The country chaired by Vladimir Putin assured that it had made the request to the agency last January.
The European Medicines Agency has clarified this Wednesday that has not received to date an application for approval of the Russian vaccine against Covid-19. In this way, the regulatory body denies the Government of Vladimir Putin, which claimed that it had presented the petition last January.
In a statement, the agency explains that Russia has not sent a request either. to start continuous assessment antigen developed by the Gamaleya National Center for Epidemiology and Microbiology in Russia.
Although the regulatory body has not received the request for approval, yes he has provided advice to the developers of Sputnik V, providing them with “normative and scientific guidance”. An action that appears in the list published by the EMA on drugs and antigens that have received advice from the agency.
Likewise, the EMA has indicated that it is collaborating with the developers, “who have expressed their interest in having their vaccine considered for continuous evaluation.” This procedure allows the agency evaluate data as it becomes available and while vaccine development is ongoing.
“Continuous review is reserved for the most promising drugs and vaccines. The EMA Committee for Human Medicines (CHMP) and the Working Group on the pandemic must first give their consent before the manufacturer can send its request to start this process, ”the agency explained in the statement.
The EMA is committed to report “immediately” on the initiation of any new Covid-19 antigen or drug evaluation.