Monitoring Desk
NEW YORK: A new monoclonal antibody approved by the Food and Drug Administration (FDA) is effective at preventing severe illnesses and hospitalizations from RSV in infants, a new study finds.
In a real-world study of more than 8,000 infants under 12 months, British researchers found that those who received Beyfortus were less likely to require hospitalization due to a severe infection from RSV.
Overall, results suggest that the shot was nearly 90% effective at preventing hospitalization and almost 76% effective at preventing RSV-associated lower respiratory tract infection.
Beyfortus, which uses the active ingredient nirsevimab, is developed and manufactured by the pair of European pharma giants AstraZeneca and Sanofi.
It was approved by the FDA in July, and the Centers for Disease Control and Prevention later recommended the shot for infants 19 months and younger.
Although nirsevimab is a shot, it is not considered an immunization and is not a vaccine in the typical sense.
It is a monoclonal antibody treatment that exposes infants to RSV proteins, which, in turn, prepare their bodies to fight off an RSV infection.
Most people who are exposed to RSV will not contract a serious illness. For healthy adults, RSV might present similar to the way a common cold would, but for certain groups of people — infants and older adults — the virus can trigger a severe infection.
The CDC estimates that there are more than 2 million outpatient visits among children younger than five due to RSV.
The virus also hospitalizes up to 80,000 children per year and is responsible for up to 300 pediatric deaths annually.
When Beyfortus was approved, many experts expressed their enthusiasm for how the shot could temper the influx of illness among children that presents during RSV season, which typically occurs between fall and spring.
However, a shortage of the treatment has dampened doctors’ optimism.
In October, the CDC issued an advisory saying that the shot would be in short supply throughout the 2023-2024 season.
Around one month later, the CDC and FDA announced plans to expedite the release of 77,000 additional doses to help meet the demand.
