The agency recommended the treatment for infants under 6 months old and infants with underlying conditions that place them at highest risk for severe RSV disease, because the 100mg dose is in short supply. The 100mg dose is recommended for babies 11 pounds and over until they’re 8 months old.
Sanofi said it was working with AstraZeneca, which is responsible for manufacturing the drug, to deliver the available doses to the market to fix the problem.
The company attributed the issue to “unprecedented demand.”
“Despite an aggressive supply plan built to outperform past pediatric vaccine launches, demand for this product, especially for the 100 mg doses used primarily for babies born before the RSV season, has been higher than anticipated,” the company said.
“We will continue to coordinate with the Centers for Disease Control and Prevention and immunization stakeholders to monitor demand across the public and private markets, and manage supply as needed over the course of the RSV season, to ensure continued equitable access to Beyfortus.”
The CDC told state immunization managers it was rationing allocations – some locations were allocated the drug and able to order it, while others who had already received proportionately more than others did not receive any allocation.
As more supply becomes available, the CDC told them it will make the drug available for ordering, but they are doing so on an allocation method to keep the supply equitably distributed.
Infant RSV treatment becoming scarce
