Vaccines – News and updates

14 January 2022

SAHPRA is currently evaluating a number of applications for emergency use (Section 21) and/or registration of COVID-19 vaccines. The table below shows the current status of the applications under consideration:

As soon as any decision has been taken on these applications, based on consideration of the available evidence of safety, quality and efficacy, SAHPRA will issue a statement in this regard. The time taken to reach finality on each application will vary and will include any time taken by the applicant to address queries posed by SAHPRA.

To date, SAHPRA has authorised the Pfizer/BioNTech vaccine “Comirnaty”, the Janssen Covid-19 vaccine, Sinovac’s “Coronavac” vaccine (submitted by Curanto Pharma). “SAHPRA is committed to prioritising all COVID-19- related health products, including vaccines, as the world and South Africa grapples with ending the scourge of a pandemic of mammoth proportions. SAHPRA will ensure that all products, including vaccines, have undergone the requisite evaluation and assessments that meet regulatory requirements prior to being made available to the public,” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.

Download PDF