SA’s medicines regulator has turned down Lamar Internationals’ emergency use authorisation application for Russia’s Sputnik V Covid-19 vaccine, saying it is concerned the jab may increase the risk of men becoming infected with HIV.
The SA Health Products Regulatory Authority (Sahpra) said previous studies found vaccines containing the adenovirus type 5 vector (Ad5), which is included in Sputnik V, increased the risk of HIV acquisition. SA has the world’s highest HIV burden, with an estimated 8.2-million people living with the virus.
“We are of the view that the risk of using this vaccine outweighs the benefit,” said Sahpra CEO Boitumelo Semete.
Lamar International is the local representative for Sputnik V and submitted an application for emergency use authorisation and a rolling review to Sahpra in February.
Sputnik V was developed by the Russian Gamaleya Centre of Epidemiology and Microbiology, which is backed by the Russian Direct Investment Fund. It uses two adenovirus vectors, each provided in a separate shot, to deliver antigens that prompt the immune system to recognise the Sars-CoV-2 virus that causes Covid-19 — adenovirus type 26 (Ad26) and Ad5.
Sahpra said it turned down the emergency use application, as it had yet to be provided with data demonstrating Sputnik V is safe to use in the context of SA’s high HIV burden. “The rolling review of the Sputnik V vaccine will, however, remain open for submission of relevant safety data in support of the application,” it said in a statement.
Sahpra said use of the Ad5 vector in the Step and Phambili HIV vaccine trials had been associated with an increased risk of HIV acquisition in men. The Step trial was stopped in September 2007 due to lack of efficacy, and subsequent follow-up investigations found that uncircumcised men with high levels of pre-existing antibodies to Ad5, who had received the shot, were at increased risk of infection.
As a result, the Phambili vaccine trial was abandoned, and subsequent analysis concluded it too increased the risk of HIV acquisition, said Sahpra.
The Gamaleya Centre said Sahpra’s concerns about HIV acquisition are “completely unfounded”. All adverse events, including the development of any new infections, were continuously monitored in the development of Sputnik V and no safety signals had been identified regarding the transmission of HIV, it said in a statement.
Sputnik V was the first coronavirus vaccine to be approved, and has been authorised in 70 countries, including Argentina, Brazil and Zimbabwe.
The Gamaleya Centre said there is no scientific or clinical evidence confirming the association of adenovirus vectors with increased risk of HIV infection, and that the scientific plausibility of this association is unlikely.
“Speculation regarding the association between Ad5 vectored vaccines and HIV transmission has been based on small-scale studies among volunteers with highly probable risky behaviour.
Chinese military
“In contrast, a meta-analysis of six clinical studies and their long-term follow-up in 7,092 participants showed that ... there was no statistically significant increase of HIV infection among Ad5-vectored vaccine recipients when all study participants and follow-up time were considered,” it said, referring to a study published in PLoS One in 2015.
“It is also important to stress that Ad5 is already used in other popular [Covid-19] vaccines, including Cansino, which is widely applied in China, including vaccination of the Chinese military, and approved around the world,” it said.
Sahpra came under intense political pressure from the EFF in June to approve Sputnik V and the Chinese vaccine Coronavac, to the point that senior staff and Semete were threatened.
Semete previously told Business Day that Sahpra is concerned only with the safety, efficacy and quality of the products it scrutinises, and not their country of origin.
The regulator approved Coronavac in July.
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