FDA approves RSV shot for all infants

On July 17, the Food and Drug Administration approved the first drug to protect babies and children up to two years old from RSV, or respiratory syncytial virus.

Beyfortus (nirsevimab-alip) is a single injection monoclonal antibody intended for all newborns and infants ahead of or during their first RSV season, regardless of their risk or gestational age. Toddlers, up to 24 months of age, who remain high risk will be eligible to get a second dose as their second RSV season approaches. While not a vaccine, it is designed to prevent illness and has been shown to reduce the risk of RSV infection in infants and toddlers by up to 75%.

“RSV can cause serious illness in infants and toddlers, resulting in outpatient office and emergency room visits as well as hospitalizations, some requiring intensive care,” says Dr. Michael Cappello, vice-chair of pediatrics at Advocate Children’s Hospital. “This will help decrease the risk for our youngest patients and be a great benefit for children and families.”

RSV is a common respiratory virus that typically causes symptoms similar to the common cold, but it can be much more dangerous, especially for infants and young children. According to the CDC, RSV causes between 56,000 and 80,000 hospitalizations and 2.1 million outpatient visits for children under 5 every year.

RSV season generally starts in the fall and peaks in the winter, although last year hospitals saw an early surge of the infection that persisted for months.

Beyfortus will be the second monoclonal antibody treatment to prevent RSV. The first, Palivizumab, also known as Synagis, is only given to premature and high-risk infants and must be given monthly during RSV season.

The CDC’s Advisory Committee for Immunization Practices will meet in August to discuss who should receive the new shots. The drug can be made available to the public once the panel’s recommendations are approved.

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