MCAZ reviews Sputnik V and HIV link

THE Medicines Control Authority of Zimbabwe (MCAZ) says it is analysing information from South Africa which suggested that men who got Sputnik V COVID vaccine are highly prone to HIV.
The South African Health Products Regulatory Authority (SAHPRA) redflagged the Russian made COVID vaccine saying they will stop for now its use in South Africa as it may increase the risk of vaccinated males acquiring HIV.
Namibia upon learning of the South African data on Sputnik V, also halted its use.
Zimbabwe approved the use of Sputnik V in March 2021 and took receipt of its first batch in June. Local authority clinics in Harare are administering this jab.
Responding to emailed questions, MCAZ Projects and Public Relations Officer Mr Shingai Gwatidzo told this publication they are evaluating information from their South African counterpart.
“In view of this, the Authority is reviewing the data from the clinical studies that prompted the decisions by other regulators to halt the use of Sputnik V vaccine owing to data that suggest. that administration of an Ad5- vectored vaccine was associated with enhanced susceptibility or acquisition of HIV in men,” he said.
He explained that MCAZ granted use of Sputnik V based on the information they had.
“Please note that Emergency Use Authorisation was granted based on information that was available at the time of submission and the Authority is constantly reviewing emerging information from COVID-I9 vaccine clinical studies,” Mr Gwatidzo noted citing, “The Authority notes the concerns raised by fellow national medical products regulatory agencies and the decisions to halt the use of Sputnik V vaccines amongst their populations due to safety concerns of Ad5-vector based vaccines in people who are at risk of HIV infection.”
The Authority’s spokesperson went on to say they will reveal their findings after their ivestigations.
“Once the Authority has conducted a robust and rigorous review of the information, appropriate regulatory guidance will be shared with the Ministry of Health and Child Care (MOHCC) and relevant stakeholders,” Mr Gwatidzo said.
South Africa has a high prevalence of HIV infections.
“The rolling review of the Sputnik V vaccine will, however, remain open for submission of relevant safety data in support of the application,” said SAHPRA.
This vaccine was developed by the Gamaleya Research Institute of Epidemiology and Microbiology in the Russian Federation.
The locally-licensed applicant is Lamar International Pty (Ltd).
The Sputnik V vaccine combines two separate adenovirus-vectored constructs, one relying on the Adenovirus Type 26 (Ad26) and the other on Adenovirus Type 5 (Ad5), as the delivery vehicles for the antigen.
“Concerns have been raised about the safety of Ad5-vectored vaccines in populations at risk for HIV infection,” said SAHPRA.
One of the challenges faced by such vaccines is the presence of pre-existing Ad-specific neutralising antibodies in the general population.
The safety of adenovirus vaccine vectors has been evaluated in a number of studies.
During the assessment of the application for approval of the Sputnik V vaccine, SAHPRA said it reviewed the outcomes of the STEP and PHAMBILI trials in detail, as well as the arguments advanced in a commentary in Lancet in 2020, by Buchbinder et al.
“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 SAHPRA.

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