Gamaleya Center changes methods of evaluation of the Sputnik V vaccine for registration with the EMA


The developers of the vaccine against coronavirus infection “Sputnik V” are to change the methods of evaluating the drug, expecting that it will contribute to the drug’s easier registration with the European Medicines Agency (EMA). This is reported by TASS with reference to Valentina Kosenko, the acting Director General of the Federal State Budgetary Institution “Research Center for the Examination of Medical Products” of the Ministry of Health of the Russian Federation.

“Today, when Sputnik V is being registered with the European Medicines Agency, some methods still used in Russia to assess the quality of medicines are not accepted in various more developed pharmaceutical countries and, in particular, in Europe. So the developers of Sputnik V are currently working to replace animal-based methods with in vitro methods,” Kosenko said during the BiotechMed forum.

The EMA has not yet allowed the use of Sputnik V in the European Union. The position of the European Commission regarding the Russian vaccine has remained unchanged since the beginning of July, when the EU COVID-19 certificate system was launched. The EC states using Sputnik V (for example, Hungary) have the right to issue European digital vaccination certificates for it, but the rest of the EU countries determine at their own discretion whether to accept such documents.

Sputnik V was registered in Russia on August 11, 2020. It became the world’s first officially registered COVID-19 vaccine.

The head of the Ministry of Health of the Russian Federation earlier announced the removal of all barriers to the recognition of Sputnik V in the WHO.

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