EU regulator begins review of Russia's Sputnik V vaccine

Thursday, March 4

By Michael Keogh

The European Medicines Agency (EMA) has launched a review of the Russian-made Sputnik V Covid-19 vaccine.

In a statement on Thursday, the agency said: "The EMA will evaluate the data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for formal marketing authorisation application," it added.

Slovakia received their first batch of the Russian vaccine on Tuesday, the second European Union member state to authorise use of Sputnik V.

Hungary has already begun to administer the vaccine, despite it not being approved by the EU regulator.

The EMA has so far approved Pfizer/BioNTech, AstraZeneca/Oxford University, and Moderna vaccines.

It is currently evaluating Johnson & Johnson and is expected to give its approval in mid-March.

Data released already by Sputnik V suggests the vaccine has a 91.6 per cent efficacy rate. 

The two-dose jab can be stored in a conventional refrigerator and costs under €10 per shot.

40 countries worldwide are now using the Sputnik V vaccine, including European nations Serbia, Montenegro, Moldova, and Hungary. 

Slovakia received its first shipment of 200,000 doses over the weekend.

Hungary, who started administering the vaccine in mid-February, said its decision to start using the jab was spurred on by Brussels' slow coordinated roll-out. 

Prime Minister Viktor Orban was critical of the EU’s slow roll out of vaccines.

Mr Orban said last month: "Every day that we spend waiting for Brussels, we lose a hundred Hungarian lives.

"Why should we think that European experts are smarter than us? I trust the Hungarian Public Health Centre more than the one in Brussels," he added. 

Hungary has also started using China's Sinopharm vaccine.

Source: Newsday and News Agencies