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SAHPRA approves the use of Pfizer vaccine for children 12 and older | Muhabarishaji News

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The South African Health Products Authority (SAHPRA) announced that the COVID-19 vaccine manufactured by Pfizer has been approved for use in children 12 years and older – under certain circumstances – on Friday, 10 September.

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SAHPRA said the use of the Pfizer COMIRNATY Vaccine – the vaccine millions of adult South Africans have already received – has been approved for use in individuals 12 years old and older in terms of Section 21 of the Medicines and Related Substance Act.

“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.

The Regulator explained that Section 21 of the Medicines Act is a mechanism that allows emergency use access and also enables SAHPRA to authorise the use of medicine subject to certain conditions.

“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,” said the Regulator.


Elsewhere, the first South African children – aged between 12 and 17 – received the first dose of Sinovac Biotech’s CoronaVac vaccine on Friday in Pretoria. South Africa is one of five countries participating in the global children’s vaccination phase III study.

Sinovac and its local partner Numolux said 2000 local children between the ages of 6 months and 17 years old are participating in the study, which is expected to last between 13 and 14 months.

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