Medicines regulator gives nod for Pfizer’s coronavirus shot to be administered in SA
Section 21 authorisation is subject to close monitoring of the safety and efficacy of the vaccine, Sahpra says
SA’s medicines regulator has granted a Section 21 authorisation for the Pfizer/BioNTech Covid-19 vaccine, clearing the way for the shot to be imported and administered before it has been registered in SA.
Section 21 of the Medicines and Related Substances Act allows the SA Health Products Regulatory Authority (Sahpra) to grant permission for the administration of unregistered medicines, provided they have been approved by a stringent regulator such as the US Food and Drug Administration or the European Medicines Authority. It has yet to finalise Pfizer’s application to register its Covid-19 vaccine, branded Comirnaty...