EU has not received an order to market Covid-19’s Sputnik V vaccine, says von der Leyen – World


The President of the European Commission said on Wednesday that, to date, no application for marketing authorization for the Russian vaccine Sputnik V against covid-19 has been received in the European Union.

Asked about this vaccine developed by Russia, during a press conference in Brussels, Ursula von der Leyen noted that she frequently reads articles about what would happen “if” an application was filed for marketing it in the community space, but stated that “it is not that’s the case “.

“It may change, but so far, at the time we speak, they have not applied for conditional market authorization,” he stressed.

The president of the community executive immediately added that, “if they do, then they will have to present the entire data set and subject themselves to the entire scrutiny process, like any vaccine”, with yet another issue to guard against, that of verification of the production process.

“Since they are not producing [esta vacina] in Europe, an inspection process at production sites would obviously be necessary. Because, as we now know, a crucial issue is to have a stable and high quality production process “, he declared.

Von der Leyen also left a question in the air: “why is Russia, in theory, offering millions and millions of doses [da Sputnik V], but you are not making enough progress in vaccinating your population? “

Just a week ago, the European Medicines Agency (EMA) had already indicated that it had not received any request for monitoring or authorization of the Russian covid-19 vaccine, Sputnik V, and only gave “scientific advice” to the drug.

“EMA has so far not received any request for continuous review or marketing authorization for the vaccine developed by the National Center for Epidemiology and Microbiology Gamaleya in Russia, the Sputnik V vaccine, despite some news claims to the contrary”, clarified the European regulator in a statement.

The agency stressed that “the breeders have received scientific advice from EMA, providing them with the latest regulatory and scientific guidance for the development of their vaccine”.

And for that reason, “the vaccine is included in the list of drugs and vaccines against covid-19 that have received scientific advice from the agency”, not as having been approved, explains the EMA.

Countries like Hungary or the Czech Republic are already available to use Sputnik V, with an efficiency of over 90%.


Source: Correio da Manhã by www.cmjornal.pt.

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