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Beyfortus, the newest drug to prevent bronchitis in children: “A new era begins”

To date, the only medication available is to treat respiratory syncytial virus (RSV), the most common cause bronchitis y pneumonia in neonates and infants it was palivizumab, with complicated dosing and high costs. But start now a “new era” in the fight against this virus that especially affects the little ones. Committee on medicinal products for human use European Medicines Agency (CHMP) has approved a license for the medicine Beyfortus, developed by Sanofi y AstraZeneca and the active ingredient is nirsevimab. “Great news” for experts.

This new drug, which still needs permission for its marketing in European Unionthat is long-acting monoclonal antibodies which according to data from clinical trials published by pharmaceutical companies is effective and safe and requires only single dose before the start of the RSV season, which usually corresponds to the cold months.

As explained by the company Sanofi in a Press release“if accepted, Beyfortus would be the first and only passive vaccination single dose for a broad population of children, incl healthy infants, born at maturity or prematurely [menos de 35 semanas de gestación]or with specific medical conditions” such as congenital heart disease (CHD) and/or chronic lung disease of prematurity (CLD).

In randomized, placebo-controlled clinical trials, 1,453 healthy preterm infants from 29 to 35 weeks’ gestation received a single intramuscular injection of 50 mg of nirsevimabi or placebo. In the group receiving this new drug, the frequency of lower respiratory tract infections caused by RSV dropped by 70% compared to the group that received nothing but a placebo. The studies were conducted in both hemispheres, at 164 centers in 23 countries.



Both affect young children and can cause breathing problems.  GTRES

Later, in phase 3 of the study – which they called the Melody study – the incidence of serious respiratory infections caused by RSV, such as bronchitis or pneumonia, was reduced by 74.5% compared to the placebo group. Different stages of the tests have been carried out between November 2016 and May 2021.

From the Vaccine Advisory Committee of the Spanish Pediatric Association (CAV-AEP) they commented, as can be read in your account Twitterthat with this preventive medicine “a new era in the fight against RSV begins”.

“If expectations are met, it could have a considerable impact on the health of the children who receive it”

One of the members of this committee, pediatrician Ángel Hernández Merino, has stated that Science Media Centerwhich is “great news” for it “potentially preventable” disease that usually saturates health care and hospital services every seasonand because of its “simple doses”, compared to palivizumab, the only drug available so far to prevent diseases caused by RSV but “with very noticeable limitations of utility, apart from high costs. Indeed, its indications, very reduced, and dose (complex, requiring repeated doses) means that while at the individual level its effect may be relevant to those who receive it, at the population level it is almost irrelevant and costly’.

According to him errand published by the European Medicines Agency (EMAfor an acronym in English), clinical trial results showed that Beyfortus had a “safety profile similar to Synagis (palivizumab)”.

Side effects

The most common side effects found in the Beyfortus trials were rash skin, fever (fever) and injection site reactions (such as redness, swelling or pain).

In the absence of details of the technical sheet and the status of the Spanish Agency for Medicines and Health Products (Aemps), “having nirsevimab will provide a. a new preventive measure of RSV infection in infants. If expectations are met, it could have a considerable impact on the health of children who receive it, special interest in the most vulnerable (individual benefits) and relieve the health system of a disease that has the capacity to collapse it (population benefits),” concludes Hernández Merino.

RSV is a common respiratory virus that usually causes mild cold symptoms and most people recover in a week or two, but it can be serious, especially in infants. As mentioned EMA“is the most common cause of lower respiratory tract infections, such as bronchitis (inflammation of the small airways in the lungs) and pneumonia (infection of the lungs) which can lead to hospitalization or even death in newborns and young children“.



Influenza infections are increasing

the pandemic of covid moved this –and others, such as the flu– virus and in the years 2020 and 2021 decreased in frequency, but as the coronavirus becomes a less serious infection for the majority of the population and preventive measures have been eliminated, “Infections are expected to start again“, warns EMA.

According to data from the European Agency, in 2015 RSV caused approx 33 million infections of the lower respiratory tract in children under the age of five worldwide, of which 3.2 million required hospitalization. Um 59,600 children diedthe vast majority (43,600) in low- and middle-income countries.


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