EU medicines agency begins ‘rolling review’ of Russia’s Sputnik V Covid shot

Amsterdam, Mar 4 (efe-epa).- The European Medicines Agency on Thursday said it had started a rolling review of Russia’s Sputnik V Covid-19 vaccine.

The fast-tracked process of reviewing clinical trial data could lead to the vaccine’s approval for use in the European Union, although the EMA’s human medicines committee did not specify when it would announce its final evaluation.

A study published by esteemed medical journal The Lancet found Sputnik V to be 92% effective against symptomatic cases of Covid-19.

The EMA said in a statement that it would “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 EU’s medicine regulator has already given market authorization to vaccines from Pfizer/BioNTech, AstraZeneca and Moderna. It is due to publish its recommendations on the single shot candidate from Johnson & Johnson on 11 March.

R-Pharm Germany GmbH submitted Sputnik V’s application to the EMA. The shot was developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology.EFE-EPA


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