EU regulator expects to evaluate Sputnik V vaccine in a shorter time frame
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 has begun a gradual review of the Sputnik V 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 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 may 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”, – indicated in the EMA.
The regulator explained that the assessment 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.
EU regulator expects to evaluate Sputnik V vaccine in a shorter time frame