26 November 2021 Embargo: Immediate release SAHPRA has received an application for the Pfizer Comirnaty Booster/3rddose vaccine on 17 November 2021. This is for the homologous booster regimen, not a mix-and-match approach. SAHPRA will now commence with the assessment of data for the safety and efficacy of the third...
Enhancing the public trust in COVID-19 vaccination: Progress and challenges in the regulation, administration and rollout of vaccines in South Africa. The race for countries to reach herd immunity continues globally. The prolonged Covid-19 pandemic has adversely affected the social and economic standing of many nations...
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...
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 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 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 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...
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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...
