Parliament, Thursday, 2 September 2021 – The Portfolio Committee on Health was briefed by the South African Health Products Regulatory Authority (Sahpra) on Covid-19 vaccine licencing, vaccine efficacy rates and on the latest vaccine research.

Briefing the committee, Sahpra CEO Dr Tumi Semete said the regulator is able to make informed decisions on the safety of vaccines. She informed the committee that the key aspects of vaccine evaluation are an assessment of the data, which necessitates an adequate number of vaccine recipients and monitoring for a sufficiently long time.

Dr Semete futher indicated that the assessment on the efficacy of the data requires robust evidence of the vaccine's ability to prevent Covid-19 infection in well-conducted phase-three clinical trials in humans and the assessment of the risk management plan the applicant requires, that is the ability to record and report side effects.

Responding to the question posed by the committee on the safety and monitoring of the vaccines after learning of 30 coincidental fatalities. Sahpra Board Chairperson, Prof Helen Reese said: “I have not seen reported cases of people being infected with Covid-19 and resulting in deaths after they have received a vaccine. You might get side-effects, as the immune system might be enhanced if you get a Covid-19 vaccine if infected. It is not about dying; not at all. There is no report of that and it has not been reported to my knowledge. Our concern is side-effects.”

Sahpra said it is monitoring vaccines worldwide and, in South Africa, working closely with the National Institute of Communicable Diseases, the Medical Research Council and academics.

Prof Reese said: “Vaccines that are 100% effective are quite rare. Similarly, the Covid-19 vaccines are not 100% effective. As such, the different vaccines that we are looking at will have various levels of efficacy.”

Regarding the new Covid-19 variant C.1.2, Prof Reese said it was first detected in May and it represents 2% of the current testing, but it has been detected in eight of the nine provinces. It has also been detected in eight countries around the world. She said mutations of the virus are a concern. “We have seen that this might be more transmissible or could be better in evading our immune systems in resisting our immune response. We are watching it closely.”

Sahpra agreed with the committee that its communication should improve. Dr Semete said Sahpra knows it must engage more and share its messages in indigenous languages. “This is something we will be focusing on to ensure that we disseminate the information expansively and across the country.”


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