Inspectors of the European Medicines Agency (EMA) came to Russia, to familiarize themselves with the production and results of clinical trials of the coronavirus drug Sputnik V, Swedish government vaccine coordinator Rickard Bergstrom told SVT on April 26.
“These are inspectors from three different countries. This is part of the approval process. Not only verification of production, but also verification of clinical trials, “TASS quoted Bergstrom.
The Minister of Health of the Russian Federation said that EMA experts have completed the first stage of examination of the Sputnik V coronavirus vaccine in Russia and are preparing for inspection of production sites.
“We have completed the first stage…, we are waiting for reports and are preparing for inspection at production sites. We are actively working on this issue, “TASS quoted Murashko as saying at a meeting of the Council of Legislators at the Federal Assembly.
If the Russian drug is approved, it can be delivered to Sweden in June. According to Bergstrom, negotiations are underway with the Swedish company on the production of vaccines in the kingdom.
“But in the first three to six months, the vaccine will come from Russia, and there are not so many capacities,” he explained.
On March 4, the Committee on Medicines for Medical Use of the European Medicines Agency (EMA) started a sequential examination of the registration dossier (rolling review) of the Russian coronavirus vaccine Sputnik V.
