South Africa Health Products Regulatory Authority (SAHPRA) has disclosed that it will not approve an emergency use application for Russia’s Sputnik V COVID-19 vaccine for now because of concerns about its safety for people at risk of HIV.
There is a high prevalence of HIV in South Africa.
According to SAHPRA, the Sputnik V vaccine combines two separate adenovirus-vectored constructs, one relying on the Adenovirus Type 26 (Ad26) and the other on Adenovirus Type 5 (Ad5), as the delivery vehicles for the antigen.
The regulatory body said concerns have been raised about the safety of Ad5-vectored vaccines in populations at risk for HIV infection.
“SAHPRA resolved that the Section 21 application for Sputnik V by Lamar international Pty (Ltd) not be
approved at this time. SAHPRA is concerned that the use of the Sputnik V vaccine in South African, a setting of a high HIV prevalence and incidence may increase the risk of vaccinated males acquiring HIV,” the agency said in a statement.