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Sputnik: Vaccine application on hold because of HIV risk concerns

The application for the use of the Sputnik V COVID-19 vaccine has been put on hold by SAHPRA after the applicant failed to provide the required data.

#SayNoToVaccineMandate

Photograph:
Patrick T. FALLON / AFP

The application for the use of the Sputnik V COVID-19 vaccine has been put on hold by the South African Health Products Regulatory Authority (SAHPRA).

The authority said one its main concerns is that it may increase the risk of HIV contraction among vaccinated males.

“SAHPRA has been engaged in a rolling review of the data for the Sputnik V COVID-19 vaccine since the initial application was submitted on 23 February 2021.”

SPUTNIK V: INCREASE RISK OF HIV AMONGST MEN

“The safety of adenovirus vaccine vectors has been evaluated in a number of studies. In particular, the results of the STEP trial (which primarily recruited men who have sex with men in the Americas), and the PHAMBILI trial (which recruited heterosexual men and women in South Africa), were considered.”

“Both clinical trials were designed to administer three doses of an Ad5-vectored vaccine encoding the HIV gag, pol and nef proteins. In both the STEP clinical and PHAMBILI trials, administration of an Ad5-vectored vaccine was associated with enhanced susceptibility/acquisition of HIV in men,” said the authority in a statement.

SAHPRA said that the STEP trial results led to the early cessation of the PHAMBILI trial. Although the initial results from the PHAMBILI trial did not show enhanced HIV risk, this risk was confirmed after extended follow-up.

The authority also said during the assessment of the application for approval of the Sputnik V vaccine, SAHPRA reviewed the outcomes of the two trials in detail, as well as the arguments advanced in a commentary in Lancet in 2020, by Buchbinder et al.

Subsequently, SAHPRA requested the applicant to provide data demonstrating the safety of the Sputnik V vaccine in settings of high HIV prevalence and incidence.

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ADDITIONAL DATA REQUESTED TO COMPLETE SUBMISSION

The applicant was not able to adequately address SAHPRA’s request. The process is on hold and is awaiting the completion of the rolling submission.

A date will be set once all data is submitted and follow-up of inspection observations completed.