Croatia’s drug regulator confirms that EMA has started review of Sputnik V

NEWS 04.03.2021 14:42
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Cjepivo Sputnik V
Source: Dmitry KURAKIN / Russia's Health Ministry / AFP

European Union's vaccine watchdog EMA started a review of the Russian-made Sputnik V coronavirus vaccine, Croatia's drug regulator Halmed reported on Thursday.

The European Medicines Agency (EMA) said on Thursday that the ongoing review is based on results from laboratory studies and clinical studies in adults.

The Russian vaccine has so far been distributed in 40 countries worldwide, and in Europe these include Serbia, Montenegro, Moldova, and Hungary. Slovakia received its first shipment of 200,000 doses this weekend, Euronews reported.

The EMA, which is the central agency approving drugs for all 27 EU countries, has so far approved three vaccines for use across the bloc – Pfizer, AstraZeneca, and Moderna. It is currently in the process of evaluating the vaccine developed by Johnson & Johnson, which is expected to get approval in mid-March.

Individual EU countries can still independently approve and use other vaccines, and Croatian health authorities are increasingly talking about importing Sputnik V, after deliveries of the three EU-approved vaccines have been delayed, which hampered the vaccination effort in the country.

On Wednesday, Croatian Health Minister, Vili Beros, said he had held talks with a Russian delegation on Tuesday on acquiring the Sputnik V vaccine. After the meeting, he said he had asked Russian officials to expedite documentation on Sputnik V so that Croatia’s Halmed could evaluate its safety and efficiency before okaying its use in Croatia.

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