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European regulator gives positive feedback on clinical trials Sputnik V vaccine — RDIF

The Sputnik V team expects to receive a vaccine registration within two months

MOSCOW, June 16. /TASS/. The European Medicines Agency (EMA) has provided a positive review on the results of clinical trials of Russia’s Sputnik V vaccine against the coronavirus, the Russian Direct Investment Fund (RDIF) said in a statement on Wednesday. 

"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 European Medicines Agency (EMA)," RDIF said.

The information about the deferral of the EU approval of the Russian vaccine does not reflect the reality, the RDIF stressed.

"The timing for Sputnik V to receive the EMA approval has become the subject of constant speculation in the media, citing anonymous sources of information. These speculations have nothing to do with reality and slow down the registration process," the fund said.

They added that the RDIF and the Gamaleya Federal Research Center for Epidemiology and Microbiology, which developed the vaccine, continue to work with the EMA as part of a rolling review, which involves the gradual filing of documents upon request.

"The expertise continues, there is no talk of any delays. Although the decision on the timing of the approval is the authority of the EMA, the Sputnik V team expects to receive a vaccine registration within two months," the RDIF explained.

Earlier, Reuters reported that approval of the Russian Sputnik V vaccine against coronavirus in the European Union had been postponed, as the necessary data from clinical trials were not provided in time.