"It is going to change the course of pediatric disease, because it will free up hospitals from having so many serious cases," Fernando Polack, scientific director of the Infant Foundation, told Télam.
The first maternal vaccine against bronchiolitis achieved a protection of more than 80% in clinical trials, which means a "revolution" in pediatric medicine to combat this acute respiratory infection, one of the main causes of death of children under one year of age, specialists explained Wednesday.
The U.S. laboratory Pfizer reported that the completion of the Phase III clinical trial showed that the vaccine achieved 81.8% protection against Respiratory Syncytial Virus (RSV) infection in the first 90 days of life and maintained 69.4% efficacy up to six months.
"This vaccine predicts a revolution in the health system. The results are tremendously conclusive, last time it was thought to reach 40% protection and it was not achieved, and now it was far exceeded. It is going to change the course of pediatric disease, because it will free hospitals from having so many serious cases", Fernando Polack, scientific director of the Infant Foundation, told Télam.
About bronchiolitis
Bronchiolitis is an acute respiratory infection that occurs most frequently in the autumn-winter months, and affects mostly children under 1 year of age. It can be caused by different viruses; the most common is Respiratory Syncytial Virus (RSV).
Data from the Ministry of Health
According to the latest National Epidemiological Bulletin of the National Ministry of Health, 173,723 cases of bronchiolitis were reported in 2022, with a cumulative incidence rate of 11,861.8 cases/100,000 inhabitants.
In Argentina, each year, this disease caused by RSV generates about 20,000 hospitalizations and about 600 preventable deaths in children under one year of age.
"With the vaccine, there would be a paradigm shift, since vaccination would prevent the hospitalization of 80% of severe cases," explained Polack.
Bronchiolitis Vaccine Tárget
This type of vaccine is given to pregnant women, just as flu or whooping cough vaccines are given today, so that the child is born prepared to face 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, so she passes the antibodies to the baby through the placenta. The baby, with its antibodies, is protected until it is 6 months old", explained to Télam Romina Libster, pediatrician, researcher and specialist in vaccines.
"The most vulnerable time is the first year, and especially the first 6 months, so what we are looking for is that when it is born it is already protected," he added.
Clinical trials
The clinical trial study involved 7,400 pregnant women under 49 years of age from 18 countries as of June 2020. Beginning late in the second trimester of gestation, half of the mothers randomly received a dose of the vaccine and the other half a placebo version.
In Argentina, 942 women participated in the study at the Buenos Aires Military Hospital, Osecac and health centers in the provinces of Salta and Tucumán.
The mothers were followed up to six months after delivery and the infants up to one year of age. A subgroup of boys will be followed for two years.
Having obtained positive results in the Maternal Immunization Study for Safety and Efficacy (Matisse), Pfizer anticipates that it will submit the data for publication in a scientific journal. Afterwards, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Argentina's Anmat, among other regulatory agencies, are expected to approve this procedure in the coming months.
If approved, it will be the world's first maternal vaccine against bronchiolitis virus in infants.
"It is going to change public health in a radical way. It protects 80% of severe disease in the first three months of life, the impact is gigantic," Libster stressed.
"This vaccine has an impact not only on saving lives but also on the reality of millions of families," the specialist concluded.
Note from Télam
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