Therapy Areas: AIDS & HIV
South Africa's drug regulator will not authorise Russia's Sputnik V COVID-19 vaccine for now
18 October 2021 -

SAHPRA, South Africa's drugs regulator, has said that it will not approve 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, Reuters news agency reported on Monday.

According to SAHPRA, it had asked for data demonstrating Sputnik V was safe in settings with high HIV prevalence, but that it had not received enough to establish this.

The regulator was reported as stating: 'SAHPRA resolved that the ... (emergency) application for Sputnik V ... not be approved at this time. SAHPRA is concerned that use of the Sputnik V vaccine in ... a setting of a high HIV prevalence and incidence may increase the risk of vaccinated males acquiring HIV.'

South Africa has one of the world's highest HIV burdens and some studies have suggested that administration of vaccines using the Adenovirus Type 5 (Ad5) vector, which Sputnik V does, can lead to higher susceptibility to HIV in men.

SAHPRA said it had consulted with local and international scientific experts to reach its decision and that relevant safety data could still be submitted as its 'rolling review' of the vaccine would remain open.

The Gamaleya Institute, which developed Sputnik V, was reported as saying: 'Concerns about the safety of Ad5-vectored vaccines in populations at risk for HIV infection are completely unfounded,' adding that SAHPRA would get all the information it needed.

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