WHO announces possible timeline for safety assessment of Sputnik V vaccine

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The World Health Organization (WHO) hopes to assess the safety of Russia’s Sputnik V coronavirus vaccine in late June or July. This was announced on Monday, May 3, by WHO expert Marianjela Simao.

“WHO still does not have a complete dossier. But this is what we call “providing data in progress.” Our team has already been in Russia for the past two weeks and is evaluating clinical trials. And from May 10 to the first week of June we will begin to inspect production, ”she said during the briefing. The event was broadcast on the WHO account in Twitter

As emphasized by Simao, the organization’s specialists will visit five different production facilities of the drug, in two of them experts from the European Medicines Agency (EMA) will join them.

As a result, WHO expects to receive complete information about the vaccine and to assess its compliance with the necessary criteria. The final assessment will be carried out at the end of June or in July, the expert of the organization concluded.

On April 27, the Minister of Health of the Russian Federation Mikhail Murashko said that the EMA experts had completed the first stage of the examination of the Russian vaccine against the Sputnik V coronavirus.

On April 22, it became known that the World Health Organization (WHO), together with EMA, will inspect the production practice of Sputnik V in Russia. It was clarified that it will be held from May 10 to the first week of June. After the inspection, a group of experts will assess the possibility of approving the Russian vaccine for emergency use in the EU countries.

The EMA began the procedure for the consecutive examination of the registration dossier of Sputnik V in early March. A month earlier, it was reported that the EU regulator completed scientific advice on Sputnik V and gave the developer the opportunity to apply for registration of the drug in the EU, which RDIF did.

The first COVID-19 vaccine in Russia and the world was registered on August 11, 2020. Sputnik V was developed by specialists from the Gamaleya Center.

All relevant information on the situation with the coronavirus is available on the websites of stopcoronavirus.rf and access vsem.rf, as well as by the hashtag # We are together. Coronavirus hotline: 8 (800) 2000-112.