Vaccines: why Moderna does not require ANMAT approval to be applied in Argentina

Carla Vizzotti arrived last night at Ezeiza International Airport, and even before performing the mandatory antigen test that is required of those arriving from abroad, she gave a press conference. His arrival was not without controversy. The civil servants are considered “strategic personnel” by Ministerial Resolution 712/2021, that is to say that they are not obliged to proceed to administrative segregation upon their return to the country, among others she renounced to avail herself of this exception.

However, he had already scheduled the dialogue with journalists on his arrival and had done so in the open air, on the runway of the AirBus 330-200 of Aerolneas Argentinas with which he returned to Buenos Aires, in a flight from Beijing with 768,000 doses of Sinopharm, who made a stopover in Madrid to take Vizzotti and Cecilia Nicolini, the presidential adviser.

Both traveled to London to meet with British health authorities and the AstraZeneca company, between the various meetings they had.

“Today, we are over 38 million doses, and with the three flights arriving this week, Argentina to reach 40 million doses“, Boasted the Minister of Health, visibly rested, after weeks especially solicited not so much by the long pandemic as by the tensions generated within the government coalition around the ideological sign of the laboratories producing vaccines.

It is to approve the DNU which made it possible to modify the law on vaccines that the government had passed last year, to facilitate contracts with the three North American laboratories They put the Front of All between a rock and a hard place. Take a step back, surrender to Yankee imperialism or continue to tolerate pressure from families who have children with co-morbidities who need doses as soon as possible to get out of the extreme danger zone in which they have been living since the very start of the pandemic?

It took months to resolve this problem. And endless avenues have been explored to avoid the role of agreeing with Pfizer’s lawyers.. From the possibility of making a one-time purchase of vaccines for pediatric use under a state protection umbrella for which the Argentine state will take charge, to having Sinopharm vaccines as the only alternative for children and adolescents. In one case it did not work because of a laboratory decision, in the other because the parents organized within the VacunaME collective anticipated that they would oppose this decision.

And as the gong was about to ring to end the fight, the proposal for Moderna to be donated by the United States government emerged, a solution with countless benefits. First, it is not Pfizer. Second, it is an investigation that has been strongly supported by the US federal state. Third, the technology is Messenger RNA, as in the case of Pfizer. Fourth, they did not have to be paid. Fifth, since it is a donation, it does not require ANMAT approval.

Vizzotti recognized it last night during a press conference: “being a donation, what the Argentine Republic does is accept it by a ministerial resolution and this is only sufficient to authorize the use of vaccines. ad referendum of the authorization for use of the FDA, which is the regulatory body of the United States. So far it has approval for people over 18 and at the moment is within the final authorization framework for minors under 18 years old; when it approves it, it is immediately triggered in Argentina, which in this case does not need authorization “from ANMAT.

The minister also stressed that “nearly 67% of people over 20 have started their vaccination program and in people over 50, it exceeds 85%, which is a very big step forward”. While, “those over 60 years of age exceed 45% of second doses ”.

Finally he says that in the coming weeks, the supply of component 2 of Sputnik V will be normalized. “We are working very hard to achieve this”, he assured, clarifying with another data the possibility of another possibility for this problem: “The signed contract from Cansino arrived last week and now we have to define the details of the purchase depending on availability which have the lab. “

The 7 million people who have been vaccinated with component 1 of Sputnik V and have not yet supplied component 2After pediatric vaccines for minors with comorbidities, this is the second serious problem to be solved at this stage of the vaccination plan.