- The Pfizer Covid-19 vaccine has been approved for use on children as young as 12 in South Africa.
- The SA Health Products Authority said it approved the use of the vaccine on children after it received safety and efficacy information from the manufacturer.
- South Africa's Sinovac vaccine trial for children started on Friday.
The SA Health Products Authority (Sahpra) has approved the use of the Pfizer Covid-19 vaccine on children aged 12 and older after receiving updated information from the manufacturers.
"This was as a consequence of the review of updated safety and efficacy information submitted as conditions of the Section 21 [application] initially authorised on 16 March 2021. Section 21 of the Medicines Act is a mechanism that enables emergency use access and also enables Sahpra to authorise the use of a medicine, subject to certain conditions," Sahpra CEO Boitumelo Semete said in a statement.
Semete added: "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 approval comes after the launch of South Africa's vaccine trial on children.
Sinovac, through Numolox, which has the local licence for the vaccine, is conducting paediatric Covid-19 trials in the country.
Two teenagers, a boy and a girl, were the first to receive the Sinovac jabs at the Sefako Makgatho University in GaRankuwa, Pretoria on Friday. Their identities are being kept secret to protect their privacy.
South Africa's adult population is receiving the J&J and Pfizer jabs. The country has administered more than 14 million vaccines so far.
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