EU takes step towards approving Russia's Sputnik V vaccine

Member countries address shortages by turning to drugs developed outside West

Europe's medicines regulator has started a rolling review of Russia's Sputnik V vaccine. AFP
Europe's medicines regulator has started a rolling review of Russia's Sputnik V vaccine. AFP

The EU’s medicines regulator took a step towards approving Russia’s Sputnik V vaccine on Thursday as member countries increasingly source their own shots developed outside the West.

The European Medicines Agency announced it had started a “rolling review” of Russia’s vaccine.

The aim is to speed up the approval process by allowing researchers to submit real-world findings before final trial data is ready.

Some EU nations have already approved Sputnik V.

Hungary became the first to do so in January, while Slovakia ordered shipments and Czech Prime Minister Andrej Babis said his country was looking to do the same.

The Czech Republic asked China for deliveries of Covid-19 vaccines made by Sinopharm.

Hungary approved that vaccine last month.

While member countries are free to buy vaccines outside the bloc, they are asked to refrain from parallel talks and deals if the EU is negotiating a joint purchase.

Vaccines made by Pfizer-BioNTech, Moderna and AstraZeneca have EU agency approval, but their delivery has been hampered by delays and disputes with makers.

The EU is trailing Britain, the approval and distribution system of which appears to be more effective.

The European Commission said on Thursday that there were no talks under way about buying Sputnik V despite the agency’s review.

The commission’s chief spokesman, Eric Mamer, said the agency was looking at the safety and efficacy of the vaccine.

“There is no other consideration than that,” Mr Mamer said.

Previously, Brussels was wary of Russian and Chinese vaccines, concerned that they could be used as soft power tools.

The President of the European Commission, Ursula Von der Leyen, raised questions about why Moscow was so keen to promote the vaccine in the EU.

"We still wonder why Russia is offering theoretically millions and millions of doses while not sufficiently progressing in vaccinating their own people," Ms von der Leyen said.

Despite scepticism about Moscow’s hasty introduction of the vaccine, which was distributed before its trials were complete, the vaccine appears to be safe and effective.

A study published last month in medical journal The Lancet said Sputnik V was 91 per cent effective.

With a global shortage of vaccines, some experts say approval of those from Russia and China would be a quicker way to increase supply.

Dr Hans Kluge, the World Health Organisation’s regional director for Europe, welcomed the agency's announcement on Sputnik V.

“We desperately need to enlarge our portfolio of vaccines,” Dr Kluge said.

The Russian Direct Investment Fund financed the development of the vaccine.

“Vaccine partnerships should be above politics and co-operation with [the EU agency] is a perfect example, demonstrating that pooling efforts is the only way to end the pandemic,” said the fund's chief executive, Kirill Dmitriev.

“Following approval, we would be able to provide vaccines for 50 million Europeans starting from June."

Updated: March 5, 2021 01:58 AM

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