A volunteer speaks about the vaccine against Covid 19 in Argentina
Pilot tests started in Latin America
The increase in infections and deaths from the pandemic around the world continues to grow. At the same rate, the race to find a saving vaccine is accelerating to stop the spread of Covid 19 almost eight months after its appearance.
Six are so far the laboratories aimed at finding a cure: Pfizer and BionTech of the United States and Germany; AstraZeneca from Great Britain and Sweden, associated with the University of Oxford; Moderna, from the United States; and three others from China, Sinopharm, Cansino Biologics and Sinovac.
Argentina is involved so far in two of the investigations for a vaccine against Covid 19. On August 13, an agreement was announced with Mexico to produce and distribute the vaccine being created by the University of Oxford and the British and Swedish laboratory AstraZeneca to starting in the first months of 2021. And on July 10, the government of President Alberto Fernández signed an agreement with the Pfizer — BioNtech laboratories in the United States and Germany to test with volunteers in the third phase of research of their vaccine.
It is about 4,500 volunteers whose ages range from 18 to 85 years, men and women, some healthy and others with pre-existing pathologies. The Pandemic Journal spoke with one of them. It is about Ezequiel Boetti, a journalist, who on August 14 received the first dose and on September 4 will receive the second, according to the schedule of the testing experience.
-¿How did you decide to join this scientific experience?
-I thought it was important to add a grain of sand to be part of the solution. The same thing happens to other volunteers with whom I am in contact. The pandemic showed that we will come out of it with the collaboration of all and not individually. Also since I am not a doctor, nor essential personnel in this circumstance, I thought I could contribute by collaborating as a volunteer for the vaccine.
-¿How are the steps in this medical experience in Argentina?
-I signed up through an online form in the middle of the second week of July. They asked for a series of basic personal data and the area of residence was especially important. Because one of the things that this study needed was against volunteers who resided in an area of community circulation of the virus and the metropolitan region of Buenos Aires is the focus of the pandemic in that sense. A week later they contacted me to let me know that I had been selected and then several more times to clear up doubts and confirm that I would accept the proposal. The organization of all this is in charge of the Infant Foundation chaired by Dr. Fernando Polack and is the point of contact for this experience in Argentina. They summoned me for an interview in which they explained to me what this experimental phase consisted of.
- ¿How was your experience on the day of the vaccine?
-The day I was summoned for the vaccine, it was a process of almost four hours in the Military Hospital of Buenos Aires, headquarters of the experience. I was summoned on a Friday, I entered the hospital, I passed a series of security checks and I had a talk with a doctor, I had to sign a contract of about thirty pages where it was explained to me what this test consists of and that I am free to abandon it whenever I want. Medical control in this sense excludes pregnant women, those who are breastfeeding and those who had some of the strains of hepatitis. Then they took my blood, then regular clinical tests, the swab to determine if I have coronavirus or not and finally they applied the substance that does not clarify if it is the vaccine itself or is it a placebo.
The procedure in all clinical trials with patients consists of testing the virus and for this the volunteers are divided into a control group and another experimental group. The experimental group is administered the substance to be tested to verify its effectiveness.
The control group, on the other hand, does not apply the element to be tested but a placebo, although the volunteers do not know this. That is why it is called a blind study. When doctors do not know either, the study is called double blind and when the person in charge of interpreting the final results does not know, it is called triple blind. This is how it works to buy the results and ensure that when the expected is not obtained it is not due to chance. If the proportion of desired results is higher in the experimental group than in the control group, the vaccine is efficient; if the result between both groups is equivalent, the vaccine is inefficient, and if the expected result is lower in the control group than in the experimental group, the vaccine will be counterproductive.
-¿And after the application, how did your life continue?
-Since that day I have a series of periodic controls that will last approximately two years. I carry with me a cell phone that I go to if I have any unusual symptoms, such as pain, dizziness or fever.
-The test and control period is long …
-Yes, in principle it is approximately two years. But that is relative because it is not yet known how the development of this vaccine and those of other laboratories that are working on this will continue. It is likely that if another effective vaccine finally appears in the intermediate period of this experience, the laboratory will have to notify the volunteers to whom it applied a placebo, for an ethical question, so that they can be vaccinated and remain immune. After applying the vaccine, I had to fill out a control form from a digital application daily during the first week, then from the second week it is another weekly form throughout the period that the test covers. Despite the fact that each volunteer is free to leave the test whenever they wish, it is important that in these first days we keep in touch with the authorities. In total there will be six visits to the hospital for controls during the two years that the test lasts.
- ¿Did you feel bad after the application or did you suffer from any unusual pain or sensation?
- I had one or two days with pain in my arm, but it is normal for any vaccine. For the rest, I led a normal life, I continued working as usual and no special diet was imposed on me.
-¿How is your experience now?
The second dose will be applied on September 4. Two weeks later I will have to do an analysis and then it will be every six months until completing the two years of the trial period. Because one of the challenges of this vaccine is to see what happens in the long term. In the short term, it was already proven that in test phases one and two, a safe and effective vaccine was demonstrated. But the challenge is to see what happens when the experience is transferred to a large number of people in very different conditions and different places as well. This phase three that we are doing in Argentina was also carried out in Germany and the United States. As there they are already a little more advanced, that experience serves to adjust some details in the Argentine tests.
-¿What application results are expected from this vaccine from Pfizer and BioNtech?
- In principle, it is proposed as a vaccine of two annual doses, but we will have to wait for the results according to the characteristics of the people who were tested. In some bodies the effect may last longer and in others less time. These are questions that will be adjusted with the results obtained, according to what the doctors told me. That is why they look for people with different characteristics and even risk factors so that the sample is large. It is about two doses because there are human organisms that do not have a single dose to generate antibodies to the coronavirus. But neither could a single dose be done because it would be overloading other bodies that would not withstand the impact and generating intense and counterproductive adverse reactions. In the case of the Oxford and AstraZeneca vaccines, it was found that with a single dose 91 percent of the volunteers already generated antibodies and with the second dose 100 percent. All vaccines, the six that are in phase three testing periods, are intended for two doses. Even the other vaccine to be tested in Argentina from the Chinese laboratory Astropharma.
The Pfizer and BioNtech laboratories chose Argentina as the only country in Latin America to carry out the testing tests in phase three of the experience due to the advanced technological development in infectology and the sanitary capacity in this matter. And with this background, they also decided that the tests with volunteers be carried out in an area with wide circulation of the virus. For this, the urban district that connects the Argentine capital with its neighbor, the province of Buenos Aires, is ideal because it concentrates almost 15 million people in permanent movement. And it is currently the main source of increased infections with a total of 65 percent of the entire country.
