“This vaccine predicts a revolution in the health system. The results are extremely conclusive, the last time it was thought to reach 40% protection and it was not achieved, and now it has been far exceeded. It is going to change the course of pediatric disease, because it is going to free hospitals from having so many serious cases“he told Telam Fernando Polack, scientific director of the Infant Foundation.
What is bronchiolitis
The bronchiolitis is an acute respiratory infection that occurs more frequently in the autumn-winter months, and It mainly affects children under 1 year of age.. It can be caused by different viruses; the most common is Respiratory Syncytial Virus (RSV).
“70% of infants hospitalized in winter are caused by bronchiolitis, they overwhelm hospitals, generating enormous tension in the medical service”, Polack specified, and explained that in developing countries “50% die at home, they are silent deaths.”
According to the latest National Epidemiological Bulletin of the Ministry of Health of the Nation, in 2022, 173,723 cases of bronchiolitis were reportedwith a cumulative incidence rate of 11,861.8 cases/100,000 inhabitants.
In Argentina, each year, this disease caused by RSV generates some 20,000 hospitalizations and some 600 preventable deaths in children under one year of age.
“With the vaccine there would be a paradigm shift, since with vaccination the hospitalization of 80% of serious cases would be avoided,” explained Polack.
Pregnant mothers will be vaccinated
This type of vaccine is given to pregnant women, just as today the flu or whooping cough is given, so that the child is born prepared to deal with these diseases thanks to the antibodies provided by the mother.
“It is a vaccine designed to be given to the mother, who had contact with the virus several times during her life, then passes the antibodies to the baby through the placenta. The baby, with its antibodies, is protected up to 6 months,” explained to Télam Romina Libster, pediatrician, researcher and specialist in vaccines.
“The most vulnerable moment is the first year, and especially the first 6 months, so what is sought is that when he is born he is already protected,” he added.
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How were the vaccine trials
The clinical trial study enrolled 7,400 pregnant women under the age of 49 from 18 countries as of June 2020. Starting in the late second trimester of pregnancy, half of the mothers randomly received one dose of the vaccine and the other half one dose. placebo version.
In Argentina, 942 women participated in the study at the Military Hospital of Buenos Aires, in Osecac and at health centers in the provinces of Salta and Tucumán.
The follow-up of the mothers lasted up to six months following delivery and that of the babies, up to one year of life. A subgroup of boys will be followed for two years.
Obtaining positive results in the Maternal Immunization Study for Safety and Efficacy (Matisse), Pfizer anticipated that it will send the data for publication in a scientific journal. Then, the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Anmat of Argentina, among other regulatory entities, are expected to approve this procedure in the coming months.
If approved, It will be the first maternal vaccine in the world once morest the bronchiolitis virus in infants. “It is going to radically change public health. It protects 80% from severe disease in the first three months of life, the impact is enormous,” Libster pointed out.
“This vaccine has an impact not only in saving lives but also in the reality of millions of families,” concluded the specialist.