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South Africa's health regulator has decided against prescribing Russian COVID-19 vaccination for now

South Africa's health regulator has decided against prescribing Russian COVID-19 vaccination for now

South Africa's drugs regulator said on Monday that it was not accepting an emergency use application for Russia'S Sputnik V COVID-19 shot for now, citing concerns about its safety for people at risk of HIV infection. JOHANNESBURG, Oct 18, South African'' s drug regulator stated on Tuesday that, because of concerns over its HIV prevalence, it is not considering an SPINK V application.

South Africa has one of the world's highest HIV burdens, and some studies have suggested that vaccination with the Adenovirus Type 5 (Ad5) vector, which Sputnik V does, may increase HIV susceptibility in men.

Viral vector vaccines such as Sputnik V use modified viruses as vehicles, or vectors, to carry genetic information that aids the body build immunity against future infections.

SAHPRA, the regulator, said it had asked for data showing that Sputnik V was safe in settings with a high HIV prevalence, but that it didn't have enough information to establish this.

"SAHPRA determined that the [emergency] request for Sputnik V... cannot be approved at this time. SAHPRA is concerned that the use of the Sputnik V vaccine in "a setting with a high HIV prevalence and incidence may increase the risk of vaccinated males contracting HIV," according to the statement.

The Gamaleya Institute, which created Sputnik V, stated: "Concerns about the safety of Ad5-vectored vaccines in HIV-infected individuals are utterly unfounded," adding that SAHPRA would receive all the information it needed.

More than 250 clinical trials and 75 international publications confirm the safety of vaccines and medicines based on human adenovirus vectors, the institute said.

SAHPRA said it had consulted with local and international scientific experts to come to a decision and that relevant safety data could still be submitted as its "rolling review" of the vaccine remained open.

South Africa, which has bilateral agreements for the two-dose Pfizer (PFE.N) and one-shot Johnson & Johnson (JNJ. N) vaccines, has now administered more than 20 million doses. Around 14 million people, or 35% of the nation's adult population, have had at least one dose of vaccine.

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