Fernando Polack, principal investigator of the study to be carried out as from August in Argentina of the vaccine against the coronavirus by the pharmaceutical companies Pfizer and BioNTech, told Télam that "being part of these trials positions the country in a privileged position for distribution".
"The intention is that the evaluation of the phase 2/3 effectiveness of the vaccine will be carried out reflecting the diversity of the population, in a range of 18 to 80 years, in people who have not been infected and we aim to look first at essential workers, especially the healthcare population, but then it will be expanded," said Polack regarding the trial study of the Covid-19 vaccine that will begin in August at the Military Hospital in the city of Buenos Aires.
The pediatric infectious disease physician and director of the Infant Foundation said that "we are going to test the vaccine in thousands and thousands of volunteers, but we aim to have answers by the end of this year".
"We're going to test the vaccine in thousands and thousands of volunteer people, but we're aiming to have answers by the end of this year."
Fernando Polack, researcher
Argentina was selected on Friday as the only country in the region to carry out one of the human testing phases of the vaccine against the coronavirus prepared by Pfizer Inc. and BioNTech SE, which announced that they are awaiting regulatory approval from the National Administration of Medicines, Food and Medical Technology (Anmat).
As regards the preparation of the study, Polack specified that they are putting together "a team with public, national and provincial organizations of the AMBA (Metropolitan Area of Buenos Aires) and with private sectors", among which he mentioned the Cemic University Institute, the De Los Arcos and Anchorena hospitals.
"I cannot answer about the possibility of success, but there are data on this vaccine in a previous trial that are published and that show that with two doses it generates antibody responses 10 to 20 times better than a normal coronavirus infection," he indicated.
The choice of Argentina
Regarding the selection of Argentina to carry out this study, Polack assured that "it was a huge competition among many other countries and researchers who were interested in having the place that our country occupies today" and highlighted that the work done here "in the area of respiratory viruses is known worldwide".
"The benefit of carrying out these tests is that it puts Argentina on a map of science and allows many actors to be thinking about us and typically to the countries that evaluate vaccines or drugs, it opens the door to access shipments of vaccines or drugs with priority," he pointed out.
The infectious disease physician has been working on respiratory vaccines since he was 29 years old and he assured that "many people know our team and since this disease started we have been in communication with the President (Alberto Fernández) and the Minister of Health (Ginés González García), who always supported us and gave us their support".
The vaccine
The study of the vaccine against Covid-19, which is already being developed in the United States and Germany, was initiated and complied with safety determinations, approved by independent committees and regulatory agencies in the United States and Europe, "which shows that it is possible to advance in its efficacy", he indicated.
Phases 1 and 2 of the vaccine began at the end of April in Germany and in May in the United States, while in the first phase of clinical trials the vaccine showed encouraging signs, demonstrating that it is well tolerated by humans. It also proved to be immunogenic, i.e. capable of generating antibodies.
The study will be carried out 75% in the United States and then Argentina will be added, while there is a possibility that Pfizer will add other countries "although nothing has been agreed so far", said Polack.
The researcher highlighted that so far no "serious adverse effects have been detected in the vaccine", and said that "more than 10,000 people in the United States" have already been inoculated out of the total of 30,000 that the study would include at a global level.
"We are going to enter the study (at a time when it is) more advanced; we will have enough information before starting", he emphasized in an interview with Télam.
Regarding the experimental technology used by this vaccine, which is known as messenger RNA, the infectologist explained that it involves "directly using the genetic code of a viral protein and letting the human body take it and produce the protein just as if it had been infected".
"To achieve that, you have to use the messenger RNA, which are instructions given by the virus to the human body to synthesize one of its proteins exactly the same; it is only a very small part of the virus, which is where you have to attack it," he detailed.
In that sense, he mentioned two benefits of this system. "These RNA plasters are very labile, one of the advantages is that once it enters the cells it gives the instruction and the body disarms it and the second is that in the future it is going to be a very easy way to develop a vaccine."
"At the moment, there are no RNA vaccines that were licensed, so we will have to see if this one will generate all the defenses that one expects," he said.
Finally, Polack emphasized that "they are not vaccines that aim to be expensive, but accessible" and recalled that the World Health Organization (WHO) established an order of priorities for their application, which is led by healthcare personnel followed by those over 65 years of age.
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