EMA to Start Review Process for Russia’s Sputnik V Covid Vaccine
The European Medicines Agency said it has started a rolling review of Russia’s Sputnik V Covid-19 vaccine to test compliance with safety and quality standards, the first major step in gaining approval for use in the European Union.
“The rolling review will continue until enough evidence is available for formal marketing authorization application,” the agency said in a statement Thursday. “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.”……
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