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EMA to start review of Russia’s Sputnik V Covid vaccine

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Europe’s medicines watchdog, namely the European Medicines Agency (EMA) on Thursday said it will start reviewing the Russian-made Sputnik V vaccine for Coronavirus, 

The decision by EMA’s human medicines committee (CHMP) “is based on results from laboratory studies and clinical studies in adults. These studies indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and may help protect against COVID-19,” the Amsterdam-based agency said in a statement.

“EMA will assess Sputnik V’s compliance with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review,” the medicines watchdog added. 

The jab, developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology has already been imported in several EU countries, despite frequent warnings by the Commission against undermining the trust in vaccines. 

The announcement came days after Slovakia became the second member-state after Hungary to receive deliveries of Sputnik V, bypassing the EU drug regulator. 

 

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