HAP's Latest News

CDC Offers Recommendations for New RSV Shots amid Shortage

Manufacturer says supply is falling behind ‘higher than anticipated’ demand

October 24, 2023

The CDC this week issued new recommendations for providers to help manage a limited supply of a new respiratory syncytial virus (RSV) drug for infants and toddlers.

Earlier this year, the FDA approved nirsevimab, a long-acting monoclonal antibody for babies and high-risk toddlers ahead of respiratory virus season.

The CDC is recommending providers prioritize the 100-milligram dosage to protect infants at highest risk as the agency manages concerns about manufacturing capacity and limited supply of the product.

The manufacturer acknowledged the supply concerns in a statement earlier this month.

“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,” Sanofi said in a statement earlier this month earlier this month.

Here’s what you need to know:

  • The recommendation:  The CDC recommends providers prioritize the 100 milligram doses for “infants at the highest risk for severe RSV disease: young infants (under 6 months) and infants with underlying conditions that place them at highest risk for severe RSV disease.”
    • This includes American Indian and Alaska Native infants under 8 months.
    • Recommendations for the smaller 50-milligram doses remain the same, and those doses should be preserved for infants weighing under 11 pounds, the CDC said.
  • About RSV:  Most RSV infections lead to cold-like symptoms, but some infants develop lower respiratory tract disease (pneumonia and bronchiolitis), the FDA notes. This is most common during their first infection.
  • Prescribed uses:  Nirsevimab can be used for newborns and babies under 1 during or entering their first RSV season and for children up to 24 months who are at risk of severe RSV disease through their second RSV season.
    • Infants between 8 months and 19 months at increased risk of severe RSV disease entering their second season are recommended to receive a 200-milligram dose.
  • What the public can do:  The CDC said all families can help limit the spread of the virus by washing hands, covering coughs and sneezes, cleaning frequently touched surfaces, and staying home when sick.
  • The bottom line:  Parents should talk with their health care provider about whether nirsevimab is available for their infant, the CDC notes. Expecting parents should talk with their health care provider about the RSV vaccine during pregnancy.

“CDC continues to work with the manufacturer to understand how it may accelerate nirsevimab supply,” the CDC statement says.

The CDC noted providers should follow recommendations from the American Academy of Pediatrics about the use of Palivizumab for eligible infants and children.

HAP encourages everyone to contact their health care provider with questions about the newly available RSV products and to ensure they are ready for the upcoming respiratory virus season.

The CDC’s official health advisory is available online.