FDA approves RSV preventative injection for infants
Gabrielle M. Etzel
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The Food and Drug Administration announced on Monday it has given full approval for a new preventative injection for infants under age 2 to protect them from contracting respiratory syncytial virus, or RSV.
The fast-track approval of AstaZeneca’s Beyfortus comes less than one year after the so-called “tripledemic” of influenza, COVID-19, and RSV put many children’s hospitals at capacity during the 2022 fall and winter infection season.
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“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, research director for the FDA’s Office of Infectious Diseases.
Beyfortus is a monoclonal antibody treatment, a laboratory-made protein that mimics the body’s natural immune system. The FDA recommends that infants receive one dose of the antibodies as an intramuscular injection prior to or during the RSV season to provide maximum protection.
In the United States, RSV annually leads to approximately 58,000 child hospitalizations and between 100 and 300 child deaths. Most children with RSV have cold or flu-like symptoms, but lower respiratory tract infections can develop in severe cases, causing swelling of the air passageways and pneumonia.
Although RSV is typically a seasonal virus, the summer and early fall of 2022 saw high rates of RSV infections among children, significantly higher than pre-COVID-19 pandemic levels.
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Clinical trials for Beyfortus began in 2016 and officially concluded last month, according to the FDA.
“Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families, and the healthcare system,” Farley said.