/ 18 October 2021

Russia’s Sputnik V Covid-19 vaccine turned down over HIV concerns

The Ampules Of The Sputnik V Covid 19 Vaccine Seen Displayed
(Photo by Mahmoud Issa/SOPA Images/LightRocket via Getty Images)

The South African Health Products Regulatory Authority (Sahpra) has turned down the Russian produced Covid-19 vaccine — Sputnik V — citing concerns that it might increase the risk of vaccinated males becoming infected with HIV. 

The authority’s announcement on Monday 18 October comes months after the locally-licensed applicant, Lamar International Pty (Ltd), submitted its application for the use of the vaccine on 23 February.

“Following consultation with local and international scientific experts and after considering all the available data … Sahpra resolved that the Section 21 application for Sputnik V by Lamar International Pty (Ltd) not be approved at this time,” said the health regulator in a statement.

“Sahpra is concerned that the use of the Sputnik V vaccine in South Africa, a setting of a high HIV prevalence and incidence, may increase the risk of vaccinated males acquiring HIV”.

Developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Russia, the Sputnik V drug uses a combination of two separate adenovirus-vectored constructs. One relies on the adenovirus type 26 (Ad26), while the other relies on adenovirus type 5 (Ad5), as the delivery vehicles for the antigen.

The use of Ad5 in the vaccine raised safety concerns for 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,” the health regulator explained. 

Based on discussions with experts, observing previous studies on Ad5 and the fact that the vaccine has not yet been added to the World Health Organisation’s (WHO) emergency use list, Sahpra gave the thumbs down for usage of the vaccine in South Africa. 

The health regulator said it had requested additional information demonstrating the safety of the vaccine “in settings of high HIV prevalence and incidence” from Lamar International, which however did not “adequately address” the issue.

The authority said it would  continue to review the vaccine once “relevant safety data in support of the application” is submitted. 

The Sputnik V jab became the world’s first registered Covid vaccine in August 2020 — but before the publication of any trial results.

Even when the results were published, they were hard to assess because the researchers didn’t release the protocol or lab data for the vaccine. Some scientists have raised questions around the trial’s findings of almost 92% efficacy due to substandard reporting.