Revolution in pediatric medicine for the first maternal vaccine against bronchiolitis

Clinical trials from Fundación Infant Photo Courtesy Silvina Frydlewsky El País
Clinical trials from Fundación Infant (Photo: Courtesy Silvina Frydlewsky/El País).

The first maternal vaccine against bronchiolitis achieved protection of more than 80% in clinical trials, which means a “revolution” in pediatric medicine to combat this acute respiratory infectionone of the Leading causes of death for children under one year of agespecialists explained this Wednesday.

The American laboratory Pfizer reported that the completion of the Phase III clinical trial showed that the vaccine achieved 81.8% protection against infection caused by the Respiratory Syncytial Virus (RSV) in the first 90 days of life and kept a 69.4% efficacy up to six months.

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,” Fernando Polack, scientific director of the Infant Foundation, told Télam.

Fernando Polack scientific director of the Infant Foundation Photo Courtesy Silvina Frydlewsky El País
Fernando Polack, scientific director of the Infant Foundation (Photo: Courtesy Silvina Frydlewsky/El País).

About bronchiolitis

Bronchiolitis is an acute respiratory infection that occurs more frequently in the autumn-winter months, and 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 in the house, they are silent death”.

Data from the Ministry of Health

According to the last 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, every year, this disease caused by RSV It 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.

Target of the bronchiolitis vaccine

This type of vaccine is given to pregnantjust like today the flu or whooping cough, 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“, Romina Libster, pediatrician, researcher and specialist in vaccines, explained to Télam.

“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.

clinical trials

In the study of clinical trials 7,400 pregnant women under 49 years of age from 18 countries participated since June 2020. Starting in the late second trimester of pregnancy, 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 Military Hospital of Buenos Aires, in Osecac and in health centers in the provinces of Salta and Tucumán.

The follow-up of the mothers lasted up to six months after delivery and that of the babies, up to one year of life. A subgroup of boys will be followed for two years.

Fernando Polack Photo Courtesy Silvina FrydlewskyEl Pas
Fernando Polack (Photo: Courtesy Silvina Frydlewsky/El País).

Obtaining positive results in the Maternal Immunization Study for Safety and Efficacy (Matisse), Pfizer anticipated submitting the data for publication in a scientific journal. Then, the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Anmat of Argentina, among other regulatory entities, 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 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.

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