On March 4, 2021, the UNLP announced with great fanfare the launch of the project to design and develop a vaccine against COVID-19, the Argenvac 221. Being a development promoted from a public university, the news took the front pages of the media and nationals and generated a light of hope, amid fears over the arrival of the Delta variant in the region. To this was added the urgency that the Government had to get the largest number of doses to immunize the population.
Now, almost a year and a half after the announcement, the situation is completely different and although the Ministry of Health warned of a rise in coronavirus infections, this did not have an impact on the number of hospitalizations in intensive care units. However, and taking into account that the virus is here to stay, It is important to know how the projects are progressing so that Argentina has its own vaccines.
In that framework, 0221.com.ar communicated with the promoters of the Argenvac 221 project to find out what the latest developments are. “It is in the last stage of the preclinical phase, precisely, in mid-December we finished the last trials of protection or challenge in mice. This is to vaccinate the mice and challenge them with live SARS-CoV-2”the doctor explained William Dozen and director of the Institute of Immunological and Physiopathological Studies (IIFP- UNLP- CONICET).
In this sense, he indicated that “they are waiting for the results to see if the vaccine protects the immunized animals and the unvaccinated ones get sick” and added: “This is the last stage prior to the end of the preclinical phase. Then comes the entire registration phase in the National Administration of Medicines, Food and Medical Technology (ANMAT) and diagram the clinical trial in volunteers”.
There is still a month left to know the results and the final conclusions of the trial stage in mice but, according to Docena, they were favorable. “It’s an appreciation for how animals look. What one does is vaccinate them, challenges them with the virus and leaves them for four days for the virus to make them sick and generate the disease. On the fourth day the animals are analyzed. That analysis, at first glance, turned out subjectively favorably. Now we have to wait for the analysis of the virus count in different organs, etc. That is what will tell us if it protected or not. That takes a month, at least, and it is done at the Malbrán Institute”complete.
It should be noted that this project arose from the joint and collaborative work of the groups of the Institute of Theoretical and Applied Physicochemical Research (INIFTA) – dependent on the UNLP and CONICET – and the Institute of Immunological and Physiopathological Studies (IIFP) – dependent on the UNLP , the CONICET and the CIC-. This development is based on the use of viral proteins to induce the generation of antibodies. “It has virus proteins and an adjuvant, this is in all vaccines and it is what is used to activate the immune system so that it generates mechanisms against the other component. In this case, that component is virus proteins”had detailed Dozen in dialogue with this portal.
If the preclinical phase is passed, the next step is for the company GIHON – Laboratorios Químicos, from Mar del Plata to finish producing Argenvac 221 and enable the vaccine production plant. “Once the vaccine is produced in that plant, we are going to have to repeat the trials, which we hope will be favorable. Once that happens, in parallel we will already start the registration in ANMAT, with all the results that they ask for.. After that we go to the clinical trial, we have already started talks with the organization of where and who is going to do it. This is to begin to anticipate that we are going to go to the next stage, to test the drug on volunteers”, stressed the Director of the IIFP.
When asked about the times to start the tests in humans, the researcher applied cold cloths and pointed out that “it is very complicated” due to the delays that arose in the assembly of the vaccine production plant in Mar del Plata. Much of the equipment that was purchased has been held at customs for months and there is still no specific date for it to be installed at the factory. “In 2023 we should be in a position to start the trials. The truth is that I do not want to risk or get excited about any date because there have been some specific events that have to do with the availability of foreign currency in the country and that delayed the program, at least six months”he commented.
It is important to remember that the development is directed by doctors Docena, from the IIFP; Y Omar Azzaroni, of INIFTA. In addition, it includes the already established collaborations of Dr. Sebastian Cavalitto from the Center for Research and Development in Industrial Fermentations (CINDEFI- UNLP/CONICET), of Dr. javier santos of the Institute of Biological Chemistry and Physicochemistry (IQUIFIB -UBA/CONICET) and the participation of Dr. Alejandro Aiello of the Cardiovascular Research Center (CIC -UNLP/CONICET).
Regarding the work carried out, the University researcher stated: “We are satisfied with everything we have been doing because it is a unique opportunity that we have had in our career. One wanted things to happen in less time than what happened. There were many unforeseen events and they all have to do with the lack of foreign currency in Argentina. It is not only difficult for the industry to import inputs, but for us too. You ask for a reagent in four to six months to arrive, it is difficult to work like this even though we are used to it. But when there is a moment of crisis, I would have expected that some situations would have changed, but that is not what we observe.”.
Along these lines, he stressed that it is important for Argentina to bet on this type of project. “Currently there are four, the one at the University of San Martín is more advanced than ours, they are already evaluating it in people and it is working well. This is important because this virus is not going to disappear, we are going to have to continue giving ourselves booster vaccines Now, for example, there is only one vaccine out of the six we had. Argentina has only one, so there is also a restriction. I don’t know the reason for the vaccine admissions”Dozen emphasized.
In turn, he stressed that “Having vaccines serves the country’s health policy” and, furthermore, “because in the future there is a capacity to produce that can be vaccines like this or another that we did not have before. In recent times, biotechnological companies were associated with some that produced some vaccines and others none, so that is something that was left for the country to take advantage of “he claimed.
Regarding the rise in COVID infections, the researcher indicated that “was what was expected” and anticipated that this will happen every year, at this time. “It is a virus that needs activity and social interaction, it does not depend on whether it is cold or hot and since it is a time of many meetings and many people on the street, added to the fact that there is normal activity as appropriate, it is what was expected. The important thing is that if people are vaccinated and even if there is a peak of cases, what there is not is a severe disease. Hospitalizations increased very slightly and that is due to the vaccine. When the vaccine was not there, the number of hospitalizations and the number of deaths increased. That hasn’t been seen since last year,” he remarked.
Finally, Docena highlighted the financial and academic support provided by the UNLP and the Faculty of Exact Sciences for each of the members of the Argenvac 221 project.
