Sputnik V

Russia’s Sputnik V vaccine developers question neutrality of EU regulator

The developers of Russia’s Sputnik V vaccine against COVID-19 on Tuesday questioned the neutrality of the European Medicines Agency (EMA) after an EMA official urged EU members to refrain from approving the Russian vaccine for now.

Christa Wirthumer-Hoche, the head of EMA’s management board, told a talk show on Austrian broadcaster ORF on March 7 that she advised European Union countries against granting Sputnik V a national emergency authorisation while EMA was still reviewing the Russian vaccine’s safety and effectiveness.

“We demand a public apology from EMA’s Christa Wirthumer-Hoche for her negative comments on EU states directly approving Sputnik V,” the vaccine developers wrote on the official Sputnik V Twitter account.

The developers added that the vaccine had already been approved by 46 countries.

“After postponing Sputnik V review for months, EMA does not have the right to undermine (the) credibility of 46 other regulators that reviewed all of the necessary data,” Sputnik V’s developers said.

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EMA earlier this month said it would review data from ongoing trials of the vaccine until there was enough evidence for a formal marketing authorisation application.

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