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EU medicine regulator evaluating Russia's Sputnik V vaccine for use in Europe

The EMA has also been in touch with representatives of the Chinese Sinopharm jab.

Image: SIPA USA/PA Images

THE EUROPEAN MEDICINES Agency (EMA) is set to inspect facilities in Russia that are producing the Sputnik V Covid-19 vaccine in the hopes of approving the jab for use in the European Union.

This morning, the EMA’s executive director Emer Cooke told the European Parliament health committee that the regulator is planning inspections of the manufacturing and clinical sites in Russia.

“We do hope this will be a valuable vaccine to add to the vaccines that are available for the EU population and that it will get an authorisation at European level based on the same standards of safety, quality and efficacy that we apply for every vaccine,” she said.

Cooke added that the agency is evaluating Stupnik V “in the same way that we have evaluated all the other vaccines that have submitted information to us.”

She didn’t set out a timeline for the inspections but Russian Health Minister Mikhail Murashko said yesterday that EMA representatives will visit Russia on 10 April.

The EMA launched a rolling review of Sputnik V earlier this month.

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Officials in the agency urged EU members to refrain from approving the jab at the national level while the regulator was still reviewing it. Despite this, Hungary and Slovakia have already purchased millions of doses of the vaccine.

Cooke also told MEPs that the EMA was in touch with representatives for the Chinese Sinopharm vaccine, as part of a drive to access more jabs as cases surge across many countries and supplies remain low.

Europe currently has four approved Covid-19 vaccines from Pfizer-BioNTech, Moderna, Oxford-AstraZeneca, and Johnson & Johnson’s single-dose jab.

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Ceimin Burke

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