FDA Approves RSV Antibody Shot for Infants

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July 18, 2023 – The FDA has approved a shot that is highly effective at protecting infants from potentially deadly illnesses caused by respiratory syncytial virus, or RSV. Nearly all children have an RSV infection by their second birthday.

The new preventive treatment, called Beyfortus, contains antibodies that reduce the chance of a severe infection by up to 75%. The protection can last up to 5 months, which is about the length of the typical RSV season. On Monday, the FDA approved the shot for babies up to 1 year old, and also for high-risk toddlers 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,” FDA Office of Infectious Diseases Director John Farley, MD, MPH, said in a statement. “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 is blamed for more than 2 million outpatient visits, up to 80,000 hospitalizations, and up to 300 deaths among children under age 5 annually. An early surge of the virus last fall filled some pediatric wards to capacity amid what became known as the “tripledemic,” when the nation faced high rates of COVID-19, flu, and RSV at the same time. 

Drugmaker AstraZeneca announced in a news release that Beyfortus will be available ahead of the start of the 2023 to 2024 RSV season. It is already approved and available in Europe and Canada. The most common side effect seen in clinical trials was a rash.

RSV symptoms are a runny nose, decreased appetite, coughing, sneezing, a fever, and wheezing, according to the CDC

“These symptoms usually appear in stages and not all at once,” the CDC’s webpage about the virus states. “In very young infants with RSV, the only symptoms may be irritability, decreased activity, and breathing difficulties.”