Demand for a new shot that protects babies against respiratory syncytial virus (RSV) has outpaced supply, prompting U.S. health officials to recommend the doses be saved for high-risk infants.
In an alert posted Monday afternoon, the U.S. Centers for Disease Control and Prevention said nirsevimab (Beyfortus) should be reserved for infants with underlying health conditions and those younger than 6 months old.
“We are going to protect some children from RSV this year. We’re not going to be able to protect as many as we’d hoped, and that’s frustrating,” Dr. Buddy Creech, a pediatrician at Vanderbilt and president of the Pediatric Infectious Disease Society, told CNN.
Babies ages 8 to 19 months old should not receive Beyfortus because they are eligible for an older medication known as palivizumab (Synagis), CNN reported. Unlike Beyfortus, which protects babies for 6 months with a single dose, Synagis has to be given once a month through the RSV season.
Beyfortus was only approved by the U.S. Food and Drug Administration this summer.
RSV can infect the lower lungs, causing them to fill with mucus, which can make it hard for infants to breathe and eat. RSV is the leading cause of hospitalization in infants younger than 1 year old.
About 81% of babies who needed intensive care for RSV last year had no underlying medical conditions and were born full term, according to a recent study published in the journal JAMA Network Open.
The medication retails for about $500 a dose, CNN reported.
Some pediatricians were reluctant to stock the shots over concern about cost and how much insurance companies would reimburse them, making it harder for parents to locate Beyfortus, CNN reported.
“Despite an aggressive supply plan built to outperform past pediatric vaccine launches, demand for this product, especially for the 100-[milligram] mg doses used primarily for babies born before the RSV season, has been higher than anticipated,” one of the shot’s makers, Sanofi, said in a statement.
“While deliveries of 100-mg doses continue, new orders are not being taken by Sanofi at this time,” the company told CNN.
Meanwhile, the American Academy of Pediatrics is asking for more information about how long the shortage will last.
“We knew there were going to be many barriers to implementation of nirsevimab that we were anticipating, and pediatricians have been working hard to overcome those barriers, but we were assured by the manufacturer that supply would not be one of the barriers,” said Dr. Sean O’Leary, who is chair of the American Academy of Pediatrics (AAP) Committee on Infectious Diseases, said in an AAP article on the shortage.
Doctors should not use two 50-mg doses in place of one 100-mg dose, the AAP advised.
“Using two 50-mg doses in place of a 100-mg dose has not been studied, and is not approved or recommended,” the AAP said.
The CDC expects more doses will be available every 2 to 3 weeks, including both the 50- and 100-milligram products, CNN reported.
Doctors should counsel pregnant women to receive the new maternal vaccine for RSV, Abryvso, which also protects newborns, the CDC added.
Natasha Halasa et al, Infants Admitted to US Intensive Care Units for RSV Infection During the 2022 Seasonal Peak, JAMA Network Open (2023). DOI: 10.1001/jamanetworkopen.2023.28950
JAMA Network Open
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