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06Oct21


Gamaleya Center modifying ways of evaluating Sputnik V for EMA certification, says expert


The developers of Russiaís Sputnik V vaccine are changing the methods of the jabís evaluation in order to facilitate its certification by the European Medicines Agency (EMA), Acting General Director of the Scientific Center for Expertise of Medicinal Products of the Ministry of Health of the Russian Federation Valentina Kosenko reported on Tuesday.

"Nowadays, when the certification of Sputnik V is underway at the European [Medicines] Agency, some methods are still used in the Russian Federation in evaluating medicines that are not accepted by various countries more developed in terms of pharmaceuticals and, in particular, in Europe. So, the developers of Sputnik V are currently working on replacing those in vitro methods conducted on animals," she said at the BioTechMed forum.

Sputnik V has not yet obtained the EMAís green light for use on the territory of the EU. The position of the European Commission with the regards to this Russian vaccine has remained the same since EU COVID certificates were introduced in early July. EU member states that use Sputnik V (for example, Hungary) have the right to issue European digital vaccination certificates to people inoculated with it but itís up to other EU countries to decide on recognizing these certificates.

Sputnik V was registered in Russia on August 11, 2020, becoming the first officially certified vaccine against coronavirus worldwide.

[Source: Tass, Gelendzhik, 05Oct21]

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