Sahpra, the South African Health Products Regulatory Authority, has not approved the Russian-developed Sputnik V Covid-19 vaccine for use in South Africa, citing safety concerns due to the country’s HIV infection rate.
In a statement on Monday the 18th of October 2021, the health products regulator noted that the Sputnik V vaccine combines two separate adenovirus-vectored constructs, one relying on the Adenovirus Type 26 (Ad26) and the other relying on the Adenovirus Type 5 (Ad5), as the delivery vehicles for the antigen.
“Concerns have been raised about the safety of Ad5-vectored vaccines in populations at risk for HIV infection. One of the challenges faced by such vaccines is the presence of pre-existing Ad-specific neutralising antibodies (NAbs) in the general population,” it said.
The regulator cited two separate HIV trials conducted in South Africa which showed that administration of an Ad5-vectored vaccine was associated with enhanced susceptibility/acquisition of HIV in men.
Sahpra also referred to medical arguments published in The Lancet, which showed similar trends in a non-human study on primates. In addition to this, Sahpra held a consultation meeting with expert committees, including leading local and international scientific community members on the matter of the Sputnik vaccine.
The regulator has also asked the Sputnik V vaccine manufacturer to provide data demonstrating the safety of the Sputnik V vaccine in settings of high HIV prevalence and incidence. However, the applicant was not able to adequately address this request, it said.
“Sahpra is concerned that use of the Sputnik V vaccine in South African, a setting of a high HIV prevalence and incidence, may increase the risk of vaccinated males acquiring HIV.
“The rolling review of the Sputnik V vaccine will, however, remain open for submission of relevant safety data in support of the application,” it said.