FDA approves Sanofi, AstraZeneca infant RSV vaccine

RSV infant vaccine overview: 

• Who: The U.S. Food & Drug Administration (FDA) has approved a new preventative treatment for respiratory syncytial virus (RSV).
• Why: RSV is the leading cause of infant hospitalization in the country.
• Where: The RSV vaccine will be available in the United States.

The U.S. Food & Drug Administration (FDA) has approved a new preventative treatment for respiratory syncytial virus (RSV) — the leading cause of infant hospitalization in the country. 

On July 17, the FDA said it had approved AstraZeneca’s Beyfortus (nirsevimab-alip) for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.

“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,” Director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research John Farley said.

“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 a virus that causes acute respiratory infection, the agency said. Approximately 1% to 3% of children under 12 months are hospitalized each year in the United States due to RSV, it said.

“One dose of Beyfortus, administered as a single intramuscular injection prior to or during RSV season, may provide protection during the RSV season,” it said. 

Approval comes after three clinical trials

The safety and efficacy of Beyfortus was supported by three clinical trials, where the risk of RSV infection was reduced by up to 75%, the FDA said. 

Possible side effects of Beyfortus include rash and injection site reactions, it added. 

The manufacturing companies, Sanofi and AstraZeneca, said in a press release they plan to make Beyfortus available in the U.S. ahead of the upcoming 2023-2024 RSV season.

RSV is the leading cause of hospitalization for infants under the age of one in the U.S., averaging 16 times higher than the annual rate for influenza, the companies said. They said, each year, an estimated 590,000 RSV disease cases in infants under one require medical care, including physician office, urgent care, emergency room visits and hospitalizations.

“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.,” AstraZeneca Executive Vice President, Vaccines and Immune Therapies Iskra Reic said.

In Dec. 2022, consumers reported shortages of medications such as Tylenol, Motrin and Advil, among others, making it more difficult to treat common child-afflicting viruses such as flu, sore throat and ear infections. 

What do you think of this RSV vaccine approval? Let us know in the comments!

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