A first preventive treatment against bronchiolitis has been authorized in France… After the European Medicines Agency a year ago and the American agency last month, the High Authority for Health (HAS) gave the green light to the marketing and reimbursement in France of Beyfortus, the first preventive treatment against bronchiolitis. It is not a vaccine but a monoclonal antibody that can be injected into infants under the age of one from September.
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Marketed under the name Beyfortus, nirsevimab, a monoclonal antibody developed by two groups, the French Sanofi and the British AstraZeneca, aims to protect babies against the respiratory syncytial virus (RSV), responsible for bronchiolitis.
Well known to parents and pediatricians, this respiratory disease affects almost 30% of children under two years old in France every winter. This represents 480,000 cases per year. During the last epidemic season, between October 2022 and March 2023, RSV bronchiolitis led to 75,000 visits to the emergency room and more than 26,000 hospitalizations. This is, on average, twice as many as the number of cases recorded between 2015 and 2020.
Injected in a single dose into the thigh of the infant just before the epidemic season, or at birth if the child is born during this period, Beyfortus immediately protects against the virus. But it is not a vaccine because it provides the body with the necessary antibodies directly instead of causing it to produce them.
According to clinical trials carried out on 8,000 children in four European countries last winter, the treatment would lead to an 83% drop in hospitalizations. But its effectiveness will be reassessed within a year, specifies the High Authority for Health.