Demand for the first FDA-approved respiratory syncytial virus drug for children is surpassing what the drugmaker expected, and the CDC has paused orders.
The product is Beyfortus (nirsevimab-alip), for which the FDA granted approval in July to its sponsors, Sanofi and AstraZeneca. Pediatrician offices and hospitals have reported problems accessing the antibody, partly because of a cloudy reimbursement model for doses that cost about $500 each.
The other holdup is demand outpacing supply.
"Despite an aggressive supply plan built to outperform past pediatric vaccine launches, demand for this product, especially for the 100 milligram doses used primarily for babies born before the RSV season, has been higher than anticipated," Sanofi said in a statement.
The CDC's Vaccines for Children program and Sanofi have temporarily put some orders on hold, according to the American Academy of Pediatrics.
The CDC plans to reopen ordering in a limited supply before the week of Oct. 23, with priority going to buyers that have not ordered yet and those requesting a small quantity, the AAP said.