The homologation of Sputnik V in Europe is delayed and this complicates the movements of Argentines



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The approval of the Sputnik V anticovid-19 vaccine in Europe, which would allow Argentines inoculated with the Russian formula to travel to this continent, is still unknown. Although it turned out that the Gamaleya Institute of Russia was late in submitting the data requested by the European Medicines Agency (EMA) from Moscow has denied it and thinks the green light will come in “two months”.

“It is the prerogative of the EMA to decide the timing of the procedure, but the Sputnik V team hopes that the vaccine will be registered in two months“The Russian Direct Investment Fund (RDIF) said in the last hours.

The Russian fund also referred to transcendent critiques: “These speculations have nothing to do with reality and slow down the registration process. The RDIF and the Gamaleya Center continue to collaborate with the EMA in the framework of the continuous review of the authorization dossier, a procedure which provides for a progressive presentation on demand of the documentation “.

The Sputnik V vaccine is undergoing continuous evaluation at the EMA March 4 and there is still no set timetable on when the Gamaleya Center will be able to apply for a license for use in the European Union (EU).

The European regulator analyzes in real time the data shared by the manufacturer, but this process, intended to accelerate the study of a possible license in the future, does not reduce approval requirements vaccine.

The EMA also warned that it would carry out “a inspection of good clinical practices“in Russia on the way in which the tests were carried out on the volunteers, in order to determine whether the appropriate procedures were followed at the scientific and ethical level.

Meanwhile, more and more countries – even European ones – approve of the use of Sputnik V, beyond the doubts of the old continent. A week ago, Slovakia became the second EU country to use the Russian vaccine behind Hungary.

Germany has also started negotiations to have the formula, although Angela Merkel’s government has assured that the agreement will be submitted to the EMA for approval.

In ArgentinaIn addition to this, you need to know more about it.

Argentina, of course, was pioneer in Latin America and imported the first doses at the end of December, at the start of the national vaccination plan. Indeed, the country has already received 20,677,145 vaccines, of which 9,415,745 correspond to Sputnik V (almost 50%). And of that, 7,875,585 doses are from component one and 1,540,160 from component two.

However, Argentines vaccinated with the Russian formula still cannot travel to EU countries, which, among other requirements, requires that visitors have received, at least 14 days before boarding, the two doses of one of the vaccines approved by the EMA.

LGP

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