Slovakian Drug Institute Unable to Evaluate Sputnik V ‘Due to Lack of Data’

Slovakia, one of Europe’s hardest-hit countries by the pandemic, received 200,000 doses of the Russian vaccine on March 1 amid accusations of political maneuvering but has yet to start administering shots.

“On March 30 2021, the State Institute officially sent an evaluation report to the Health Ministry stating that it was not possible to decide on the risk-benefit balance of Sputnik V due to the lack of data from the manufacturer, inconsistencies in dosages and inability to compare batches used in various studies and countries,” the institute said in a statement.

The Russian Direct Investment Fund (RDIF), which has financed the development of the vaccine, did not immediately respond to a request to comment. Last month, the RDIF said in a statement that it had been approved after a “comprehensive assessment of the vaccine by experts in Slovakia.”

Slovakia’s State Institute for Drug Control has told the country’s Health Ministry it has been unable to evaluate the risks and benefits of Russia’s Sputnik V vaccine due to a lack of data and inconsistencies in dosages, the watchdog’s spokeswoman Magdaléna Jurkemíková told The Moscow Times on Wednesday.

The purchase of Sputnik V pushed Slovakia into a political crisis after coalition partners of ruling Prime Minister Igor Matovic accused him of orchestrating the deal without their approval. Matovic found himself at the center of another scandal after he joked in a radio interview about paying for Sputnik V shipments with Ukrainian territory.

On March 30, Matovic resigned, making Slovakia the first European government to collapse with so-called “vaccine diplomacy” as a catalyst. Slovakia’s Health Minister, who has since been replaced, granted the country’s original approval for Sputnik V March 1, before the political crisis erupted.

On Wednesday, Slovakia’s Health Minister Vladimir Lengvarsky said during a parliamentary meeting that a decision on whether or not to use Sputnik V will be taken early next week as the Health Ministry is waiting for a final recommendation from the State Institute for Drug Control. A positive response would make Slovakia the second EU country after Hungary to approve Sputnik V.

The delay is another blow to Russia’s ambitions to export the Sputnik V vaccine to the EU market. Russian officials have accused the EU of foot-dragging on the approval process for the vaccine, saying its regulators are delaying their review of the drug.

On Wednesday, the Financial Times reported that European Union’s medicines regulator will investigate whether the developers of Sputnik V went against global ethical and scientific standards in clinical trials.

Slovakia Receives First Shipment of Russia’s Sputnik V Vaccine

Slovakia on Monday received a first shipment of Russian vaccines as it battles the world’s highest Covid death rate, the second EU state after Hungary to receive the Sputnik doses.

“You can see behind me the first shipment of the two million Sputnik V vaccines,” Slovak Prime Minister Igor Matovic told reporters at a press conference at the airport in Kosice in eastern Slovakia.

Slovakia has shown growing interest in the Russian vaccine in recent weeks.

“It is right to buy the Russian vaccine as Covid-19 does not know anything about geopolitics,” he said in comments broadcast on Slovak television.

“I do not have a problem getting a Sputnik [jab] myself,” he said.

Health Minister Marek Krajci said he would sign a decree allowing the use of the Russian vaccines, which have not been authorized by the European Medicines Agency (EMA).

“It will take at least two weeks until we can begin the vaccination,” Krajci said.

Slovakia has seen an average of 22.66 Covid-related deaths per 100,000 inhabitants in the last 14 days, followed by neighboring Czech Republic with 20.51, according to an AFP tally.

The Czech Republic said on Sunday it too had put in an order for Sputnik vaccines and Austria has said it is in talks over the delivery and joint production of Sputnik.

Russia approved its vaccine last August ahead of large-scale clinical trials, sparking concerns over the fast-track procedure. But leading medical journal The Lancet this month published results showing the jab to be safe and over 90% effective.

The Russian Direct Investment Fund, which helped finance the development of Sputnik V, has said that more than 35 countries have registered it. Rather than exporting the vaccine in bulk, Moscow hopes to agree production partnerships with local factories.

Brazil, India, Kazakhstan and South Korea have begun producing Sputnik V, though not all of them have made it available to the public yet.

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