The South African Health Products Regulatory Authority (SAHPRA) on Monday said it will not be approving – for now – the use of the Russian Covid-19 vaccination, Sputnik V.
“The Section 21 application for Sputnik V by Lamar international Pty (Ltd) will not be approved at this time,” said the South African regulator.
SAHPRA said it was concerned that use of the Sputnik V vaccine in South Africa may increase the risk of vaccinated males acquiring HIV.
South Africa has a high prevalence of HIV infections.
“The rolling review of the Sputnik V vaccine will, however, remain open for submission of relevant safety data in support of the application,” said SAHPRA.
This vaccine was developed by the Gamaleya Research Institute of Epidemiology and Microbiology in the Russian Federation.
The locally-licensed applicant is Lamar International Pty (Ltd).
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.
“Concerns have been raised about the safety of Ad5-vectored vaccines in populations at risk for HIV infection,” said SAHPRA.
One of the challenges faced by such vaccines is the presence of pre-existing Ad-specific neutralising antibodies in the general population.
The safety of adenovirus vaccine vectors has been evaluated in a number of studies.
During the assessment of the application for approval of the Sputnik V vaccine, SAHPRA said it reviewed the outcomes of the STEP and PHAMBILI trials in detail, as well as the arguments advanced in a commentary in Lancet in 2020, by Buchbinder et al.
“In both the STEP clinical and PHAMBILI trials, administration of an Ad5-vectored vaccine was associated with enhanced susceptibility/acquisition of HIV in men,” said SAHPRA.