Madrid
Updated:
Keep
The virus respiratorio sincitial (RSV) is the leading cause of lower respiratory tract infections such as bronchiolitis and pneumonia in children under 1 year of age. In Spain, this virus causes 80% of bronchiolitis, a common lung infection in babies and young children that causes inflammation and congestion in the bronchioles of the lung. Most cases are mild and usually resolve following a few weeks without treatment, but in others, respiratory distress can worsen and require hospitalization.
Currently, the only treatment for mild infection is limited to symptomatic relief and can be treated on an outpatient basis, while more severe cases may require hospitalization. Once hospitalized, these children may require care such as supplemental oxygen, intravenous fluids, and/or require mechanical ventilation.
But according to a study published today in
«The New England Journal of Medicine»it is possible that an effective treatment has finally been found: it is regarding Nirsevimab, a monoclonal antibodywhich showed 74.5% efficacy once morest medically attended lower respiratory tract infections caused by RSV in healthy infants.
This is an international, randomized, placebo-controlled phase 3 clinical trial, presenting the first potential immunization once morest bronchiolitis virus in the general child population. A single dose provides safe protection throughout the virus season.
The evolution of the disease caused by RSV is unpredictable. There are certain vulnerability factors in some children, such as being born prematurely or having chronic heart or respiratory diseases, which lead to a higher risk of hospitalization or admission to pediatric intensive care units (PICU).
However, this risk also extends to all children, since in Spain 98.3% of those under 1 year of age hospitalized for RSV are healthy full-term infants; Similarly, 3 out of 4 PICU admissions occur in children without vulnerability factors.
“These data show that nirsevimab has the potential to offer protection once morest RSV for all infants, which would be a paradigm shift in the approach to this disease,” said lead researcher William Muller of the
Hospital Infantil Ann & Robert H. Lurie de Chicago and of the
Universidad Northwestern (EE.UU.).
The trial was conducted in healthy term and late preterm infants (gestational age ≥35 weeks).
Nirsevimab is an investigational long-acting monoclonal antibody developed by
AstraZeneca and
Sanofidesigned to protect all babies during their first RSV season with a single dose.
Although monoclonal antibodies do not require activation of the immune system to help provide rapid and direct protection once morest disease.
Currently, the only preventive option available for RSV is palivizumab, which is limited to high-risk infants and provides protection for one month, requiring five injections to cover one season.
A separate Phase 2/3 trial, also published in
«The New England Journal of Medicine»which evaluated the safety of nirsevimab in infants with congenital heart disease, chronic lung disease, and premature infants entering their first season of RSV, demonstrated that nirsevimab had a safety and tolerability profile compared to palivizumab.
Results in this population of infants indicated similar protection once morest RSV as healthy term and late preterm infants.
“We know that this virus has experienced a resurgence with the relaxation of public health measures from Covid-19. This shows us that a comprehensive immunization approach is needed to help mitigate the substantial global burden of RSV on infants, their families, and healthcare services.Muller says.
