29 April 2021 Background Pregnant women are at higher risk of severe COVID-19 compared with women of childbearing age who are not pregnant, and COVID-19 has been associated with an increased risk of preterm birth. This document offers some preliminary recommendations on the use of the Janssen...
17 April 2021 SAHPRA has engaged with the Sisonke Phase 3B Implementation Study team and Janssen Pharmaceutica. The focus of the engagement was on the safety data reported from the Sisonke study, following administration of the COVID-19 vaccine Janssen, as well as the adverse events reported...
13 April 2021 We have noted the decision taken by the Food and Drug Administration in the United States of America to advise the temporary suspension of the Johnson and Johnson vaccine rollout in the US. This has occurred to due reports of 6 females who developed...
01 April 2021 The South African Health Products Authority (SAHPRA) registered the Covid-19 Vaccine Janssen on 31 March 2021. The registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965, which allows SAHPRA to register a medicine subject...
01 April 2021 SAHPRA registered the Covid-19 Vaccine Janssen on 31 March 2021, with conditions. The registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965. The Covid-19 Vaccine Janssen is an adenovirus type 26 vectored vaccine indicated for...
16 March 2021 SAHPRA has approved the Section 21 application for the Pfizer/Biontech Comirnaty Vaccine. Download PDF ...
12 March 2021 SAHPRA received documentation for the Coronavac vaccine developed by Sinovac on 10 March 2021 SAHPRA will now commence with evaluating the data in assessing the efficacy of the vaccine. Download PDF ...
24 February 2021 SAHPRA has received documentation for the SputnikV vaccine developed by the Gamaleya Institute in Russia on 24 February 2021. SAHPRA will now commence with evaluating the data provided for safety, quality and efficacy of the vaccine. Download PDF ...
18 February 2021 SAHPRA has approved the protocol amendment of the J&J implementation study targeted at Health Care Workers (HCW) for the inclusion of the President and the Deputy President. Whilst they are not classified as HCW, this initiative would assist greatly in encouraging vaccine uptake...
28 January 2021 The second wave of the COVID-19 epidemic in South Africa has put enormous pressure on all aspects of South Africa’s health system and on its communities. SAHPRA appreciates the frustration and pain experienced by healthcare practitioners, patients and families given the limited availability...
