Failure to launch: SA rejects Sputnik V Covid-19 vaccine over HIV concerns

The South African Health Products Regulatory Authority (Sahpra) has not approved the Sputnik V Covid-19 vaccine because of concerns that it might lead to higher HIV infection rates among vaccinated males.

This followed a review of an application submitted on February 23 by the Gamaleya Research Institute of Epidemiology and Microbiology, based in Russia, for the vaccine to be approved for South African use.

Sahpra said on Monday that there were concerns about the vaccine’s use of Adenovirus Type 26 (Ad26) and Adenovirus Type 5 (Ad5) as delivery vehicles for the antigens.

Sahpra two studies — the Step trial, which primarily recruited men who have sex with men in the Americas, and the Phambili trial, which recruited heterosexual men and women in SA — showed significant evidence that vaccines which used adenovirus as a vector were associated with enhanced susceptibility to HIV in men.

Sahpra said it asked Gamaleya to provide data demonstrating the safety of the Sputnik V vaccine but that the research institute was not able to.

According to its statement, the regulatory authority held a consultation meeting with experts, including “leading members of the local and international scientific community, on this matter”.

“To date, the Sputnik V Covid-19 vaccine has not received Emergency Use Listing by the World Health Organisation (WHO). The most recent WHO update indicates that the process is 'on hold, awaiting completion of rolling submission'," said Sahpra.

It said a further WHO note stated that an anticipated date would be set once “all data is submitted and follow-up of inspection observations completed”.  

“Recent media coverage has confirmed that there is ongoing engagement between WHO and the Russian authorities,” read the Sahpra statement. It said a rolling review of the Sputnik V vaccine would remain open for submission of relevant safety data in support of their application.

“Sahpra notes media reports that applications for the approval of the Ad26-vectored component only (denoted as Sputnik Light) are expected to be submitted to a number of national medicines regulatory authorities. Sahpra has not yet received an application for Sputnik Light.”

Responding to the news, the Gamaleya Centre of Epidemiology and Microbiology said that Sahpra had confirmed that its “rolling review” of the Sputnik V vaccine was continuing.

“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,” the centre said.

It added that there was “no evidence of increased risk of HIV infection among human populations after common cold or conjunctivitis”, and that there was “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,” it said.

The centre continued: “Speculation regarding the association between adenovirus type-5 vectored vaccines and HIV transmission has been based on small-scale studies among volunteers with highly probable risky behaviour (1-3). In contrast, a meta-analysis of six clinical studies and their long-term follow-up in 7,092 participants showed that, after rigorous statistical analysis of pooled individual participant-level data, there was no statistically significant increase of HIV-1 infection among adenovirus type-5 vectored vaccine recipients when all study participants and follow-up time were considered (4).

“It is also important to stress that the human adenovirus 5 is already used in other popular vaccines, including Cansino, which is widely applied in China, including during vaccination of the Chinese military, and approved around the world.

“The efficacy of the human adenoviral vector platform has been widely and internationally proven in non-Covid-19 vaccines. More than 250 clinical trials and 75 international publications confirm the safety of vaccines and medicines that are based on human adenovirus vectors.”

TimesLIVE