why the Johnson & Johnson vaccine has been in the ANMAT for 5 months and is not approved

Two days after the Pfizer laboratory submitted the application for registration of its Covid-19 vaccine to the ANMAT, it did so the Belgian Janssen laboratory, a subsidiary of the American company Johnson & Johnson. The Pfizer process began on December 5, 2020, and the Janssen process on December 7. Pfizer’s vaccine has been approved in a record time (17 days), while Janssen’s is still awaiting authorization in Argentina.

Past five months since this presentation. There is another fact that “sister” of these two vaccines: like Pfizer, Janssen conducted part of its phase 3 trial in the country. The protocol was approved by ANMAT on August 13. The principal investigator was Mercedes Deluca, of the Tamboulien Center for Infectious Studies.

The Johnson & Johnson vaccine It was past in the United States, by the FDA on February 27; for the European Union, March 11; and by the World Health Organization on March 12. On April 13, he was suspended due to the appearance of pictures of thrombosis. At the end of the month, it was announced that these conditions were rare and vaccinations resumed. The only country that decided to eliminate it permanently from its portfolio was Denmark.

Baptized Ad26.COV2.S, Janssen vaccine is used in Austria, Belgium, Czech Republic, France, Italy, Hungary, Latvia, Lithuania, Poland, Netherlands, Spain, South Africa and the United States -United. Was the fourth company to start phase 3 trials in the United States, after Moderna, Pfizer and AstraZeneca. The latter has not yet received authorization in this country.

The Janssen vaccine uses a human adenovirus as a vector of its immune architecture. Its peculiarity is that, unlike the most popular vaccines circulating in the market, such as Pfizer, Moderna, Sputnik V, AstraZeneca and Sinopharm, this one is applied in a single dose.

Phase 3 results based on 39 thousand patients were published April 21 in the New England Journal of Medicine. The level of efficiency is something below compared to other vaccines mentioned: in global trials it achieved an average immunity of 66.9 percent 28 days after its application.

At the same time, he demonstrated a 85 percent efficacy against serious diseases, although a reduced potency compared to the South African variant, which has so far not been detected in Argentina. Its single-dose format makes it attractive, especially for Logistics of distribution. It is also the favorite of vaccine tourism, like that of the United States.

Bugle he followed the fate of the Janssen case in Argentina. ANMAT’s response on March 12 was that the health regulator continued to integrate the information requested from the laboratory, “sequentially”, in order to make a decision. After almost two months with no news, a new concise official response to this medium arrived: “The company is still in information aggregation process“.

Hermeticism prevails in the laboratory. No one wants to explain why the approval process in Argentina has far exceeded the deadlines that have been recorded by the main centers of reference of the world. The case is also attracting attention because of the contrast to the speed with which other vaccines have had to receive approval in the country, or the recommendation that the government approve them.

The Department of Health has said on several occasions that Janssen is among the laboratories with which it is researching a possible new dose purchase, in a context where the country lacks few vaccines to continue its national operation.

Presidential adviser Cecilia Nicolini said a few days ago that these talks are advanced. Perhaps in this negotiation, of which we do not yet know any concrete results, is the reason for the delay to approve the vaccine, although at first it seems a contradiction.

Pressure regulator

A source from the pharmaceutical industry, who has ties to Janssen and prefers anonymity, speculated that the delay could be related to “Release the pressure on the government.” In other words, the strict technique would not be a stumbling block: “It has shown good efficiency and the problem of thrombi is not significant”, he explained to Bugle infectologist Eduardo López when consulted.

The interpretation, strictly political then, would be that if the ANMAT I would have already published the authorization of the vaccine in Argentina, which would probably have generated an expectation hard to be satisfied short term. Strictly speaking, as these media have learned, any pledge Janssen would be willing to sign at this point in the pandemic would be for him. Second part of the year.

However, one information could play for from Argentina: the rejection of part of the American population to be vaccinated. It is known that certain governors of this country seek to attract “rebellious” citizens in the most heterodox way, with free beer and marijuana, for example, or directly with money, in order to make them vaccinated. It could exist jobless and profitable demand by other countries lacking doses.

The need to articular the authorization of the Janssen vaccine in Argentina with a possible purchase contract could be a reasonable argument. In the case of the Pfizer vaccine, that timeline did not work, as evidenced by the timeline of events that took place towards the end of last year.

Only one week After Pfizer applied to register its drug with ANMAT, President Alberto Fernández announced the agreement with the Gamaleya Institute, Russia, for 20 million doses. The negotiation table with the American laboratory had entered the threshold of failure.

There, then, the paradox occurred that the first vaccine authorized in the country (Pfizer) I had no chance some landed in Ezeiza, while Sputnik V had a signed contract without having the papers in order yet. If you are looking for Janssen avoid this difficult situationIt would not be strange for bureaucratic and commercial bodies to go hand in hand.

PS