The trials were conducted at the Central Military Hospital of Buenos Aires. It is Abrysvo, from Pfizer laboratory, a vaccine intended for adults over 60 years of age for RSV.
The U.S. Food and Drug Administration (FDA) approved a vaccine against Respiratory Syncytial Virus (RSV), whose trials were carried out at the Central Military Hospital of Buenos Aires, and has an "efficacy of over 80%", according to Gonzalo Pérez Marc, the principal investigator of these studies, who told Cadena 3.
It is Abrysvo, from the Pfizer laboratory, a vaccine intended for adults over 60 years of age for RSV, the main cause of bronchiolitis in the pediatric population and severe respiratory conditions in the elderly population.
"What was approved is the second vaccine against RSV, and there is another one that was approved a month ago. It is the first time in history that we have this vaccine," said Perez Marc, principal investigator of the clinical research studies that were done to evaluate the safety and efficacy of this vaccine in our country.
A month ago, the FDA approved the vaccine Arexvy, 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 specialist, since 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 from La Plata and Mar del Plata participated, as well as clinical centers from Salta, Córdoba and Tucumán.
"It was quite federal and with population from all over Argentina, which is very interesting," he said.
The clinical trial evaluating the efficacy and safety of this new vaccine was conducted as a double-blind study, which means that neither the person receiving the vaccine nor the health center administering it knows whether the volunteer is receiving the vaccine or the placebo.
The specialist indicated that, in addition to the trials on adults, tests were carried out on pregnant women, "which would allow children to be born with the defenses".
If approved, "it would totally change the epidemiology and the way of working in pediatrics because it is one of the main pediatric problems we have every winter," he said.
"The protein that the virus will ingest is the one that triggers the immune defense response, that same protein, without the virus, you build it in the lab and introduce it into the vaccine," he explained.
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 the safety, which they will continue to evaluate until the end of the year.
The study involved 240 centers around the world from countries such as Canada, Finland, Japan, the Netherlands, South Africa and the United States, and the results of the study were published in April in the New England Journal of Medicine, which indicated 85.7% efficacy of the vaccine against this disease with at least three signs or symptoms.
Bronchiolitis affects the small airways causing varying degrees of difficulty in breathing and manifests itself with agitation, coughing, decay, difficulty in feeding or sleeping, warned the Ministry of Health.
In addition, viruses that cause acute respiratory infection are transmitted from one person to another by direct contact between contaminated hands and surfaces, and through nasal secretions or saliva droplets that travel through the air when a sick person talks, sneezes or coughs.
Children under 3 months of age, premature infants and those with chronic health problems (such as heart disease, chronic lung disease or compromised immunity) are more at risk of presenting with severe forms.
Mass enrollment of people over 60 years of age for the Phase 2/3 clinical trial of this vaccine began in August 2022 at the Central Military Hospital "Cirujano Mayor Cosme Argerich", where the study of the Pfizer laboratory's vaccine against the coronavirus was also centralized.
