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The Centers for Disease Control and Prevention issued a health alert Monday in response to limited supplies of an antibody drug meant to protect infants from the respiratory disease RSV. The update comes as parts of the United States have seen an increase in RSV cases as cold and flu season begins, creating a mystery to many pediatricians.
The CDC is now advising pediatricians and other health care providers to prioritize giving specific doses of nirsevimab, a monoclonal antibody sold under the brand name Beyfortus, to infants at highest risk of developing severe respiratory syncytial virus.
“The shortage is pretty discouraging,” said Scott Roberts, an infectious disease doctor at Yale School of Medicine. “I was hoping that we would learn lessons from Covid where we foresee these challenges [because] It appears that this was an avoidable shortage that we should have anticipated demand.”
Pharmaceutical giant Sanofi said in a statement to The Washington Post that it was working closely with its manufacturing partner AstraZeneca to “accelerate additional supply.”
RSV primarily affects the respiratory tract, particularly in older people, young children and people with weakened immune systems. The disease is transmitted through respiratory droplets and is highly contagious. According to the CDC, RSV causes up to 80,000 hospitalizations in children under 5 years of age and up to 160,000 hospitalizations in adults 65 years and older each year in the United States.
Beyfortus was approved by the Food and Drug Administration in July to protect infants from the disease. It is a single shot that can be given to children under 8 months of age and children up to 24 months of age who are at greatest risk of developing a serious RSV infection. It’s not a vaccine, but it offers similar protection by releasing 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 recommendations for the 50 milligram dose remain unchanged. However, to ration the 100-milligram doses, the CDC recommends pausing administration of nirsevimab to infants between 8 and 19 months of age unless they fall into certain categories that the agency considers to be most at risk.
The 100-milligram dose should be given primarily to infants in the high-risk category, including American Indian and Alaska Native children under 8 months of age who live in remote areas, as well as infants born before 29 weeks of gestation and those who live there According to warning, severely immunocompromised.
The American Academy of Pediatrics does not recommend using two 50-milligram doses instead of one 100-milligram dose for safety reasons.
In an attempt to meet demand, Sanofi said it was temporarily not accepting new orders for 100-milligram doses but was meeting ongoing shipments; 50-milligram doses can still be ordered. AstraZeneca said it was working closely with health authorities to manage significant demand.
The shortage appears to be due to two factors: demand and cost. Drug companies attribute the shortfalls to increasing demand, while doctors say the drug’s cost is the main factor. The private cost of nirsevimab is $495 per dose, while the government-funded Vaccines for Children program pays $395 per dose, making it the most expensive vaccine given to children.
Steven Abelowitz, a Southern California pediatrician, said the price is one of the biggest deterrents for his practice because many pediatric primary care practices buy the injections directly from suppliers and then have to file claims with their patients’ insurance companies to get reimbursed.
“People hesitate to order because [many of the] “The insurance companies have not yet committed to covering the costs,” Abelowitz said. “It is difficult for us to make a decision. It’s just an exorbitant amount of money.”
But health care providers must make these decisions in light of last year’s disastrous RSV season, when an early surge in cases left beds at many children’s hospitals near or full.
“At Yale we only had a single ICU bed left last year, so I think … that’s a hard sell, but I think that has to be weighed against the downside of the burden on our health care systems from RSV hospitalizations,” Roberts said , adding that high costs lead to disparities in care. “These are challenges that show the deficits in our health system.”
The CDC now recommends expectant parents consider the RSV vaccine Abrysvo, which is recommended for pregnant people to provide protection for newborns. The alert also advises parents to take everyday measures to limit the spread of RSV, including washing hands regularly, covering coughs and sneezes, and staying home when sick.