The Centers for Disease Control and Prevention issued a health alert Monday in response to limited supplies of an antibody drug designed to protect infants from the respiratory disease RSV. The update comes as RSV cases have started to rise in parts of the United States with the onset of cold and flu season, creating a conundrum for many pediatricians.
The CDC is now advising pediatricians and other health-care providers to prioritize administering certain doses of nirsevimab, a monoclonal antibody sold under the brand name Beyfortus, to infants with the highest risk of developing severe respiratory syncytial virus.
"The shortage is pretty disheartening," said Scott Roberts, an infectious-disease physician at Yale School of Medicine. "I had hoped we learned lessons from covid, where we foresee these challenges [because] it seems like this was a preventable shortage where we should have anticipated the demand."
The drug company Sanofi said in a statement to The Washington Post that it is working closely with its manufacturing partner, AstraZeneca, to "accelerate additional supply."
RSV primarily affects the respiratory system, particularly in older people, young children and individuals with weakened immune systems. The disease is spread through respiratory droplets and is highly contagious. In the United States each year, RSV leads to as many as 80,000 hospitalizations in children younger than 5 and up to 160,000 hospitalizations in adults 65 and older, the CDC reports.
Beyfortus was approved by the Food and Drug Administration in July to help protect infants from the disease. It is a single shot that can be given to children younger than 8 months and to kids up to 24 months who are most at risk for developing a severe RSV infection. It is not a vaccine, but it provides similar protection by delivering lab-made antibodies that can block the virus from invading cells.
The drug is available in two doses - 50 milligrams and 100 milligrams - depending on a child's age and weight. The recommendations for the 50-milligram dose remain unchanged. But to ration the 100-milligram doses, the CDC advises suspending administration of nirsevimab to infants between 8 and 19 months unless they fall into certain categories the agency deems most vulnerable.
Priority for the 100-milligram dosage should be given to infants in the high-risk category, including American Indian and Alaska Native children younger than 8 months who live in remote areas, as well as infants born before 29 weeks of gestation and those who are severely immunocompromised, according to the alert.
The American Academy of Pediatrics does not recommend using two 50-milligram doses in place of a 100-milligram dose for safety reasons.
While trying to meet the demand, Sanofi said it is temporarily not accepting new orders for 100-milligram doses but is fulfilling current deliveries; 50-milligram doses are still available to order. AstraZeneca said it was working closely with health authorities to manage the significant demand.
The shortage seems to be driven by two factors: the demand and the cost. Pharmaceutical companies attribute the shortfalls to surging need, whereas physicians say the cost of the drug is the primary factor. The private-sector cost for nirsevimab is $495 per dose, while the federally funded Vaccines for Children program pays $395 per dose, making it the most expensive shot administered to children.
Steven Abelowitz, a pediatrician from Southern California, said the price is one of the most significant deterrents for his practice, since many pediatric primary care offices must purchase the injections directly from suppliers and then file claims with their patients' insurance companies to get reimbursed.
"People are holding out on ordering it because [many of the] insurance companies haven't committed yet to cover it," Abelowitz said. "We're struggling to come to a decision; it's just an exorbitant amount of money."
But health-care providers must make these decisions against the backdrop of last year's disastrous RSV season, when an early surge in cases meant beds were near or at capacity in many pediatric hospitals.
"At Yale last year, we had a single ICU bed left, so I think . . . it's a hard sell, but I think that needs to be weighed against the downsides of the burden of RSV hospitalizations on our health-care systems," Roberts said, adding that the high cost creates disparities in care. "These are challenges that show the shortcomings in our health-care system."
The CDC in the meantime advises expectant parents to consider the RSV vaccine Abrysvo, which is recommended for pregnant people to confer 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 when sick.