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PRAGUE — The Czech drugs regulator doesn’t have enough data to adequately assess Russia’s Sputnik V vaccine for clinical trials, its chief said Thursday.
“We received so little material that we could not say if we would recommend its use or not,” said Irena Storová, the head of the State Institute for Drug Control, in an interview with Radiožurnál. “It was only a fraction of the documentation that is submitted by default for the registration or assessment of a drug or medicine.”
Czech Health Minister Petr Arenberger said earlier this month that Sputnik V could be used in clinical trials to determine its efficacy. But according to Storová, her agency has yet to receive an application for clinical trials.
The news comes against the backdrop of growing Czech-Russian tensions. Last week, Prague expelled 60 diplomats and staff from its Russian embassy in an escalating standoff over allegations the Kremlin was behind a deadly 2014 explosion in the Czech Republic.
But it’s also the latest setback in what has been a rocky week for the Russian jab. On Wednesday, Brazil’s drug regulator said it had found abnormalities in its Sputnik V samples, leading it to refuse to import the vaccine. This follows a negative assessment from Slovakia’s drug regulator earlier in the month, when it said that the Sputnik V doses delivered were different to those supplied elsewhere or to the European Medicines Agency.
As a result, Russia has taken back 600 doses of vaccine purchased by Slovakia for further analysis. Hungary, which is the only EU country to have approved Sputnik, is also performing tests on Slovakia’s behalf.
Slovak Health Minister Vladimír Lengvarský has said all of these tests would take about one month to complete — and that the final decision on whether to use Sputnik V would be made after the analyses are concluded.
Slovakia has been deeply divided over the jab in early March, when then-prime minister Igor Matovič unilaterally purchased 2 million doses, a move that led to his resignation and subsequent demotion to finance minister after a cabinet reshuffle. But so far, Slovakia’s new prime minister, Eduard Heger, has said he will stick with Sputnik.
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