Parents across the globe are facing substantial hurdles in securing doses of the new preventive antibody, nirsevimab, to shield their infants from bronchiolitis, a respiratory illness associated with the respiratory syncytial virus (RSV). Experts and officials acknowledge that this scarcity of supply is a consequence of the treatment’s remarkable efficacy.
Isabelle, a 41-year-old mother from France, has been patiently awaiting a dose of the groundbreaking preventive antibody nirsevimab, marketed as Beyfortus, for her two-month-old infant since its rollout in mid-September.
Beyfortus is the first intervention widely available to deter severe RSV infection, a common ailment that stands as a primary cause of pediatric hospitalization throughout Europe.
Isabelle promptly received a prescription from her pediatrician, but the pharmacy in the Paris region, despite receiving an overwhelming initial demand for 30 doses, only obtained 10 doses. This setback has left her feeling “very angry” as her prematurely born infant could not receive the necessary dosage due to insufficient weight.
Currently, her newborn grapples with COVID-19, which accentuates her concerns regarding RSV, an illness manifesting as cold-like symptoms but with potentially severe repercussions for neonates and the elderly.
Officials concur that the fervent demand for this novel antibody, authorized in the European Union last year, is unparalleled for a non-mandatory preventive measure.
The French government initially procured 200,000 doses of Beyfortus, but the surge in parental demand after initiating an immunization campaign in September led them to allocate certain doses to maternity wards to ensure adequate supply.
The Ministry of Health in France attributes this measure to the “success” of the campaign, emphasizing that preventive interventions of this nature typically exhibit lower adherence rates.
A representative from the pharmaceutical firm Sanofi, which manufactures the antibody Beyfortus in partnership with AstraZeneca, confirms that the adherence rate has far exceeded expectations. Initially predicting a 5 to 10 percent demand, France has witnessed rates as high as 60 to 80 percent in specific hospitals.
Sanofi clarifies that the issue is not one of production capacity but rather stems from the varying distribution agreements with individual governments, given the new nature of this intervention.
As of now, Beyfortus has been introduced in the United States, France, and Spain.
A Game-Changer in Disease Prevention
Dr. Rick Malley, a Harvard Medical School professor of pediatrics and a physician at Boston Children’s Hospital, highlights two approaches to infection prevention: vaccines to bolster the body’s resistance to infections and antibodies to immediately neutralize viruses. Beyfortus is a monoclonal antibody designed to target a specific RSV protein.
Another RSV antibody, palivizumab (marketed as Synagis), necessitates monthly doses and offers shorter-lasting protection compared to Beyfortus.
“Beyfortus requires only one shot, one dose, to provide protection for the entire RSV season in clinical trials,” explains Dr. Malley, underscoring the simplicity and efficacy of the new intervention. Phase III clinical trials demonstrated a 75.7 percent reduction in severe RSV cases among infants under 12 months who received the antibody.
This development holds the potential to reduce hospitalizations, as currently, there are no effective treatments for RSV or bronchiolitis. Management for children with RSV primarily involves supportive care, including oxygen supplementation and assisted breathing when necessary.
Prioritizing High-Risk Newborns
Caroline Combot, president of France’s National Union of Midwives, notes that many parents were enthusiastic about this preventive intervention once it became accessible. She highlights the significance of conveying it as a “preventive treatment” rather than a vaccine, a distinction that seemed to reassure parents.
In France, a surge in births during September and October has contributed to increased demand for the antibody’s rollout. The government’s messaging on winter immunization campaigns focuses on preventing a potential triple epidemic, with COVID-19, flu, and RSV co-circulating during the winter months.
The past year’s stretched healthcare systems may also have fueled this heightened demand.
As a result, the French government has earmarked the smaller 50 mg dose of Beyfortus exclusively for infants weighing under 5 kg in maternity wards.
In the United States, the limited supply of Beyfortus prompted the Centers for Disease Control and Prevention (CDC) to prioritize the higher dose for babies over 5 kg, especially those at risk of severe RSV, including infants under 6 months and those with underlying conditions.
