From September 15, all newborns can benefit from Beyfortus, a drug aimed at protecting them against the main virus causing the respiratory disease.
It is a source of hope for parents of newborns. A preventive treatment for bronchiolitis, intended for children born since February, arrived in health establishments and pharmacies on Friday September 15. Developed by the Sanofi and AstraZeneca laboratories and marketed under the name Beyfortus, nirsevimab aims to reduce the risk of infection by the respiratory syncytial virus (RSV), the main cause of bronchiolitis. The drug could become a strong ally for health authorities, faced last winter with a virulent epidemic of bronchiolitis, which required more than 26,000 hospitalizations after a trip to the emergency room in children under two years old, according to emergency services figures. But the effectiveness of this antibody still remains uncertain.
To whom it is addressed ?
The Ministry of Health recommends immunizing all babies “before leaving maternity ward”, which concerns children born in recent days and those to be born from mid-September. The Beyfortus can also “be prescribed to all infants born from February 6, 2023 in mainland France”. Outside of maternity, it will be necessary “a prescription by the doctor who is treating the child”explains the ministry. “The parents will then go to the community pharmacy to order and then collect the medication”made available within three to four working days, all “without billing to families”.
The drug is administered by an injection, like a vaccine, in a single dose, preferably in the thigh. The injection can be given at the same time as an infant vaccination, in another arm or another leg, in general medicine or pediatric offices, health centers, etc. It should be emphasized that this treatment is not obligatory and that it may give rise to undesirable effects. “uncommon” (rash, fever, etc.) and an allergic reaction, as specified by the National Medicines Safety Agency (PDF).
Why does it bring hope?
Beyfortus is the second monoclonal antibody made available in France to prevent the risk of RSV infection in infants. The first was palivizumab, authorized since 1999 and marketed by AstraZeneca under the name Synagis. This molecule is cumbersome to administer (one injection per month) and only indicated in premature babies and high-risk infants.
Beyfortus has had European marketing authorization since October 2022 in a broader indication, for all newborns and infants during their first season of RSV circulation. A single injection should protect for five months, or the entire epidemic season, according to the laboratories, cited by The world.
The arsenal could soon be strengthened by a first vaccine against bronchiolitis. Developed by Pfizer, Abrysvo must be administered before birth to pregnant women. This vaccine was authorized by the European Commission at the end of August, but not yet in France. This is about “make the immune system produce antibodies” For “teach him to protect himself”while the Beyfortus consists of “directly inject antibodies” For “give the system the weapons to defend itself”explains emergency doctor Aurel Guedj to BFMTV.
Can it prevent an epidemic?
The deployment of preventive treatment against bronchiolitis constitutes “one of the major challenges of the start of the school year”, declared the Minister of Health, Aurélien Rousseau, at the beginning of August, the day after the green light from the High Authority of Health for the reimbursement of Beyfortus. The fight is daunting: in France, bronchiolitis affects nearly 30% of infants under two years old each winter, or around 480,000 cases per year. According to the Ministry of Health, 80% of cases are due to RSV infection, hence the importance of targeting this virus. Severe bronchiolitis may require hospitalization, a situation that affects “2 to 3% of infants under one year old” every year.
The Beyfortus arrives in France with a part of unknown, lack of data allowing“support a possible impact” on the duration of hospitalization, on transfer to intensive care or on mortality, warns the HAS. One of the three studies provided by Sanofi did not show a significant effect in terms of reducing hospitalizations. Another reported an 83% drop, but it has not yet been published in a scientific journal and was carried out using a slightly less strict methodology. At this stage, the improvement in the medical benefit rendered by the treatment is judged “minor” by HAS.
Limited by their size, Sanofi’s studies have not “not a level of proof that allows us to know what will happen in France in winter”, recognizes hospital pediatrician Christèle Gras-Le Guen. However, according to this expert commissioned by the government in this matter, they allow us to hope “a very significant improvement compared to what we experienced last winter”. Citing a report published this week by British health authorities, infectious disease specialist Piero Olliaro believes that “the analyzes carried out on the data seem quite convincing as to the effectiveness” of treatment. One thing is certain: respecting barrier gestures remains one of the keys to avoiding exposing your baby to the virus.