8 questions and answers about the new bronchiolitis vaccine


Source: Two Pediatricians at Home

within a few days Nirsevimab Vaccination Campaignis a monoclonal antibody directed against respiratory syncytial virus (RSV), the cause of most cases of bronchiolitis in young children.

As with everything new, parents of children whose vaccinations are recommended often have questions, which is why we felt it necessary to publish this article postal In recent days we have received queries in consultation and on social networks.

We hope these questions will be resolved after you finish reading this article.

What is bronchiolitis?

According to the classic definition, bronchiolitis is First wheeze in a child under two years of age In case of viral infection.

Clinically, we pediatricians encounter babies who are several months old Cough and runny noseand often have fever, People who have trouble breathing When we listen to them, we hear a wheezing or micro-crackling sound in the lungs.

Now No treatment can change the course of the diseasewhich ultimately means many children, especially the youngest, end up in hospital with difficulty breathing or needing oxygen.

Expressed in numbers, it is estimated that One in three children under two years old develops bronchiolitis, 5% of whom require hospitalization hospitable. As you can imagine, these numbers are very high, which means during bronchiolitis season, pediatricians are seeing many young children with the disease day in and day out.

Who is RSV?

There is no doubt that of all the viruses that can cause bronchiolitis, he respiratory syncytial virus (short for VRS) is the most important because Up to 80-90% of clinical diseases are caused by it.

RSV is a seasonal virus, which means it visits us with almost mathematical frequency every year.Generally speaking, this virus is cold months of the yearthis means in Spain that we see clinical symptoms caused by RSV from the end of October to March.

This virus does not leave lifelong immunity after infection, although in older children it often causes a cold rather than clinical symptoms consistent with bronchiolitis.

Therefore, when fighting or preventing bronchiolitis, the main target should be RSV since it is its primary cause.


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What is nirumab?

In October 2022, the European Medicines Agency authorized the use of Monoclonal antibodies against RSV in neonates and infants. This monoclonal antibody is called Nirsevimab.

When we talk about monoclonal antibodies, we mean giving your child an antibody that neutralizes RSV. In this sense, it is not a vaccine that we are accustomed to, since viral particles, antigens, or toxoids are administered in the remaining cases where children receive the vaccines contemplated in the vaccination program. It reacts and creates its own defenses.

in other words, When the baby is treated with Nirsevimab, it will be given to the soldiers who will protect him from RSV infection. Your immune system doesn’t have to do anything. This is what is called passive immunity in medicine.

NOTE: As you may have noticed, this medication Prevent RSV only. This means that Nirsevimab does not prevent all viruses that cause bronchiolitis, although it does protect against the viruses that cause the most severe cases.

Is this new vaccine safe?

Since the launch of Nirsevimab commercialization studies in 2014, No serious adverse reactions were recorded. According to the technical sheet, the most common condition is a rash within 14 days of vaccination, in addition to fever or pain at the site of vaccination. The reported incidence of these minor adverse reactions is less than 1%.

We know that when something new comes along, it always raises questions about the safety of its administration. However, Nirsevimab has passed all necessary controls and is considered a safe vaccine with clear benefits for children who receive it.

On the other hand, it also gives everyone more confidence in this new Medically, premature infants have been given an anti-RSV monoclonal antibody called palivizumab for many years. The problem with this antibody is that it only protects for a month, so children have to get a new puncture every 30 days.

This suggests that preventing RSV with monoclonal antibodies is nothing new, so if you decide to vaccinate your child, you will do so with all the assurances science provides.

How effective is this vaccine?

If this new vaccine is recommended, it is because studies have been conducted that show it has clear health benefits for those who receive it.

If we look at the data, we see that when comparing placebo to Nirsevimab, Prevent severe cases of RSV bronchiolitis and the need for hospitalization and reduce the need for medical care in children.

And don’t think the numbers are small because In the studies conducted, an 80% reduction in the frequency of these variables was observed. This means that children who received the monoclonal antibody in the study required approximately 80% less medical care when infected with RSV, had 80% fewer hospitalizations for RSV, and had 80% fewer severe cases of RSV bronchiolitis.

Considering that RSV bronchiolitis is very common in the winter, these “80% reduction” are very encouraging figures. In fact, given these results, a fellow pediatrician commented on RRSS the other day that if Nirsevimab works as expected, maybe we pediatricians will be out of a job…

Different from the palivizumab we talked about before, A single dose of Nirsevimab provides protection against RSV for at least 150 days (5 months) after dosing. In other words, with just one puncture, we can protect the child during RSV transmission.

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Who is recommended to get vaccinated?

On July 12, 2023, the Public Health Committee of the Territorial Council of the Spanish National Health System published a document containing recommendations from groups recommending vaccination with Nirsevimab vaccine. They are:

  • Children under 6 months old at the start of the vaccination campaign. This means that all children born between April 1, 2023 and March 31, 2024 are recommended to receive Nirsevimab treatment.
  • Children younger than 2 years of age with risk factors for severe RSV bronchiolitis. This group includes, for example, premature infants with a gestational age of less than 35 weeks, children with congenital heart disease with significant hemodynamic changes, infants with pulmonary bronchial dysplasia, children with immunodeficiencies, or patients with Children with neuromuscular or pulmonary disorders that reduce the ability to eliminate secretions. airway.

The “only” (in quotation marks) recommendation to vaccinate these children is based on epidemiological cost-benefit studies, that is, since it is a public health measure and the aim is to gain benefits by avoiding the most severe cases. RSV bronchiolitis (in children younger than 6 months and those with underlying medical conditions) is the disease that imposes the greatest costs on the system.

NOTE: Among the risk groups for severe bronchiolitis are not included those children who do not have any type of underlying medical condition, who have recurrent bronchitis, or even those who are receiving maintenance therapy with inhaled corticosteroids.

How will the immunization campaign be carried out?

These recommendations of the interregional committee must be collected by each autonomous region and implemented according to its protocols. But in general, most autonomous regions will take the following measures:

  • for children Born on or after October 1, 2023 They will be administered Nirsevimab Postpartum and before discharge.
  • to Children born from April 1, 2023 to September 30, 2023 will be offered to be vaccinated by self-appointment, at their health center or some hospitals.
  • Children under two years of age with risk factors will proceed in the same manner as in the previous point.

The last two assumptions, that of children born before October 1, are the ones that differ the most between autonomous regions.If you are in doubt, what you should do is Ask your pediatrician or nurse so they can provide you with information Be as up to date as possible.

Can I buy Nirsevimab myself?

Many parents whose children do not meet the recommended criteria for Nirsevimab vaccination wonder whether they can privately purchase the monoclonal antibody to protect their children.

However, according to the technical sheet, Nirsevimab is a hospital-prescribed monoclonal antibody, so it is unlikely to be sold for free in pharmacies..

Nonetheless, it must be clear that current vaccination campaigns against RSV are designed to protect the most vulnerable children from severe disease caused by bronchiolitis and, therefore, may be significantly cost-effective.

In summary, the new vaccination campaign against Nirsevimab may represent a before-and-after change in pediatrics, relegating bronchiolitis to a rare and less serious disease than what we are accustomed to. Pediatricians are eager to see whether it finally lives up to expectations.

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