CDC Panel Recommends Promising RSV Drug for Children Under 19 Months

A panel of independent advisors have recommended a new drug that would help protect young children from a deadly virus that strikes each fall.

A Centers for Disease Control and Prevention (CDC) panel, called the Advisory Committee on Immunization Practices (ACIP), recommended Beyfortus, a new treatment developed jointly by European pharma companies Sanofi and AstraZeneca, for children 19 months and younger.

The drug can prevent infection from the respiratory syncytial virus (RSV). The virus is an annual nuisance that erupts alongside the flu each fall and winter. It is the leading cause of hospitalizations for infants in the United States and causes up to 300 deaths in children under five each year.

Last year was an especially notable year for RSV, as it rampaged across America’s youth coming out of the COVID-19 pandemic, packing children’s hospitals around the country and leading to some schools temporarily closing.

Post-COVID RSV outbreaks have put increased attention on the virus. The first vaccine for RSV is rolling out this year, with shots from GlaxoSmithKline and Pfizer having received regulatory approval.

Beyfortus is a monoclonal antibody which exposes the body to synthetic RSV proteins to prepare the immune system to fight the virus. Similar to the vaccine designed for older individuals, this one can be taken at the start of flu season to provide protection during the cold weather months.

In clinical trials, babies that received the drug were 76% less likely to suffer an RSV infection.

It is expected to cost $495 per dose of the shot, though costs will likely be covered by insurance. Advocates are also pushing to add it to the federal government's Vaccine for Children program, meaning costs will be covered for uninsured children.

The Food and Drug Administration (FDA) approved the shot for the same age group last month. Now, the CDC will need to approve the drug for it to begin to be administered to young children ahead of flu season this fall. While the agency is not obliged to follow the guidance of its panel, it is expected to approve Beyfortus this week.

European regulators approved Beyfortus in November.