The United States Food and Drug Administration (FDA) this Thursday approved a vaccine against respiratory syncytial virus (RSV), which Tests were carried out at the Central Military Hospital of Buenos Airesand there is a “efficiency above 80%”, According to Gonzalo Pérez Mark of Argentina, the principal investigator of these studies.
This is Abrisvo, from Pfizer Laboratory, a vaccine for adults over the age of 60 against RSV, the main cause of bronchiolitis in the pediatric population and serious respiratory conditions in the elderly population.
“The one that was approved is the second vaccine against RSV, and there’s another one that was approved a month ago,” Marc, the principal investigator of the research study, told Telam Perez. “It’s the first time in history that we have this vaccine.” Is.” Clinical trials that were conducted in our country to evaluate the safety and efficacy of this vaccine.
In Argentina, in addition to the military hospital, three other health centers from the Autonomous City of Buenos Aires and one each from La Plata and Mar del Plata participated, as well as clinical centers in Salta, Córdoba and Tucumán.
A month earlier, the FDA approved the Arexvy vaccine from the GlaxoSmithKline laboratory for the same adult population.
“Argentina was the network of centers that included the largest number of volunteers in a single country after the United States,” said the expert, as more than 8,500 people participated.
In Argentina, in addition to the military hospital, three other health centers from the Autonomous City of Buenos Aires and one each from La Plata and Mar del Plata participated, as well as clinical centers in Salta, Córdoba and Tucumán.
“It was quite federal and with the population of the entire Argentine Republic, which is very interesting,” he said.
The clinical trial evaluating the efficacy and safety of this new vaccine was conducted through a double-blind study, meaning that neither the person receiving it nor the health facility administering it knew whether Whether the volunteer is receiving the vaccine or not. placebo.
The expert indicated that, in addition to the tests in adults, tests were done to apply to pregnant women, “which would allow babies to be born with protection.”
If approved, “this will completely change the way we work in epidemiology and pediatrics because this is one of the main pediatric problems we have every winter,” he said.
The technology used in these vaccines, the expert said, is a “recombinant protein”, that is, a “manufactured protein”.
“The protein that the virus will ingest is the one that triggers the immune defense response, the same protein, without the virus, you make in the lab and introduce it into the vaccine,” he explained.
“The one that was approved is the second vaccine against RSV, and there’s another one that was approved a month ago,” Marc, the principal investigator of the research study, told Telam Perez. “It’s the first time in history that we have this vaccine.” Is.” Clinical trials that were conducted in our country to evaluate the safety and efficacy of this vaccine
And he added, “The vaccine is a disease simulator. What it produces is the same immune response that it would produce if you had the virus, so your defenses are already in place when you’re exposed to the virus at some point.” come.”
Perez Mark explained that the study began two years ago with a “network of centers” where they first evaluated the efficacy of the vaccine for one year, and then evaluated safety, which would continue to be evaluated until the end of the year.
“We are continuing the study with volunteers, but we already know that the vaccine works and is very safe and proven, with a high efficacy of over 80% for severe disease,” he commented.
The study included 240 centers around the world from countries such as Canada, Finland, Japan, the Netherlands, South Africa and the United States, and the study results were published in April in the New England Journal of Medicine, where 85, 7 had at least three % of vaccine efficacy against the disease with signs or symptoms.
Bronchiolitis affects the small airways causing difficulty in breathing and manifests with agitation, cough, weakness, difficulty eating or sleeping, warns the Ministry of Health.
In addition, the viruses that cause acute respiratory infections are transmitted from person to person by direct contact between hands and contaminated surfaces and through droplets of nasal secretions or saliva that are spread when an ill person talks, sneezes, or Spread through the air when coughing.
The clinical trial evaluating the efficacy and safety of this new vaccine was conducted through a double-blind study, meaning that neither the person receiving it nor the health facility administering it knew whether Whether the volunteer is receiving the vaccine or not. placebo
The expert pointed out that RSV is the leading cause of hospitalization due to respiratory viruses in children, and one of the main causes of respiratory mortality in children.
and that “when they are over 60 years of age, it can cause severe respiratory symptoms, with viral pneumonia, and make them worse if they have severe or chronic respiratory diseases, such as that heart disease,” he warned.
Babies less than 3 months old, premature babies, and people with chronic health problems (such as heart disease, chronic lung disease, or compromised immunity) are at higher risk of severe forms.
Large-scale enrollment of people over 60 years of age for the Phase 2/3 clinical trial of this vaccine began in August 2022 at the Cirujano Mayor Cosme Argerich Central Military Hospital, where the study of the Pfizer laboratory vaccine was also centralized.
