Antibody recently endorsed may provide additional shield for safeguarding infants against RSV, a widespread disease known for its potential to be fatal.

Antibody recently endorsed may provide additional shield for safeguarding infants against RSV, a widespread disease known for its potential to be fatal.

Fight Against RSV: Merck's Enflonsia Approved by FDA

The United States might witness a new weapon in the battle against respiratory syncytial virus (RSV), the predominant cause of hospitalization in infants.

In a late-Monday announcement, drug manufacturer Merck received approval from the US Food and Drug Administration (FDA) for a new monoclonal antibody targeted at preventing RSV infection.

This antibody, called Enflonsia, is intended for a single 105-milligram shot to shield newborns and infants from mild, moderate, or severe RSV during the entire five months of their initial virus season. Typically spanning from fall to the next spring, this season arrives annually.

Data submitted by Merck to the FDA revealed that Enflonsia boasted a comparable safety profile to a placebo. Common side effects from the antibody included mild injection-site swelling and a minimal number of rashes in infants.

During a mid- to late-stage trial, Enflonsia outperformed a placebo, decreasing RSV-related hospitalizations in infants by more than 84%. Not only that, but the shot effectively reduced lower respiratory infections necessitating medical attention by over 60% compared to a placebo.

"Enflonsia provides an essential new preventive option to help safeguard healthy and at-risk infants during the first RSV season," expressed Dr. Dean Y. Li, president of Merck Research Laboratories, in a statement. "We are pledged to ensuring Enflonsia's availability in the US before the start of the impending RSV season to help lessen the significant impact of this widespread seasonal virus on families and healthcare systems."

Merck anticipates making Enflonsia accessible before the 2025-26 respiratory virus season. However, it needs the recommendations of the US Centers for Disease Control and Prevention (CDC), which involves the Agency's Advisory Committee on Immunization Practices (ACIP). This item is on the Committee's meeting agenda for this month, but US Health and Human Services Secretary Robert F. Kennedy briefly removed ACIP members earlier this week. He plans to appoint new members, but it remains uncertain how long the process will take.

Doctors claim an additional tool to stave off RSV is long overdue.

RSV is incredibly common, ranking as one of the leading causes of childhood sickness. Most children catch this highly transmissible respiratory virus before they turn 2, according to the CDC.

While healthy adults and older kids typically experience mild illness, resembling a common cold, symptoms that can usually resolve at home, young children and infants face a distinct scenario.

Infants' immature immune systems are still learning to combat infections, and they possess tiny airways. Infection by RSV aggravates these airways, making it difficult for babies to breathe, and can result in serious lower respiratory diseases such as bronchiolitis or pneumonia. More severe RSV infections can be fatal.

Two to three percent of infants under six months are hospitalized with RSV each year in the United States, according to the CDC. Approximately 58,000 to 80,000 children younger than 5 are hospitalized due to RSV yearly.

No specific medication exists to treat RSV. Doctors can provide supportive care and oxygen, but they must wait until the infant's oxygen levels return to normal. Dr. Amy Edwards, director of pediatric infection control at UH Rainbow Babies and Children's Hospital in Cleveland, added, "I detest RSV. Watching them struggle to breathe, which of course makes the breathing worse, and their lips turn blue…it's hard to watch."

Enflonsia joins a limited arsenal of preventative measures to protect babies from RSV. The FDA momentarily halted RSV vaccine trials involving infants and young children aged 2 to 5 last year due to some participants developing severe illness.

At present, the CDC suggests an RSV antibody manufactured by Sanofi and AstraZeneca, dubbed Beyfortus, which was approved in 2023. Due to supply issues last season, Beyfortus was in short supply during the 2024 year's RSV season. Although Edwards declared supply has since caught up with demand in her healthcare system, the company has pledged to create more.

The other choice to safeguard infants is a vaccine that can be administered during pregnancy.

Together, Beyfortus and the vaccine have had a noticeable impact. A CDC study published in March discovered that RSV-associated hospitalization rates in infants under 7 months during the 2024-25 season were lower than rates in seasons where these prevention measures were unavailable.

Edwards hopes parents will protect their infants in the upcoming RSV season. "Every RSV season drains us completely," she stated. "This should theoretically empty us out, if we have good uptake."

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