The South African Health Products Regulatory Authority (SAPHRA) has not approved the use of the Russian Sputnik Covid-19 vaccine in South Africa, citing safety concerns due to the country’s HIV rate.
South Africa has one of the world’s highest HIV rates and some studies have suggested that administrations of vaccines using the Adenovirus Type 5 vector –which the Russian vaccine uses – can lead to higher susceptibility to HIV in men.
SAPHRA said that it had asked for data demonstrating if the Russian Sputnik vaccine was safe insetting with high HIV prevalence but that it had not received enough data to establish this.
“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,” the statement read.
The Gamaleya Institute, which developed the Sputnik vaccine, said: “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.
The institute added that more than 250 clinical trials and 75 international publication confirm the safety of the vaccines and medicine based on human adenovirus vectors.
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.
Sources: BusinessTech, MoneyWeb
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