By I. Edwards HealthDay Reporter<\/b>
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THURSDAY, June 12, 2025 (HealthDay News) \u2014 A newly approved shot could soon help protect babies from respiratory syncytial virus<\/a> (RSV), the top cause of hospitalization in U.S. infants.<\/p>\n The U.S. Food and Drug Administration (FDA) has approved a monoclonal antibody called Enflonsia<\/a>, the drugmaker Merck<\/a> announced<\/a> June 9.<\/p>\n Given as a single 105-milligram injection, Enflonsia is designed to protect newborns and infants throughout their first RSV season \u2014 which usually runs from fall through early spring, CNN <\/em>reported.<\/p>\n In a clinical trial, Enflonsia cut RSV-related hospital stays in infants by more than 84% compared to a placebo. It also reduced serious lower respiratory infections, like pneumonia<\/a>, by more than 60%.<\/p>\n \u201cEnflonsia provides an important new preventive option to help protect healthy and at-risk infants born during or entering their first RSV season,\u201d Dr. Dean Li<\/a>, president of Merck Research Laboratories, said.<\/p>\n \u201cWe are committed to ensuring availability of Enflonsia in the US before the start of the upcoming RSV season to help reduce the significant burden of this widespread seasonal infection on families and health care systems,\u201d he added in a news release.<\/p>\n The most common side effects identified in the study were mild and included swelling at the injection site and rash. Merck says the safety of the shot was similar to that of a placebo.<\/p>\n Before Enflonsia can be used, it must be recommended by the U.S. Centers for Disease Control and Prevention (CDC).<\/p>\n The CDC\u2019s Advisory Committee on Immunization Practices was expected to review the shot this month \u2014 but that process has been delayed, as U.S. Health and Human Services Secretary Robert F. Kennedy Jr<\/a>. removed and replaced members of the panel this week. The new members include some vaccine critics.<\/p>\n Doctors say another tool to fight RSV can\u2019t come soon enough.<\/p>\n RSV is very common \u2014 most kids get it by age 2, according to the CDC. For older children and adults, it often feels like a cold.<\/p>\n But for infants, RSV can be much more serious. Their small airways can become inflamed, making it hard to breathe. In some cases, the virus leads to bronchiolitis or pneumonia and even death.<\/p>\n Each year, 2% to 3% of U.S. infants under 6 months of age are hospitalized with RSV. Between 58,000 and 80,000 kids under age 5 are hospitalized with the virus annually.<\/p>\n There\u2019s no specific treatment for RSV, Dr. Amy Edwards<\/a>, a pediatric infectious disease expert at UH Rainbow Babies and Children\u2019s Hospital in Cleveland, told CNN<\/em>.<\/p>\n Doctors basically support them with oxygen and wait for them to recover, Edwards added.<\/p>\n \u201cI hate RSV,\u201d said Edwards, who was not involved in the Merck trial.<\/p>\n \u201cJust to watch them struggle to breathe, and then they get scared, and then they cry, which of course makes the breathing worse, and their little lips turn blue,” she said. “It\u2019s just so hard to watch.\u201d<\/p>\n Enflonsia joins a short list of new tools to prevent RSV in infants.<\/p>\n Another RSV antibody called Beyfortus<\/a>, made by Sanofi<\/a> and AstraZeneca<\/a>, was approved in 2023. But there were supply shortages during last year\u2019s RSV season.<\/p>\n A vaccine given during pregnancy can also protect newborns, and together, these efforts seem to be working.<\/p>\n A CDC study<\/a> published in May found that hospitalization rates for RSV in babies under 7 months were lower during the 2024\u20132025 season compared to past years when no protection was available.<\/p>\n Edwards hopes parents take advantage of all the options.<\/p>\n \u201cEvery RSV season fills us to the gills,\u201d she said. \u201cThis should theoretically empty us out, if we have good uptake.\u201d<\/p>\n More information<\/strong><\/p>\n The Mayo Clinic has more on the respiratory syncytial virus<\/a> (RSV).<\/p>\n