BRUSSELS, 4 Mar – RIA Novosti. The European Medicines Regulator – the European Medicines Agency EMA, which on Thursday announced the start of a rolling review procedure for the Russian vaccine against coronavirus Sputnik V, expects that the evaluation of the Russian drug will take place in a shorter time frame, but the drug approval dates are still cannot name, the regulator said in a statement.
“The EMA Human Medicines Committee CHMP has begun a gradual review of the Sputnik V (Gam-COVID-Vac) vaccine against COVID-19 developed by the Russian National Center for Epidemiology and Microbiology Gamaleya. The EU applicant for this drug is R-Pharm Germany GmbH. “, – said in a statement. The spread of the coronavirus
The document clarifies that the decision to start a gradual examination procedure was made “based on the results of laboratory and clinical trials. These studies show that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus, and can help protect against coronavirus “.
“The EMA will evaluate the data (on the Sputnik V vaccine) as they become available to decide whether the benefits of this drug outweigh the risks associated with it. an official application for a registration certificate “, – indicated in the EMA.
The regulator explained that the evaluation of the Russian vaccine will be carried out according to the usual EU standards to prove its effectiveness, safety and quality. “Although the EMA cannot predict the overall timing of the assessment, this process should take less time than usual as a gradual examination will be applied,” the statement said.