It is one of the most feared diseases by parents of young children. Each year, bronchiolitis affects 30% of children under 2 in France, according to the Ministry of Health. Most often due to respiratory syncytial virus (RSV), this highly contagious respiratory infection of the small bronchi is most often benign. However, it remains one of the main causes of winter hospitalization in infants and, in very rare cases (0.08%), can lead to the death of the child.
Many elements that, for years, have led pharmaceutical companies to take an interest in bronchiolitis. This is the case of the French Sanofi and the British AstraZeneca, which have joined forces to develop a “vaccine”, nirsevimab, just approved by the EMA, the European Medicines Agency. Published March 2022 in New England Journal of MedicineResults from the phase III study showed a 74.5% reduction in lower respiratory tract infections caused by RSV and requiring medical treatment.
A single dose
Regularly presented as a “vaccine”, Beyfortus, its trade name, is in fact a monoclonal antibody, to be injected in the first months of a child’s life, before or during the bronchiolitis epidemic, ie between the end of October and January. . It confers what is called passive immunity, unlike live attenuated vaccines (such as BCG or MMR), which contain an infectious agent and induce active immunity.
A novelty? Not entirely. “There are other monoclonal antibodies against RSV, such as Synagis, but it requires frequent injections and affects only premature or at-risk babies, which is just 2% of babies,” indicates the president of the French Society of Pediatrics, Professor Robert Cohen, who participated in the coordination of the clinical trial in France.
The Beyfortus only requires one injection and could protect for six months. “This does not mean that there is no longer any protection afterwards, but it allows to overcome the fragility of children in the face of this disease”, says Robert Cohen. For him, the arrival of such treatment would therefore mark an important turning point in terms of children’s health, but also a change in the culture of public health. “For a long time we were only interested in vaccines that prevented mortality. That’s why rotavirus vaccination (responsible for gastroenteritis, ed) it took years to be authorized in France. Today, and more particularly after Covid, we measure how heavy a visit to the emergency room or hospitalization can be, not only for young patients and their families, but also for health services. “
Hospitals overwhelmed every year
By limiting the number of RSV infections, which also cause pneumonia, bronchitis and otitis, Beyfortus would lighten the hospital’s burden every winter. Last year the epidemic, which occurred earlier than usual, had led to the transfer of several newborns, due to lack of space in the surrounding structures.
Now approved by the EMA, Beyfortus has yet to get the green light from the European Commission, which is expected to decide within two months. It will therefore be up to the French authorities to draw up national recommendations. For Robert Cohen, therefore, treatment shouldn’t be available for at least a year.
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