Russia has not yet asked EU for COVID-19 vaccine approval
The agency headquartered in Amsterdam said 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."
EMA is in dialogue and collaborating with the company to define the next steps. The developers have expressed their interest that the vaccine be considered for a rolling review.
This ad-hoc procedure can only be used during emergencies such as the current pandemic. It allows EMA to assess data on a vaccine or a medicine as they become available, while the development is still ongoing.
The formal marketing authorisation procedure can then take place in a very short timeframe. Rolling review is reserved for the most promising medicines and vaccines. EMA’s Human Medicines Committee (CHMP) and the COVID-19 EMA pandemic Task Force (COVID-ETF) need to give their agreement first before developers can submit their application for initiation of the rolling review process.
EMA will promptly inform the public of any new assessments of COVID-19 vaccines or medicines started by the Agency. EMA always publishes a news announcement when, following agreement by CHMP and COVID-ETF, an application for rolling review is received from the developers and the assessment starts.
Similarly, EMA publishes a news announcement when it receives a valid application for marketing authorisation. The list of treatments and vaccines for COVID-19 under evaluation is updated in parallel to the publication. This means that if EMA has not communicated, the status of a given COVID-19 medicine/vaccine remains unchanged.
Russia's state-run news agency RIA Novosti reported earlier this week that the European Union has approved Russia’s application to register its Sputnik V coronavirus vaccine in the bloc. It also said The EMA had concluded its scientific opinion procedure for the vaccine on 19 January.
The Russian Fund for Direct Investments (RFPI), which has financed the development of the Spútnik V and is responsible for its distribution to the countries of the world that have requested it, has clarified that, on 19 January, they presented a request for a “Scientific consultation on the vaccine” and, on 29 January, another request for the registration of the drug.
According to the RFPI statement, which was referred to here but we were unable to find on the RFPI website, “this procedure marked the beginning of the process of sending information to the EMA to undertake continuous review”.
"The Fund has at its disposal an official confirmation from EMA that the application has been accepted and must proceed to its evaluation," the RFPI reportedly said.
Kirill Dmitriev, general director of the RFPI, says he is confident “that the EMA will decide quickly and without politicization”. According to his calculations, the Russian vaccine could already be approved for use in the EU by early March. Dmitriev, however, has warned in statements to the Russian publication RBC that, until at least the end of April, when vaccination in Russia is supposed to be well advanced, “we will not be able to send the doses of Sputnik V to Europe” .
The European Union is open to buying COVID-19 vaccines developed in China and Russia if the jabs meet certain criteria, the European Commission’s spokesperson confirmed on Monday.
Besides clinically proven efficiency and safety, the bloc requires vaccines producers to fit into “the right budget” and “to have right production capacities in the territory of the EU so that they could supply more quickly to EU citizens”, Stefan De Keersmaecker said at the European Commission’s daily press briefing.
“If companies feel they can meet these criteria, they can get in touch with the European Commission”, the spokesperson for health added.
Cover photo: Getty Images
