PRAGUE – The Czech drug regulator does not have enough data to properly assess Russia’s Sputnik V vaccine for clinical trials, its chief said on Thursday.
“We received so little material that we couldn’t say whether we would recommend its use or not,” said Irena Storová, head of the State Institute for Drug Control, in an interview with Radiožurnál. “It was only a fraction of the documentation submitted by default for registration or evaluation of a drug or drug.”
Czech Health Minister Petr Arenberger said earlier this month that Sputnik V could be used in clinical trials to determine its effectiveness. But according to Storová, his agency has yet to receive a request for clinical trials.
The news comes amid growing Czech-Russian tensions. Last week, Prague expelled 60 diplomats and staff from its Russian embassy amid growing deadlock 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 tough week for the Russian jab. Wednesday, Brazil’s drug regulatory body said he found abnormalities in his Sputnik V samples, which led him to refuse to import the vaccine. This follows a negative review by the Slovak medicines regulator earlier this month, when it said the doses of Sputnik V delivered were different from those provided 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 carrying out tests on behalf of Slovakia.
The Slovak Minister of Health, Vladimír Lengvarský, has says all these tests would take about a month to complete – and that the final decision on whether or not to use Sputnik V would be made once the scans are complete.
Slovakia was deeply divided over the attack in early March, when then Prime Minister Igor Matovič unilaterally bought 2 million doses, a move that led to his resignation and demotion to the post. Minister of Finance after a cabinet reshuffle. But so far the new Slovak prime minister, Eduard Heger, has said he will stay with Sputnik.