Health Committee Chairperson notes Sahpra’s decision on Russia’s Sputnik V Covid-19 vaccine

20 October 2021

The Chairperson for Portfolio Committee on Health, Dr Kenneth Jacobs, has noted the South African Health Products Regulatory Authority’s (Sahpra’s) decision not to approve Russia’s Sputnik V Covid-19 vaccine for use in South Africa.

In a media statement the regulator released on Monday, it raised concerns about the use of Sputnik V vaccine in South Africa due to the high prevalence of HIV. Sahpra said the vaccine may increase the risk of HIV infection among vaccinated males.

Sahpra’s decision was based on studies showing that the vaccine uses two adenoviruses in its manufacture, Type 26 (Ad26) and Type 5 (Ad5), as the delivery vehicles for the antigen. Pre-existing Ad-specific neutralising antibodies (NAbs) are present in the general population, which poses a challenge to the use of such vaccines.

The regulator also indicated in its media statement that is has requested the applicant to provide data demonstrating the safety of the Sputnik V vaccine in settings where there is a high prevalence of HIV.

Dr Jacobs said what has arisen from Sahpra’s observations is that concerns have been raised about the safety of Ad5-vectored vaccines in populations at risk for HIV infection. Furthermore, based on the scientific evidence provided and presented by Sahpra, Dr Jacobs said it is important to accept the outcome of Sahpra’s decision.

Issued by Yoliswa Landu, Media Officer, Parliamentary Communication Services, 20 October 2021