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WHO Expects to Complete Safety Assessment of Russia's Sputnik V Vaccine by July

GENEVA (Sputnik) - The World Health Organisation (WHO) said on Monday that it expects to give its safety assessment of Russia's coronavirus vaccine Sputnik V in late June or in July.
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According to Mariangela Simao, WHO assistant director general for access to medicines, the health organisation still does not have a complete dossier from the Sputnik V developer.

"So we expect that as soon as we have the entire dossier, the full dossier, plus the compliance to both good manufacturing practices and the good clinical practice, the vaccine can be assessed then by the technical expert group, and we expect this is likely to happen in the end of June or probably in July", she said.

From 10 May to the first week of June, the WHO will begin to inspect production sites in Russia. According to Simao, WHO experts will visit five different Russian vaccine production facilities. At the same time, the visits to two manufacturers will be made together with experts from the European Medicines Agency.

Sputnik V, the world's first registered coronavirus vaccine, has been approved for emergency use in more than 60 countries across the globe. According to an interim analysis from the trial published in The Lancet, the vaccine has 91.6 percent efficacy.

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