26 Oct Update on COVID-19 vaccines
Pretoria, 26 October 2023 – The South African Health Products Regulatory Authority (SAHPRA) currently has four (4) COVID-19 vaccines which are under review, the COMIRNATY Bivalent paediatric and adult vaccines, mRNA (COMIRNATY Bivalent Infant DTU vaccine), and non-mRNA vaccine Coviccine.
SAHPRA has so far registered three (3) mRNA vaccines: COMIRNATY, Pfizer COVID -19 Adult RTU, and Pfizer COVID- 19 Paediatric DTU.
SAHPRA has to date register eight (8) COVID-19 vaccines namely, Covovax COVID-19 vaccine, COVID-19 vaccine (BBIBP-CortV-Vaccine) MC Pharma, COVID-19 vaccine (vero-cell) inactivated LHC Pharma, COMIRNATY vaccine, Pfizer /BNT COVID -19 Vaccine Paedatric DTU, Pfizer /BNT COVID-19 Vaccine Adult RTU, COVID-19 Vaccine Janssen, and Coronavac.
“We continue to review the registration of these vaccines as SAHPRA plays its role in the fight against COVID-19. SAHPRA will continue to play its part in ensuring the quality, safety and efficacy of all health products, including all vaccines to ensure that the South African public is protected at all times,” indicates SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
Please note: Vaccines are registered in terms of Section 15 of the Medicines and Related Substance Act (Act 101 of 1965 as amended), with conditions. This means that these products are not under Emergency Use Authorisation but have a full registration.