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European Medicines Agency (EMA) has started a rolling review of the Russia-made Sputnik V vaccine based on results from laboratory studies and clinical studies in adults, it was confirmed on Thursday.
According to the agency, 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.
“EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for formal marketing authorisation application,” said the European Union's medical authority.
It added that the assessment will include 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,” said the agency.
The EU applicant for Sputnik V vaccine developed by Russia's Gamaleya National Centre of Epidemiology and Microbiology is R-Pharm Germany GmbH.
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