EFF not surprised at regulatory authority’s rejection of Sputnik V vaccine for emergency use
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THE Economic Freedom Fighters said they were not surprised that the South African Health Products Regulatory Authority (Sahpra) did not approve the Sputnik Covid-19 jab's application for emergency use.
In a statement Sahpra said it was concerned the vaccine may increase the risk of males (vaccinated with Sputnik) getting infected with HIV.
The vaccine was developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Russian. The locally-licensed applicant is Lamar International Pty (Ltd).
“We are not surprised,” said EFF secretary-general Marshall Dlamini. “It has never been about saving lives but profit. They have no access to the Russians and cannot get anything from them hence they did not approve the vaccine.”
Dlamini said Sahpra’s argument that Sputnik V increases the risk of susceptibility to HIV infection is not backed by any evidence. His party has been advocating for Sputnik vaccine to be approved for use in SA.
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 said the safety of adenovirus vaccine vectors has been evaluated in a number of studies. In particular, the results of the STEP trial (which primarily recruited men who have sex with men in the Americas)1 and the PHAMBILI trial (which recruited heterosexual men and women in South Africa) were considered.
“Both clinical trials were designed to administer three doses of an Ad5-vectored vaccine encoding the HIV gag, pol and nef proteins. In both the STEP clinical and PHAMBILI trials, administration of an Ad5-vectored vaccine was associated with enhanced susceptibility/acquisition of HIV in men.”
The STEP trial was stopped in September 2007 due to lack of efficacy, but evidence quickly emerged of an enhanced risk of HIV infection in a particular subgroup of participants (uncircumcised men with high titers of pre-existing antibodies to Ad5).
“Over an extended follow-up, the increased risk of HIV among vaccine recipients became statistically significant when the entire trial population was analysed. The STEP trial results led to the early cessation of the PHAMBILI trial. Although the initial results from the PHAMBILI trial did not show enhanced HIV risk, this risk was confirmed after extended follow-up.”
Sahpra said it asked Sputnik's applicants to submit data demonstrating the safety of Sputnik in settings of high HIV prevalence but did not receive adequate data.
Responding to Sahpra’s statement, Russia’s Gamaleya Centre of Epidemiology and Microbiology said that the concerns around the Sputnik V vaccine and HIV are unfounded.
“Sahpra has confirmed that the rolling review of Sputnik V continues. All the required information confirming that possible concerns about the safety of Ad5-vectored vaccines in populations at risk for HIV infection are completely unfounded will be submitted to the South African regulator.”
It said there is no scientific or clinical evidence confirming the association of wild type adenoviruses or replicative defective adenovirus vectors with increased risk of HIV infection, it said.
“Speculation regarding the association between adenovirus type-5 vectored vaccines and HIV transmission has been based on small-scale studies among volunteers with highly probable risky behaviour.
“In contrast, a meta-analysis of six clinical studies and their long-term follow-up in 7092 participants showed that, after rigorous statistical analysis of pooled individual participant-level data, there was no statistically significant increase of HIV-1 infection among adenovirus type-5 vectored vaccine recipients when all study participants and follow-up time were considered.”