CAPE TOWN: The South African Health Products Regulatory Authority (Sahpra) had approved two Covid-19 vaccines: the Comirnaty (Pfizer) vaccine for adults 12 years and older and the Sinopharm vaccine for adults 18 years and older.
This culminates in the registration of both vaccinations under section 15 of the Medicines and Related Substances Act.
Pfizer's vaccine had already been granted "Section 21 Emergency Use" authorisation in South Africa, which allows for the use of unregistered medicinal items.
However, the approval is subject to a number of requirements, one of which is that manufacturers disclose to the regulator the findings of continuing investigations.
The Sinopharm vaccine would be known as the MC Pharma vaccination in South Africa. This is because overseas firms are required to submit their vaccine application to Sahpra through a local entity. Sinopharm partnered with MC Pharma, a Gauteng-based pharmaceutical firm.