The rebound of cases in the City, the scenes of crowds in popular demonstrations, the proximity of the Holidays and the imminent tourist movement for the holidays, once again drive the question of when will we have a vaccine in Argentina against coronavirus. The government expects their arrival before the end of the year and plans to launch an aggressive vaccination plan during the summer. But in the last days the voices that they questioned make this possible.
President Alberto Fernández announced on Thursday that Argentina signed the agreement for the vaccine with Russia Sputnik-V. I assure that before the end of the year 600 thousand doses will arrive, with which it will be possible to vaccinate 300 thousand people. In addition, he said, between January and February another 20 million doses will arrive. The contract includes the preference in favor of Argentina to be able to vaccinate another 5 million people in March
The official position is that it was important to close this acquisition “in case the rest of the vaccines with which we also have contracts delay their arrival.” At the same conference, the Minister of Health, Ginés González García, admitted that the possibility of reaching a purchase agreement with the Pfizer laboratory is still immature. And that is why the only possibility of safe access to the vaccine is for now the one offered by Russia.
The problem is that everything indicates that the Russian vaccine will step on Argentine soil without the endorsement Regulatory entities of the United States (FDA) and the European Community (EMA). That is why this Saturday officials from the Anmat – the body that must authorize the country – travel to Russia to evaluate the Sputnik V vaccine. They will return next weekend.
The clock is ticking. The one of the pandemic and that of this 2020 that the Government hopes to end with an immunization plan underway. That’s why Anmat’s usual times make noise: the agency takes at least a year to approve a vaccine. But this case will be different: you will not approve it, but rather authorization for use under pandemic emergency.
The experts consulted by Clarion explain what will be important to do a very strong pharmacovigilance system in case serious, unforeseen adverse effects appear. Also to monitor and see if people are effectively protected.
What other countries bet on Sputnik V? The Russian Direct Investment Fund (RDIF) informed Clarion which has signed agreements with India, South Korea, Venezuela, Egypt, Nepal, Belarus, Uzbekistan, Kazakhstan, Mexico and two Brazilian states: Bahia and Paraná.
In early November documentation of the Russian vaccine began to arrive at ANMAT. What did the Argentine officials travel for? “To see exactly all the development of the research. See where it is produced, how it is produced,” explained Alberto Fernández.
From the pharmaceutical sector came some critical voices to the trip. Laura Raccagni, coordinator of the Observatory of Health, Medicines and Society of COFA (Argentine Pharmaceutical Confederation), assured that she does not consider it necessary. “I understand it politically, not healthily,” he said.
Along the same lines, Deputy Graciela Ocaña presented a request for access to information. “Anmat is supposed to receive all the information here in Buenos Aires and not go looking for it. That’s pretty spotty”He commented.
“Russia is not a country that has a pre-qualified agency. Therefore, the regulatory approval process it should be much more exhaustive, more rigorous, and obviously slower ”, assured the former Minister of Health, Adolfo Rubinstein.
“My impression is that there will not be enough time to start vaccinating in December”, He added.
The doctor and politician mentions that the vaccine has not passed all the regulatory approval phases, that the clinical trials have not finished, that the studies are very preliminary, and that nothing has yet been published. “With which, there is a lot of uncertainty”, He maintains.
The proposed times do not close either to Graciela Ocaña, also a former Minister of National Health. “It seems that it is another of the promises, the many things that have been said. It would seem that it is impossible”, He says.
Beyond the controversy over travel and times, what will Anmat evaluate? The president of the Argentine Society of Infectious Diseases, Omar Sued, explained to Clarín that “the analysis is made of 40 thousand people who have already been vaccinated, how many of those people were infected and how many were not, and how many people had adverse effects. That information is validated and verifiable If the ANMAT considers it adequate, it will approve it and if it considers that it needs more information, it will request it. You will not be able to vaccinate until the ANMAT gives the green light “.
Outside of the Russian vaccine, Argentina maintains negotiations with several laboratories and some – such as Pfizer – have already started the procedures in Anmat to authorize the use of their vaccine in the country.
The country also participates in the COVAX mechanism, a plan promoted in part by the World Health Organization (WHO) to guarantee equitable access to the vaccine. Our country has already paid an advance for 9 million doses.