In response to soaring demand, the supply of nirsevimab (Beyfortus), a novel vaccine designed to safeguard babies against respiratory syncytial virus (RSV), has been strained, prompting U.S. health officials to issue recommendations for prioritizing its use. The U.S. Centers for Disease Control and Prevention (CDC) has advised that nirsevimab should be reserved for high-risk infants and those younger than 6 months old.
Dr. Buddy Creech, a pediatrician at Vanderbilt and president of the Pediatric Infectious Disease Society, expressed frustration at the situation, emphasizing the need to protect as many children from RSV as possible this year.
It has been further stipulated that babies aged 8 to 19 months should not receive Beyfortus since an older medication called palivizumab (Synagis) is available for this age group. While Beyfortus offers six months of protection with a single dose, Synagis necessitates monthly administration throughout the RSV season.
Notably, Beyfortus gained approval from the U.S. Food and Drug Administration during the summer, marking it as a new entrant to the market.
RSV is a virus that primarily infects the lower lungs, causing mucus buildup and potentially impeding infants’ breathing and feeding. RSV is the leading cause of hospitalization in infants under 1 year of age.
A recent study published in the journal JAMA Network Open revealed that approximately 81% of babies who required intensive care for RSV last year had no underlying medical conditions and were born full term.
Beyfortus is priced at around $500 per dose, which has raised concerns among some pediatricians regarding cost and insurance reimbursement. Consequently, these concerns have led to difficulties for parents in locating Beyfortus.
One of the vaccine’s manufacturers, Sanofi, acknowledged the high demand for Beyfortus, particularly the 100-milligram doses used for premature infants, which exceeded their initial expectations. As a result, Sanofi has temporarily halted new orders for this product.
The American Academy of Pediatrics (AAP) is seeking further information about the expected duration of the shortage.
Dr. Sean O’Leary, chair of the AAP Committee on Infectious Diseases, expressed the disappointment that, despite expecting implementation challenges, the shortage was not anticipated as one of the barriers, as indicated by the manufacturer.
The CDC has indicated that additional doses are expected to become available every 2 to 3 weeks, including both the 50- and 100-milligram products.
Furthermore, the CDC has recommended that doctors counsel pregnant women to receive the new maternal vaccine for RSV, Abryvso, which not only protects expectant mothers but also offers protection to their newborns.