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EU regulator urges caution on Sputnik V vaccine

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eMediNexus    08 March 2021

European Medicines Agency (EMA) official has urged members of the European Union to avoid granting national approvals for Sputnik V COVID-19 vaccine while the agency is reviewing the vaccine’s safety and effectiveness.

EMA managing board head Christa Wirthumer-Hoche stated that they needed documents to review, adding that they did not have data about vaccinated people. Wirthumer-Hoche cautioned against granting a national emergency use authorization. She further stated that Sputnik V could be available on the market in future when the data have been reviewed and added that the rolling review has started at EMA. The vaccine has already received approval or is being evaluated for approval in three EU member states, including Hungary, Slovakia and the Czech Republic… (Reuters, March 8, 2021)

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