Russia’s Sputnik V vaccine rejected due to link to HIV

THE South African Health Products Regulatory Authority (Sahpra) has rejected the application for Russia’s Sputnik V Covid-19 vaccine over concerns related to HIV acquisition.

Sahpra has been reviewing the data for the vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in the Russian Federation, since the initial application submitted on February 23.

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 in the general population.”

In a statement, Sahpra said it had requested the applicant to provide data demonstrating the safety of the 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) would 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, could 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,” the statement read.

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.”