The South African Health Products Regulatory Authority (SAHPRA) said on Monday it would not approve Russia's Sputnik V Covid-19 vaccine at this time, after consideration of its Section 21 application.
The regulator had been engaged in a rolling review of the data for the Sputnik V vaccine since the initial application was submitted on February 23.
SAHPRA is concerned that use of the Sputnik V vaccine in South Africa, a setting of high HIV prevalence and incidence, may increase the risk of vaccinated males acquiring HIV.
“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 in the general population,” SAHPRA explained.
SAHPRA requested the manufacturer provide data showing safety of the Sputnik V vaccine in settings of high HIV prevalence and incidence.
The applicant was not able to adequately address SAHPRA’s request, the regulator said.
SAHPRA added that the Sputnik V vaccine has not received Emergency Use Listing by the World Health Organization (WHO).
“Anticipated date will be set once all data is submitted and follow-up of inspection observations completed. Recent media coverage has confirmed that there is ongoing engagement between the WHO and the Russian authorities,” SAHPRA said.
However, the Russian Direct Investment Fund, which is involved in the development and distribution of the Russian Sputnik V vaccine, disputed SAHPRA's statement.
The Fund quoted a statement from the Gamaleya National Center of Epidemiology and Microbiology which says "there is no evidence of increased risk of HIV infection among human population after common cold or conjunctivitis".
It added that there is no scientific or clinical evidence confirming the association of wild type adenoviruses or replicative defective adenovirus vectors with increased risk of HIV infection, adding that the scientific plausibility of this association is also unlikely.
"SAHPRA has confirmed that the rolling review of Sputnik V continues. All the required information confirming that possible concerns about the safety of Ad5-vectored vaccines in populations at risk for HIV infection are completely unfounded will be submitted to the South African regulator," said the Russian Direct Investment Fund.