Sputnik V vaccine not approved in South Africa due to potential increased risk of HIV

Simon Collins, HIV i-Base

On 18 October 2021, after an eight-month review, the South African Health Products Regulatory Authority (SAPHRA) decided not to grant emergency use approval to the Sputnik V vaccine. [1]

This was due to lack of data proving safety in a population with high background of HIV infection.

The concerns came from previous Ad-5 vector HIV vaccine studies (STEP and PHAMBILI) , that reported increased risk of HIV acquisition in uncircumcised heterosexual men. This issue was raised by other researchers in a letter to the Lancet in October 2020. [2]

The Sputnik V vaccine was developed by the Gamaleya Research Institute of Epidemiology and Microbiology in the Russian Federation. It has also not received emergency use listing by the WHO.

Namibia has also followed the South African decision by suspending use of the Sputnik V vaccine.

References

1. SAHPRA press release. Update on the SAHPRA review of the Sputnik V vaccine. (18 October 2021).
   https://www.sahpra.org.za/wp-content/uploads/2021/10/MEDIA-RELEASE-Sputnik-Vaccine_18Oct-2021.pdf (PDF)
2. HIV risk from some COVID-19 vaccines might be unlikely due to rarity of vector viruses involved. HTB (December 2020).
   https://i-base.info/htb/39455
3. Reuters. Namibia suspends use of Russian COVID vaccine after South Africa flags HIV concerns. (23 October 2021).
   https://www.reuters.com/world/africa/namibia-suspends-use-russian-covid-vaccine-after-safrica-flags-hiv-concerns-2021-10-23

The article was first posted on 23 October 2021.