EU regulator warns over Russia's COVID-19 vaccine Sputnik V, advises against approval

European Medicines Agency (EMA) managing board chief on Sunday cautioned against the efficacy and safety of Russia’s Sputnik V coronavirus vaccine. In a statement to Austrian broadcaster ORF on March 7, the chair of the EMA warned the European Union (EU) nations about giving the emergency approval to the Russian manufactured jab questioning the data from the vaccine’s clinical trials. Suggesting that no emergency use authorisation should be given to Sputnik V unless the EMA completes the safety review, Christa Wirthumer-Hoche said that the jab’s safety was “unknown”. “That's why I would urgently advise against giving a national emergency authorization," she said in a televised statement. 

Further, the EMA managing board chief said that the EMA has sought documents that it can review in order to feel more confident about the vaccine’s approval. She said, that at the moment, EMA had no data about the vaccinated population and the side effects that they may have suffered after the shot was administered. "We can have Sputnik V on the market here in the future when the appropriate data have been reviewed. The rolling review has begun now at EMA,"  Wirthumer-Hoche added. Stressing that the vaccine’s safety must be monitored basis the European standards for quality, safety, and efficacy, the EMA chief said that the data packages received from the Russian health authorities will be critically reviewed “of course”, adding that it was a key step towards vaccine’s approval across the 27-nation European Union. 

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EMA sounds skepiticism

EMA has repeatedly made claims about Russia’s Sputnik V being unsafe as even earlier, the medicinal agency issued a statement saying that there was uncertainty surrounding any scientific evidence that the jab was safe for public use.  “European Medicines Agency has to date not received an application for a rolling review or a marketing authorization for the vaccine developed by the Gamaleya National Centre of Epidemiology and Microbiology in Russia, the Sputnik V vaccine (Gam-COVID-Vac), despite reports stating the opposite,” the European agency said. It added that the EMA’s Human Medicines Committee (CHMP) and the COVID-19 EMA pandemic Task Force (COVID-ETF) needs to give their agreement after the rolling review process in order to authorize the vaccine. Sputnik V has been approved in Hungary, Slovakia, and the Czech Republic and Brussels might also start negotiations if at least 4 more EU nations demanded the purchase. 

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