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Agenzia Italiana del Farmaco
Clarification on Sputnik V vaccine in the EU approval process - Clarification on Sputnik V vaccine in the EU approval process
Clarification on Sputnik V vaccine in the EU approval process
The European Medicines Agency has to date not received an application for a rolling review or a marketing authorisation for the vaccine developed by the Gamaleya National Centre of Epidemiology and Microbiology in Russia, the Sputnik V vaccine (Gam-COVID-Vac), despite reports stating the opposite.
The developers have received scientific advice from EMA providing them with the latest regulatory and scientific guidance for the development of their vaccine. In line with the Agency’s transparency policy, the vaccine is included in the list of COVID-19 medicines and vaccines that have received scientific advice from the Agency.
Published on: 10 February 2021
