Argentina is the country in the region with the most vaccine trials, but the one with the fewest contracts



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A few weeks ago, the clinical study of a new vaccine against the coronavirus began in Argentina, that of the German CoronaVac, which already has practically all its quotas filled. Yes indeed, there are already five phase III trials developed in the country.

Among the approved vaccines, Argentina is the country that has collected the most trials: four. However, only contracted with one of these four laboratories. When you look at the rest of the countries in the region that have also participated in trials, the count is different and many have purchased doses of these vaccines. Why are they doing it and we are not?

The Pfizer case

Much has been said and written on the subject Pfizer, the first vaccine tested in Argentina and which seemed to open the doors to a guaranteed purchase. Argentina contributed the most volunteers when testing this vaccine, which achieved an effectiveness of 95%. The 6,000 Argentines who put up arms for the puncture were the key to these results.

The inclusion of unfair terms in the contract of the American company, it appears in the official discourse as the reason which thwarted the agreement, although other political questions are not excluded. The real thing is that what in July seemed a reality, at the end of the year, had already vanished into thin air.

“These trials often open the door for participating countries to increase their chances of accessing vaccines as quickly as possible,” he said at the time. Bugle the infectologist Fernando Polack, head of the investigation. This same idea was stirred up by the Ministry of Health, which then commanded Ginés González García: participating in a study could promote the arrival of batches of vaccines.

Fernando Polack, the researcher who led the Pfizer clinical trial in Argentina.  Photo Germán García Adrasti / Archives

Fernando Polack, the researcher who led the Pfizer clinical trial in Argentina. Photo Germán García Adrasti / Archives

But this, as the Pfizer case shows, it was not necessarily and it is not like that. “The negotiations that were conducted between the government and the pharmaceutical companies in this matter were unfortunately not made public, so we do not know what the commitments were. But overall, in no clinical trial is there a prior arrangement of these characteristicsSays Georgina Sposetti, founder of A Trial for Me, a platform which allows you to apply for clinical trials and which was recently recognized by The Lancet.

“It is a” smoke “that has been created – recognizes Adolfo Rubinstein, former Minister of Health of the Macrista administration and master in clinical epidemiology -. One thing is clinical trials and another is trade negotiations“.

terms

Rubinstein explains that for a laboratory to decide to conduct a clinical trial of a Covid vaccine in a country, three conditions must be met, and that Argentina unites the three.

First the epidemiological situation: there must be a high number of cases for the sample size to be large enough to show the differences. Second, the country has a very good track record in clinical research and has participated in many global multicenter trials like these. And third, regulations that facilitate investigations that, he underlined, “the ANMAT in my direction has greatly improved the procedures and accelerated the approvals”.

These are the reasons, he notes, why the country was chosen for both the Pfizer study and the Chinese vaccines Sinopharm and CanSino Biologics, and the Belgian Janssen. No others.

Country by country

the Rough draft World Health Organization Vaccines List is a long list in which news of all ongoing investigations is updated. In it, clinical trials are obviously listed.

Thus, it is possible to cross the information available on the countries whose headquarters were with that contained in Our World in Data on the vaccines that each state applies and what is published by the journalistic media on the pre-purchase announcements. agreements. Because vaccines, in many cases, are purchased before approval.

Analyzing all this data, it appears that seven Latin American countries have hosted clinical trials of approved vaccines in at least one country. In most cases, their governments have signed purchase or pre-purchase contracts with the producing laboratories.

  • Brazil: it was one of the AstraZeneca and Sinovac test sites. The agreement with the two companies concerned local production. Manufacturing of the Chinese vaccine began in February at the Butantan Institute in São Paulo, one of the country’s main medical research centers. Another important research center, the Oswaldo Cruz Foundation, carries out the production of AstraZeneca. In mid-March, Brazil announced the purchase of 100 million doses from Pfizer. In those days, the contract signed with the American pharmaceutical company transcended itself.
  • Chile: the government of Sebastián Piñera is one of those who have guaranteed the highest number of doses in relation to its population in Latin America. He not only contracted with Sinovac, CanSino and Janssen, who tested the vaccine on their citizens, but also with Pfizer and AstraZeneca.
  • Colombia: With a population of 50 million people, he signed a contract to vaccinate nearly 20% of them with the Janssen vaccine, a single dose.
  • Peru: seat of the Sinopharm and Janssen trials, it has reached a 38 million deal with the Chinese and, according to the Peruvian government, it is in negotiations with Janssen.
  • Venezuela: Currently, the only vaccine in use in the country is Sputnik V, which has been tested in the country and the purchase of 10 million units has been agreed.
A woman receives the CanSino vaccine in Tlaxcala state, Mexico.  Xinhua Photo

A woman receives the CanSino vaccine in Tlaxcala state, Mexico. Xinhua Photo

Vaccines in Argentina

While last week in Argentina the vaccination rate accelerated, the lack of additional doses is what prevents the campaign from being able to place definitively fifth.

According to the latest data from the Ministry of Health, the country received 7,268,600 doses, which break down into 4,470,200 for Sputnik V (3,410,045 for component 1 and 1,060,155 for component 2); 798,400 from AstraZeneca (including 580,000 from Covishield); and 2 million from Sinopharm.

According to Alberto Fernández, further shipments from Sinopharm and Sputnik V will arrive in the coming days, and the first 900,000 AstraZeneca units produced here are expected in the second half of the month. However, this Tuesday at a press conference, Minister Carla Vizzotti admitted that there were still no confirmed arrival dates.

Regarding negotiations with other pharmaceutical companies, Vizzotti said last week in his presentation to the Chamber of Deputies that “They are open ” with “other laboratories such as Janssen, CanSino, Bharat, Sinovac, as well as with the Cuban government”, but no concrete progress has yet been made in this regard.

Throughout this scenario, and returning to the beginning of this note, Rubinstein points out that what failed was the negotiation strategy, which at the time “wasn’t done to many bands, and that’s what we’re paying for now.” He adds that he is not aware of any progress in pre-purchase agreements with others that are about to be released, such as the Novavax vaccine.

“These types of agreements pay part of the purchase, in order to ensure the supply. And in them, they weigh the expected conditions that the laboratories put and also the capacity of payment of the countries. You must have dollars available to pay“, specifies. The science, the tests, are only accessories at this stage: the central question is the economy and the negotiation.

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