The first stage of obtaining permission for the emergency use of the Russian Sputnik V coronavirus vaccine in the European Union is scheduled for January 19. This was announced on Wednesday, January 13, by the head of the Russian Direct Investment Fund (RDIF) Kirill Dmitriev.
“This is a so-called scientific review. An application for an emergency use authorization (EUA) for the Sputnik V vaccine was filed by RDIF on December 22, “he said in a conversation with TASS.
Dmitriev added that the registration process for the Russian drug with the European Medicines Agency (EMA) was launched at the end of October.
On the eve of the official representative of the European Commission Stefan De Keersmaker said that the manufacturer of “Sputnik V” did not request certification of the drug to enter the EU market, but is in contact with EMA.
Earlier, on January 8, the head of the European Commission Ursula von der Leyen, answering a question about the possibility of purchasing the Russian vaccine Sputnik V, said that the EU countries can buy vaccines against coronavirus only through European negotiations.
On January 6, it was reported that the production of vaccines against coronavirus in the European Union, including the Russian drug Sputnik V, is theoretically possible only if certified by the European Medicines Agency. This was stated by the deputy official representative of the German government Ulrike Demmer. At the same time, she could not clarify whether such a request had been received by EMA from Russia, and recommended to contact there directly.
The Sputnik V drug, which was developed at the Gamaleya Center, became the world’s first vaccine against coronavirus. It was registered on August 11. Its final efficiency was 91.4%, in severe cases – 100%.
The drug has already started arriving abroad. Thus, the first samples of “Sputnik V” arrived in Hungary on November 19. The country became the first in the EU to receive this vaccine for clinical trials. The delivery of samples was organized with the support of the Russian Direct Investment Fund (RDIF).