2023-09-15 05:12:36
It looks like a vaccine. It is injected like a vaccine. This is intended to protect against a disease, like a vaccine. But Beyfortus is not a vaccine, it is a preventive treatment against the main virus responsible for bronchiolitis, and which will be available for the very first time this Friday.
How does it work ? Who is he talking to ? And is it effective? 20 Minutes explains what we know about this new drug.
Antibody immunization against RSV
Marketed under the name Beyfortus by the pharmaceutical giant Sanofi, nirsevimab is a monoclonal antibody administered by injection. However, it is not a vaccine, we repeat, but rather a prophylactic, or preventive, treatment which aims to immunize infants against the respiratory syncytial virus (RSV).
This RSV is the main cause of bronchiolitis, which affects many infants each year. “In France, RSV bronchiolitis, whose epidemic generally begins in the fall and ends at the end of winter, is one of the leading causes of hospitalization of infants under 1 year old during the winter season, indicates the National Medicines Safety Agency (ANSM). It is estimated that bronchiolitis affects nearly 30% of infants under 2 years old each winter, or around 480,000 cases. Each year, 2 to 3% of infants under 1 year of age are hospitalized for more severe bronchiolitis.
Last season, the epidemic of bronchiolitis, which causes coughing and difficult breathing, was the most intense in more than a decade, with tens of thousands of babies hospitalized. “The winter was a disaster, between the virulence of the epidemic and the difficulties from a hospital point of view, with many closed beds,” says Dr Anne Béguin, pediatrician and member of the French Pediatric Association. ambulatory (AFPA).
Treatment intended for children born from February 6, 2023
Until now, there was almost no preventive treatment, with one exception: Synagis, developed by AstraZeneca. A treatment that is, however, cumbersome to administer and reserved only for babies at risk. In this context, the Minister of Health, Aurélien Rousseau, made the deployment of Beyfortus “one of the major challenges of the start of the school year”, considering that it represents “a major advance for the health of infants”.
An enthusiasm shared in particular by learned societies of pediatricians and general practitioners. “We are delighted with the arrival of this treatment”, rejoices Dr Béguin who, “since the end of August”, has “already written the first prescriptions: it is very well received and awaited by the parents, who are really afraid bronchiolitis, and who are aware of the seriousness of a severe form in a toddler. From these days we will begin the administration. And unborn babies will receive it directly in the maternity ward.”
But who will be able to receive it starting this Friday? “Beyfortus is indicated (…) in newborns and infants during their first season of RSV circulation,” indicates the European Medicines Agency (EMA). (It) should be administered before the start of the RSV epidemic season, or at birth in infants born during the RSV epidemic season.” In France, this monoclonal antibody is intended for all babies born since February 6, 2023.
Discrepancies on the effectiveness of the treatment
However, there are disagreements about its effectiveness. There is “a certain excitement, a little rapid in my opinion, in terms of evidence”, judges Professor Rémy Boussageon, professor of general medicine. Like other critics, he points out that one of the three studies provided by Sanofi did not show a significant effect in reducing hospitalizations. Certainly, such an effect was then clearly (- 83%) proven by another study by Sanofi, but which has not yet been published in a scientific journal and was carried out according to a slightly less strict methodology.
“The results of three clinical trials conducted between 2016 and 2023, and including around 12,000 infants, show good effectiveness (more than 80% reduction in hospitalizations for RSV lower respiratory infection, and 75% reduction in very severe forms of bronchiolitis in the most recent clinical trial)”, recall the National Council of Pediatric Professionals (CNPP) and the French Society of Neonatology in an opinion reviewed on August 21.
“A very significant improvement” expected
So, what to think? Skeptics point out that the High Authority for Health (HAS), the body responsible for evaluating a new treatment, has only mentioned “minor” progress in terms of “medical benefit rendered”. “It is quite usual to see the HAS initially take rather cautious positions,” responds Professor Christèle Gras Le Guen, hospital pediatrician at Nantes University Hospital, charged by the government with supporting the deployment of the treatment.
Limited by their size, Sanofi’s studies do not have “a level of proof which allows us to know what will happen in France in winter”, she admitted, also stressing that Beyfortus would in no way exempt parents from Avoid exposing their baby to public places or to a large family circle. But the pediatrician believes that these data give ample reason to hope for “a very significant improvement, compared to what we experienced last winter”. An opinion shared by Dr Béguin: “this treatment should revolutionize the winter season, by significantly reducing the risk of severe forms”. For now, the government has ordered 200,000 doses.
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