CDC Recommends mAbs to Prevent RSV in Infants

The CDC is recommending a new immunization starting this fall to help protect all infants under eight months and some older babies at increased risk of severe illness caused by respiratory syncytial virus (RSV). The CDC director Mandy Cohen, MD, MPH, adopted the CDC Advisory Committee on Immunization Practices’ (ACIP’s) recommendation for the use of nirsevimab (Beyfortus^TM), a long-acting monoclonal antibody product, which has been shown to reduce the risk of both hospitalizations and health care visits for RSV in infants by about 80 percent.

Monoclonal antibodies are man-made proteins that mimic the antibodies that our bodies naturally produce. Making this immunization available means that babies will be able to receive antibodies to prevent severe RSV disease, providing a critical tool to protect against a virus that is the leading cause of hospitalization among infants in the US.

How will the new immunization help prevent RSV infection in infants?

RSV is one of the most common causes of childhood respiratory illness and results in annual outbreaks of respiratory illnesses in all age groups. An estimated 58,000 to 80,000 children under five years of age—most of them infants—are hospitalized each year nationwide due to RSV infection: Some require oxygen, intravenous (IV) fluids, or mechanical ventilation support. Each year, an estimated 100 to 300 children younger than five years of age die due to RSV.

The CDC recommends one dose of nirsevimab for all infants younger than eight months, born during, or entering, their first RSV season (typically fall through spring). For a small group of children between the ages of 8 and 19 months who are at increased risk of severe RSV disease, such as children who are severely immunocompromised, a dose is recommended in their second season.

Nirsevimab—approved last month by the U.S. Food and Drug Administration (FDA)—is administered as an injection and provides infants and toddlers with antibodies to protect against severe RSV illness. It provides critical protection during a baby’s first RSV season when they’re most at risk for severe illness.

Nirsevimab is expected to be available this fall. Expectant parents and parents of infants under the age of eight months, as well as those with older babies, should talk with their healthcare providers and request this added layer of protection against RSV this season.

ACIP voted to include nirsevimab in the Vaccines for Children program, an initiative that provides recommended vaccines and immunizations at no cost to about half of the nation’s children. The CDC is currently working to make nirsevimab available through this program. Healthcare providers will be key to the CDC’s outreach efforts. Additional clinical guidance and healthcare provider education material will be provided by the CDC in the coming months.

“As we head into respiratory virus season this fall, it’s important to use these new tools available to help prevent severe RSV illness,” said Cohen. “I encourage parents of infants to talk to their pediatricians about this new immunization and the importance of preventing severe RSV.”

- This press release was originally published on the Centers for Disease Control and Prevention website