Cape Town - 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.
Sahpra has been reviewing the data for the Sputnik V vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology in the Russian Federation, since the initial application was submitted on February 23, 2021.
The locally-licensed applicant is Lamar International Pty (Ltd).
Sahpra chief executive Dr Boitumelo Semete said: “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.”
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.
The Sputnik V Covid-19 vaccine has not received Emergency Use Listing by the World Health Organization.
Sahpra said the Section 21 application for Sputnik V by Lamar international Pty (Ltd) 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.
“The rolling review of the Sputnik V vaccine will, however, remain open for submission of relevant safety data in support of the application,” read the statement.
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.
“The published data based on a well-designed HIV vaccine trial design may be a caution that there is risk for the Covid-19 vaccine to have a similar outcome in settings where there is a high prevalence of HIV. It would be difficult therefore to approve a vaccine given the evidence.”
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.
“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.
“There is no evidence of increased risk of HIV infection among human population after common cold or conjunctivitis,” the centre 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. The scientific plausibility of this association is also unlikely.”