South Africa Declines Sputnik COVID-19 Vaccine Approval Over HIV Infection Risk COVID-19 Science 18/10/2021 • Kerry Cullinan Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Sputnik V Vaccine South Africa has decided not to grant approval to Russia’s Sputnik V COVID-19 vaccine as there is a risk that it might make vaccinated men more vulnerable to HIV infection, the South African Health Products Regulatory Authority (SAHPRA) announced on Monday. SAPHRA’s caution stems from fact that Sputnik uses an Adenovirus Type 5 (Ad5) vector as one of the delivery mechanisms for its vaccine. A few years back, two trials of a candidate vaccine for HIV that also used an Ad5 vector were found to make men more susceptible to HIV infection. After the two HIV vaccine trials – called STEP and Phambili – were abandoned, researchers concluded during follow-up that men with “pre-existing Ad-specific neutralising antibodies” were particularly vulnerable to HIV infection after being vaccinated. Sputnik uses two different adenovirus vectors to deliver each of its two-dose COVID-19 vaccine, Adenovirus Type 26 (Ad26) for the first dose and Ad5 for the second. Concerns about Ad5-based vaccine STEP and Phambili researchers Susan Buchbinder and colleagues cautioned against the use of an Ad5-based vaccine for COVID-19 in an article published a year ago in The Lancet. Buchbinder notes that a 2013 consensus conference on Ad5 vectors sponsored by the National Institutes of Health “warned that non-HIV vaccine trials that used similar vectors in areas of high HIV prevalence could lead to an increased risk of HIV-1 acquisition in the vaccinated population”. South Africa has one of the biggest HIV positive populations in the world – over eight million people – and almost 20% of people aged 15 to 49 are living with HIV. SAHPRA has been considering Sputnik’s application since February and, in light of the HIV trials, it “requested the applicant to provide data demonstrating the safety of the Sputnik V vaccine in settings of high HIV prevalence and incidence”, said the body’s CEO, Dr Boitumelo Semete, in a statement. “The applicant was not able to adequately address SAHPRA’s request,” she added. After reading Buchbinder’s article and consulting local experts, SAHRA decided not to approve the Sputnik vaccine “at this time”. “SAHPRA is concerned that use of the Sputnik V vaccine in South Africa, a setting of a high HIV prevalence and incidence, may increase the risk of vaccinated males acquiring HIV,” said the statement. “The rolling review of the Sputnik V vaccine will, however, remain open for submission of relevant safety data in support of the application.” No WHO approval yet The World Health Organization (WHO) has also not given Sputnik Emergency Use Listing (EUL) yet. Mariangelo Simao, WHO’s Assistant Director-General for Access to Medicines and Vaccines, said last week that the “Sputnik process is still on hold it pending some legal procedures that we expect will be sorted out quite soon”. “We are working very almost on a daily basis with the Ministry of Health in Russia to address the remaining issues to be to be fulfilled by the applicant, the Russian Direct Investment Fund (RDIF),” Simao told the WHO’s weekly COVID-19 media briefing. “As soon as this letter of agreement is signed, WHO will reopen the assessment, which includes the submission of the data in the dossiers – it’s still incomplete – and resuming the inspections in the sites in Russia,” she said. However, she said she did not know how long the process would take as it would depend first on finalising the legal procedure, then an assessment of both the applicant and vaccine manufacturers. The RDIF applied for EUL for Sputnik back in February but the process has been dogged with problems. Initially, the RDIF had not submitted all the required data. More recently, WHO inspectors flagged a number of concerns when they visited manufacturing sites in Russia, including control of aseptic operation and filling. Earlier this month, a representative from the European Medicines Agency told the New York Times that Russia had repeatedly postponed planned inspections of the Sputnik manufacturing sites. At the time of publication, the RDIF had not responded to a request for comment on South Africa’s decision. Sputnik has been approved in 70 countries, according to the company. These are mostly countries that are politically aligned with Russia, or that have few other vaccines choices. With registration in Indonesia Sputnik V is now authorized in 70 countries with total population of 4 billion people or 50% of the world’s population. Together we will defeat #COVID ✌️ pic.twitter.com/zQKtUYZvTr — Sputnik V (@sputnikvaccine) August 25, 2021 Meanwhile, the RDIF has announced that it will be seeking approval for what it calls “Sputnik Light”, a single dose of the vaccine that only uses the Ad26 vector to deliver its antigen. The company is promoting it as a potential booster shot for “vaccines produced by AstraZeneca, Sinopharm, Moderna and Cansino”, according to a media release. China’s Cansino also uses an Ad5 delivery method for its vaccine. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. 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