Illustration of the Russian vaccine candidate Sputnik V. -
RDIF / Cover-Images.com / SIPA
An application for registration of the Sputnik V vaccine against the new coronavirus was filed this Tuesday by the Russian authorities with the European Medicines Agency (EMA), announced the Russian sovereign wealth fund, which participated in the development of the produced this Wednesday.
The fund "has applied for registration and expects the first review (of the documents sent) to take place in February," he said in a statement.
Use the vaccine in the EU
Required documents, such as interim results from ongoing Phase 3 clinical trials, will be sent and reviewed as they arise.
"On the basis of the series of reviews, the EMA will decide on the authorization of the Sputnik V vaccine for the European Union", specifies the fund.
The EMA for its part said in a statement that it "will communicate when a continuous review procedure begins".
“At the end of October, we started the vaccine authorization process in Europe.
It is a large-scale process, the objective of which is to obtain permission to use the vaccine in the EU, "added the spokesperson for the sovereign wealth fund, adding that" registration is an important step. ".
Russian vaccine already authorized in several countries
Called "Sputnik V" in homage to the first satellite launched by the USSR in 1957, the Russian vaccine against the coronavirus had been greeted with skepticism internationally in the face of an announcement deemed premature, in August, even before the start of clinical trials mass (phase 3) and publication of scientific results.
According to the sovereign wealth fund, Sputnik V is registered in Belarus, Serbia, Argentina, Bolivia, Algeria, the Palestinian territories, Venezuela, Paraguay and Turkmenistan.
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