SAHPRA rejects Sputnik V Covid-19 vaccine

Johannesburg- SAHPRA has rejected the Sputnik V Covid-19 vaccine.

This comes after SAHPRA’s engagement in rolling a review of the data for the Sputnik V Covid-19 vaccine.

The initial application for the vaccine was submitted earlier this year by locally licensed applicant, Lamar International Pty (Ltd).

The vaccine was developed in Russia by the Gamaleya Research Institute of Epidemiology and Microbiology in the Russian Federation.

The new proposed Sputnik V vaccine is made up of two separate adenovirus-vectored constructs.

One relies on the Adenovirus Type 26 (Ad26) and the other on Adenovirus Type 5 (Ad5), as the delivery vehicles for the antigen.

During the assessment of the application for approval of the Sputnik V vaccine, SAHPRA reviewed the outcomes of the STEP and PHAMBILI trials in detail, as well as the arguments advanced in a commentary in Lancet in 2020.

“Infecting rhesus macaques with Ad5 and then immunizing them with a replication-incompetent Simian immunodeficiency virus (SIV) vaccine based on Ad5 increased the risk of SIV acquisition from low-dose SIV penile challenge”.

SAHPRA has requested the applicant to provide data that shows the safety of the Sputnik V vaccine in settings of high HIV prevalence and incidence. The applicant however was not able to adequately address SAHPRA’s request.

SAHPRA also held a consultation meeting with expert committees, which include leading members of the local and international scientific community, on this matter.

To date, the Sputnik V COVID-19 vaccine has not received Emergency Use Listing by the World Health Organization (WHO).

The most recent WHO update indicates that the process is “On hold, awaiting completion of rolling submission”.

“Anticipated dates 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 WHO and the Russian authorities.

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