12 May 2022Embargo: Immediate release In both the United States and South Africa, the COVID-19 Vaccine Janssen has been approved as a single primary vaccination dose, a single booster dose at least two months after the primary vaccination dose, and as a heterologous booster dose following...
23 December 2021 Embargo: Immediate release The South African Health Products Regulatory Authority (SAHPRA) initially registered the COVID-19 Vaccine Janssen, with conditions on 30 March 2021, in terms of section 15 of the Medicines and Related Substance Act (Act 101 of 1965). On 10 December 2021, SAHPRA received...
01 July 2021 The South African Health Products Regulatory Authority (SAHPRA) has reduced the time taken to register COVID-19 vaccines to less than three months where the required standard of data is available, while continuing to adhere to strict guidelines to ensure the safety of South...
21 June 2021 The South African Health Products Regulatory Authority (SAHPRA) is an independent health products regulatory authority, governed by national legislation, whose mandate is to ensure the safety, quality and efficacy of health products available in South Africa. These essential requirements have been similarly applied...
13 June 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...
7 June 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...
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...
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...
