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US donation: why Janssen and Moderna vaccines are not yet licensed in Argentina

2021-06-05T01:40:23.370Z


From the Ministry of Health they explain what happens with those two American vaccines that Joe Biden offers to donate.


Irene Hartmann

06/04/2021 18:18

  • Clarín.com

  • Society

Updated 06/04/2021 18:18

The response of

Sonia Tarragona

, Chief of Staff of the Ministry of Health of the Nation, was "it depends."

Clarín

had asked him if Argentina, in fact, could receive in the not-so-distant future any of the brands of vaccines against the coronavirus that are manufactured in the United States, within the framework of President Joe Biden's intention to distribute 6 million doses to Latin America through the Covax mechanism.

The question was for Moderna and Janssen ... and as we are, Pfizer.

"Depends. It depends what vaccine; It depends on which way ... it depends ”, Tarragona introduced before clarifying:“ Among Moderna, Janssen and Pfizer, the only one that has a registry in Argentina was Pfizer. We already tried for the Covax fund. It is complex because this mechanism has two instances: the optional purchase model and the committed purchase model. Both

include a contract

, even if it is free of charge ”.

From

Janssen

, the unit dose against Covid developed by Johnson & Johnson, Tarragona recalled that "conversations began with them at the same time as with Pfizer, but they were slower with their development and for now they have

not finished presenting the papers,

" in reference to the authorization request that the company made before the ANMAT half a year ago.

To be more precise, on December 4, 2020.

For a drug to have “full” approval, it must have

completed phase 3 of the trials

.

This is how the Janssen process is delayed and the delivery of documentation is “sequential”, using a common term in the industry.

As for Moderna, Tarragona suggested that until now there had been no interest in the Argentine market.

However, the official clarified that “

it is always a possibility

.

We are in negotiations with both Moderna and Janssen.

But everything has to have a regulatory body of the ANMAT ”, he emphasized.

On Moderna, Tarragona detailed some more points: “Last year they did not initially demonstrate ... we had no dialogue with them.

Apparently they

put their targets in Europe and the United States

, I don't know.

Now that we are in talks there could be a possibility, but the laboratory for now has not started an entry in the Argentine registry.

That is a strictly commercial decision ”.

Regarding the timing of a possible agreement with the United States, Tarragona clarified that "there is nothing official, nothing formal, although there are conversations between the foreign ministries to

organize meetings

, but there is nothing on the agenda with a date and time." Then he specified that "it could be in these days, tomorrow, this weekend, perhaps ..."

As for Pfizer, the issue is more complex, clarified, in a brief dialogue with this medium, the deputy of the interblock Together for Change Graciela Ocaña: "Even if it were a donation, who takes charge if an Argentine has problems with that drug? The issue is who supports. For this,

a legal framework

is given

, a contract in the nature of a donation

. Argentine law does not provide full indemnity, so again we would return to the same problem that caused the contract with Pfizer to be frustrated. The issue is that donation legal framework ”.

Although everything seems quite "green", it is a fact that if doses of American vaccines arrive it will be with the rules imposed by the Covax mechanism, it is a fund of 190 countries, among which is Argentina, made up of three main legs: the WHO , the GAVI-Vaccines Alliance (a body created in 2000, with the encouragement of the Bill and Melinda Gates Foundation) and CEPI, the acronym for

Coalition for Epidemic Preparedness Innovations

.

During the Donald Trump administration, the United States, completely alienated from the UN, had remained outside of imprints like this one.

The American collaboration with the Covax fund is one of the reasons for the worldwide expectation of the inauguration of Joe Biden.

$

Look also

Argentina in its labyrinth: the three missed chances of having the Pfizer vaccine, now for free

Efficacy and dosage: what is known about Covaxin, the Indian vaccine against Covid that the Province will buy

Source: clarin

All life articles on 2021-06-05

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