The CDC now recommends that pediatricians and other health care providers prioritize administering nilsevimab, a monoclonal antibody sold under the brand name Bayfortus, to infants at highest risk of developing severe RSV. are doing.
“The shortage is pretty disappointing,” said Scott Roberts, an infectious disease physician at Yale University School of Medicine. “We had hoped to learn lessons from COVID-19, but these challenges were foreseen.” [because] This appears to have been a preventable shortage that we should have anticipated demand for. ”
Pharmaceutical company Sanofi said in a statement to the Washington Post that it is working closely with manufacturing partner AstraZeneca to “accelerate additional supply.”
RSV primarily affects the respiratory system, especially the elderly, young children, and people with weakened immune systems. The disease is spread through respiratory droplets and is highly contagious. Each year in the United States, RSV results in 80,000 hospitalizations in children younger than 5 years and up to 160,000 hospitalizations in adults 65 years and older. CDC report.
Bayfortas was approved by the Food and Drug Administration in July to protect infants from the disease. This is a single-dose vaccination that can be given to children under 8 months of age and up to 24 months of age, who are most at risk of developing severe RSV infection. Although it is not a vaccine, it provides similar protection by delivering lab-made antibodies that can block the virus from entering cells.
The drug is available in two doses, 50 milligrams and 100 milligrams, depending on the child’s age and weight. The 50-milligram dose recommendation remains unchanged. However, to allocate the 100-milligram dose, the CDC recommends that infants between 8 and 19 months of age be stopped receiving nilsevimab unless they fall into certain categories that the agency determines are the most vulnerable. .
The 100-milligram dose is prioritized for infants in high-risk categories, including American Indian and Alaska Native children younger than 8 months living in remote areas, infants born before 29 weeks of gestation, and infants during pregnancy. should be given. According to the alert, he is severely immunocompromised.
The American Academy of Pediatrics does not recommend using two 50-milligram doses instead of a 100-milligram dose for safety reasons.
Sanofi said it is trying to meet demand and is temporarily not accepting new orders for the 100-milligram dose, but is fulfilling current deliveries. The 50-milligram dose is still available for order. AstraZeneca said it was working closely with health authorities to manage the significant demand.
The shortage appears to be driven by two factors: demand and cost.Pharmaceutical company blame the cause of the shortage Doctors say the cost of drugs is a major factor.private sector Nilsevimab costs $495 Meanwhile, the federally funded childhood vaccine program pays $395 per dose, making it the most expensive shot. administered to children.
Steven Abelowitz, a pediatrician in Southern California, said many pediatric primary care practices buy injectables directly from suppliers and have to file claims with patients’ insurance companies to get reimbursed, which can reduce prices. He said that this is one of the biggest impediments to medical treatment.
“People are holding orders because [many of the] Insurance companies have not yet committed to covering it,” Abelowitz said. “We’re having a hard time making decisions. It’s just an exorbitant amount of money.”
But health care providers must make these decisions against the backdrop of last year’s devastating RSV season. At the time, many children’s hospitals had nearly full or full beds due to the initial surge in cases.
“I think this is difficult because last year at Yale, there was one ICU bed left, but I think it has to be weighed against the downside of the burden of RSV hospitalizations on the health care system,” Roberts said. the professor said. He added that high costs are creating disparities in care. “These are challenges that demonstrate the flaws in our health care system.”
Meanwhile, the CDC advises expectant parents to consider using the RSV vaccine Abrysvo, which is recommended for pregnant people to provide protection to newborns. The alert also advises parents to take everyday steps to limit the spread of RSV, including regular hand washing, covering coughs and sneezes, and staying home if sick. .
