FDA approves RSV injection for infants

The Food and Drug Administration on Monday approved an injectable drug that can protect children up to 2 years old from respiratory syncytial virus.

The Food and Drug Administration on Monday approved an injectable drug that can protect children up to 2 years old from respiratory syncytial virus.

The drug, a monoclonal antibody injection called Beyfortus, can be given as a single injection to newborns and infants during their first RSV season. Children up to age 2 who are vulnerable to severe infections from the respiratory virus — such as those with congenital heart disease or premature babies with long-term breathing and lung problems — can receive a second dose during their second RSV season.  

The Centers for Disease Control and Prevention's Advisory Committee for Immunization Practices will meet to discuss recommendations about who should receive the shots. Once the CDC director, Dr. Mandy Cohen, signs off on the panel’s recommendation, the injections can be distributed to the public.

An independent advisory committee to the FDA unanimously voted last month to recommend Beyfortus for newborns and infants, and it voted 19-2 in favor of second doses for high-risk children up to age 2.

Beyfortus acts similarly to a vaccine, but instead of prompting the immune system to develop antibodies to the virus — what's known as "active immunization" — it delivers the antibodies directly to the bloodstream via so-called passive immunization.