The U.S. Food and Drug Administration announced approval of nirsevimab, sold under the name Beyfortus, in a press release Monday.

The drug is designed to prevent respiratory syncytial virus lower respiratory tract disease in babies born during or entering their first RSV season, as well as in vulnerable children up to age 2 who are more susceptible to severe illness within their second RSV season.

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

Thomas Triomphe, executive vice president of pharmaceutical company Sanofi, said in a statement that the approval “marks an unprecedented moment for protecting infant health in the U.S., following an RSV season that took a record toll on infants, their families, and the U.S. health care system.”

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Drug manufacturers Sanofi and AstraZeneca will sell Beyfortus, which CBS News said decreased infant RSV hospitalizations by 83.2%.

CNN said that unlike a vaccine, which prompts the body to make antibodies against pathogens, this drug is “a ready-made antibody that can bind to the virus and block it from infecting healthy cells.”

NBC News said it’s administered as a single injection given before or during a baby’s first RSV season or as a second injection for vulnerable children up to age 2 during their second RSV season.

“We expect Beyfortus to be priced similarly to an innovative pediatric vaccine series, in accordance with the value and innovation it delivers,” a Sanofi spokesperson told CBS News.

Side effects from Beyfortus may include a rash and injection site reactions and the vaccine should not be given to babies that are allergic to the active ingredients, the press release said.

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Respiratory syncytial virus 

CBS News said respiratory syncytial virus has flu-like symptoms that are mild in healthy adults but can lead to pneumonia and bronchiolitis in serious cases, especially for infants and older adults.

“The virus leads to up to 80,000 hospitalizations and up to 300 deaths a year among children under age 5 in the U.S.,” CBS News said.

NBC News said Beyfortus’ approval follows that of Synagis, a different monoclonal antibody injection meant to prevent RSV in high-risk infants. It’s administered monthly and reduced hospitalization risk by 45% to 55% in clinical trials.

The Advisory Committee on Immunization Practices — experts who advise the U.S. Centers for Disease Control and Prevention — is expected to meet and discuss recommendations for who should receive the shot and clinical considerations, according to CNN.