Sputnik V order that led to PM’s resignation cannot be used owing to incomplete or inaccurate information
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A 200,000-dose order of Russia’s Sputnik V vaccine that triggered a political crisis in Slovakia should not be administered yet because of incomplete or inaccurate information from the manufacturer, the national medicines agency has said.
The Dennik N news site quoted the agency as saying it could not properly assess the shots, which it said were different from the vaccine whose favourable peer-reviewed late-stage trial results were published in The Lancet medical journal in February.
The agency said it had carried out several tests on the vaccine but recommended it be administered only after approval by the European Medicines Agency (EMA), which is carrying out a rolling review of the Russian shot.
The Slovakian president, Zuzana Čaputová, last week named Eduard Heger as prime minister after his predecessor, Igor Matovič resigned amid a bitter dispute sparked by his Sputnik purchase.
Matovič had struck a secret deal to buy 2m doses of the vaccine despite the disagreement of many in his four-party coalition, prompting the resignation of at least six cabinet members. Critics said the deal cast doubt on the country’s allegiance to the west.
Only one other EU member has bought Sputnik V doses: Hungary, which has started using them. Austria is in talks to buy 1m doses, and autonomous regions in Italy and Spain have also sought to acquire shots.
The two-dose Sputnik V vaccine’s reported efficacy was initially greeted with scepticism after Russia approved its use in August last year without waiting for the results of full clinical trials, but based on the trial published in the Lancet it has almost 92% efficacy.
Germany and France have said they are open to using the shot if it is approved by the EMA, although the French foreign minister, Jean-Yves Le Drian, has described it as more “a means of propaganda and aggressive diplomacy” than a medical asset.
The EU’s vaccine programme has been dogged by an early shortage of doses, but the shortfall is expected to ease significantly with more than 300m doses of vaccines from four suppliers due to arrive in April, May and June.
The EMA has launched a rolling review of Sputnik V, which according to the Russian Direct Investment Fund (RDIF) has been approved for use in 58 countries. Russia has, however, struggled to produce enough Sputnik V to meet domestic demand.
Next week, the EU medicines regulator will investigate whether clinical trials of the vaccine met so-called “good clinical practice” standards after Russia said soldiers and state employees took part, with some reportedly saying they had been pressured to do so.