Filenews 16 June 2021
The European Union's approval of the Russian Sputnik V vaccine against covid will be delayed after the June 10 deadline, two people familiar with the matter said, limiting the prospects of the Russian formulation joining the European vaccination campaign.
A German government official, one of the sources, said the fact that the European Medicines Agency (EMA) has not received the necessary data from clinical trials of the vaccine has postponed its approval until at least September.
"An approval of Sputnik will probably be delayed until September, perhaps until the end of the year," the official, who was not named, said.
A second source said that the June 10 deadline had passed and that the EMA had given Russia's Gamaleya Institute another week to submit the required data accompanying each vaccine approved by the European regulator.
The Russian Direct Investment Fund (RDIF) responsible for the commercial exploitation of the vaccine announced that the evaluation of Sputnik V is ongoing.
All information on the clinical trials of the Sputnik V vaccine has been provided and the GCP (General Clinical Practice) evaluation has been completed with a positive evaluation by the EMA, the RDIF announced.
'Although it is at the discretion of the EMA to decide the time of approval, the Sputnik V team of experts expects approval within the next two months.' The EMA has not commented on information and announcements.
Slovakia is the second post-Hungary country in the European Union to begin vaccinations with Sputnik V this month, despite the lack of EMA approval.
Initially, the EMA was due to approve the Russian vaccine in May or June if the conditions required by European authorities were met.
Source: RES-BE
