According to Reuters, the EU drug regulator, European Medicines Agency (EMA), won’t review the Sputnik V vaccine since the Russian manufacturer hasn’t yet provided the required data for the review.
Moreover, according to an unnamed source of Reuters, EMA said in an email that Sputnik V has yet to be examined under a rolling review until the agency receives an official marketing authorization application.
Furthermore, Reuters’ source revealed that the EMA had asked the Russian manufacturer to fully complete the application dossier on Sputnik V’s production, including information such as active ingredients and the bottling of the final product.