RSV Injection for Infants Approved

RSV Injection for Infants Approved

On July 17, 2023, the Food and Drug Administration approved an injectable drug designed to protect children up to 2 years of age from respiratory syncytial virus (RSV). The Centers for Disease Control and Prevention’s (CDC) Advisory Committee for Immunization Practices is set to meet to determine who should be recommended to receive the shots. The director of the CDC must sign off on the panel’s recommendation before the injections are made available to the public.


The drug, called Beyfortus, is a monoclonal antibody injection made by AstraZeneca and Sanofi and aims to protect children up to two years old from RSV through a single injection. Notably, especially vulnerable children under 2 years old may be able to receive a second dose during their second RSV season. Beyfortus is not a vaccine because it delivers antibodies directly into the bloodstream through passive immunization.

In a study, the drug lowered the risk of developing an RSV-related respiratory illness that required a doctor’s care by 75% for a minimum of 5 months. The most common side effects discovered in the study trials were rash and injection site reactions.

This monoclonal antibody is already approved in Europe, Canada, and the United Kingdom.

What is RSV?

The virus causes a lower respiratory illness which varies from mild to serious cases. Serious cases can lead to pneumonia or bronchitis. Most children have been infected by RSV by age 2, and each year there are up to 300 RSV-related deaths in children under the age of 5 in the U.S. Older adults and babies under 6 months old are the most susceptible to serious cases of RSV.

The RSV season typically peaks in the winter and fall, but last year cases started in June and peaked in November. It is important to stay vigilant and protect at-risk groups against RSV, especially as RSV season approaches.