Drug to prevent RSV in babies approved: What you need to know

By Deb Balzer, Mayo Clinic News Network

The Food and Drug Administration (FDA) approved a drug to help protect infants from respiratory syncytial virus (RSV). The medication, given as a single-dose injection prior to or during RSV season, is a monoclonal antibody. It is intended for babies born during or entering their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

The Advisory Committee on Immunization Practices, the vaccine advisory board for the Centers for Disease Control and Prevention (CDC) is expected to review and vote on the drug its next meeting on Aug. 3. The FDA is also evaluating an RSV vaccine for pregnant women.

“This is especially exciting for us in pediatrics because vaccinating pregnant women in the second or third trimester of pregnancy can protect babies when they’re most vulnerable for developing severe illness with RSV, usually in the first six to 12 months of life,” says Dr. Nipunie Rajapakse, a pediatric infectious diseases physician with the Mayo Clinic Children’s Center.

RSV is often a seasonal illness that typically starts circulating in the fall. It is transmitted from person to person through close contact with an infected person.

“This is a relatively common virus that used to be seasonal in the fall and winter. But over the COVID-19 years, we’ve seen some changes in that seasonality with seasons starting earlier or ending later than usual,” says Dr. Rajapakse.

A surge of RSV infection during last season resulted in many young children needing medical attention or being hospitalized. The CDC says 58,000 to 80,000 infants and children are hospitalized yearly due to RSV.

“RSV, when it presents to young infants or babies, can present initially with cold-type symptoms and may include some cough, runny nose fever,” says Dr. Rajapakse. “But in these young children, it tends to move down into the chest and cause bronchiolitis or inflammation of the small airways in the lungs. When that happens, kids can have difficulty breathing and shortness of breath. They have to use more of their muscles to breathe and can get tired. And when that happens, their oxygen levels can drop.”