2023-08-30 15:20:00
The Beyfortus monoclonal antibody will be able to protect newborns in France to prevent severe forms of the disease from this winter. A vaccine for pregnant women, also promising, has just been authorized by the European Commission.
With 73,000 emergency visits, 26,000 hospitalizations and the cry of alarm from health professionals, the bronchiolitis epidemic reached record levels in infants this winter, disrupting pediatric services and panicking caregivers and families. “It was an exhausting and traumatic situation, breathes Christèle Gras Le Guen, head of pediatric emergencies at the Nantes University Hospital and former president of the French Pediatric Society (SFP). With the approach of winter, the apprehension is immense. Except that in this return to school the hope of being able to reduce the intensity of the epidemic and especially its serious cases is growing within the medical troops. Two serious avenues of preventive treatment are confirmed: a monoclonal antibody for infants, available in France in mid-September, and a vaccine for pregnant women.
Bronchiolitis affects nearly 30% of infants under 2 years of age each winter, or regarding 480,000. It is a common respiratory disease, mainly caused by the highly contagious respiratory syncytial virus (RSV). Which causes seasonal epidemics, from mid-October to the end of winter, with a peak in December. “If a healthy adult catches this virus, they have a runny nose. A toddler will cough, stop drinking, even take breathing breaks and may end up in artificial respiration in intensive care, ”recalls the Nantes pediatrician. Each year, 1 to 2% of children under the age of one are hospitalized for severe bronchiolitis. “The ideal is to encounter RSV when you are over a year old and strong enough to cope.”
There is no specific treatment for bronchiolitis. And despite its recurrence, caregivers have until now only had palivizumab – “Synagis” by its trade name – for preventive purposes. Old and especially expensive, it is only used in newborns most at risk. But it will very soon no longer be the only preventive option in France. According to one note from the General Directorate of Health (DGS) broadcast on August 24, French health establishments and pharmacies will have a new molecule available from September 15: nirsevimab. Marketed by Sanofi and AstraZeneca laboratories under the name of Beyfortus. Like palivizumab, it is a monoclonal antibody. In other words, it provides the body with something to defend itself directly, unlike a vaccine which stimulates the immune system to produce antibodies. In scientific jargon, we speak of “passive immunization”. The Haute Autorité de santé gave a final favorable opinion for its reimbursement on August 1.
Available for all infants from September 15
The news raises a wave of enthusiasm among health professionals. The “Harmonie” study, conducted between September 2022 and February 2023 on 8,000 children in four European countries, showed an 83% reduction in RSV-related hospitalizations in children under one year old. With few side effects. As a bonus, it only requires one injection in the newborn’s thigh to protect it throughout the epidemic season – more practical than the five required for the old treatment. “Every winter, this damn bronchiolitis disrupts the lives of children, families, the healthcare system. For the first time in history, we have hope that it might be different, ”rejoices Christèle Gras Le Guen. Because, another essential point: it is recommended for all newborns, at the earliest.
From September 15, Beyfortus “may be prescribed to all infants born from February 6, 2023 in mainland France”, indicates the note from the DGS. From this date, immunization will be recommended to all infants even before they leave the maternity ward. “One of the apprehensions that we have is that children go out without having been immunized and catch the virus in the first days of their life, fears the hospital practitioner. However, it is often babies from 8 to 15 days old who are hospitalized in intensive care. Families whose children born before September 15 and who have not been able to be offered treatment at the maternity ward can approach their doctor to obtain a prescription and have their infant immunized.
Nothing mandatory though. “Parents remain the only decision-makers,” recalls Andreas Werner, president of the French Association of Ambulatory Pediatrics (Afpa). Hence the importance of informing them of the existence of this treatment before delivery. And convince the undecided. “When we talk regarding immunization or vaccine, there are always fears of parents, whatever the product, underlines the liberal pediatrician in Villeneuve-lès-Avignon (Gard). Some will always be once morest – very few – others trust their doctor. Our efforts and explanations must above all concentrate on the hesitant parents, there are many of them.
Vaccine for pregnant women
Nirsevimab is not the only molecule recently developed by the laboratories: a real race once morest time has been launched for several months, with around thirty preventive treatments in the course of more or less advanced development. A vaccine developed by the GSK laboratory was authorized in June by the European Commission, but it is only intended for people over 60. Pfizer has the other most serious track for young children: a vaccine for pregnant women, called “Abrysvo”. In November, the company announced that its product reduced the rate of serious illnesses in infants by 81.8% in their first three months of life. “If these data are confirmed, it also represents great hope, agrees Christèle Gras Le Guen. The advantage with this serum is to protect children from birth, via their mother.”
Here once more, even if this vaccine will not be available immediately in France, the role of midwives, obstetricians and general practitioners will be essential in convincing pregnant women of the interest of vaccination. On the regulatory side, the European Commission has just authorized its marketing on August 25, a few days following the United States. In France, the green light from the High Authority for Health is now required, but some specialists doubt that it will occur this season.
Even if they emphasize their optimism, the two pediatricians remain cautious. Treatments cannot, alone, prevent the outbreak of bronchiolitis and prevent the circulation of the virus responsible. “Any vaccination or immunization is partial, even if the risk reduction is high. Preventive measures remain essential,” insists Andreas Werner. Namely, be extra vigilant for babies during the winter, ventilate the rooms, clean the objects they take, limit contact with sick people, avoid crowded places and public transport, large family gatherings where children pass “arm to arm”. In short, all the repeated barrier gestures to limit the circulation of Covid, which apply to all viruses. “All these common sense measures must be reinforced for the little ones who will be born in the coming days and go through the winter period, insists Christèle Gras Le Guen. Small children are very fragile during their first months of life. Even if we manage to protect them from bronchiolitis, there are other viruses during the winter.
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