SAHPRA update on Section 21 authorisation for Pfizer Comirnaty Vaccine

10 September 2021

The South African Health Products Authority (SAHPRA) has 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 twelve years (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. 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.

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.

Download PDF