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...
Pretoria, 21 April 2023 - The South African Health Products Regulatory Authority (SAHPRA) issued media statements on 4 August 2022 and 12September 2022, relating to two fatal cases of Guillain-Barré syndrome (GBS) following vaccination with COVID-19 Vaccine Janssen. SAHPRA has been informed of a third...
UPDATE ON COVID-19 HEALTH PRODUCTS: SAHPRA registers the Covovax COVID-19 vaccine from Cipla (Pty) Ltd and additional indication of use of COVID-19 vaccine MC Pharma from MC Pharma (Pty) Ltd in the age group 3 -17 years. Pretoria, 28 September 2022 – SAHPRA registered a COVID-19...
Pretoria, 12 September 2022 - On the 04th of August 2022, SAHPRA issued a media statement relating to the first fatal case of GBS following vaccination with COVID-19 Vaccine Janssen. Recently, SAHPRA has been informed of a second fatal case of Guillain-Barré syndrome (GBS) following...
04 August 2022 On 31 March 2021, SAHPRA approved the use of the COVID-19 Vaccine Janssen for individuals 18 years of age and older as a single primary vaccination dose. COVID-19 Vaccine Janssen was later approved as a single booster dose given at least two months...
07 June 2022 Embargo: Immediate release1. The COVID-19 vaccine LHC has been registered with conditions on 24 May 2022.The registration of the COVID-19 vaccine LHC was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965. This COVID-19 vaccine (Sinopharm...
03 May 2022 Embargo: Immediate release Pretoria, 3 May 2022 - In October 2021, the African Christian Democratic Party (ACDP); Free the Children -Save the Nation NPC, Caring Healthcare Workers Coalition NPC, and the COVID Care Alliance NPC initiated court action against the Minister of Health and...
