MOSCOW (Reuters) – Russia is finalising paperwork required to complete certification of its Sputnik V vaccine by the European Medicines Agency (EMA), the RIA news agency reported on Thursday.
RIA cited the Russian healthcare ministry as saying that it also expected an EMA mission to visit the country this year.
The EU drug regulator is unlikely to decide whether to approve Sputnik V until at least the first quarter of 2022 because some data needed for the review was still missing, a source with knowledge of the matter told Reuters.
(Reporting by Maxim Rodionov; Writing by Olzhas Auyezov; Editing by Andrew Cawthorne)