SAHPRA rejects Sputnik V COVID-19 vaccine amid major safety concerns

Concerned about the vaccine’s use in high-HIV prevalence settings, regulator turns down Sputnik’s application.

On Monday, the South African Health Products Regulatory Authority (SAHPRA) announced it had decided not to approve the use of the Sputnik V COVID-19 vaccine for use in South Africa. The regulatory authority has been performing rolling review of the vaccine’s data since the initial application was submitted by Lamar International on the 23rd of February this year. In a media release, SAHPRA highlighted it consulted leading members of the local and international scientific community on the matter, before arriving at its decision. Developed by the Gamaleya Research Institute of Epidemiology and Microbiology of the Russian Federation, 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. One of the challenges faced by such vaccines is the presence of pre-existing Ad-specific neutralising antibodies (NAbs) in the general population,” read the statement. SAHPRA cited data from two HIV studies, the STEP and PHAMBILI trials, which showed that administration of an Ad5-vectored vaccine was ‘associated with enhanced susceptibility/acquisition of HIV in men’. The regulator also referred to arguments advanced in a commentary published in The Lancet, which highlighted similar findings from a non-human primate study. In the release, SAHPRA noted it had asked the vaccine’s manufacturer to provide data demonstrating its safety in a setting with a high HIV prevalence and incidence. However, this was not adequately addressed by the applicant.