Limited Availability of Newly Approved Antibody Drug for RSV Prevention Raises Concerns
The Centers for Disease Control and Prevention (CDC) issued an alert to doctors nationwide regarding the limited availability of certain doses of a recently approved antibody drug used to prevent infection with Respiratory Syncytial Virus (RSV). As cases of RSV increase with the onset of cold and flu season, the CDC’s warning comes as a cause for concern.
Named Beyfortus, the antibody drug was approved by the Food and Drug Administration (FDA) in July as an alternative to vaccines. Instead of stimulating the body’s immune system to develop its own antibodies against the virus, Beyfortus delivers ready-made antibodies through injections. Infants can receive doses during their first RSV seasons, while high-risk children up to 2 years old can receive second doses during subsequent seasons.
The limited availability of the highest dose, 100 milligrams, has prompted the CDC to instruct doctors to prioritize its administration to infants at the highest risk of severe RSV cases. This includes infants younger than 6 months and those with underlying health conditions. For babies weighing less than 11 pounds, the CDC advises using 50 mg doses. Despite efforts by drug manufacturer Sanofi to meet demand, the 100 mg doses have been in higher demand than expected.
The FDA, however, has stated that the drug is not listed as in short supply in its database. To prevent RSV infections in infants, another option is the antibody drug Synagis, which is only approved for high-risk infants and can be administered solely during RSV season.
In August, the FDA also approved the RSV vaccine Abrysvo for use in pregnant women during the third trimester. This decision aims to provide protection for newborns during their first six months of life.
The limited availability of the Beyfortus antibody drug highlights the importance of prioritizing the health and safety of vulnerable infants in preventing RSV infections. Efforts to ensure an adequate supply of the drug and the availability of alternative preventive options are crucial in tackling the rising cases of RSV during the cold and flu season.