Beyfortus, developed by AstraZeneca and marketed by Sanofi, was cleared by the FDA for use in children up to the age of 24 months for preventing RSV infections.
This is the first RSV drug for healthy children to be approved by regulators. Earlier this year, two RSV vaccines for seniors were approved by the FDA.
The newly approved medication is a single-dose monoclonal antibody. It is not a vaccine but works in a similar way.
The drug was approved for use in newborns and infants born during or entering their first RSV season, as well as for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
The shot will likely provide comfort to many parents following last year’s surge, when small children unexposed to the virus were infected and hospitals scrambled to find room for all of them.
While most people infected with RSV will experience some cold-like symptoms and recover with rest and care, infants and toddlers stand at a higher risk of developing respiratory diseases like pneumonia.
An existing monoclonal antibody treatment is intended only for high-risk infants with heart or lung conditions, or high-risk preemies. The most that clinicians can usually do for healthy children admitted with severe RSV is supplemental oxygen or putting them on a ventilator.
The drug will now be discussed and voted on by the Centers for Disease Control and Prevention’s expert advisory panel on Aug. 3. The committee is likely to formalize its draft recommendations in February.
The companies plan to make Beyfortus available ahead of the upcoming 2023-2024 RSV season.
With the approval, Sanofi and AstraZeneca officially beat out a maternal RSV vaccine developed by Pfizer that’s also under review.
