why the most sought-after vaccine in the US today is not approved in Argentina

The possibility of the United States preventing From November the income of people vaccinated with Sputnik V It accelerated the concern of a part of the Argentines who took out a plane ticket to fly to that country in the remaining period and access the simplest safe-conduct: a dose of Johnson & Johnson as an immune passport.

This vaccine, which in the emergency room has become more precious because it consists of a single dose and does not require a long stay in the destination country to wait for the second application, still is not authorized in Argentina. The laboratory made its first presentation at ANMAT in December 2020, two days after Pfizer, and is still waiting for the go-ahead.

Almost ten months have passed. Clarion investigated the subject to try to understand why two vaccines presented at the same time have had a difference so wide in the approval deadlines. It should be remembered that Pfizer was the first vaccine to be licensed in Argentina, when the possibility of signing a contract in 2020 was still viable. Then everything got complicated.

A first data, which sources from the pharmaceutical industry explained to Clarion, is that “Pfizer began phase 3 of its clinical trial in March 2020, while Johnson & Johnson began it several months later.” This, according to this argument, resulted in the fact that when the first laboratory presented its request for approval in ANMAT, it already had all the documentation that the regulatory body required.

The Johnson & Johnson case was different. The clinical trial began in September 2020 globally and in November in Argentina. When he made his first presentation at ANMAT he still had several issues to be defined. Between them, what would the plant be to produce the vaccines that would bring to Argentina. Although the data is not official, it would be the one you have in South Africa.

All eyes are on Joe Biden’s impending decision. Photo: AP

In this way, the owner of one of the two unit-dose vaccines on the market (the other is Cansino) was presenting the required papers over the months, to satisfy the requests of the Argentine State. That stage, as he learned Clarion, concluded in July. Since then there have been no requests for new information from ANMAT. The laboratory awaits the approval or disapproval.

On occasions prior to July, the health entity had explained to Clarion that, indeed, the laboratory was “In the process of adding information”. The last consultation that deserved that response had been made on May 4. Clarion he consulted the ANMAT about it again this week. His spokesmen did not reply. In the world, at least 53 countries already use it.

The question then returns: why did Pfizer, with all the papers filed at once, have to wait one week for its vaccine to be approved in the country and Johnson & Johnson, which ended the bureaucracy 60 days ago, still has no answer? There the current context of the pandemic and the market for vaccines against Covid would come into play. It’s not the same today than December.

Argentina currently has contracts with AstraZeneca, Sputnik V, Sinopharm, Cansino, Pfizer and Moderna. One of the questions one might ask is why the Government decided to rush a contract for the Chinese unit dose vaccines of Cansino, which as Sputnik V does not have WHO approval, and does not do so with Johnson & Johnson, which does. But that would be the subject of another article.

Many Argentines would be grateful if they could remedy their uncertainty with that second or third dose -according to the status of each vaccinated with Sputnik- from Johnson & Johnson, in order to amend the transnational deficit that weighs on the Russian vaccine, and not having to make an emergency trip – especially those who need to continue traveling for work – to ensure the continuity of their usual routines after November 1.

The ANMAT must define what it will do with the third American vaccine.

The ANMAT must define what it will do with the third American vaccine.

What would the scenario be like today if ANMAT had approved the Johnson & Johnson vaccine and was available in the country? How much pressure would there be from these people, whose freedom of movement around the world remains in doubt, to be the recipients of those doses, instead of having to go looking for them – only those who can afford the expense – by their own means?

There are two more issues, linked to the US unit dose. The first is that if the Government authorized it now and there was the remote possibility of bringing it into the country to solve the problem of the global legitimacy of the Russian drug applied to 11 million people, I could not. Johnson & Johnson has all your committed stock this year and only in 2022 could it send the first batches.

It would be a situation similar to the one he came across Moderna, with a late contract that resulted in a promise from that company to satisfy Argentina only in the first quarter of next year. If the Government had been interested in the single-dose vaccine being offered in Joe Biden’s country – and that Europe authorized last April– He should have sharpened his political will first.

On the other hand, there is the suspicion that, as the times go by, the ANMAT will finish approving the Johnson and Johnson vaccine – if that finally happens – not under the category of “emergency”, but definitively. That would mean that, when the time comes, the laboratory could market its drug not only with the Argentine State, but also Without restrictions with the private sector.




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