HALMED Confirms News That EMA Starts Review of Sputnik V

By 4 March 2021
HALMED Confirms News That EMA Starts Review of Sputnik V
© HZJZ - Hrvatski zavod za javno zdravstvo

ZAGREB, 4 March, 2021 - Croatia's Agency for Medicinal Products and Medical Services (HALMED) reported on Thursday that the European Union's vaccine watchdog had started a review of the Russian-made Sputnik V COVID-19 vaccine.

HALMED recalls that Sputnik V jab was developed by the Russian Gamaleya Research Institute of Epidemiology and Microbiology.

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

The Russian vaccine has been deployed in 40 countries worldwide, including European nations Serbia, Montenegro, Moldova, and Hungary. Slovakia received its first shipment of 200,000 doses over the weekend, the Euronews said on its website.

The EMA has so far approved three vaccines for use across the bloc. These were developed by Pfizer/BioNTech, AstraZeneca/Oxford University, and Moderna. It is currently evaluating the jab by Johnson & Johnson and is expected to give its approval in mid-March.

On Wednesday, Croatian Health Minister Vili Beroš said he had held talks with a Russian delegation on Tuesday on Sputnik V vaccines.

He said that during the meeting he had called for expediting the delivery of documentation on the Russian COVID-19 vaccine so that Croatia's HALMED regulator could evaluate the vaccine's safety and efficiency.