FDA Approves Beyfortus: First Drug for Infants and Toddlers to Prevent Respiratory Virus

UNITED STATES — The Food and Drug Administration (FDA) has approved the first monoclonal antibody drug designed to protect infants and toddlers from respiratory syncytial virus (RSV).

The drug called Beyfortus, was developed by Sanofi and AstraZeneca, and is the first drug of its kind to be widely available to individuals up to 24 months of age.

RSV infects the respiratory tract and can lead to serious and sometimes fatal illnesses among children. Currently, preventative measures only exist for immunocompromised children, but Beyfortus will now provide the wider public access to additional protection from RSV.

The FDA has previously approved only one other monoclonal antibody, Palivizumab, which is only recommended for high-risk infants who are born severely premature at 29 weeks or earlier.

Beyfortus reduces the risk of RSV infection by 70% to 75%, as reported by the three studies submitted to the FDA. The drug is not a vaccine, but it is intended to prevent severe illnesses like one.