Until now, there has been no formal request from the developers of the Russian Sputnik V vaccine against coronavirus (Gam-COVID-Vac) to begin either a rolling review or a marketing authorization process, the European Medicines Agency (EMA) said on Wednesday.
According to a statement from an EU agency based in The Hague
despite allegations made several times, the Russian vaccine developer did not apply for the placing on the EU market of a vaccine against the coronavirus.
The agency, which acts as the EU’s pharmacovigilance authority, reported that developers had so far received scientific advice from the EMA, providing them with the latest regulatory and scientific guidance for vaccine development. It was also reported that Russian developers have expressed the need to initiate an ongoing review process of their coronavirus vaccine. However, the EMA emphasized that the ongoing review procedure is reserved for the most promising medicines and vaccines. The consent of the EMA’s Committee for Medicinal Products for Human Use (CHMP) and the Working Group on Coronavirus Pandemic Influenza (Covid-ETF) is required for developers to apply for a review procedure.
It was noted that the EMA will always publish a notice when the agency receives a request from Iran for ongoing review by the developers and the evaluation begins. It shall likewise publish if the Agency has received a formal application for marketing.
The Russian Direct Investment Fund (RFPI), which finances the development of Russian vaccines, announced on Tuesday that it had submitted an application for registration of the Sputnik V vaccine against Covid-19 disease to the European Medicines Agency (EMA).
“On January 29, 2021, the RFPI applied for the registration of the Sputnik V vaccine in the European Union and initiated the transfer of information to the EMA through the rolling review process.”
– states the statement of the Russian Sovereign Fund.
The European Commission has previously announced that the European Medicines Agency is in preliminary negotiations with the manufacturer of the Russian coronavirus vaccine, Sputnik V, but the Russian company has not yet decided to apply for EU approval.
(MTI)
