Pediatricians and parents will now have a new option that they can opt for to protect infants from the lung-attacking respiratory syncytial virus (RSV), which is the leading cause of infant hospitalization in the US among those who are less than a year old.
FDA Approves Antibody That Offers Infants Protection Against RSV
The US Food and Drug Administration has granted approval for nirsevimab, which will be distributed under the Beyfortus brand, CNN reports. As such, the antibody is not a vaccine, as vaccines prompt the bodily creation of antibodies that can guard the body against pathogenic invaders. Nirsevimab, however, works as passive immunity. The antibody is ready-made and can bind to the RSV and stop it from infecting healthy cells.
The antibody is administered through a single injection prior to the start of RSV season, which tends to peak during the winter and fall. As such, the approval of the FDA also allows babies up to 24 months old, who may still be vulnerable during their second RSV season, to have a second injection.
Moving forward, experts that advise the Centers for Disease Control and Prevention will be weighing things next. Clinical considerations and draft recommendations regarding the antibody's use have also been granted by the ACIP (Advisory Committee on Immunization Practices). However, these are expected to be further formalized by those who have the right to vote during the coming meeting.
Two RSV-Combatting Antibodies Available
After the signing of the CDC, this antibody would become the second one available that could help guard children against the lung-attacking virus.
Other than nirsevimab, there is Synagis or palivizumab, which has only been used to protect babies who are most vulnerable. This antibody only lasts for a short time within the body, which is why it is regularly administered once a month before RSV season and until the risk passes.
Synagis has been quite a help, but the scale of its effectiveness is only partial. Babies are kept out of the hospital around 50% of the time, CNN reports.
Respiratory Syncytial Virus (RSV)
According to Sanofi, RSV is the leading hospitalization cause among infants in the US who are under one year old. It averages 16 times higher compared to influenza's annual rate. The Centers for Disease Control and Prevention also add that RSV is the leading cause of pneumonia and bronchiolitis among infants who are less than one year old.
The CDC further explains that RSV typically causes cold-like and mild symptoms. While several people could get better within one to two weeks, the condition could be serious for infants and older adults.
Dr. John Farley, who serves as the director at FDA's Center for Drug Evaluation and Research's Office of Infectious Diseases, explains that RSV could lead to severe conditions for infants and children. It could also result in more physician and emergency visits annually.
Now, the FDA approval can address the need for options that could help reduce RSV's impact on infants, families, and the whole healthcare system.
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