Sputnik’s HIV problem in South Africa

By Janice Kew 

The nagging, unresolved issue of whether immunizations relying on a cold virus promote the spread of HIV has escalated again. That’s after South Africa’s health products regulator vetoed initial approval of Russia’s Sputnik V coronavirus vaccine last week.

While Africa desperately needs more vaccines, governments know that to avoid vaccine hesitancy, their populations have to be confident that Covid-19 protection won’t come with increased risk for those already facing other prevalent diseases.

The two-dose Sputnik V uses two components, which are not interchangeable. One part is a harmless cold germ called adenovirus type-5 that carries the genetic material of SARS-Cov-2 into patients’ cells to trigger an immune response. But South Africa’s regulator flagged concerns that it may increase the risk of vaccinated men getting HIV.

More than a decade ago an experimental AIDS vaccine from Merck & Co. that relied on the cold virus was tied to increased infections with HIV, and research was halted.

 

Part of the problem in figuring out which vaccines get approval and which don’t is that research into the effects of a new shot on immune-compromised people is often not prioritized, according to Shabir Madhi, a vaccinologist from the University of the Witwatersrand who led trials of both AstraZeneca’s and Novavax’s shots in South Africa. That’s especially critical for a disease like HIV, where the bulk of cases are in poor countries.

“It’s the legacy of many vaccines that doing research that is specific to low-income countries is often delayed,” he says. Also, because South Africa already has vaccines recommended for use, including for people with HIV, it’s unethical to do large scale tests where some HIV-positive people are inoculated and other are not, he said.

While the moral complexity may be obvious, the issue has also been raised as a political one. The decision to not give approval was strongly opposed by Russia, whose Gamaleya Research Institute developed the shot.

Gamaleya has said that a long-term analysis of six studies including more than 7,000 participants has found no link between vaccines using the cold virus in Sputnik and increased HIV risk.

The South African regulator says it hasn’t closed the door on Sputnik V and will take note of any decision by the World Health Organization to give the shot an emergency use listing. It will also evaluate any application it gets for the so-called Sputnik Light, which only uses the component of the original vaccine that has not been linked to increased HIV risk.

For now, it will continue a rolling review, considering data that shows the safety of the Sputnik V vaccine where there is high HIV prevalence. Still, it may be very hard for Gamaleya to address this fully in further trials.—Bloomberg

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