2023-09-13 19:39:09
“A major breakthrough”. It is in these terms that the Minister of Health Aurélien Rousseau welcomed this summer the arrival of nirsevimab, a treatment which will be available free of charge from Friday to all babies born since February 6.
Marketed under the name Beyfortus by the pharmaceutical giant Sanofi, this molecule aims to immunize – via the direct injection of an antibody and not a vaccine – infants once morest the respiratory syncytial virus (RSV).
This virus is the most common cause of bronchiolitis, an infection that affects many infants. The share of hospitalizations is low but their number increases mechanically when contamination explodes, at the cost of a heavy burden on the health system.
Last season, the epidemic of bronchiolitis, which results in coughing and difficult breathing, was the most intense in more than a decade with tens of thousands of babies hospitalized.
Until then, there was almost no preventive treatment, with one exception: a molecule developed by AstraZeneca – which is also collaborating with Sanofi on Beyfortus – but is cumbersome to administer and reserved for babies at risk.
In this context, the Minister of Health logically made the deployment of Beyfortus “one of the major challenges of the start of the school year”, followed in his enthusiasm by the majority of the health world, in particular the societies of pediatricians and general practitioners.
However, some discordant voices are heard.
There is “a certain excitement, a little rapid in my opinion, in terms of evidence”, judged Rémy Boussageon, professor of general medicine, to AFP.
Opacity on price
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 using a slightly less strict methodology.
What to conclude? Beyfortus’ skeptics point out that the High Authority for Health (HAS), the body responsible for evaluating a new treatment, has only mentioned “minor” progress.
“It’s quite usual to see the HAS initially take rather cautious positions,” responded to AFP the hospital pediatrician Christèle Gras Le Guen (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 specialist estimated that these data give ample reason to hope for “a very significant improvement compared to what we experienced last winter”.
It is difficult to judge between now and then whether the French government made the right choice in banking on Beyfortus, while other preventive treatments for RSV infection are in the running, notably a vaccine developed by Pfizer and approved by the level of the European Union (EU) but not yet in France.
Some experts emphasize that the merits of an immunization campaign are not assessed only on the effectiveness of the drug but on the cost paid by the authorities in relation to the number of hospitalizations or deaths avoided.
“The analyzes carried out on the data seem quite convincing as to the effectiveness” of Beyfortus, infectious disease specialist Piero Olliaro told AFP, citing in particular a report published this week by the British health authorities. “The problem is that the price of a drug is also a major criterion in public health choices.”
This data is not communicated. While waiting for the official price of Beyfortus to be set by negotiations between Sanofi and the health authorities, the government has ordered – via the Public Health France agency – 200,000 doses, for an unknown amount.
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