No expert stance on Sputnik vaccine due to lack of data

No expert stance on Sputnik vaccine due to lack of data

The Slovak State Institute for Drugs Control cannot adopt an expert stance on the ratio of benefits and risks surrounding the Sputnik V vaccine without sufficient evidence, and it is missing such evidence due to incomplete data from the manufacturer and the inconsistency of individual batches, its spokesperson Magdalena Jurkemiková stated on Tuesday. The Institute compared its data with that submitted by the manufacturer to the European Medicines Agency (EMA) which evaluates the existing data on Sputnik V, and the Slovak side concluded that the doses imported to Slovakia have a different pharmaceutical form than the vaccine submitted for the so called "rolling review" to the EMA. The Institute also wanted to compare its data with that from Hungary where Sputnik V has been used for a while but the Hungarian Medicines Agency did not give access to such data citing a confidentiality clause in the contract with the Russian side.

Former Prime Minister Igor Matovič decided to buy 2 million doses of Russian made Sputnik V vaccine, with the first 200,000 doses landing in Slovakia in March. The vaccine, which is not registered in the European Union at the moment, was stored at a pharmaceutical company in Eastern Slovakia while the Slovak State Institute for Drugs Control was tasked with issuing an expert stance that would serve as the basis for the Health Ministry to allow the vaccine to be used in Slovakia, based on a special permission for those who explicitly want to get this jab. The purchase of the Sputnik V vaccine was the last straw that led to the fall of Matovič's Government last week.

Anca Dragu, Photo: TASR