Covid-19 Tag
18 Oct Update on the SAHPRA review of the Sputnik V Vaccine
18 October 2021 SAHPRA has been engaged in a rolling review of the data for the Sputnik V COVID-19 vaccine since the initial application was submitted on 23 February 2021. This vaccine was developed by the Gamaleya Research Institute of Epidemiology and Microbiology in the Russian...
30 Sep Extension of Post Importation Testing Exemptions
30 September 2021 Attention all stakeholders Post Importation Testing Exemptions (PITE) granted due to COVID-19 pandemic Post importation testing exemption approvals granted since March 2020 due to the Covid-19 pandemic, are extended to March 2022 without further need of an application thereof. Post-Importation Testing Exemptions (PITE) expiring prior to...
10 Sep SAHPRA update on Section 21 authorisation for Pfizer Comirnaty Vaccine
10 September 2021 The South African Health Products Authority (SAHPRA) has approved the use of the Pfizer COMIRNATY Vaccine in terms of Section 21 of the Medicines and Related Substance Act 101 of 1965 (The Medicines Act) to include individuals twelve years (12) years and older....
26 Aug A Signal Of Myocarditis / Pericarditis Associated With Pfizer-BioNTech’s Covid-19 Vaccine, Comirnaty (Bnt162b2)
26 July 2021 The South African Health Products Regulatory Authority (SAHPRA) would like to inform you of a signal of myocarditis/pericarditis associated with Pfizer-BioNTech’s Covid-19 vaccine, Comirnaty® (BNT162b2). The Pfizer/BioNTech Comirnaty® Vaccine was approved by SAHPRA in March 2021. The authorisation was done in terms of...
13 Jul How COVID-19 vaccines are regulated for safety and effectiveness
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24 May Covid-19 has catapulted Boitumelo Semete- Makokotlela into the public eye
24 May 2021 Boitumelo Semete-Makokotlela’s children have nicknamed her “meeting”, because she spends so many evenings and weekends on virtual calls. A biochemist by training, she was appointed CEO of SA’s medicines regulator barely two months before the coronavirus crisis hit SA. Taking the helm at...
29 Apr Guidance on the use of the Janssen Ad26.COV2.S (COVID-19) vaccine in pregnant and lactating women
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 Apr SAHPRA Statement – Update on Sisonke Phase 3B Implementation Study
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 Apr Statement by the Minister of Health, Dr Zwelini Mkhize, on the FDA’s Temporary Suspension of Johnson and Johnson vaccine rollout in the United States
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...