comirnaty vaccine has been approved in terms of Section 21 of The Medicines Act to include individuals 12 years and older. “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,” said SAHPRA. According to the regulator, section 21 of the Medicines Act establishes a framework for emergency access to medicines and also enables the regulator to authorise the use of medicines under certain conditions. Adding, “The regulatory decisions of SAHPRA do not translate into a procurement decision as SAHPRA’s mandate is limited to the safety, quality and efficacy of health products.”


The countries current surge in COVID-19 infections seems to be showing signs of a sustained downward trend. Yesterday the total number of new cases reported was 6 270, which brings the total number of confirmed cases to 2,843,042. As per the National Department of Health, a further 175 COVID-19 related deaths have been reported, bringing total fatalities to 84 327 to date. Also making history in Pretoria today, the first South African children aged 12 to 17 received the first dose of Sinovac Biotech's CoronaVac vaccine. South Africa is one of five countries taking part in the global children’s vaccination phase III study. The study will see more than 2 000 South African children and teenagers participate with seven research sites being utilized.