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...
22 November 2022 Embargo: Immediate release Pretoria, 22 November 2022 - The South African Health Products Regulatory Authority (SAHPRA) has registered Pfizer’s COMIRNATY Ready To Use (RTU) ADULT VACCINE and Dilute To Use (DTU) PAEDIATRIC VACCINE on 15 November 2022. The RTU vaccine, as the name...
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...
11 March 2022 Embargo: Immediate release The South Africa Health Products Regulatory Authority (SAHPRA) has noted that a safety report in relation to the COVID-19 Pfizer Comirnaty vaccine directed to the United States Food and Drug Administration (FDA) has been distributed on various communication platforms in South...
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...
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...
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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16 March 2021 SAHPRA has approved the Section 21 application for the Pfizer/Biontech Comirnaty Vaccine. Download PDF ...
