CDC recommends new drug to protect infants from RSV
In July, FDA approved nirsevimab-alip (Beyfortus—Sanofi/AstraZeneca). A few weeks later, on August 3, 2023, CDC’s ACIP voted unanimously to recommend the broad use of the new drug to infants and high-risk children for protection against respiratory syncytial virus (RSV).
Nirsevimab-alip is the first ever drug to safeguard infants against RSV. CDC advisers who recommended its use described nirsevimab as a significant breakthrough against a respiratory disease that causes the deaths of as many as 300 children a year in the United States and is the primary cause of hospitalization among infants in the United States.
FDA said it approved the drug based on studies indicating that it safely prevented severe RSV-associated lower respiratory tract infections.
Although nirsevimab-alip is not a vaccine, it has a similar goal. The drug gives infants antibodies to neutralize the virus before their immune systems are sufficiently mature enough to combat the pathogens.
Nirsevimab-alip will usually require a single dose. Under FDA approval, infants can receive nirsevimab-alip at the start of an RSV season or during it if the season has already commenced. Children who are at high risk for developing severe RSV can receive a second dose for a second RSV season if they are younger than 2 years old, according to Sanofi.
The company expects to make nirsevimab-alip available in time for this year’s RSV season.
ACIP recommended the drug be offered to all infants born during the RSV season or to those who are less than 8 months old as they enter their first RSV season. They also recommended that high-risk children ages 8–19 months receive a second dose of nirsevimab prior to their second RSV season.
ACIP’s third recommendation was to include nirsevimab in the Vaccines for Children program, even though the drug is not a vaccine. Inclusion in the program ensures that children of parents without health insurance can receive the drug at no cost.
Sanofi indicated to ACIP it will charge $495 per dose, which is costlier than a typical vaccine.