Slovakia approves Russian vaccine, defying its own regulator

The Slovak government approved on Wednesday the use of Russia’s Sputnik V vaccine starting in the first week in June, making it the second EU country after Hungary to deploy the jab.

The decision, passed by the cabinet, contradicts the judgment of the country’s own drugs regulator. Sputnik has also not been approved yet by the European Medicines Agency (EMA), where it’s under rolling review.

In announcing the decision, Health Minister Vladimír Lengvarský said he wouldn’t allow himself to be vaccinated by Sputnik and wouldn’t recommend it to others.

The approval is a rare bright spot for Sputnik, which has been hit with several setbacks recently. Like the Slovak drug regulator, Brazil also rejected the vaccine on grounds it didn’t find sufficient documentation, and charged that the doses delivered didn’t match those supplied elsewhere.

The wrangling over the jab in Slovakia began in early March, when then-Prime Minister Igor Matovič purchased 2 million doses without consulting his cabinet. As a result of the ensuing uproar, he was forced to resign and switch posts with then-Finance Minister Eduard Heger.

But Matovič kept up the fight, charging that the Slovak labs that had carried out the analysis weren’t properly accredited. He then had the vaccine analyzed by a Hungarian lab, which rubber-stamped it.

Lengvarský said that the cabinet’s approval applies only the 200,000 Sputnik doses that had already been delivered. Additional batches will be purchased only under European rules and after EMA approval, he stressed.

Economy Minister Richard Sulík, meanwhile, suggested take-up will be slow, telling journalists that “the problem will be to use all of these doses.”

Another problem might be liability. The contract that Matovič signed stipulates that the buyer, Slovakia, is responsible for all defects and negative side effects caused by the vaccine.

Slovaks will be given the choice of using Sputnik or another vaccine, but those who choose it may have trouble traveling in Europe this summer. Under a compromise on EU travel rules that’s close to final approval, countries have the right to exclude from the scheme vaccines that don’t have EMA approval.