Sahpra did not approve the Sputnik V Covid-19 vaccine - the regulator highlighted a major concern | Health24

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The South African Health Products Regulatory Authority will not approve Russia's Sputnik V Covid-19 vaccine for use in South Africa until the developer can confirm that it doesn’t make people more vulnerable to HIV infection. | Health24com

, scientists highlighted this concern, noting that Covid shots relying on the same vector as the Merck one “could similarly increase the risk of HIV acquisition among men who receive the vaccine”. They requested that these safety concerns be thoroughly evaluated before any further development of Ad5 vaccines for Covid-19.Another past study, known as the Phambili trial, used the same vaccine and recruited heterosexual men and women in South Africa.

The conclusion of a consensus conference in 2013, sponsored by the National Institutes of Health, “warned that non-HIV vaccine trials that used similar vectors in areas of high HIV prevalence could lead to an increased risk of HIV-1 acquisition in the vaccinated population”, wrote the authors ofIt’s not entirely clear how Merck's Ad5 vaccine increased participants’ risk of HIV acquisition.

“It doesn’t have to be a clinical study,” he said. “It could be a study in animals, it could be some laboratory marker.” The manufacturers, he said, must “show us that the Ad5 used in the HIV vaccine trial and their Ad5 are behaving differently”.The developer of Sputnik V, the Gamaleya Institute, has received a request from Sahpra to provide additional data demonstrating the safety of Sputnik V in populations with HIV prevalence and incidence.

 

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