Despite reports to the contrary, the European Medicines Agency (EMA) has so far not received a request for an ongoing review of the Russian Sputnik vaccine, the EMA said, refuting yesterday’s Russian announcement.

The Russian Fund for Direct Investment (RFPI) has requested the European Medicines Agency (EMA) to register the vaccine against the coronavirus Sputnik V, the MTI in Moscow reported on Tuesday. On this basis, in addition to submitting the request, the transfer of information to the EMA was initiated through a continuous review procedure. However, the EMA issued a statement on Wednesday afternoon saying that all of this was not true.

To date, the European Medicines Agency has not received any request for the ongoing review or marketing authorization of the vaccine developed by the Gamaleya National Center for Epidemiology and Microbiology in Russia, the Sputnik V (Gam-COVID- Vac).

writes EMA. They add that the developers have received scientific advice from the agency, providing them with the latest regulatory and scientific guidance for vaccine development. However, this is still not the same as the ongoing review process. The EMA will immediately inform the public of any new evaluation of Covid-19 vaccines or drugs initiated by the Agency.

Sputnik vaccination will begin in Hungary this week, after the Hungarian authorities, the only ones in the EU, have approved its use.



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