2023-04-18 04:31:11
Towards the end of this year, Argentina could reach a milestone in the history of local science and technology. If the last phase of clinical trials is successful, the country will be able to apply the first formula thought, designed and manufactured 100 percent in domestic territory. The ARVAC Cecilia Grierson is expected to function as a reinforcement and protect against the different variants of the coronavirus that may arise. In this dialogue, Juliana Cassataro, in charge of the research team from the National University of San Martín and the Conicet, describes the obstacles she overcame, what are the next steps, and the responsibility of conducting a project of this caliber.
-The registration of volunteers to continue with phase II and III of the clinical trials began. What is the challenge?
-We are looking for 1,800 people for the trials that will be carried out in different centers in Argentina such as Mar del Plata, La Plata, Córdoba and the Autonomous City of Buenos Aires. At arvac.com.ar people can apply and we request volunteers who have had a complete primary scheme with a maximum booster dose. That is, they must have three inoculations in total. It is complex because in the country there are people who were immunized four, five or more times, but to compare ourselves with other vaccines in the world we need that profile.
-The idea is to complete the number of registrations before the end of the month…
-Hopefully we can. So far almost two thousand people have signed up, but only about 30 percent meet the characteristics we requested. We need the largest number of people to sign up to reach a sufficient number.
-What deadlines do you have to start vaccination?
-The objective is to complete the remaining phases between June and July to present the results to the ANMAT. Once approved, you can register and use it. The Cassará Laboratory has already produced four million doses. If the vaccine is approved and the State makes the purchase, we could apply the ARVAC in the second quarter of the year.
-Why do you test three formulas in the trial: one against Gamma, another against Omicron and a bivalent one with both variants?
-What happened is that the vaccine had to be adapted because the Omicron variant was circulating and escaped much of the immune response of the previous formulas. It is very important for us to do it this way because It is the first time in the world that a bivalent vaccine is compared with a monovalent one in the same clinical trial. The idea is to obtain a platform with the ability to make a bivalent for this or new variants.
–Is the goal for ANMAT to approve the bivalent first?
-Surely all three can be approved if the results are good, but the interesting thing is to have the platform approved because we would not have to do all the clinical trials again if we want to make a bivalent formula but with another variant.
A necessary balance: from fear to pride
-It is the first time that an Argentine vaccine has reached this stage. What does this mean?
-Analyzing the work that was done, we are very happy to have been able to go through and reach this stage. We feel much more secure and convinced that our project is real and we can obtain registration.
There is light at the end of the tunnel…
-Perhaps it seemed more striking to people at first, but I felt a lot of uncertainty that we could arrive and I was afraid of not meeting expectations. Now we did everything to reach the end and we are very proud of all the people who participate in this project. We are more than 300 specialists and we deployed all the Argentine capabilities to finish this trial.
-How do you carry the weight of leading a project of this magnitude?
-At the beginning I had a lot of pressure because it was something very necessary and I knew that we were going to take longer than other countries. I felt a lot of anguish because we were eight people in the laboratory and we were not going to be able to carry out the vaccine in a year. However, I always knew that we could and that it was important for the country to do it.
-Even in storage mode, the production of your own vaccine makes sense.
-Of course, since we wanted it to happen in our country, from the beginning we thought about what type of vaccine could be made from scratch in Argentina. The temperature is important because to distribute it in our region it has to be something that does not need a freezer of 70 degrees below zero.
Were there obstacles along the way?
–At all stages there was always someone who told us that what we were doing did not make sense, because others were doing it before or because vaccines were imported. There was permanently an explanation of why we had to stop working and today they tell us that the ARVAC has no reason to exist. However, in Argentina there will be millions of people to vaccinate every year for covid. To make your own vaccine you have to start and develop it, as we did. The important thing is not to arrive first, but to arrive.
public and private
-The role of the State was fundamental in this case…
-The pandemic showed that in all types of government where vaccines were created, both Cuba, Russia, the United States and England, the Ministries of Health were the ones that invested in their development.
–From some sectors private participation is questioned. What function does the Cassará Laboratory fulfill?
I think it’s crucial. Vaccine prototypes can be made in university laboratories, but good manufacturing practices are needed to produce at scale. Companies have manufacturing capabilities and standardization of processes that we do not have elsewhere. A vaccine is not something simple or handmade, it requires a level of regulation that does not exist in laboratories, but in plants approved through a pharmaceutical development that exists in Argentina.
–Many people did not want to apply Sputnik or Pfizer for their country of origin. What is your goal with the ARVAC?
-One of our objectives is that the vaccine does not remain in the crack. People with different political positions worked on the investigation and are convinced that this is important for Argentina.
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