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The approval of Sputnik V in Europe is delayed and that complicates the trips of Argentines

2021-06-19T19:48:11.878Z

From Moscow they expect the Russian formula to have the approval of the EMA in about two months. 06/16/2021 2:47 PM Clarín.com Society Updated 06/16/2021 2:47 PM The approval of the anticovid-19 Sputnik V vaccine in Europe, which would allow Argentines inoculated with the Russian formula to travel to that continent, is still unknown . Although it turned out that the Gamaleya Institute of Russia had been delayed in presenting the data requested by theEuropean Medicines Agency (EMA), from Mos



06/16/2021 2:47 PM

  • Clarín.com

  • Society

Updated 06/16/2021 2:47 PM

The approval of the anticovid-19 Sputnik V vaccine in Europe, which would allow Argentines inoculated with the Russian formula to travel to that continent,

is still unknown

.

Although it turned out that the Gamaleya Institute of Russia had been delayed in presenting the data requested by the

European Medicines Agency

(EMA), from Moscow denied it and believe that the go-ahead will come within "two months."

"It is the prerogative of the EMA to decide on the timing of the procedure, but the Sputnik V team expects the vaccine to receive registration

in two months,

" the Russian Direct Investment Fund (RDIF) said in the last hours.

The Russian fund also referred to transcendent critics: "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 file, a procedure that foresees a

gradual presentation and demand

of the documentation ".


The Sputnik V vaccine is in a continuous evaluation process at the EMA

since March 4

and there is still no defined timetable on when the Gamaleya Center will be able to apply for a license for use in the European Union (EU).

With the recent authorization in Brazil, Sputnik V is now in 67 countries.

pic.twitter.com/LcY6W6l5BC

- Sputnik V (@sputnikvaccine) June 5, 2021

The European regulator is analyzing in real time the data shared by the manufacturer, but this process, intended to speed up the study of a possible license in the future,

does not reduce the requirements for approval

 of the vaccine.

The EMA also warned that it will carry out "an

inspection of good clinical practice

" in Russia on the way in which the tests were carried out on the volunteers, to determine if the appropriate procedures were followed on a scientific and ethical level.

Meanwhile, more and more countries - even European - approve 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 also began negotiations to have the formula, although the government of Angela Merkel assured that the agreement will be subject to the endorsement of the EMA.

In Argentina


Argentina, of course, was a

pioneer in Latin America

and imported the first doses at the end of December, at the beginning of the national vaccination plan.

In fact, the country has already received 20,677,145 vaccines, of which 9,415,745 correspond to Sputnik V (almost 50%).

And of that figure, 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 visitors to have received, at least 14 days before boarding, the two doses of

any of the vaccines approved by the EMA

.

LGP


Look also

Coronavirus cases fell 12% worldwide in the last week

Moscow orders mandatory vaccination due to “dramatic” advance of coronavirus

Source: clarin

All life articles on 2021-06-19

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