FDA approves preventive RSV treatment for infants and toddlers

The Food and Drug Administration (FDA) has approved a treatment for the prevention of RSV among infants and toddlers, making it the first preventive drug for the common virus that surged last winter among small children.

The FDA approved nirsevimab-alip, or Beyfortus, for the prevention of respiratory syncytial virus (RSV) among newborns and infants born during or entering into their first RSV season, which typically starts in the fall, peaks in the winter and ends in the spring.

Beyfortus is a monoclonal antibody administered in one dose. The safety of efficacy of the medicine is supported by three clinical trials, according to the FDA’s release Monday.

“Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system,” John Farley, director of the FDA’s Office of Infectious Diseases, said in a statement.

In June, the FDA’s antimicrobial drug advisory panel unanimously voted to recommend that nirsevimab be approved, with the committee of experts finding the overall benefit-risk assessment to be favorable.

The shot has been approved for children up to 24 months of age.

The drug is manufactured by AstraZeneca and will be marketed by Sanofi. The FDA indicated a rash around the injection site as a possible side effect of Beyfortus and advised that it be administered with caution in children with clinically significant bleeding disorders.

“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,” Iskra Reic, executive vice president of AstraZeneca, said in a release.

Known as a “daycare disease,” RSV is extremely common with the vast majority of people being exposed to it by the time they’re two-years-old. During COVID lockdowns, however, infants and toddlers born shortly before or during the pandemic were unlikely to be exposed to the pathogen, leading to lower immunity among this younger age group.

The majority of those who get RSV experience cold-like symptoms that go away with rest and self-care. But first-time infections in infants can lead to respiratory diseases like pneumonia and bronchiolitis.

Infants younger than six months are at the highest risk of developing severe cases of RSV that lead to hospitalization, which was seen last winter when hospitals were inundated with sick children, with many quickly reaching capacity.

The surge this past winter brought attention to the lack of real treatment options for RSV. There were no preventive medicines for anybody at that time and the only treatment available was monoclonal antibodies that were typically reserved for extremely high-risk cases. Apart from that, clinicians could only provide supplemental oxygen or place children on ventilators in cases of respiratory failure.

The FDA has already approved two RSV vaccines for use in older adults this year, but the announcement on Monday marks the first preventive treatment approved by the agency for children.

An RSV vaccine candidate for infants is currently under review. Created by Pfizer, the shot is administered to pregnant mothers to confer immunity to their children before they’re born. An FDA advisory panel unanimously voted in favor of approving the shot in May.

The Advisory Committee on Immunization Practices under the Centers for Disease Control and Prevention (CDC) is scheduled to meet on August 3 to discuss and vote on recommending Beyfortus for children.

This story was updated at 2:19 p.m.