In The News: CDC Advisors Back Therapeutic to Prevent RSV in Infants

Medpage Today reports on the unanimous ACIP vote in favor of nirsevimab for protecting infants at risk of respiratory syncytial virus. The advisory committee recommended that all infants younger than eight years of age born during or approaching their first RSV season receive one dose. Children eight to nineteen months of age who are at increased risk of RSV and approaching their second season were also recommended to receive one dose. The CDC has accepted ACIP’s recommendations.

The advisory committee defined the increased risk group to match the American Academy of Pediatrics’ recommendation for palivizumab. The increased risk includes those with chronic lung disease of prematurity requiring medical support in the six months before the RSV season, severe immunocompromise, and cystic fibrosis with pulmonary exacerbation hospitalization by age one or persistent abnormalities on chest imaging. They also added Alaska Native and Native American infants to the at-risk group based on studies showing increased risk (six to 10 times greater) in this demographic.

Members discussed implementation challenges amongst one another. Many issues revolved around nirsevimab being coded as a therapeutic rather than a vaccine. They identified how that could affect internal provider ordering, administration of nirsevimab in immunization information systems, and reimbursement. The first season will also be a transition year for the RSV cycle.

A large point of emphasis involved cost. Sanofi, the manufacturer of nirsevimab, anticipates pricing at $495 per dose on the commercial market and $395 per dose in the CDC’s Vaccines for Children program. The price point is an important consideration for availability if hospitals and family physicians need to pay up front for the drug without knowing whether insurers will reimburse.

Administration of the therapeutic is recommended from October through March. Providers should adhere to local epidemiologists on timing, however, due to seasonality differences in different parts of the country.

PIDS members Sarah Long and Grace Lee (chair) are also ACIP members and are quoted in the article. Dr. Long said, “This is the very first antibody protection against a remaining burden of disease in children. So, parents should be very, very much relieved that they won’t have to be concerned about the likelihood that their child could be hospitalized with the RSV disease.” And Dr. Lee spoke of the cost concerns, “This is a plea generally to ask for a reconsideration of where the risk is actually laid, because right now it is a huge cost and, honestly, a disincentive to be able to get people to do the right thing.”