{"198695":{"id":"198695","parent":"0","time":"1638374760","url":"https:\/\/www.pharmaceutical-technology.com\/news\/south-africa-rejects-sputnik-hiv\/","category":"sant\u00e9","title":"South Africa rejects Sputnik V Covid-19 vaccine due to Hiv concerns","image":"http:\/\/www.newsnet.fr\/img\/newsnet_198695_033996.jpg","hub":"newsnet","url-explicit":"south-africa-rejects-sputnik-v-covid-19-vaccine-due-to-hiv-concerns","admin":"newsnet","views":"236","priority":"3","length":"2440","lang":"en","content":"\u003Cfigure\u003E\u003Cimg src=\"http:\/\/www.newsnet.fr\/img\/newsnet_198695_473577.jpg\" \/\u003E\u003Cfigcaption\u003EThe Sputnik V vaccine is developed by the Gamaleya Research Institute of Epidemiology and Microbiology. Credit: IMF Photo\/Sergey Ponomarev \/ Flickr.\u003C\/figcaption\u003E\u003C\/figure\u003E\u003Cp\u003ESouth African Health Products Regulatory Authority (SAHPRA) has decided not to approve Russia's Sputnik V Covid-19 vaccine due to human immunodeficiency virus (HIV) concerns.\u003C\/p\u003E\u003Cp\u003EDeveloped by the Gamaleya Research Institute of Epidemiology and Microbiology, the vaccine merges two dissimilar adenovirus-vectored constructs based on Adenovirus Type 26 (Ad26) and Adenovirus Type 5 (Ad5).\u003C\/p\u003E\u003Cp\u003EThe initial application for the vaccine was submitted on 23 February and since then, the vaccine data was analysed by SAHPRA under a rolling review process.\u003C\/p\u003E\u003Cp\u003ESAHPRA noted that there were concerns about the safety of Ad5-vectored shots in people who are at the risk for HIV infection.\u003C\/p\u003E\u003Cp\u003EThe presence of already existing Ad-specific neutralising antibodies (NAbs) in people is a challenge faced by such types of vaccines.\u003C\/p\u003E\u003Cp\u003EThe latest decision is based on clinical trials which analysed the safety of Ad5-vectored vaccines and those contained in the Russian vaccine.\u003C\/p\u003E\u003Cp\u003EData from the STEP and PHAMBILI trials were taken into consideration. These trials assessed three doses of an Ad5-vectored vaccine that encodes the HIV gag, pol and nef proteins.\u003C\/p\u003E\u003Cp\u003EFindings from the trials showed that the Ad5-vectored vaccine was linked to increased chances of HIV acquisition in men.\u003C\/p\u003E\u003Cp\u003ESAHPRA, therefore, sought additional information on the Sputnik V vaccine's safety in settings with increased HIV occurrence.\u003C\/p\u003E\u003Cp\u003EThe authority added that the applicant could not furnish the related data.\u003C\/p\u003E\u003Cp\u003EFurthermore, SAHPRA held discussions with expert panels, including the domestic and global scientific community's key members.\u003C\/p\u003E\u003Cp\u003EIn a statement, SAHPRA said: \"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.\u003C\/p\u003E\u003Cp\u003E\"The rolling review of the Sputnik V vaccine will, however, remain open for submission of relevant safety data in support of the application.\"\u003C\/p\u003E\u003Cp\u003EThe World Health Organization (WHO) still put on hold \u003Ca href=\"https:\/\/www.pharmaceutical-technology.com\/news\/who-sputnik-v-eul-process-on-hold\"\u003ESputnik V's Emergency Use Listing (EUL) process\u003C\/a\u003E citing pending legal procedures and missing data.\u003C\/p\u003E\u003Cp\u003E\u003Ca href=\"https:\/\/www.pharmaceutical-technology.com\/news\/south-africa-rejects-sputnik-hiv\"\u003Epharmaceutical-technology.com\u003C\/a\u003E\u003C\/p\u003E"}}