Nirsevimab, against respiratory syncytial virus
“This innovative drug, along with other preventive measures, represents a paradigm change in the prevention of respiratory syncytial virus, which is cruel and tearing apart families,” said Gregorio Marañon, president of seNeo and freshman at the General Hospital said Dr. Manuel Sánchez Luna, Chief of Pediatrics at University Hospital.
“Nirsevimab offers additional advantages over previous monoclonal antibodies (traditional palivizumab) in that it has the same or greater potential to be administered as a single dose at the beginning of the season when infection prevalence is highest and to ensure that Protection against RSV is provided throughout. “This season,” he emphasizes.
In addition to these children with no risk factors, it is also prescribed to premature infants, infants under 35 weeks gestation, and infants under one year old; as well as those with chronic respiratory, cardiac or immune system diseases and poor organic defenses. Infants under 10 years of age.
Epidemic outbreaks of RSV in the global northern hemisphere occur between November and April. In Spain, the months with the highest incidence are mainly December and January.
The monoclonal antibody was approved in the EU on November 3, 2022, allowing it to be widely used during the first epidemic season in 2023-2024, which Spain has indicated will start on October 1.
The U.S. Food and Drug Administration (FDA) did the same on July 17, 2023, in response to the devastating consequences of respiratory syncytial virus.
This preventive drug is therefore essential for the health of all babies under two years of age, although it is largely reserved for babies who are less than six months old at the start of the epidemic season, or who, like panizumab, are inherently more fragile Dating.
Respiratory syncytial virus, a global public health problem
Infections caused by respiratory syncytial virus are one of the major health disorders worldwide as they affect the entire population, as respiratory syncytial virus is one of the leading causes of hospitalization in children under five years of age.
“Currently we know that this is an infectious disease with the highest prevalence in all countries, whether developing or economically developed,” the neonatologist said.
Up to 90% of boys and girls under the age of two are infected with at least one RSV infection during this time. A large proportion of cases develop the disease in the lower respiratory tract.
In fact, approximately 2-5% of these patients typically require hospital intervention, of which 3-11% will occur upon admission to the appropriate neonatal or pediatric ICU.
A Spanish study led by Dr. Manuel Sánchez Luna and published in 2016 collected data over nine years (2004-2012) and found that 98.3% of RSV hospitalizations were children with no risk factors.
The mortality rate for this period was also determined to be 120 deaths per 100,000 hospitalized patients, compared with 69 deaths in 2012.
Conclusions: RSV bronchiolitis is the leading cause of hospitalization in infants under 1 year of age.
“Respiratory syncytial virus has become the second leading cause of infant death in the world due to respiratory problems,” said Dr. Manuel Sánchez Luna.
A 2017 World Health Organization study showed that respiratory diseases in this age group can kill up to 60,000 people each year, half of which are caused by respiratory syncytial virus.
These infections are especially serious in newborns and babies two to three months old.
“There is a particularly vulnerable group that is susceptible to very serious respiratory problems caused by this virus, and they are premature babies, basically those babies who weigh less than 1,500 grams at birth,” he stressed.
He warned: “The mortality rate caused by RSV in these children is 15 times higher than in other children born at an advanced gestational age, that is, they have more and better developed defenses and structures in the body.”
RSV bronchiolitis, a worrying lung infection
he respiratory syncytial virusSince the 1950s, old acquaintances in paediatrics, neonatology, pulmonology and cardiology belong to Paramyxovirusand the viruses that cause measles and mumps (mumps).
“RSV, 70-80% of origins of bronchiolitis, requiring hospitalization in 3% of infected infants; in the most severe cases, some may die due to breathing difficulties, immune problems, or preexisting congenital heart disease. ” Senio.
Other, but less common, viruses that cause bronchiolitis include influenza viruses (influenza A and B), parainfluenza viruses, adenoviruses, and metapneumoviruses.
The virus is spread through droplets expelled when an infected person breathes or sneezes. This microorganism enters our body through the mucous membranes of the mouth and nose or the conjunctiva of the eyes.
Additionally, our infected hands and lips become vectors of indirect infection.
It’s worth remembering that RSV can survive for several hours on objects, whether it’s a pacifier, a bottle, a toy, the railing of a crib or the innocent handle of a cradle.
By the same token, don’t feed babies breast milkNaliving in tobacco smoke or receiving care and attention in child care centers can lead to an increased risk of infection.
The virus can spread within the body within three or four days, Its pathological effects begin with clinical manifestations similar to those of the common cold.
In the most severe cases, the virus damages the thinnest and most fragile lining of the bronchi and bronchioles, causing the well-known bronchiolitis or even pneumonia.
RSV has also been linked to the development of asthma in people without a history of atopy (who are prone to allergic reactions).
Symptoms first appear as the nasal cavity is blocked by mucus, sometimes with coughing for several days, and sometimes fever.
If the baby or child does not improve, he or she will breathe faster and more laboredly, with well-defined ribs and exaggerated rise and fall in the abdomen, along with a constant emphasis on coughing.
From there, noisy breathing accompanied by wheezing occurs, which is a clear sign of inflammation of the bronchial tubes with mucus.
Likewise, negative evolution may cause vomiting, dehydration, lethargy, loss of appetite, fatigue, bluish skin, especially around the lips and fingertips; in addition, symptoms such as paleness and sweating may occur.
In infants, especially in the first three months of life, the capacity of the pulmonary system is systematically reduced, producing breathing difficulties that may require hospitalization and treatment. advanced life support (ECMO): 20-25 per 1,000 boys or girls over the past decade.
These cases can cause serious problems in children during the winter and are a real danger for babies with pre-existing risk factors such as premature birth and respiratory disease.dbronchopulmonary dysplasia), congenital heart disease, people born with Down syndrome, especially immunocompromised babies.
“For these groups of infants, we have not been using this drug until now, and fortunately for two decades, palivizumab“This is a highly effective monoclonal antibody, but it has a short half-life and high cost,” said Dr. Manuel Sánchez Luna.
With this monthly preventive immunization throughout the seasonal infectious period, hospitalizations for bronchiolitis after RSV infection are reduced by 60% to 80%.
from Spanish Society of Neonatology We have communicated some recommendations so that monoclonal antibodies Niselumab Since there are currently no alternative vaccines, preventive vaccinations must be administered to these groups of infants.
We hope that, thanks to the decision of the Ministry of Health and its autonomous communities, we can once and for all reduce the terrible impact of respiratory syncytial virus infection on children, in addition to becoming pioneers in the management of this drug.
Dr. Manuel Sánchez Luna, Chief of Department and Head of Neonatology, Gregorio Marañon University Hospital in Madrid