The Food and Drug Administration (FDA) has granted approval for a groundbreaking treatment to prevent respiratory syncytial virus (RSV) in infants and toddlers. This is the first preventive drug available for the common virus that particularly affects young children during the winter months.
The approved treatment, called nirsevimab-alip or Beyfortus, is a monoclonal antibody that is administered in a single dose. The FDA’s release on Monday stated that the safety and effectiveness of the medicine have been established through three clinical trials.
John Farley, the director of the FDA’s Office of Infectious Diseases, stated, “Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families, and the healthcare system.”
In June, the FDA’s antimicrobial drug advisory panel unanimously recommended the approval of nirsevimab. The committee of experts found the overall benefit-risk assessment to be favorable.
Beyfortus is approved for children up to 24 months old. Manufactured by AstraZeneca and marketed by Sanofi, the FDA has identified a potential side effect of a rash around the injection site. Additionally, it is advised to administer Beyfortus with caution in children with clinically significant bleeding disorders.
Iskra Reic, the executive vice president of AstraZeneca, expressed, “Beyfortus represents an opportunity for a paradigm-shift in preventing serious respiratory disease due to RSV across a broad infant population in the U.S.”
RSV, often referred to as a “daycare disease,” is highly prevalent, with the majority of people being exposed to it by the age of two. However, due to COVID-19 lockdowns, infants and toddlers born during the pandemic had limited exposure to the virus, leading to reduced immunity in this age group.
While most individuals with RSV experience cold-like symptoms that resolve with rest and self-care, infants can develop more severe respiratory illnesses such as pneumonia and bronchiolitis after their first infection. Infants under six months old face the highest risk of developing severe RSV cases requiring hospitalization. Last winter, hospitals were overwhelmed with sick children, reaching their capacity quickly.
The surge in RSV cases brought attention to the lack of effective treatment options. At that time, there were no preventive medications available, and monoclonal antibodies, reserved for high-risk cases, were the only treatment option. Clinicians could only provide supplemental oxygen or resort to placing children on ventilators in cases of respiratory failure.
While the FDA has already approved two RSV vaccines for older adults this year, the recent approval of Beyfortus marks the first preventive treatment for children.
Another RSV vaccine candidate for infants is currently under review. Developed by Pfizer, this shot is administered to pregnant mothers to confer immunity to their unborn children. In May, an FDA advisory panel unanimously voted in favor of approving the vaccine.
The Advisory Committee on Immunization Practices, under the Centers for Disease Control and Prevention (CDC), is scheduled to discuss and vote on recommending Beyfortus for children during a meeting on August 3.
Please note that this content has been updated as of 2:19 p.m.
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