{"id":530008,"date":"2021-10-18T12:19:12","date_gmt":"2021-10-18T10:19:12","guid":{"rendered":"https:\/\/businesstech.co.za\/news\/?p=530008"},"modified":"2021-10-18T13:16:29","modified_gmt":"2021-10-18T11:16:29","slug":"regulator-rejects-russian-covid-19-vaccine-for-south-africa","status":"publish","type":"post","link":"https:\/\/businesstech.co.za\/news\/lifestyle\/530008\/regulator-rejects-russian-covid-19-vaccine-for-south-africa\/","title":{"rendered":"Regulator rejects Russian Covid-19 vaccine for South Africa"},"content":{"rendered":"

The South African Health Products Regulatory Authority (Sahpra) has not approved the Russian-developed Sputnik V Covid-19 vaccine for use in South Africa, citing safety concerns due to the country’s HIV rate.<\/p>\n

In a statement<\/a> <\/strong>on Monday (18 October), the regulator noted that 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.<\/p>\n

“Concerns have been raised about the safety of Ad5-vectored vaccines in populations at risk for HIV infection. One of the challenges faced by such vaccines is the presence of pre-existing Ad-specific neutralising antibodies (NAbs) in the general population,” it said.<\/p>\n

The regulator cited two HIV trials conducted in South Africa which showed that administration of an Ad5-vectored vaccine was associated with enhanced susceptibility\/acquisition of HIV in men.<\/p>\n

Sahpra also referred to medical arguments published in The Lancet, <\/a><\/strong>which showed similar trends in a non-human primate study. In addition, Sahpra held a consultation meeting with expert committees, including leading local and international scientific community members on this matter.<\/p>\n

The regulator has also asked the Sputnik V vaccine maker to provide data demonstrating the safety of the Sputnik V vaccine in settings of high HIV prevalence and incidence. However, the applicant was not able to adequately address this request, it said.<\/p>\n

“Sahpra is concerned that use of the Sputnik V vaccine in South African, a setting of a high HIV prevalence and incidence, may increase the risk of vaccinated males acquiring HIV.<\/p>\n

“The rolling review of the Sputnik V vaccine will, however, remain open for submission of relevant safety data in support of the application,” it said.<\/p>\n

No risk\u00a0<\/strong><\/p>\n

In response to Sahpra’s statement, Russia’s Gamaleya Center of Epidemiology and Microbiology said that the concerns around the Sputnik V vaccine and HIV are unfounded.<\/p>\n

“Sahpra has confirmed that the rolling review of Sputnik V continues. All the required information confirming that possible concerns about the safety of Ad5-vectored vaccines in populations at risk for HIV infection are completely unfounded will be submitted to the South African regulator,” it said.<\/p>\n

There is no scientific or clinical evidence confirming the association of wild type adenoviruses or replicative defective adenovirus vectors with increased risk of HIV infection, it said.<\/p>\n

“Speculation regarding the association between adenovirus type-5 vectored vaccines and HIV transmission has been based on small-scale studies among volunteers with highly probable risky behaviour.<\/p>\n

In contrast, a meta-analysis of six clinical studies and their long-term follow-up in 7,092 participants showed that, after rigorous statistical analysis of pooled individual participant-level data, there was no statistically significant increase of HIV-1 infection among adenovirus type-5 vectored vac\u0441ine recipients when all study participants and follow-up time were considered.”<\/p>\n

The human adenovirus 5 is already used in other popular vaccines, including Cansino, which is widely applied in China, including during vaccination of the Chinese military, and approved around the world, the center added.<\/p>\n

“The efficacy of the human adenoviral vector platform has been widely and internationally proven in non-Covid-19 vaccines. More than 250 clinical trials and 75 international publications confirm the safety of vaccines and medicines that are based on human adenovirus vectors.”<\/p>\n

This article has been updated with comments from the Russian Direct Investment Fund and the Gamaleya Center of Epidemiology and Microbiology.<\/em><\/p>\n

\n

Read: CEO says the government should scrap work-from-home rules in South Africa \u2013 and make vaccines mandatory for some<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

The South African Health Products Regulatory Authority (Sahpra) has not approved the Russian-developed Sputnik V Covid-19 vaccine for use in South Africa, citing safety concerns due to the country’s HIV rate.<\/p>\n","protected":false},"author":10,"featured_media":468506,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9876],"tags":[26],"class_list":["post-530008","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-lifestyle","tag-headline"],"_links":{"self":[{"href":"https:\/\/businesstech.co.za\/news\/wp-json\/wp\/v2\/posts\/530008","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/businesstech.co.za\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/businesstech.co.za\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/businesstech.co.za\/news\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/businesstech.co.za\/news\/wp-json\/wp\/v2\/comments?post=530008"}],"version-history":[{"count":9,"href":"https:\/\/businesstech.co.za\/news\/wp-json\/wp\/v2\/posts\/530008\/revisions"}],"predecessor-version":[{"id":530080,"href":"https:\/\/businesstech.co.za\/news\/wp-json\/wp\/v2\/posts\/530008\/revisions\/530080"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/businesstech.co.za\/news\/wp-json\/wp\/v2\/media\/468506"}],"wp:attachment":[{"href":"https:\/\/businesstech.co.za\/news\/wp-json\/wp\/v2\/media?parent=530008"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/businesstech.co.za\/news\/wp-json\/wp\/v2\/categories?post=530008"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/businesstech.co.za\/news\/wp-json\/wp\/v2\/tags?post=530008"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}