SAHPRA turns down Sputnik V vaccine application
The South African Health Products Regulatory Authority (SAHPRA) has turned down an application to use the Sputnik V vaccine in the country.
The authority made the announcement on Monday.
This comes after concerns have been raised about the safety of Adenovirus Type 5-vectored vaccines in populations at risk for HIV infection.
The Gamaleya Research Institute of Epidemiology and Microbiology in the Russian Federation submitted an application earlier this year for the jab to be added into South Africa’s arsenal against Covid-19.
In a statement released, SAHPRA’s Dr Boitumelo Semete says they requested the Gamaleya Research Institute provide data demonstrating the safety of the Sputnik V vaccine especially for those with HIV.
However, they were not able to address SAHPRA’s request with satisfactory data.
“Following the consultation with local and international scientific experts and after considering all the available data, SAHPRA is concerned that 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.”
Semete adds that to date the Sputnik V vaccine has not received emergency use clearing by the World Health Organization (WHO).
“WHO update indicates that the process is ‘On hold, awaiting completion of rolling submission’. However, the rolling review of the Sputnik V vaccine will remain open for the submission of relevant safety data in support of the application.”
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