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July 18, 2023

Preventive RSV shot for infants and toddlers approved by FDA

Beyfortus, a monoclonal antibody, reduced the risk of illness by 70-75% in children age 2 and younger during studies

Babies and toddlers will soon have added protection from respiratory syncytial virus, also known as RSV. On Monday, the U.S. Food and Drug Administration approved a first-of-its-kind injectable drug, Beyfortus, designed to protect children up to 2 years old. 

"RSV can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year," said John Farley, director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research. "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."

RSV, common among young children, can cause cold-like symptoms and develop into bronchiolitis or pneumonia for those under 1 year old; each year, 1-3% of U.S. children under 12 months old are hospitalized due to RSV, according to the American Academy of Pediatrics. 

Beyfortus was developed from lab-made proteins and copies the immune system in fighting off the virus. It is a monoclonal antibody injection, meaning it delivers antibodies directly to the bloodstream in what is called passive immunization. (It is not a vaccine, which prompts the immune system to develop antibodies to a virus and is referred to as active immunization.) One dose should be injected before RSV season, which is usually from fall through spring.

Injections will become available to the public after the Centers for Disease Control and Prevention discusses who should get the shot, with the CDC director's approval.

The drug endured three trials before its approval, with infants born full-term and prematurely participating. In the first trial, approximately 70% of infants who received a drug dose had a reduced risk of RSV. In the second trial, Beyfortus reduced the risk by about 75%. The final trial included infants with chronic lung disease and congenital heart disease, and the results determined that Beyfortus helped prevent RSV among those immunocompromised babies.

Beyfortus has some possible side effects, including a rash and a reaction at the injection site. Canada, Europe and the United Kindgom have approved the drug. 

In May, the FDA approved the first RSV vaccine for adults age 60 and older. Results from its trail testing showed it was 83% effective at preventing lower respiratory tract illnesses caused by RSV and 95% effective for patients with at least one other medical condition. 

Last year, doctors said cases of RSV were the worst doctors had seen in years. Annually, between 58,000 and 80,000 children age 5 and younger are hospitalized with RSV, the CDC reportsAmong older adults, there are more than 177,000 hospitalizations and 14,000 deaths yearly

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