13 Jul 2021, 18:48

EU regulator silent on Reuters report concerning Sputnik V

"While the evaluation of a COVID-19 vaccine is ongoing we cannot comment on or discuss the data/information we are reviewing, nor disclose any other details," the agency pointed out

THE HAGUE, July 13. /TASS/. The European Medicines Agency (EMA) refused to comment on the Reuters report that producers of the Russian Sputnik V developers failed to furnish the required data in accordance with the standards and approval requirements in the EU, according to the EMA press service’s statement received by TASS on Tuesday.

"The Sputnik V vaccine is currently under rolling review by EMA, and the rolling review will continue until sufficient evidence is available for a formal marketing authorization application, which has not been received yet," the regulator said.

"While the evaluation of a COVID-19 vaccine is ongoing we cannot comment on or discuss the data/information we are reviewing, nor disclose any other details," the EMA said. "Such information will be included in the final assessment report, which will be published on our website at the time of EMA’s recommendation on the marketing authorization, if an application is received," it added.

The EMA did not indicate the possible timeline for completion of the review. "EMA will be in a better position to comment on possible timelines for an authorization of Sputnik V COVID-19 vaccine once a marketing authorization application has been submitted to the Agency, allowing a better understanding of the robustness of the data available," it added.

The article by Reuters regarding problems with the registration of the Sputnik V coronavirus vaccine in the EU is just fake news, a spokesperson of the Russian Direct Investment Fund (RDIF) told TASS today.

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