“A major breakthrough”. It is in these terms that Minister of Health Aurélien Rousseau welcomed the arrival of nirsévimab this summer, a treatment that will be available for free to all babies born since February 6, starting this Friday.
Marketed under the name Beyfortus by the pharmaceutical giant Sanofi, this molecule aims to immunize infants against respiratory syncytial virus (RSV) through the direct injection of an antibody, rather than a vaccine.
This virus is the most common cause of bronchiolitis, an infection that affects many infants. The rate of hospitalizations is low, but their number increases significantly when contaminations explode, putting a heavy burden on the healthcare system.
Last season, the bronchiolitis epidemic, characterized by coughing and difficulty breathing, was the most severe in over ten years, with tens of thousands of hospitalized babies.
Until now, there was virtually no preventive treatment, with one exception: a molecule developed by AstraZeneca – which also collaborates with Sanofi on Beyfortus – but it is difficult to administer and reserved for at-risk babies.
In this context, it is logical that the Minister of Health made the deployment of Beyfortus “one of the main challenges of the season”, followed in his enthusiasm by the majority of the healthcare community, particularly pediatric and general practitioner societies.
However, some dissenting voices are being heard.
“There is a certain, somewhat hasty, excitement in terms of evidence,” said Rémy Boussageon, a 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 terms of reducing hospitalizations.
Indeed, such an effect was subsequently (-83%) evidenced by another Sanofi study, but it has not yet been published in a scientific journal and was conducted using a slightly less strict methodology.
What can be concluded? Beyfortus skeptics point out that the Higher Health Authority (HAS), the agency responsible for evaluating a new treatment, only mentioned “minor” progress.
“It is quite usual to see the HAS initially take a cautious position,” said hospital pediatrician Christèle Gras Le Guen (CHU de Nantes), who has been tasked by the government with supporting the treatment’s deployment, in response to AFP.
Due to their size, the Sanofi studies do not have “a level of evidence that allows us to know what will happen in France in the winter,” she acknowledged, also emphasizing that Beyfortus does not exempt parents from avoiding exposing their baby to public places or a large family circle.
However, the specialist believed that these data largely indicate “a significant improvement compared to what we experienced last winter.”
It is difficult to judge whether the French government made the right choice in betting on Beyfortus, as other preventive treatments for RSV infection are also being considered, including a vaccine developed by Pfizer that has been approved at the European Union (EU) level but not yet in France.
Some experts emphasize that the validity of an immunization campaign is not only assessed based on the effectiveness of the medication, but also on the cost incurred by the authorities in terms of the number of hospitalizations or avoidable deaths.
“The analysis of the data seems quite convincing regarding the effectiveness” of Beyfortus, said infectious disease specialist Piero Olliaro, citing in particular a report published this week by British health authorities. “The problem is that the price of a medication is also a major criterion in public health decisions.”
This information is not disclosed. While waiting for the official price of Beyfortus to be determined through negotiations between Sanofi and health authorities, the government has ordered – through the French Public Health Agency – 200,000 doses for an unknown amount.
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2023-09-13 22:39:09
