The South African Health Products Regulatory Authority (Sahpra) has for the moment rejected the application for the use of Russia’s Sputnik V Covid-19 vaccine over concerns related to HIV acquisition.
In a statement released on Monday, Sahpra said it had requested the applicant to provide data demonstrating the safety of the Sputnik V vaccine in settings of high HIV prevalence and incidence, with the applicant unable to adequately address the request.
Sahpra said the Section 21 application for Sputnik V by Lamar international Pty will not be approved at this time, due to concerns that the use of the vaccine in South Africa, the setting of a high HIV prevalence and incidence, may increase the risk of vaccinated men acquiring HIV. National Institute for Communicable Diseases acting executive director Adrian Puren said: “There was initial precedent-setting evidence that there was a risk of the Adenovirus 5 backbone being associated with HIV acquisition.
In statement on Tuesday, the Gamaleya Center of Epidemiology and Microbiology, one of the world's leading research institution, has come out against these claims.
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