“Widespread access [to the new antibody drug] will take time across many sectors of the pediatric population and won’t have as great an impact on volumes this immediate respiratory season,” the Children’s Hospital Association said in a statement.
Nirsevimab, marketed as Beyfortus, was approved in August. It’s a single shot that can be given to infants up to 8 months old and high-risk babies up to 19 months old.
The drug cuts the risk of hospitalizations in infants by about 80 percent and has been hailed as a game changer.
But the Centers for Disease Control and Prevention (CDC) last week urged pediatricians to ration the drug due to supply constraints and prioritize infants at highest risk of complications.
The federal Vaccines for Children program, which covers the cost of the shots for uninsured and underinsured kids, paused orders for the 100-milligram dose earlier this month. The 100-milligram dose is recommended for babies 11 pounds and over until they’re 8 months old.
The agency only recently resumed orders for the 50-milligram dose for babies who weigh less than 11 pounds. Sanofi, which markets the drug, said it was temporarily not accepting new orders for 100-milligram doses but is fulfilling current deliveries.
According to Sanofi, demand has been much higher than anticipated, and it is working with manufacturer AstraZeneca to deliver available doses quickly.
“Children’s hospitals are working with community hospitals and other health systems to help manage pediatric beds, equipment and medicine supplies as well as pediatric workforce staffing, but undoubtedly there will be capacity challenges this fall and winter,” Children’s Hospital Association CEO Matt Cook said in a statement.
Current RSV levels are low nationally, but “sustained increases in RSV activity in the southern U.S. indicate the start of the 2023-2024 RSV season, with the mid-Atlantic and Northeastern regions also now experiencing elevated activity,” CDC said.
