Time for optimism | Sputnik V prepares for EU launch

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  • RT published this video item, entitled “Time for optimism | Sputnik V prepares for EU launch” – below is their description.

    Brussels’ beleaguered coronavirus vaccination program could be poised to get a shot in the arm as the #EU’s central regulator completes its initial stage in appraising #SputnikV, the #vaccine developed by Moscow’s Gamaleya Center.

    The European Medicines Agency (EMA) told Russian media on Tuesday that the scientific consultation process was now finalized. “As a next step, the company can prepare an application for a registration certificate” for the EU market, a source at the agency informed RIA Novosti.

    Later that morning, the Russian Direct Investment Fund (RDIF), which financed the development of the formula, announced that it “has official confirmation from the EMA that the application was accepted.” How quickly it could receive final approval to be used is now up to the regulator.

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  • In This Story: Sputnik V

    Gam-COVID-Vac, trade-named Sputnik V, is a COVID-19 vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology, and registered on 11 August 2020 by the Russian Ministry of Health. It has been approved for distribution in Russia.

    The phase III trial for Gam-COVID-Vac was registered on 28 August 2020, and is a randomised, double-blind, placebo-controlled, multi-centre clinical trial involving 40,000 volunteers. The phase III trial is scheduled to run until May 2021.

    On 5 December 2020, Russia began mass vaccinations in Moscow, with 70 clinics inoculating those most at risk from the virus. Health workers and teachers were said to have priority in the first mass immunisation programme. People who had received injections in the last 30 days or had respiratory diseases in the previous two weeks were excluded, as well as those with certain chronic illnesses, and pregnant and breastfeeding women.

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