Slovak health ministry says Sputnik V doses tested in Hungary satisfactory

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Vials of the Sputnik V (Gam-COVID-Vac) vaccine are seen at the Del-Pest Central Hospital in Budapest, Hungary, February 12, 2021. Zoltan Balogh/MTI/MTVA/Pool via REUTERS

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PRAGUE, May 9 (Reuters) - A Slovakia health ministry spokeswoman said on Sunday a Hungarian lab has confirmed that the first batch of Russia’s Sputnik V COVID-19 vaccines sent to Slovakia were satisfactory and the government would discuss the next steps with Russia.

The tests were carried out in Hungary after Russia had requested additional tests in an EU-certified laboratory, saying the Slovaks had not tested them in such a facility. The Slovak government is considering whether to use the Russian shots in the country of 5.5 million that has been hit hard by the COVID-19 outbreak.

The Slovak health ministry's spokeswoman, Zuzana Eliasova, said on Sunday that Slovakia is now waiting for further test results from Russia, which are expected at the end of May.

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She did not provide details on what kind of tests were carried out in Hungary or how the results might address any data gaps raised by Slovakia's drug regulator.

Hungary's drug regulator said in April it would help Slovakia examine batches of Russian Sputnik V vaccines that Slovakia had received, and Slovak Health Minister Vladimir Lengvarsky said on Friday the tests were satisfactory.

"Yesterday we received by email from the Hungarian side the results of the tests, which are negative, they are alright," Lengvarsky told reporters on Friday. "In the next round we will communicate with our experts and mainly with the Russian side about the next development in this question.”

To date Russia has not won approval from the EU regulator, the European Medicines Agency, for Sputnik V. So far, Hungary is the only EU country to have begun inoculations with Sputnik V without waiting for EMA approval.

Peer-reviewed late-stage trial results published in The Lancet medical journal in February showed Sputnik V was almost 92% effective. read more

Russian's RDIF sovereign wealth fund, which markets the Sputnik V vaccine abroad, says the shot's safety and efficacy had been assessed by regulators in 61 countries that approved it for use. The Gamaleya Institute, the vaccine's developer, has said Sputnik V is 97.6% effective against COVID-19 in a "real-world" assessment based on data from 3.8 million people.

"Now the test run by Hungary's National Public Health Center in the EU-certified lab confirms that Sputnik V batch sent to Slovakia meets all safety and other requirements, debunking earlier incorrect Slovak statements to the contrary," a statement, shared on the vaccine's official Twitter account run by RDIF, said.

Slovakia received 200,000 doses in March, part of a deal for 2 million doses, a delivery that caused a political storm and led former Prime Minister Igor Matovic to resign. read more

The Slovak health ministry authorised the use of Sputnik V as an unregistered drug in March, but asked national drug agency SUKL to evaluate the vaccine before rolling out the so-far unused doses.

SUKL concluded that it could not determine the benefits and risks of Sputnik V due to gaps in the data provided by Moscow but said in an opinion in April that Sputnik V passed tests for sterility, clarity, colour, abnormal toxicity and other measures.

German Chancellor Angela Merkel said last month the EMA has not yet received sufficient information about Russia’s Sputnik V coronavirus vaccine to approve it but if approval does come soon, Germany will buy it. read more

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Reporting by Michael Kahn and Jan Lopatka Editing by Frances Kerry

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