EU regulator says Russia yet to submit COVID-19 vaccine application

FILE PHOTO: A medical specialist holds a vial of Sputnik V vaccine against the coronavirus in a department store in Moscow, Russia, January 18, 2021 REUTERS/Shamil Zhumatov/File Photo

(Reuters) – Europe’s medicines regulator said on Wednesday it has so far not received any application seeking approval for the Sputnik V COVID-19 vaccine developed by Russia’s Gamaleya institute.

However, the European Medicines Agency (EMA) said the vaccine’s developers have expressed an interest that their vaccine be considered for a real-time review in Europe.

“The developers have received scientific advice from EMA providing them with the latest regulatory and scientific guidance for the development of their vaccine,” the EMA said.

It added that the vaccine is on its list of COVID-19 medicines and vaccines that have received such advice.

The regulator said it was in talks with Gamaleya to map out the next steps. (

Russia has already shared data from its late-stage trial with regulators in several countries and has begun the process of submitting it to the EMA for approval in the European Union, Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), which is responsible for marketing the vaccine abroad, said last week.

A two-dose regimen of Sputnik V was 91.6% effective against symptomatic COVID-19, according to peer-reviewed late-stage trial results published earlier this month in The Lancet international medical journal.

Europe has so far conditionally approved three vaccines – those developed by Pfizer and BioNtech, Moderna, and AstraZeneca and Oxford.

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