Russian Sputnik V vaccine under scrutiny by European institutions. European Commission and European Medicines Agency, new reviews.

Following the announcement of the differences between the batches of Russian Sputnik V vaccine delivered to Slovakia and those examined by the European Medicines Agency (EMA), USRPLUS MEP Vlad Gheorghe has called on the European institutions to intervene to have the serum produced by the Russian Direct Investment Fund re-examined. The request comes after the Russian manufacturer insisted on the return of doses.  The reason is that the Slovak State Institute for Drug Control have spotted a different composition from those sent by Russia to EMA and the scientific journal Lancet.

In an official letter the MEP calls for a European investigation into the Sputnik V vaccine doses received by Slovakia. The letter is addressed to the European Commissioner for Health and Food Safety, Stella Kyriakides, EMA Executive Director Emer Cooke and Slovak Health Minister Vladimír Lengvarský. He invokes the EU’s regulatory powers alongside national health authorities. They need to guarantee European citizens that they receive only safe and scientifically tested vaccines. The MEP justifies the need for European intervention by the fact that the Slovak authorities have not been able to carry out a full examination. The Russian side refused to provide the necessary documents on the safety of the serum.

Vlad Gheorghe, lawyer, considers the case of the Russian serum in Slovakia a “precedent that requires maximum attention from the European Medicines Agency”. He is warning of an alarming situation that could pose a direct risk to public health in the Member States. This is especially dangerous as it comes at a sensitive time in the fight against COVID-19. It could jeopardise  citizens’ trust in EU and national authorities.

The USRPLUS MEP explicitly cites unfair trade practices in the case of Russia. He speaks of the deliberate undermining of the European Union’s common position on vaccination against the new coronavirus.

“Only 4.3% of the Russian population has so far been vaccinated with Sputnik V, the only serum available for immunisation against Covid19 in this country”, Vlad Gheorghe points out in the context of Russia’s aggressive strategy to promote the export of the serum to European Member States and beyond.

The scandal in Slovakia comes after the EMA confirmed on 7 April that it was reviewing how tests for the Sputnik V vaccine were carried out. It is already in the process of ongoing evaluation. The Russian vaccine is not authorised in the European Union. But it is present in 59 countries and will be produced including in Italy, following an agreement. Germany recently announced that it is waiting for European authorisation of the Russian serum before buying 2.5 million doses. Of the EU countries, only Hungary has used Sputnik V vaccine, as well as the Chinese Sinopharm serum.  Neither is declared safe by the relevant European authority.

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