The European Medicines Agency (EMA) continues to review the data on clinical trials of Russia's coronavirus vaccine Sputnik V, the Russian Direct Investment Fund (RDIF) said on Wednesday, adding that it expects the drug's registration within two months
MOSCOW (Pakistan Point News / Sputnik - 16th June, 2021) The European Medicines Agency (EMA) continues to review the data on clinical trials of Russia's coronavirus vaccine Sputnik V, the Russian Direct Investment Fund (RDIF) said on Wednesday, adding that it expects the drug's registration within two months.
Earlier in the day, Reuters reported, citing sources, that the vaccine's authorization within the bloc would be postponed, as the developers failed to submit the necessary documents on time.
"This information does not correspond to reality. All data on the clinical trials of Sputnik V have been provided, the GCP [good clinical practice] inspection has been completed and a positive review has been received from the EMA," RDIF said in a statement.
"Though the decision on the timing of the procedure is the EMA's prerogative, the Sputnik V team expects to receive the vaccine's registration within two months," RDIF said in a statement.
