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

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.

Keep the powerful accountable

Subscribe for R30/mth for the first three months. Cancel anytime.

Subscribers get access to all our best journalism, subscriber-only newsletters, events and a weekly cryptic crossword.

Eunice Stoltz
Eunice Stoltz is a junior daily news reporter at the Mail & Guardian. She was previously a freelance journalist and a broadcaster at Maroela Media and Smile90.4FM.

Related stories


Already a subscriber? Sign in here


Latest stories

Small businesses need more climate financing

Small businesses are integral to climate-change mitigation, adaptation and resilience. But they need to be given the funds and support to succeed

What the Omicron variant and Mashaba’s election ticket have in...

Stigmatising the marginalised is driven by vested interests, both in the case of African foreign nationals subject to xenophobia and South Africans facing economic doom

DRC investigates Kabila for corruption

Last week, journalists exposed corruption linked to Joseph Kabila. Now a judicial inquiry is looking into the former president’s link with a major bank

Ingonyama Trust to get permanent board

Staff members suspended five years ago are now being reinstated

press releases

Loading latest Press Releases…