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How will the approval of the Russian vaccine Sputnik V against the coronavirus be in Argentina

2020-12-11T07:59:16.412Z


ANMAT officials will travel to Russia this Saturday to carry out the technical verification of the plants.


Vanesa Lopez

12/10/2020 15:00

  • Clarín.com

  • Society

Updated 12/10/2020 3:00 PM

President Alberto Fernández announced this Thursday that Argentina signed an agreement with Russia for the arrival of the

Sputnik V

vaccine

against the coronavirus in the country.

In that sense, he confirmed that before the end of the year

600 thousand doses will arrive

, which will allow 300 thousand people to be vaccinated.

In addition, between January and February another 20 million doses will arrive.

"We are working so that the vaccine has the definitive authorization of our control body, which is the ANMAT," said the president during the press conference.

"To this end,

officials of the National Government and ANMAT officials

are traveling next week

to be able to

'in situ'

verify all the doubts that have to be raised regarding the production conditions and the quality of the vaccine," he continued Fernandez.

In a statement, the ANMAT detailed that the officials

will travel

to the Russian Federation

this Saturday

.

From Monday to Friday of next week they will visit the plants of the Gamleya Institute -developer of the Sputnik V vaccine- and of Generium, which is part of its production process.

During the visits, the

technical verification of the establishments

and the manufacturing processes used in the products will be carried out.

"This action is part of the functions of this National Administration and the strengthening of bilateral relations that are being established with the Russian Federation in the areas of quality, efficacy and safety of medicines," the statement closed.

The supply for Argentina will be facilitated by RDIF's international partners in India, China and South Korea.

Photo Bloomberg.

During the announcement, the national Health Minister, Ginés González García, stated that "the only vaccine that has been approved in the world with

emergency approval

is the one made by the United Kingdom a few days ago."

“I believe that this week, or this month, there

will be several of that type

.

And we are going to work improving the times that this takes, with this technical team that is going directly to Russia ”, the minister completed.

According to what is published on the ANMAT website, our country has the possibility of

authorizing vaccines in case of emergencies

or special sanitary conditions.

The agency indicates that, in these cases, "they

may be authorized in

accordance with the specific procedure established by this Administration in order to assess the risk / benefit conditions for the availability of this vaccine within the framework of the strategy established by our country."

More than 50 countries made requests to obtain more than 1,200 million doses of the Sputnik V vaccine. Photo Reuters.

At the press conference, the president explained that "

the documentation has been arriving

for a long time and we have been in contact with Russia for a long time" and added that "this procedure is being done by AstraZeneca, Pfizer is doing it, everyone is doing it."

“What we did and are going to do now is that ANMAT technicians can go 'in situ' and see exactly all the research development.

See where it is produced, how it is produced.

What the ANMAT technically has to know to be

able to approve a vaccine

”, completed Fernández.

He added that Russia has its own operating and approval rules for these types of products, which

do not exactly match

those of the West.

"So what we try to see is

how we make it compatible,

" he said.

“The information is.

You have to go looking for it, you have to go and verify it, and what ANMAT must give us is certainty that what we are buying is the quality that Argentines can receive, "Fernández closed, and insisted that" the information is already being received for a long time".

The Russian Sputnik V vaccine showed 42 days after the first dose an efficacy of more than 95%.

AFP photo.

For its part, the Russian Direct Investment Fund (RDIF) highlighted in a statement that "the vaccine will allow Argentina to have a diversified portfolio of vaccines against the coronavirus."

The RDIF detailed that the supply for Argentina will be facilitated by the RDIF's international partners in

India, China and South Korea

, among other countries.

As reported by the RDIF, its differential factor lies in the use of

two different vectors

, based on human adenovirus, which makes it possible to generate a stronger and more durable immune response than vaccines that use a single vector for both doses.

Preliminary data obtained from volunteers, 42 days after they received the first dose (equivalent to 21 days after receiving the second dose), when they had generated a stable immune response, indicate an efficacy greater than 95%.

Requests for

more than 1.2 billion doses

of the Sputnik V vaccine were received from more than 50 countries.

Vaccine supplies for the global market will be produced by RDIF's international partners in India, Brazil, China, South Korea, and other countries.

DD

Source: clarin

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