The South African Health Product Regulatory Authority (SAHPRA) on Monday rejected Russia’s Sputnik V Covid-19 vaccine for use in the country due to concerns that it could increase the risk of HIV infection among men, reported Africa News.
The health regulator said the decision not to approve the vaccine was taken after thorough discussions with national and international scientific experts and reviewing all available data about the vaccine.
“SAHPRA is concerned that use of the Sputnik V vaccine in South Africa, a setting of a high HIV prevalence and incidence, may increase the risk of vaccinated males acquiring HIV,” the regulator said in the statement.
According to SAHPRA, the Sputnik V vaccine combines two different adenovirus-vectored constructs, one that relies on the Adenovirus Type 26 (Ad26) and the other on Adenovirus Type 5 (Ad5), for the delivery of the antigen.
“Concerns have been raised about the safety of Ad5-vectored vaccines in populations at risk for HIV infection,” the health regulatory body said adding that, “One of the challenges faced by such vaccines is the presence of pre-existing Ad-specific neutralizing antibodies (NAbs) in the general population.”
Notably, the Sputnik V coronavirus vaccine is yet to get listed in the World Health Organization’s list of emergency use vaccines, although it is already being administered in 45 countries.
The Sputnik V maker company, Gamaleya Centre, said it would soon come up with information to prove that the South African health regulator’s concerns were completely unfounded.
In a statement, the Russian vaccine-making company said information related to the association between adenovirus type-5 vectored vaccines and HIV transmission was based on small studies.
The South African government will soon begin vaccinating children as young as 12 as they currently offering booster shots to certain immuno-compromised citizens.
South Africa is currently giving the Johnson & Johnson vaccine, and the rMNA Pfizer/BioNTech jab.
