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The European Medicines Agency launched an in-depth review of the Russian coronavirus vaccine Sputnik V on Thursday. This makes it the first non-Western vaccine to be used in the EU of 27 countries.
Russia, which has been pushing for swift approval, was quick to say it was ready to shock 50 million Europeans as soon as the shot gets the green light from the Amsterdam-based European Medicines Agency.
Leading companies in Europe have embraced the idea of using the vaccine developed in Russia as the continent grapples with the shortcomings of the three shocks currently approved for use.
“The EMA has launched an ongoing review of Sputnik V, a COVID-19 vaccine developed by Russia’s Gamaleya National Center for Epidemiology and Microbiology,” said a statement from the Amsterdam-based European Medicines Agency (EMA) .
The watchdog said its decision was based on clinical studies and laboratory tests that “suggest Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and may help protect against COVID-19” .
“EMA will evaluate Sputnik V’s compliance with usual EU standards for efficacy, safety and quality,” she added.
The schedule for a possible approval should “take less time than normal” due to the work already done during the on-going review.
After a quick process that saw Sputnik approved for use in Russia last August and used in December prior to large-scale clinical trials, concerns about Sputnik initially arose.
However, the Lancet Medical Journal published results in February showing that Sputnik V is 91.6 percent effective, based on studies in the third phase with more than 20,000 volunteers.
Hungary has since broken its ranks and is the first EU country to approve and order the vaccine, while the Czech Republic and Slovakia have also ordered Sputnik shares.
The three products approved so far for use in the block are the US-German Pfizer BioNTech shot, the shot from the US company Moderna and the vaccine developed by the British-Swedish company AstraZeneca at Oxford University.
US-based Johnson & Johnson has also applied for approval while Novavax and CureVac are currently under review.
Russia and the EMA have been arguing over the approval process for Sputnik in recent weeks.
The makers of Sputnik insisted in February that they had requested an ongoing review to begin and told the watchdog to hurry up. However, the EMA said at the time that it had not received such a request.
As it is the first non-Western developed vaccine to be used in the EU, officials have stated that Sputnik’s manufacturing facilities outside the block would need to be inspected.
“They do not produce in Europe, so there should of course be an inspection process at the production sites,” said the head of the European Commission, Ursula von der Leyen, on February 17th.
Brussels was concerned about Russian and Chinese vaccines, fearing Moscow and Beijing would use them as soft-power tools.
Von der Leyen himself raised questions about why Moscow was so keen to enforce the vaccine against the EU.
“Overall, I have to say we are still wondering why Russia is theoretically offering billions and billions of doses while not making sufficient progress in vaccinating its own people,” she said.
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© 2021 AFP
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