South Africa will not approve Russia’s Sputnik V Covid vaccine for the time being. The country’s drug agency said it will not give the green light due to concerns about a possible increased risk of HIV infection among men. Fears based on studies that tested the safety of a modified form of adenovirus, Ad5, the vector on which the Russian shield injection is based.
“The use of the Sputnik V vaccine in South Africa, a context of high prevalence and incidence of HIV, could increase the risk of vaccinated males contracting HIV”, was explained in a note from the South African Authority for HIV. regulation of health products (Sahpra). The body pointed out that the dossier for the application for authorization for the use of Sputnik V in South Africa does not bring evidence that the vaccine is safe in environments with a high prevalence of HIV. Hence the decision. Although, it is specified, “the ongoing review of Sputnik V will remain open” to accommodate the possible submission of “relevant safety data to support the application”.
The center that developed the vaccine, the Gamaleya Institute, called the concerns about the safety of the Ad5 vector in populations at risk of HIV infection “baseless” and based on small-scale studies, according to reports from various media including the ‘ Moscow Times’, assuring that it would give the South African regulator the information it needs and pointing to several studies on over 7,000 people that would show the absence of a statistically significant increase in HIV-1 infection among those vaccinated with the vector adenoviral in the viewfinder.
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