EU Drug Watchdog Reviewing Russia's Sputnik V COVID-19 Vaccine
By RFE/RL March 04, 2021
Europe's medicines regulator says it has started a "rolling review" of the Russian-developed Sputnik V coronavirus vaccine, a key step toward approval for use across the 27-nation European Union.
The human medicines committee of the European Medicines Agency (EMA) will review data from ongoing trials of the vaccine until there is enough clinical data for approval, the Amsterdam-based EMA said in a statement on March 4.
Last month, peer-reviewed, late-stage trial results published in The Lancet medical journal showed the two-dose regimen of Sputnik V was 91.6 percent effective against symptomatic COVID-19, about the same level as the leading Western-developed vaccines.
EMA's "rolling reviews" are intended to speed up the process of approving a successful vaccine by allowing researchers to submit findings in real time, even before final trial data is ready.
The agency has already approved vaccines from Pfizer/BioNTech, Moderna, and AstraZeneca /Oxford, and is expected to give its verdict on Johnson & Johnson's single-shot vaccine next week. Reviews for CureVac and Novavax's candidates are also under way.
The head of the Russian Direct Investment Fund, which has funded the vaccine and is responsible for selling it globally, said on March 4 that the country would be able to provide the vaccine for 50 million Europeans from June if it was approved by the EMA
Kirill Dmitriyev also said that the country expected several European countries to approve Sputnik V this month.
Slovakia earlier this month received its first shipment of Sputnik V doses, becoming the second EU member state to obtain the vaccine after Hungary, even though it lacks approval by the EMA.
With reporting by Reuters and AFP
Copyright (c) 2021. RFE/RL, Inc. Reprinted with the permission of Radio Free Europe/Radio Liberty, 1201 Connecticut Ave., N.W. Washington DC 20036.
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